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FDA to tighten regulatory process around CBD food & supplements

CBD Products food and supplements

Introduction:

The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling supplements containing CBD in the United States but they’re like to start issuing more warning letters when drug claims are made.  With the FDA enforcement of CBD supplements being like pet supplements the FDA is concluding that the existing regulatory framework isn’t appropriate for CBD supplements.

The cannabidiol (CBD) product market has seen accelerated growth in 2022, leading FDA to take a closer look at the regulatory pathways.  They’ve since concluded that a new pathway for CBD is required to balance risks and desire for CBD products.  While working with Congress to adjust regulations they’ve decided to deny petitions/rulemaking for marketing CBD products as dietary supplements.

The various usages of CBD (safety concerns):

Studies have shown that long-term usage of CBD has the potential to harm your liver, and the male reproductive system and interact negatively with various medications. CBD exposure can hurt young children and pregnant women.  The new impending regulatory pathway would aim to benefit consumers by providing safety measures to minimize risks.  This could be carried out by; CBD content limits, measures, minimum age requirements, prevention of contaminants, etc.  The current authorities have very limited tools for managing the risks of CBD products and health officials plan to change that.

CBD impact on animals (pet supplements)

CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk, and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.

What do the FDA officials have to say?

“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” FDA Principal Deputy Commissioner Janet Woodcock said.

“A new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” the agency said.

Conclusion:

Although as of January 26th, 2023, the FDA said that it doesn’t intend to make any new guidance related to CBD, they may have to depend on how effective the framework proves to be once it’s created.  Having mainly focused on unsubstantiated health claims of food/beverage and supplements in the past it will be interesting to see how they approach creating a regulatory framework for CBD.

The FDA has stated that the available data didn’t show how CBD products could meet the standards of safety for animal food substances and didn’t intend to provide new rules for its use in human or animal foods.

How Quality Smart Solutions can help:

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, dietary supplement compliance, NHP compliance, and food labeling projects. Our specialists are here to help with the following services; Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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10 tips to Prepare for the Safe Food License Application Process

A safe food license is an essential part of any credible food business and understanding the application process is key. Learn how to prepare for it now!

Introduction:

There are many reasons that you might want to get licensed as a food processor or retail operator. You might be interested in expanding your business, or you might want to make sure that your food safety program is compliant with new regulations. Regardless of the reason, it’s important to know what you’re getting into and how much time it will take before you start applying for a license under Canada’s Safe Food for Canadians Regulations (SFCR).

A safe food for Canadians (SFC) license is essential for any credible food business. The process of obtaining a license can be complex and time-consuming, so it’s important to understand what steps you need to take to prepare for it and ensure your business meets all the necessary criteria.  In this blog, we’ll provide you with suggestions to help you prepare for the Safe Food for Canadians License application process.

1.     Set your goals.

The first step in the process of applying for a food license is to set goals. What are you trying to accomplish? What do you hope to achieve? How will this license help your business succeed, and what does that mean for you?

When thinking about your goals, it’s helpful to consider the end goal: what kind of restaurant do you want your establishment to be? Do you want it to be a place where people come in and get a quick bite before they run out the door again or are they going to sit down and enjoy their meal as part of an evening out with friends at one of the best restaurants in town? Your answers here will help guide how much time and energy should be spent on pursuing any number of different licenses.

2.     Do your research.

When you’re preparing to apply for safe food for Canadians license, it’s important to do your research. There are plenty of ways to find out more about the regulator and their guidelines:

  • Check their website. Every regulator will have information on their website regarding how to apply for a safe food license or how to become a member of the industry association in your province/territory. This will give you an idea of what is expected from you during the application process and where you can go for help if necessary.
  • Look through local papers and social media channels like LinkedIn or Facebook groups where other food businesses can share advice on how they got through this process successfully (or not).
  • Talk with other people working in your field who may have already applied for a safe food license with another government department or authority in another part of Canada—they may be able to offer valuable insights into what makes that jurisdiction so different from yours!

3.     Study the regulations.

You should start by learning about the regulations that govern your industry, which you can do by reading through the relevant sections of your provincial or local government’s website. Make sure to review all of the requirements for applying for a license and then check that you understand them before starting your application.

4.     Check if you need a Safe Food License.

You can also check if you need a Safe Food License by checking the list of requirements for your business. There are two ways to do this:

5.     Gather Your Documentation.

Before applying for safe food for Canadians license, it is important to gather all the documentation you will need as part of the application process. This includes information about your business and products, proof of insurance, and any other certifications or licenses that may be required. Additionally, make sure you have up-to-date food safety documentation on hand. Having all of this information at hand will help expedite the application process and ensure you are following the proper procedures.

6.     Make Sure Your Food Safety Plan Is Up to Date.

An integral part of the safe food for Canadians license application process is having an up-to-date food safety plan. This will help you demonstrate to regulators that your business is following current best practices in terms of food handling and preparation. Your food safety plan should outline steps taken to prevent contamination and set clear guidelines for employees when it comes to hygiene and sanitation.

7.     Have a Plan for Testing and Record Keeping.

Testing and record keeping are crucial parts of the food safety plan. This helps ensure that you have evidence to demonstrate to regulators that your business is taking proper precautions about food safety. Regularly test products during all stages of processing and handling, as well as any equipment for potential contamination. Record results in a log and have it available for review by regulators when requested.

8.     Prepare for the Inspector’s Visit.

An inspector may request to visit your site or review your food safety plan before a final license is approved. Before they come, make sure your facility is clean, organized, and up to health standards. Have all of the paperwork necessary for the inspection on hand, as well as relevant certificates from the government or your suppliers. Be prepared to answer any questions regarding your plan so you can show them why you should be approved for a safe food license.

9.     Complete these activities before applying for a Safe Food License:

Make a list of activities that need to be completed before you apply for a license under the Safe Food for Canadians Regulations (SFCR). These are the preliminary steps you must complete to ensure that your application is complete and compliant.

Example:

  • Reviewing food safety program requirements and completing an internal audit of systems to determine what areas need improvements or changes. You will also want to consider how much time it will take for staff members who are currently responsible for preparing food to learn about new processes, as well as those who will be responsible for conducting audits, inspections, and reviews.

10.  Show What You Know about Food Safety.

You will need to demonstrate you are knowledgeable about food safety regulations and that your establishment meets the requirements. Be sure to thoroughly research all applicable food safety requirements in your area, so you know the best practices for keeping food safe and healthy and how they should be applied to your premises. Understanding everything related to food safety not only helps with license approvals but also proves you are devoted to offering high-quality, safe products to customers.

How can we help?

Now that you know how important it is for someone else besides yourself to handle this process, what can our experts do exactly? The most important thing is that our consultants will look over all of your application materials thoroughly and make sure everything is up-to-date (guiding you on how to best update things). Then based on their expertise in food safety law, regulations, and standards set by governing bodies like the Canadian Food Inspection Agency (CFIA), etc., we’ll ensure everything looks good from both an internal perspective within your business as well as externally—from a regulatory standpoint.

How We Can Help

Our Experts at Quality Smart Solutions offer support with understanding the Safe Foods for Canadians Regulations and applying for the SFCR License.

Contact us today to learn more about how we can support your food compliance needs during and after licensing!  Our services include; label compliance, french translation, Nutrition Facts Table Creation, TMA License, Novel Food Notification, HACCP/PCP Setup, and FDA compliance services.

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FDA Proposes New Rule for Investigational New Drug Applications (IND)

Introduction:Investigational New Drug Applications (IND)

The FDA recently announced a proposal to change the current regulations for Investigational New Drug (IND) applications. The proposal includes two exemptions from IND requirements for clinical trials involving lawfully marketed foods (including functional foods and dietary supplements) and cosmetics when they are being studied for use as drugs.

In this blog, we will aim to unpack the key highlights of the FDA’s proposal on IND applications but if you wish to read the full proposal to learn about the clinical investigations, exemptions, and more click here.  If you want to submit a comment to the FDA after reading this proposal you can make comments until March 9th, 2023.

IND Application Background:

The purpose of an IND application is to help ensure the safety and rights of clinical trial participants are protected, as well as to ensure the quality of data is adequate to allow evaluation of the safety and effectiveness of a drug seeking marketing approval.

What is the proposal’s purpose?

  1. Firstly, to help speed up clinical trials involving legally marketed foods and cosmetics by removing them from the IND pathway.
  2. Additionally, to help incur cost-saving benefits by reducing the number of IND applications filed with the FDA.

Looking for Investigational New Drug Applications regulatory assistance?

There were 2 exemptions proposed:

  1. Self-determined exemption: Food or cosmetics would be exempt from IND requirements if the following requirements were met:
  • The investigation is not intended to support a drug development plan, including a future IND or application for marketing approval.
  • The investigation is conducted in compliance with an institutional review, informed consent, and commercial distribution of investigational drugs:
    • Meeting with the requirements for institutional review in 21 CFR Part 56and the requirements for informed consent in 21 CFR Part 50; and
    • Meeting with the requirements of 7.
  • The route of administration is the same as that of the lawfully marketed product.
  • The investigation meets the following participant health, safety, and welfare requirements:
    • No participants below 12 months.
    • No pregnant or lactating mothers.
    • No participants with compromised immune systems.
    • Does not restrict participants from taking a prescribed therapeutic.
    • Does not increase risk beyond routine physical or psychological evaluations or standard of care procedures.
    • The product is being used in a way that is consistent with its labelled conditions of use.
    • No other product taken by or used to treat subjects during the investigation would significantly increase the risks (or decrease acceptability of the risks) encountered in the investigation.
    • There were no participants with weakened immune systems.
    • Participants are not prohibited from taking a prescribed therapeutic.
    • Increases risk in addition to routine physical or psychological evaluations or standard of care procedures.
    • The product is being used in accordance with its labelled conditions of use.
    • No other product taken by or used to treat subjects during the investigation would significantly increase (or decrease acceptability of) the risks encountered.
  1. FDA-determined exemption: While some products may not meet all the safety-related eligibility requirements for the self-determined exemption, the FDA may conclude that the study does not pose a significant risk to participants’ health, safety, or welfare. To qualify for the FDA-approved exemption, products must meet the following criteria:

*The product must be legally marketed as a Food or Cosmetic in the United States.

  • The FDA would require a copy of the study protocol, which would include the following information: design and duration.
  • Endpoints that have been proposed.
  • The study population, as well as the inclusion and exclusion criteria.
  • Description of the investigational product, including all ingredients, formulation, and labelling information.
  • The dosage form and regimen.
  • Administration path.
  • Examine the procedures.
  • In the event of an adverse/serious adverse event, the protocol is altered.
  • Provide evidence that the investigational product does not pose a significant risk to:
  • Participants must be less than 12 months old, pregnant, or lactating.
  • Participants with weakened immune systems or who suffer from serious or life-threatening diseases or conditions.
  • If participation necessitates the discontinuation of therapy or treatment prescribed by a healthcare provider.
  • If the study procedures put participants in greater danger than they would normally face during routine physical or psychological evaluations or standard-of-care procedures.
  • If the proposed conditions of use of the product in the investigation differ from the labelled or usual conditions of use of the product.
  • If the investigational product is used in conjunction with other medications or treatments that a subject is taking or receiving,
  • If the investigational product is being used concurrently with other products that a subject is taking or being treated with, either as part of the study or as prescribed or recommended by a healthcare provider outside the study.

How Quality Smart Solutions can help

The experts at Quality Smart Solutions can support your compliance needs with National Drug Code Labeler Registration, drug label compliance, US agent service, facility registration/renewal, and US Drug Listing (DRLS) in North America. Contact Quality Smart Solutions today! We can help.

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Clearing Regulatory Hurdles with a 510K Premarket Notification

510K Premarket Notification

 

Submitting a 510 K Premarket Notification is an essential step in the process of getting medical devices approved by the FDA. This notification includes detailed information about the device and its intended use and data regarding safety and efficacy. Learn more about the procedure for submitting a 510 K Premarket Notification here.

What is a 510 K Premarket Notification?

A 510 K Premarket Notification is a type of federal regulatory filing that must be completed before the FDA will approve the marketing of any medical device in the United States. This notification must include extensive information about the device, its intended use, and how it works. Companies need to make sure their 510 K submission includes all the necessary components before submitting it to the FDA, as incomplete or incorrect filings can cause delays in the approval process.

When Should Companies File a 510k premarket notification?

Companies should submit the 510 K Premarket Notification as soon as they know that their product meets the criteria for medical device clearance. It’s important to note that some devices may require multiple filings or additional components like clinical studies. Companies should consider submitting their notification at least six months before marketing their product, allowing time for FDA review and approval.

How to Prepare and Submit the Notification?

A 510 K Premarket Notification consists of two parts: an Executive Summary and a Technical Document. The Executive Summary will provide the FDA with an overview of the medical device and will also include statements on how it meets the pre-defined criteria for submission. The Technical Document should include a detailed explanation of the design, performance, labeling, and quality of the device. Companies can work with regulatory consultants to ensure the submission is complete and accurate before submitting it to the FDA for review.

Benefits of Submitting a 510 K (PMN)?

Submitting a 510K Premarket Notification can help to reduce regulatory complexity and simplify the process of getting necessary FDA clearance for a medical device. It also helps speed up the timeline, as the FDA can review medical device applications more quickly with the information provided in the submission package. Submitting a 510K PMN allows organizations to gain an understanding of any potential risks associated with their product and make changes before launching it on the market.

Know the Time Frame for the submitted 510k PMN?

Most 510K submissions take 90-120 days for FDA approval. However, different factors can influence the speed of the process such as the complexity of the device, amount and quality of supporting information, type of product, and submission medium used. It is important to determine how long it typically takes before beginning the process to ensure that you work with realistic timelines and expectations.

 

 

Tips to Successfully Navigate Through the FDA’s Medical Device 510(k) Submissions:

Submitting a 510(k) application to the FDA for your medical device can be a stressful and complicated process. Luckily, there are a few tips and tricks you can use to make the submission process easier and increase the likelihood of your device being approved. Here are helpful steps to help you get your device cleared by the FDA.

Collect Device Information and Data:

Before you can prepare your application, you’ll need to collect all of the relevant device information and data. This includes technical documentation such as user manuals, drawings, Schematics, and specifications. You should also provide safety and performance testing results (if applicable) as well as supporting clinical research or studies that validate the use of your device. Make sure to submit up-to-date documents so that the FDA gets an accurate picture of your device.

Understand FDA Requirements for a 510(k):

Before you can submit your Medical Device 510(k) application to the FDA, it is important to understand the FDA’s requirements and guidelines. Applications must include detailed information about your device, such as its intended use and components so that the FDA can assess whether or not it meets all applicable safety and performance standards. Additionally, complete and accurate labeling with clear instructions for use should also be provided. This information will help the FDA evaluate your device before approving it.

Formulate Your Submission Plan:

Creating a comprehensive plan will help you map out the steps required to successfully apply. This includes gathering all relevant device data, test results, and safety reports; determining any applicable FDA regulations and standards; and planning review and submission timelines. Additionally, if your device is being marketed internationally, it is important to familiarize yourself with the requirements in those countries so that you can ensure that your device meets all necessary criteria.

Create an FDA Regulatory Strategy:

When submitting a 510(k) application, it is important to create a regulatory strategy. This should include identifying any applicable FDA regulations and standards that your device needs to meet, as well as understanding the specific requirements for your type of product. Additionally, you will need to determine the most suitable submission process and pathway, such as traditional or abbreviated 510(k), Special 510(k), or notified body review/certification. Knowing which pathway works best for your device will ensure a successful and timely submission.

Compile your Test Results and Supporting Documentation:

Your 510(k) application will likely need to include a considerable amount of supporting documentation, such as full product specifications, results from preclinical testing, and comprehensive safety and performance data. These must be sourced, detailed, and organized into the submission package. This is one of the most important steps when submitting a 510(k) application as you must compile all relevant test results and device information that proves the safety and efficacy of your device before approval.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information: 

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The 12 Steps of HACCP & 7 Principles of HACCP License (Plan) Development

The purpose of a Hazard Analysis Critical Control Points (HACCP) plan is to identify and control any hazards that may arise during the process of manufacturing, storing, distributing, and consuming food products. HACCP plans are meant to reduce, eliminate, and avoid risks that may negatively impact the consumer and the organization. They will vary based on the product, process and other factors that can occur in the facility. Developing a HACCP plan consists of 12 tasks with seven principles, which are further explained below.

1. Establish a HACCP Team

The HACCP team consists of individuals possessing a wide range of disciplines and knowledge to contribute to the process of food safety. A typical team includes:

  • Team Leader: orchestrates and organizes the planning process; identifies the scope and specific problem(s) of the plan.
  • Specialist(s): provide consultation and formulation of the plan through their expertise and knowledge.
  • Front Line Staff: includes farmers, distributors, processors, etc.; have in-depth perspective on creating the food product.
  • Stakeholders: e.g. consumers, board of directors, departments, etc.

2. Describe the Product

A full description of the final product should have the following elements in order for the HACCP team to identify hazards in creating the product:

  • Ingredients, and their characteristics;
  • Formulation (aka “recipe”) of the product;
  • Process of packaging, storing, and transporting;
  • Shelf life.

3. Purpose of the Product

The team determines the main intent of how the product will be used. Will it be cooked, eaten directly, or require further processing? The team needs to identify its intended consumers and determine any vulnerabilities when using the product.  Lastly, the team should consider the effects of misuse or abuse of the product to the general population.

4. Process Flow Diagram

A process flow diagram gives the HACCP team a broader view on the manufacturing process of the product. The diagram can also consist of a schematic of the facility, lending an easier understanding of the steps of each process.

5. On Site Confirmation of Flow Diagram

The HACCP performs a review of the operating/manufacturing process to determine the quality of the flow diagram. Multiple reviews can be done and compared to iron out deficiencies in the process.  The site for which the HACCP plan is being designed should be visited as many times as possible to make sure all relevant information is collected.

6. Identify and analyze hazards (Principle # 1)

While identifying potential hazards, the HACCP team must do some background research on the following:

  • Ingredients and materials used in the product
  • Activities performed in each step of the manufacturing process
  • Method of storage and distribution
  • Use/consumption of product

During analysis, the HACCP evaluates the product’s effects on human, environmental, and organizational interaction.

Control measures are considered once hazards are identified and analyzed during the manufacturing process. At times, organizations may have to hire external food safety consultants to offer different perspectives.

7. Determine the Critical Control Points (CCPs) (Principle # 2)

A critical control point is a step in the process flow diagram that involves reducing, eliminating, and preventing food safety hazards. If CCPs are not in place, the production will stop and cannot continue further.

8. Establish Critical Limits for each CCP (Principle # 3)

A critical limit measures the maximum/minimum value of certain factors that have impact on reducing, preventing, and eliminating food safety hazards. Factors such as temperature, time, moisture level, and visual appearance are considered.

9. Establish a Monitoring Procedure (Principle # 4)

A general monitoring procedure consists of:

  • Ensuring critical limits of each CCP are being met;
  • Detecting any inefficiencies of the control measures;
  • Corrective actions need to be taken as quickly as possible to avoid and minimize loss of the product;
  • Observing or measuring samples using a statistically-based sampling plan;
  • Common measurements taken are time, temperature, moisture, and content.

10. Establish Corrective Actions (Principle # 5)

Corrective actions must be taken immediately if critical limits are not being met. Management and employees should be trained on how to perform and respond appropriately.

11. Verify the HACCP Plan (Principle # 6)

Once the plan is drafted and CCPs have been validated, the HACCP plan can then be verified. The team must evaluate if CCPs and control measures are effective. Internal auditing may be required to demonstrate ongoing commitment to complying and updating the HACCP plan. Asking questions, observing operational procedures, and collecting samples are just some of the ways to verify the plan.

12. Keep Records (Principle # 7)

Record keeping is an essential step of the HACCP plan due to the following:

  • Offers traceability and transparency
  • Ensures due diligence
  • Provides record of complaints with critical limits set
  • Identifies potential problems

Record keeping can be carried out in a number of ways, such as checklists or control charts. Manual and computer records are acceptable, but the documentation method should be designed such that it is appropriate for the size and nature of the organization.

If you or your company is seeking assistance in implementing a HACCP plan we’re ready to serve you.  Quality Smart Solutions has a team of experts who can implement a HACCP plan, coach and train your staff. Get prepared now and contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 14 years in the areas of compliance and quality assurance for Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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FTC guidance for sellers & marketers of Health Products Unlocked

FTC Health Products

Introduction:

In this blog, we’ll aim to summarize the principles that help advertisers comply with FTC laws (deceptive claims/facts) for OTC drugs, food, homeopathic products, supplements, health equipment, and more.

Overview of Regulatory Framework: FTC Authority over Advertising Health Products:

The responsibility of the Federal Trade Commission (FTC) is to prevent unfair/deceptive acts and practices in marketing or selling health-related products.  To summarize:

  1. Advertising must be truthful and not misleading; and
  2. Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims conveyed, expressly or by implication, to consumers acting reasonably.
  3. “Advertising” refers to a wide variety of marketing techniques (social media, digital content, brochures, influencer marketing, etc).
  4. Anyone participating in deceptive marketing is potentially liable under FTC law.
  5. The FTC can seek a variety of remedies for deceptive advertising up to legally bringing courts in to ban companies from certain activities.

Coordination between the FTC and FDA:

The FTC and the Food and Drug Administration (FDA) share jurisdiction over the marketing of dietary supplements, foods, drugs, devices, and other health-related products. The agencies coordinate their enforcement and regulatory efforts under a Memorandum of Understanding – often called the “FDA-FTC Liaison Agreement” – that governs the basic division of responsibilities between them. The FDA has primary responsibility for claims that appear in labeling, including the package, product inserts, and other promotional materials available at the point of sale. The FTC has primary responsibility for claims in all forms of advertising. Due to the shared jurisdiction, the two agencies work closely to ensure that their enforcement efforts are fully consistent and feasible.

What are the differences between the FTC and FDA Laws?

While both the FTC and the FDA require truthful and accurate marketing of dietary supplements and other health-related products, there are some key differences in the agencies’ legal frameworks and approaches that marketers should be aware of.

  • FTC advertising law applies to all products and claims
  • The FTC doesn’t pre-approve “health” claims, as that term is defined by FDA labeling laws
  • The FTC doesn’t require notification for “structure/function” claims

How to apply FTC law to advertising Health-Related Products:

To determine whether advertising complies with FTC law, it is necessary to first identify all claims communicated to reasonable consumers through advertising materials. Once the claims are identified, the FTC evaluates the scientific evidence on which the company relies to determine whether the claims are adequately supported. We can assist you by helping you;

  1. Identify Claims and Interpreting Ad Meaning Express and Implied Claims
  2. When to disclose qualifying information
  3. How to disclose clearly

How to substantiate health-related product claims?

Marketers must ensure that their claims are adequately supported in addition to conveying them clearly and accurately. Advertisers must have a reasonable basis for their product claims under FTC law before running an ad. What constitutes a reasonable basis is highly dependent on the claims made, how they are presented in the context of the entire advertisement, and how they are qualified. The FTC’s substantiation standard is stringent, especially when it comes to health claims. It is intended to give consumers confidence in the accuracy of information presented in advertisements. A variety of factors influence the amount and type of substantiation required, including:        

Need help with NHP or Dietary Supplement FTC-FDA compliance of Health Products

  1. The type of product
  2. The type of claim
  3. The benefits of a truthful & cost or feasibility of developing substantiation for the claim
  4. The consequences of a false claim
  5. The amount of substantiation that experts suggest is reasonable

Claims based on traditional use:

Several health-related products, such as botanical supplements, homeopathic medicines, and other alternative products, have a long history of use as traditional medicine in the United States or elsewhere to treat specific conditions or symptoms. Under FTC law, claims for products based on traditional use must be substantiated with competent and reliable scientific evidence, just like any other product.

At the same time, FTC law does not prohibit advertising that is sufficiently qualified to be truthful and not misleading. Advertising that merely describes the traditional or historic use of a product and is carefully qualified to avoid any misleading implications about the product’s efficacy or health benefits may be permissible.

Avoid Misleading Messages in your Health Product labeling:

To avoid communicating a misleading message about the product’s efficacy or the scientific basis for any health benefit, an advertiser who wants to describe a product’s historic or traditional use should take the following steps: Guidance for Health Product Compliance

⊲ The advertiser should identify the historic or traditional use and make sure that its product is consistent with that use – for example, that it contains the same ingredients and formulation, the same strength or dose, the same form of administration, and the same indications for use. If there is a significant difference between the traditional use of the product and the marketed product, a “traditional use” claim isn’t appropriate. ⊲ A claim that suggests a health-related benefit for which there isn’t competent and reliable scientific evidence must communicate the lack of scientific evidence. To avoid any deceptive implication, a disclosure that there is no scientific basis for the traditional use should stand out and be near the claim. To be effective, it may need to be incorporated into the claim.

⊲As with all claims, marketers shouldn’t undercut a disclosure about the lack of science with additional positive statements, consumer endorsements, images, or other elements of the ad suggesting the product is effective.

⊲ Given the inherent difficulty of discussing the traditional use of a product while also effectively communicating that there is no scientific basis for its efficacy, an advertiser should consider conducting a copy test or other consumer research to confirm that consumers understand the limited nature of the claim. The FTC will look closely at how consumers perceive a traditional use claim and whether they assume the claim means the product is effective and backed by more evidence than the marketers have. An ad that, despite a disclosure, conveys more substantiation than a marketer has, is deceptive.

The Quality of the Evidence:

The scientific community has generally accepted several basic principles as enhancing the validity of test results. Whether designing and conducting their research or relying on research conducted by third parties, marketers should ensure that the research upon which they rely for any health-related claim complies with these basic principles.

  1. Control Group
  2. Randomization
  3. Double Blinding
  4. Statistically Significant Results
  5. Clinically Meaningful Results

Other Advertising Issues:

In addition to the principles of ad meaning and substantiation discussed above, several other issues commonly arise in the context of health-related advertising. These include the use of consumer testimonials and expert endorsements; claims based on alternative medicine or traditional use; the effect of DSHEA disclaimers in advertising; claims about FDA approval or compliance; and the relevance to FTC advertising law of the FDA’s “third-party literature” exemption.

  • Claims based on consumer testimonials or expert endorsements
  • Claims based on traditional use
  • Use of the DSHEA Disclaimer in advertising
  • Mischaracterizations of FDA Approval
  • Third-party literature

Conclusion:

Marketers of health-related products, including dietary supplements, should be familiar with FDA and FTC requirements that labeling and advertising claims be truthful, not misleading, and substantiated. In general, the FTC requires that health-related claims be supported by competent and reliable scientific evidence proving that the representations are true. Marketers of any health-related product should take two important steps to ensure FTC compliance:

1) Consider what explicit and implied messages your advertisements are likely to convey to consumers.

2) Carefully review the support for each claim to ensure it is scientifically sound, adequate, and relevant, and qualify your claims as needed.

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FDA GRAS Notice | FDA GRAS Database Unlocked

FDA GRAS Notice | FDA GRAS Database Unlocked

Introduction

Like most food businesses, you probably spend a lot of time thinking about what’s in your food and how to ensure it’s safe. One of the ways you can do this is by checking the FDA GRAS (Generally Recognized as Safe) database.

This database is a compilation of food substances/ingredients that have been found to be safe for human consumption. This means that when you see a food listed on the FDA GRAS Database, the Food and Drug Administration has determined that the food is generally considered safe for human consumption.

We will walk you through the process of accessing the FDA GRAS Database and show you some of the food substances that are currently listed.

What is an FDA GRAS Notice?

The FDA GRAS Notice is a formal notification from the FDA declaring that a food or food substance/ingredient is generally recognized as safe. The database of FDA GRAS Database can be accessed online here.

This database can be useful for scientists and researchers who are interested in determining if a particular food substance is safe to use in a food product or recipe during product development stages. It can also be used by manufacturers to determine which additives may be safely included in their products.

GRAS Notification Process:

The Food and Drug Administration (FDA) notifies the public of a food substance that has been determined to be Generally Recognized As Safe (GRAS). The GRAS notification dossier process follows a specific, standardized template that is published on the FDA’s website.

Food manufacturers must submit an application containing information about the food substance, as well as evidence that it is safe for use. Manufacturers can also request emergency approval if the substance is new and has not been previously tested by the FDA. After reviewing the application, the FDA will either issue a GRAS notification or determine that further safety testing is necessary.

If the substance is already listed in the FDA’s GRAS database, manufacturers do not need to submit an application or provide additional evidence. However, they must still follow all other applicable regulations when using this substance in food products.

How to use the FDA GRAS Database?

The Food and Drug Administration (FDA) GRAS Database is a searchable database that lists all of the food ingredients that have been determined to be GRAS by the FDA. This database can be used to determine if an ingredient is safe for use in your food products. The database can also be used to find out if an ingredient has been recalled or is under investigation by the FDA.

To access the GRAS Database, visit the FDA website. On the main page, click on “Searching For Information” in the left-hand navigation bar. In the search field, type “GRAS” and click on the “Search” button. The GRAS Database will appear at the top of the results page.

To learn more about how to use the GRAS Database, please review our blog post entitled “How to Use the FDA GRAS Database.”

FDA GRAS lists essential oils:

The FDA has updated its website to include a list of essential oils that are GRAS (Generally Recognized as Safe) according to the FDA. The essential oils on the list have been deemed safe by the FDA and they do not believe there to be any harmful effects associated with using these essential oils.

Some of the essential oils that are on the GRAS list are lavender, peppermint, thyme, rosemary, and chamomile. It is important to remember that these essential oils are only considered safe if used in accordance with the instructions on the bottle or package. If you are pregnant or breastfeeding, it is always best to speak with your doctor before using any type of essential oil.

FDA GRAS:

Until recently, the identities of many food additives were a closely guarded trade secret. But with the passage of the Food Quality Protection Act (FQPA) in 1996, this policy changed. Now all food additives must be listed in the Federal Register and be subject to public review and comment. This open process allows consumers and other interested parties to learn about potential hazards and health concerns associated with these ingredients.

Foods that contain GRAS substances are not required to disclose their contents, but they are still subject to regulatory scrutiny. In March of this year, FDA released its GRAS Notice database, which provides detailed information on more than 1,500 GRAS substances currently used in foods. This expansive database will help ensure that foods containing these ingredients are safely consumed by Americans.

The release of this database is an important step in ensuring that Americans have access to safe and healthy foods. By publicly disclosing the ingredients used in American food products, FDA is ensuring that consumers can make informed choices about what they eat.

Conclusion:

The FDA GRAS Database is a compilation of food substances/ingredients that have been found to be safe for human consumption. This means that when you see a food substance or ingredient listed on the FDA GRAS Database, the Food and Drug Administration has determined that the food is generally considered safe for human consumption.

The FDA GRAS Database is a useful tool that can be used by industry and consumers to determine the safety of food and food substances.

How Quality Smart Solutions can help:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health and the environment. If you want to learn even more, reach out to us today!

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labelling projects. Our specialists are here to help with the following services; Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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FDA Dietary Supplements Labeling Requirements in the USA

FDA Dietary Supplements Labeling Requirements in the USA

Introduction:

The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers issues such as Supplement Facts Panel (SFP) labeling, ingredient labeling, and health claims.

In the USA, there are strict requirements for supplement labels. The FDA (Food and Drug Administration) requires all supplement labels to list the following: • Supplement name • Net quantity of contents • Direction for use • Warning statements if any • Supplement Facts Table • List of ingredients. All of this information must be displayed clearly and concisely.

You must comply with all the requirements if you want to do business in the USA, otherwise, the FDA may issue you a Warning Letter.

If you are unsure how to comply with these requirements, you can always consult a professional consultancy service, such as Quality Smart Solutions.

What is a dietary supplement?

A dietary supplement is a product that contains nutrients derived from food sources that are intended to supplement the diet. The most common type of dietary supplement is a vitamin or mineral supplement, which can be used to treat deficiencies or prevent health problems. Other types of dietary supplements include protein supplements, omega-3 fatty acid supplements, and herbal supplements.

Dietary supplements may be found in many forms, such as pills, tablets, capsules, gummies, soft gels, liquids, and powders. They can also be in the same form as a conventional food category, such as teas or bars, but only if the product is not represented as a conventional food or as a “sole item of a meal or the diet.” To be a dietary supplement, a product must also be labeled as a dietary supplement; that is, the product label must include the term “dietary supplement” or equivalent (e.g., “iron supplement” or “herbal supplement”).

Dietary supplements are not meant to replace food or medicine. They should be used as part of a healthy lifestyle.

What are the labeling requirements for dietary supplements?

In order for a dietary supplement to be sold in the USA, it must comply with the FDA’s labeling requirements. These requirements are designed to ensure that consumers can make informed decisions about the supplements they purchase and to protect them from products that may be harmful.

Dietary supplements in the USA must be properly labeled according to the FDA’s requirements. The label must include the supplement’s name, net quantity of contents, list of ingredients, and the manufacturer’s or distributor’s name and address.

Additionally, the label must state any warnings or precautions associated with the supplement.

Need help with your dietary supplement labeling?

What information must be included on the supplement label?

All dietary supplements must be labeled with the following information:

  • The product’s name/identity and contact information for the manufacturer or distributor
  • The term “dietary supplement” or equivalent on the principal display panel
  • A list of all ingredients
  • The recommended dosage
  • Net quantity of contents
  • Nutrition labeling/Supplement Facts Panel
  • Any warnings or precautions associated with the product
  • The expiration date or “best before” date

Who is responsible for ensuring that dietary supplements are labeled correctly?

It is the responsibility of the supplement manufacturer to ensure that their products are properly labeled by American law. The Dietary Supplement Health and Education Act of 1994 (the DSHEA) defines what a “dietary supplement” is, and includes specific labeling requirements for dietary supplements, as well as optional labeling statements.

The FDA recommends that consumers consult a healthcare professional before taking any dietary supplements, especially if they have pre-existing health conditions.

Supplement Facts Panel (SFP):

The nutrition label for a dietary supplement is called a “Supplement Facts” panel. The major differences between the “Supplement Facts” panel and the “Nutrition Facts” panel are as follows:

  • You must list dietary ingredients without Recommended Daily Intake (RDIs) or Daily Reference Values (DRVs) in the “Supplement Facts” panel for dietary supplements. You are not permitted to list these ingredients in the “Nutrition Facts” panel for foods.
  • You may list the source of a dietary ingredient in the “Supplement Facts” panel for dietary supplements. You cannot list the source of a dietary ingredient in the “Nutrition Facts” panel for foods.
  • You are not required to list the source of a dietary ingredient in the ingredient statement for dietary supplements if it is listed in the “Supplement Facts” panel.
  • You must include the part of the plant from which a dietary ingredient is derived in the “Supplement Facts” panel for dietary supplements. You are not permitted to list the part of a plant in the “Nutrition Facts” panel for foods.
  • You are not permitted to list “zero” amounts of nutrients in the “Supplement Facts” panel for dietary supplements. You are required to list “zero” amounts of nutrients in the “Nutrition Facts” panel for food.

You must list the names and quantities of dietary ingredients present in your product, the “Serving Size” and the “Servings Per Container.” However, the listing of “Servings Per Container” is not required when it is the same information as in the net quantity of contents statement.

What are the penalties for mislabeling dietary supplements?

The penalties for mislabeling dietary supplements in the USA can be severe. The FDA generally issues warning letters if companies are illegally marketing dietary supplements. If the warning letter is not addressed or acknowledged, more severe compliance and enforcement steps can be taken.

Prohibited Health Claims:

There are a few prohibited health claims that you cannot make when labeling your dietary supplement products in the USA. These claims are:

  • Claims that the product can cure, treat, or prevent any disease
  • Claims that the product can have an immediate or dramatic effect on the structure or function of the body
  • Claims that the product is completely safe and has no side effects

In addition, all health claims made on dietary supplement labels must be supported by scientific evidence. It means that you will need to do your research and have studies to back up any claims you make about your product.

Conclusion:

In conclusion, the FDA dietary supplement labeling regulations are very important to follow. They help ensure that your dietary supplement is safe for use.

The FDA’s dietary supplement labeling guide provides clear and concise requirements for supplement labels in the USA.

These requirements ensure that consumers can easily understand the key information about a supplement, including its benefits, risks, and how to use it safely.

By following these guidelines, manufacturers can provide consumers with the information they need to make informed decisions about their health and well-being.

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Global Food Safety Initiative (GFSI Certification) How to get GFSI Certified?

GFSI Certification Benchmarking Audit

The Global Food Safety Initiative: What You Need to Know:

The Global Food Safety Initiative (GFSI), founded in 2000, is an international collaboration among the world’s leading food safety experts and organizations. To ensure safe food worldwide, GFSI has developed a holistic approach to building consumer trust in the global food system by setting strict standards for food production, manufacturing, and distribution. Here, find out all you need to know about the initiative including its purpose, key principles, and how to become a member.

The Global Food Safety Initiative (GFSI) is a comprehensive food safety initiative that helps to ensure that only the safest and most high-quality products are being imported into the local market. It is also used to verify that these products are meeting the standards set by national laws and regulations. GFSI was established to ensure confidence in the delivery of safer food to consumers while continuing to improve food safety throughout the supply chain.

These global standards address food, packaging, packaging materials, storage, and distribution for primary producers, manufacturers, and distributors. GFSI Certification allows companies to gain access to new markets, improve their reputation, and add value through better quality assurance programs.

What is Global Food Safety Initiative?

The Global Food Safety Initiative (GFSI) is a global collaboration of food safety experts from the retail, manufacturing, and food service industries. GFSI’s primary mission is to provide a single, comprehensive approach for ensuring that internationally recognized food safety standards are consistently applied across all parts of the global food supply chain.

How Does GFSI Certification Work?

GFSI certification is a process carried out by certified organizations and specific auditors to ensure that proper safety measures are in place and followed at steps throughout the food supply chain. Companies that have achieved GFSI certification are required to submit their operations, quality systems, and production environments to third-party audits regularly to remain certified. The GFSI audit seeks to identify non-conformance of standards set by recognized industry sectors such as the Global Retailer Produce Group (GRPG)and Codex Alimentarius.

The Benefits of GFSI Certified Standards:

GFSI Certified Standards are among the most rigorous and comprehensive food safety requirements available, helping businesses ensure that their products meet safety and quality standards. Learn more about the benefits of GFSI Certification and how it can help your business maintain food safety.

Not only is GFSI recognition and certification beneficial to the supplier, but it also allows retailers and other food business owners to assure their customers that the food products purchased from them are safe for consumption. Additionally, GFSI certification reduces the chances of food product recalls due to safety concerns, which can cause significant financial costs to businesses in terms of lost sales and reputational impacts. Furthermore, obtaining GFSI certification helps businesses qualify for certain government contracts.

Requirements To Achieve Global Food Safety Initiative Certification:

To be recognized as a GFSI-certified supplier, businesses must demonstrate that their food safety measures are compliant with GFSI’s seven principles and regularly undergo assessment and auditing. The principles include food safety management procedures that should be implemented in production, pest management, product labeling, logistical control systems, sanitation operations, and recalls/withdrawals. Additionally, suppliers must have a comprehensive system of traceability in place to ensure easy one-step forward and one-step back tracing capabilities should a problem arise.

Understanding GFSI Certified Standards:

GFSI Certified Standards provide a comprehensive set of requirements and procedures for companies looking to demonstrate their commitment to food safety excellence. By demonstrating a commitment to these standards, businesses can improve operational efficiency, reduce product recalls and mitigate legal issues associated with food safety violations. Additionally, GFSI Certified Standards can attract new customers and open up new markets by showcasing that the company is serious about its food safety efforts.

Do I Need GFSI Certification?

It is not a legal requirement to have GSFI certification (ie. it is not required by the regulations) however it does have many benefits for the food industry and its consumers.

The following are some of them:

  • GFSI certification ensures that your product is safe to eat as it meets international standards of quality and safety, which is important for you as a manufacturer or seller in the global market;
  • For consumers, you can assure them that their food will be safe to eat because you have been certified according to international standards;
  • This also helps protect against counterfeiting since they know they are buying original products from reputable companies;

Is GFSI Certification Mandatory?

  • GFSI Certification is not a law.
  • There are no regulations that require GFSI certification.
  • GFSI is a voluntary food safety initiative and there are no legal or regulatory requirements for complying with the standard.

Why do some companies seek GFSI Certification?

GFSI Certification is a means for companies to demonstrate how they manage food safety. To become GFSI certified, a company must first have a food safety management system in place and then seek certification by one of the recognized bodies that offer the accreditation (e.g., BRC or IFS). Once certified, companies assure their customers that they are doing what is necessary to ensure the manufacturing of safe food products. In addition, they show their suppliers that they know what is needed to be globally competitive and efficient with multiple buyers.

Need help obtaining your GFSI certification or doing an audit.

Which Audits are considered Global Food Safety Initiative (GFSI) Recognized?

GFSI Recognized standards include:

  • FSSC 22000
  • SQF Code Edition 8
  • BRC Global Standard for Food Safety
  • BRC-IOP Global Standard for Packaging and Packaging Materials
  • IFS Version 6
  • CanadaGAP
  • Global Red Meat Standard (GRMS)
  • PrimusGFS Standard
  • IFS PACsecure Version 1
  • IFS Logistics Version 2.1

What is a GFSI Benchmarking Audit Scheme?

The GFSI Benchmarking Audit Scheme is a program that allows you to compare your food safety management system with other companies. You can then benchmark your food safety management system against the best practices of other companies and use this information to improve your food safety management system.

Achieving Global Food Safety Initiative (GFSI) Certification

GFSI Certification is not mandatory. It is not the only way to achieve food safety, nor is it required by any government agency anywhere in the world. The Global Food Safety Initiative (GFSI) certification process requires you to meet a series of requirements that are specific to your company while demonstrating your commitment to quality management systems.

To become GFSI certified, companies need to:

  1. Select a standard to become certified to
  2. Get trained on the requirements
  3. Implement a food safety management system and document your processes.
  4. Be audited by a certification body to receive your certification

Compliance and Market Advantages:

GFSI Certified Standards not only help ensure that a company is compliant with applicable food safety regulations and requirements but also provide many market advantages. By demonstrating a commitment to GFSI Certified Standards, businesses can attract new customers and open up new markets due to the reputation associated with certification. Additionally, certification can result in fewer product recalls, quicker responses to customer complaints, and lower costs associated with premium freight rates or insurance premiums.

Improved Manufacturing Procedures:

GFSI Certified Standards are in place to ensure that food safety meets the highest possible standards. As such, they require companies to adhere to improved manufacturing procedures, employ protocols like HACCP plans, and ensure that their facilities are constantly monitored to meet any updates or changes in industry standards. This helps to prevent potential breaches in protocol and ensures that all parties involved remain compliant.

Increased Consumer Confidence:

By securing GFSI certification, food producers can demonstrate their adherence to the highest safety standards possible. This increased level of trust helps to build consumer confidence and also gives retailers peace of mind knowing that they are providing safe and healthy products to their customers. Furthermore, certifications can help producers differentiate themselves in the marketplace, making it simpler for buyers to differentiate between certified-aligned or non-certified companies.

Conclusion:

At the end of the day, it all comes down to food safety. If you are interested in starting a new business or expanding an existing one, then we can help you achieve GFSI certification. It will give your business an edge over others by proving its commitment to quality control and ensuring that all products meet international standards for both safety and quality assurance.

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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FDA Prior Notice: When and How to Submit for Food Importers

Introduction

Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is imported into the United States. It ensures that the U.S. Food and Drug Administration (FDA) has the opportunity to evaluate the safety of a food shipment before it enters U.S. commerce and provides an opportunity for the FDA to inspect food products at their first port of arrival in the United States. In addition to protecting public health, prior notice allows FDA to reduce costs associated with detaining or refusing entry of potentially unsafe foods from entering U.S commerce

FDA prior notice food manufacturer importing

Submitting your FDA Prior Notice:

Prior Notice requires the submitter to provide certain information related to the food shipment to the FDA, including:

  • The name and address of the manufacturer, packer, or distributor
  • The name of the product
  • The quantity of each product being shipped
  • The anticipated arrival date of the shipment in the United States (or another applicable country)
  • Ports of entry through which the shipment will be imported into that country (e.g., “Port of Entry #1”) or another country relevant to a particular prior notice submission. This can be helpful if multiple countries are involved in your food importation process, and you wish to track your products as they move across borders—a very common situation for global brands selling products across continents!

Food Importers Submitting their FDA Prior Notice

The FDA has authority under section 801(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) to require that importers provide prior notice before the food product is imported into the United States.

  • The FDCA ensures that foods are safe for consumers by prohibiting adulterated foods from entering or being sold in interstate commerce, and by requiring all foods shipped in interstate commerce be labeled accurately.
  • The FDCA also requires that FDA inspects imported food products at ports of entry to ensure they are free from filth, pesticide residues, and natural or artificial poisonous or deleterious substances added after harvest but before such entry into the United States; do not contain any substance which renders it injurious to health; their labeling bears no false or misleading statement as defined in section 403(a)(1); have been processed in compliance with section 404; bear labeling information required by specific provisions of law set forth in 21 CFR 101-40.

Looking for help submitting your FDA prior notice or importing your food products?

When to Submit your FDA Prior Notices

Prior Notice submissions must be submitted at least 24 hours before the shipment arrives in the United States. The FDA allows Prior Notice submissions to be submitted any time after a transaction has been agreed upon but no later than two hours before the shipment arrives at its first port of arrival in the United States.

The FDA also requires that each shipment must be accompanied by a valid Prior Notice submission or it will be refused entry. Any importer or shipper can submit a prior notice on behalf of an importer, but they must have authorization from the foreign manufacturer or distributor and have access to certain information about their products, such as ingredient lists and country of origin. A complete list of the required information can be found in FDA’s guidance document which provides detailed instructions on submitting Prior Notice Submissions online through ACES (Automated Commercial Environment) via an eManifest system used by Customs & Border Protection (CBP).

How to Submit Prior Notice:

  • To submit a prior notice electronically, a submitter must use FDA’s Prior Notice System Interface (PNSi), which is available online. We recommend that you verify your submission information before submitting it to the FDA.

Can my Prior Notice Submissions be Refused?

If the FDA is not able to receive the information required by Prior Notice before a particular shipment of food arrives at its first port of arrival, the FDA may refuse entry of the food into the United States. It is important to note that in order for a submission to be considered “on-time,” the submission must be received by the FDA within 30 calendar days from when the product enters into U.S. commerce (i.e., when it is entered into any port).

Need Help Submitting your FDA Prior Notice?

In addition to webinars and videos, the FDA also offers a series of e-learning modules on Prior Notice for Human Food. The most recent module, “ePrior Notice for Human Food,” was released in 2017. The video explains what happens when a Prior Notice is missing and gives step-by-step instructions on how to file an effective Prior Notice submission. This includes providing details on how to create an electronic submission using the FDA’s eSubmitter tool and submitting it to the FDA through certain portals.

The video also covers common problems that are encountered when submitting a Prior Notice submission as well as ways to avoid them during submissions by giving best practices advice such as providing all required information upfront instead of waiting until after submission has been submitted before finding out missing data needs adding or updating later on down the road – something that could delay approvals unnecessarily due delays caused by rework efforts needed afterward!

Conclusion

In summary, the FDA expects a prior notice submission to be complete and accurate, as well as timely. This means submitting an appropriate quantity of information at the right time and in an approved format. If your company is required to submit a prior notice for food imports or exports and is not doing so consistently or accurately, you may be subject to enforcement action. Contact us today for more information!

How Quality Smart Solutions can help:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health.

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labeling projects. Our specialists are here to help with the following services: Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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GRAS, NDI, ODI, Food Additives & Food Classification Unlocked

Food Classification NDI, ODI, GRAS Food AdditivesIntroduction

Food classification is a tricky topic. There are so many different names for additives and preservatives, and it can be hard to keep track of them all. But that’s okay! The goal of this post is to help you understand the different types of food ingredients, food additives, and preservatives and what they do in food. It’s an important topic to understand because there are so many terms and acronyms! However, it’s critical to know what each term means because these ingredients can have a big impact on your health and the environment. So, let’s dive right in!

What Do GRAS, NDI, and ODI mean?

These terms can sometimes be confusing because they all have similar-sounding names.

GRAS stands for “Generally Recognized as Safe”, NDI stands for “New Dietary Ingredient” and ODI stands for “Old Dietary Ingredient”. To be used in conventional foods, ingredients must be classified as either GRAS, NDI, or ODI.

In this post, we will focus on the different types of food additives and preservatives which can be considered GRAS, NDIs, or ODIs. We’ll also be discussing what they do in food and how they can impact your health, as well as the environment.

What are Food Additives and Food Preservatives?

Food additives are used to improve the quality, safety, and longevity of foods by changing their color, flavor, or consistency. They may also be used to prevent spoilage (oxidation), reduce the microbial load, or improve the nutritional value of food products such as cereals or dairy products that have been processed using heat treatment technology (pasteurization).

Here is a list of the most common food additives:

  • Artificial sweeteners such as sucralose (Splenda), aspartame (Equal), and saccharin (Sweet’N Low)
  • Artificial colours (e.g. Red 40 dye)
  • Food preservatives like sodium benzoate or potassium sorbate used in wine production

Food Classification Complications:

You may have noticed that there are many different names for the same type of additive. For example, you might see “diglyceride” or “diglyceride esters” listed on a label and think they’re two different things when they’re the same thing. This is because FDA regulations allow manufacturers to use one name for an ingredient if it’s followed by another more specific type of name (e.g., shortening).

Another complication is that there are many types of food additives and preservatives, so knowing what each does can be confusing at first. Here’s a quick breakdown of some common categories:

  • Preservatives prevent spoilage from microorganisms such as bacteria and mold in foods like cheese or spices; examples include sodium nitrite/nitrate and calcium propionate/propionic acid.
  • Antioxidants help protect fats from going rancid (oxidizing) during storage; common ones include butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tertiary butylhydroquinone (TBHQ).
  • Stabilizers help keep ingredients mixed together so they don’t separate out over time; examples include carrageenan gum or xanthan gum.

How Are Additives and Preservatives Approved for Use in Foods?

Today, food and color additives are more strictly studied, regulated, and monitored than at any other time in history. FDA has the primary legal responsibility for determining their safe use. To market, a new food or color additive (or before using an additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first petition FDA for its approval. These petitions must provide evidence that the substance is safe for the ways in which it will be used. As a result of recent legislation, since 1999, indirect additives have been approved via a premarket notification process requiring the same data as was previously required by petition.

When evaluating the safety of a substance and whether it should be approved, FDA considers:

  • The composition and properties of the substance,
  • The amount that would typically be consumed,
  • Immediate and long-term health effects,
  • Various safety factors.

The evaluation determines an appropriate level of use that includes a built-in safety margin – a factor that allows for uncertainty about the levels of consumption that are expected to be harmless. In other words, the levels of use that gain approval are much lower than what would be expected to have any adverse effect.

Does FDA have databases for GRAS ingredients and Food Additives?

YES! The FDA’s Food Additives Status List, formerly called Appendix A of the Investigations Operations Manual (IOM), organizes additives found in many parts of 21 CFR into one alphabetized list.

The Food Additives Status List includes short notations on use limitations for each additive.

The Food Additive Status List omits certain categories of additives, such as those that are considered GRAS and are obviously safe substances. You may find such substances in the GRAS Notice Inventory on the FDA website.

How Quality Smart Solutions can help:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health and the environment. If you want to learn even more, reach out to us today!

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labelling projects. Our specialists are here to help with the following services; Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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FDA Food Safety Requirements FSMA Traceability BRC Standards

GFSI BRC FDA Food Safety

Introduction:

Meeting FSMA compliance requirements is one of the most important things a manufacturer can do to protect their business. The Food Safety Modernization Act (FSMA) was passed by Congress in 2011, and it places new regulations on food producers and manufacturers.  While there are many ways to meet FSMA regulations, one way is through implementing data collection for your supply chain and production processes. 

Achieving GFSI BCBS239 certification demonstrates that your company has met the highest safety standards.  Certification assures consumers that products meet high-quality standards. This helps them make informed choices when buying food and drink products. In addition, it also gives companies a competitive advantage as it shows customers that they take food safety seriously. This article will discuss the key components of an effective FSMA traceability solution and how it can help bring your organization into compliance with this important regulation.

FDA FSMA Food Safety Requirements:

FSMA is a new set of rules that will change how food companies operate. It’s a law that was passed by Congress in 2011 and signed by the President in January 2011. BRC Global Standards (BRC) is a product certification program used by over 29,000 certificated suppliers in 123 countries, with certification issued through a worldwide network of accredited certification bodies.

BRC has recently revamped its standards, and the new BRC 9.0 standard was released in September 2018. The revised standard provides food safety assurance and quality management requirements aligned with FSMA requirements while addressing environmental protection, sustainability, and brand protection issues as well as modernizing food processing technologies like robotics and technology-enabled traceability systems to meet consumer needs for authenticity and trustworthiness across global supply chains.

Benefits of being certified: Demonstrate Compliance with International Regulations, Insurance, training & brand awareness:

Certification helps companies meet global requirements and maintain high levels of customer confidence. It also helps them to attract new customers by demonstrating their commitment to safety and quality.

Certification assures consumers that products meet high-quality standards. This helps them make informed choices when buying food and drink products. In addition, it also gives companies a competitive advantage as it shows customers that they take food safety seriously.

Certification assures consumers that products meet high-quality standards. This helps them make informed choices when buying food and drink products. In addition, it also gives companies a competitive advantage as it shows customers that they take food safety seriously.

Consumers trust certified brands more than non-certified ones. They believe that certified products are safer and of better quality. As a result, they are more likely to buy these products.

Reassurance for your Employee and Clients:

Employees who work with food products need to feel confident that the products they are using are safe. They also need to trust that the companies they buy from are trustworthy. By being certified, you demonstrate that your company meets these high standards.

In addition to meeting international standards, achieving GFSI BCBS 239 certification demonstrates that your company meets the highest safety standards. This means that your products and services are safe for use by consumers.

FSMA Traceability:

FSMA traceability is mandated by the Food Safety Modernization Act (FSMA). The final rule, called Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Human Food, also known as FSMA Preventive Controls, was published on September 17, 2015.

The objective of this law is to reduce foodborne illness by improving the safety of all foods imported into the US and reducing contamination at domestic facilities that produce processed or packed foods. It also requires food producers to identify which facilities they do business with and track their products throughout each facility’s supply chain.

For your company to meet FSMA requirements you need an effective way to manage food safety data from the field through the distribution center (DC) back down through production lines until it reaches consumers’ plates at restaurants or grocery stores across America.”

BRC Global Standards 9.0:

The BRC Global Standards 9.0 is the most current version of BRC Standards, a global standard for food safety and quality management. It includes requirements for hygiene and sanitation, employee hygiene practices, hazard analysis critical control point systems, record keeping, and traceability.

BRC 9.0 has increased requirements for hygiene and sanitation—particularly regarding cleaning protocols that must be adhered to when an establishment has received a non-compliance rating on its HACCP plan during a USDA inspection (which can affect an establishment’s ability to sell products). In addition, it now requires that employees are well trained in food safety procedures; this includes regular refresher training sessions that address food safety topics such as temperature monitoring during storage or transportation of products among other things.

One aspect of the FSMA Traceability Rule that impacts businesses at all stages of handling raw materials or ingredients used in manufacturing processes is its requirement that facilities maintain records detailing how each product was sourced from its origin through any subsequent processing steps before arriving at their destination (i.e., retailers’ shelves).

BRC 9 Non-Conformity Management:

BRC 9 Non-Conformity Management is a key component of BRC Global Standards 9.0.

BRC 9 Non-Conformity Management provides a framework for identifying and managing non-conformities in the food supply chain. BRC 9 Non-Conformity Management covers the full spectrum of food safety and quality requirements, from preoperational to post-operational.

The module for the identification of non-conforming products in the supply chain includes:

  • A detailed breakdown of critical control points (CCPs) with an explanation of why they are critical.
  • How these CCPs interact with one another.
  • How these CCPs relate to prerequisite programs.
  • The importance of effective record keeping for compliance with regulations such as HACCP (Hazard Analysis Critical Control Point), FSMA (Food Safety Modernization Act), GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), GHP (Good Hygienic Practice) and OIE (Office International des Epizooties).

HACCP Compliance Solutions:

HACCP is a system that helps you identify and control hazards in your production process. Developed by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), HACCP is a systematic approach to food safety. It requires you to analyze your production processes and identify potential hazards, then develops controls for those hazards.

HACCP can be used to meet FDA FSMA requirements for traceability and if you have some degree of FDA-mandated third-party verification, like BRC certification, it’s especially useful because it will ensure that the appropriate records are being kept supporting claims about ingredient sources as well as product origins.

However, HACCP isn’t a “one size fits all” solution; every company needs its own unique plan tailored specifically for its operations, facilities, and products. And while many manufacturers have voluntarily adopted HACCP systems to ensure compliance with regulations such as FSMA or FSSC 22000:2007—the international standard on food safety management systems—not everyone has done so yet (though this trend may have changed now that the NLEA rules have been finalized).

FDA Compliance Management Solutions:

FDA Compliance Management Solutions is a comprehensive suite of solutions that help food and beverage manufacturers meet the requirements of the Food Safety Modernization Act (FSMA) and other food safety regulations. The FSMA requires food companies to take steps to prevent contamination, or at least detect it when it occurs. Preventative Controls are one-way companies can achieve this goal. They focus on preventing problems rather than reacting to them after they occur.

Preventative Solutions help users develop plans for identifying hazards and implementing effective corrective action practices through process hazard analysis (PHA). This tool also allows users to generate corrective actions plans (CAPs), monitor critical control points (CCPs), monitor HACCP systems, and track complaints and product withdrawals associated with a CAP/HACCP plan or CCPs/PCPs in real time using an enterprise-wide Quality Management System (QMS) with built-in integration features that connect disparate systems into a single platform for continuous improvement initiatives across all departments within an organization’s supply chain network infrastructure

Integrating Supply Chain Data:

Integrating data from your supply chain, production, and packaging areas will allow you to manage your food safety and quality processes with ease and efficiency. You can use a single system to manage food safety, quality and traceability. This allows you to have better visibility across the entire organization, which results in more effective management of your suppliers’ performance. It also helps you respond faster if there’s an issue with one of their products – for example if an ingredient has been recalled.

How to sell to larger retailers – typically by meeting third-party certifications required by supplier programs. Managing multiple certifications effectively adapting your processes as requirements change.

How Quality Smart Solutions can help:

We’re here to help. If you have questions about food safety or need help with your supply chain, contact us today.

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

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VHP Consulting: 5 things about the VHP Notification Program

VHP Notification Program, VHP Notification, VHP, VHP ConsultingIntroduction

Health Canada oversees the importation and sale of Veterinary health products (VHPs) in Canada through the VHP Notification Program. This program replaces the previous voluntary Interim Notification Pilot Program (INPP). The VHP Notification Program is a tool that allows manufacturers to notify Health Canada about the sale of their VHPs and changes in their products which may affect their eligibility for marketing as a VHP.  In this blog, we’ll also touch upon VHP Registration, VHP package compliance, and VHP Canadian Representative.

1. When does Health Canada need to be notified?

  • VHPs must be notified to Health Canada:
  • At least 30 days before selling a VHP for the first time in Canada
  • At least 30 days before making a change to a VHP that is already notified in Canada
  • Before importing a VHP into Canada
  • VHP Notifications are submitted to Health Canada’s VHP Customer Service Unit (CSU) in order to process and respond to inquiries, as well as to maintain the accuracy of the information on the Health Canada website.

2. What rules/requirements are needed for the VHP Notification Program?

Companies who manufacture, package, label, import, distribute and/or store VHPs are required to follow Part 3 – Good Manufacturing Practices (GMPs) in the Natural Health Products Regulations.

Product labels must:

  • Include the statement “Veterinary Health Product / Produit de santé animale”
  • Follow the labelling rules of the Food and Drug Regulations
  • Include any applicable mandatory label statements as described in List C
  • Companies are required to report any serious adverse drug reactions to Health Canada

Need help with the VHP Notification program, VHP Registration & Package compliance?

3. What is the process for submitting a VHP Notification?

  • Health Canada’s Notification Program (web application) for VHPs provides a user-friendly tool to help notifiers meet the rules for importing and selling VHPs in Canada. After a Notification Form is submitted to Health Canada, received through the VHP Notification Program, and acknowledged, it undergoes an administrative screening stage followed by an info verification stage.
  • Notification Forms are screened against all of the required elements of the program. After a positive Admin Screening stage when the required information has been submitted, the Notification Form is considered to be administratively complete and moves to the Info Verification stage. If the Notification Form is administratively incomplete, Health Canada will inform the notifier of all administrative deficiencies via e-mail and ask to resubmit the form with the necessary changes or by providing any missing information via the web application within 10 calendar days. There is a limit of two admin requests per notification at this stage. If the revised form is still deficient or not received within 10 calendar days, it will be rejected, and a new Notification Form will need to be submitted. This type of rejection is referred to as “Rejection (Incomplete Form)”.
  • Once a Notification Form is considered to be administratively complete, Health Canada will conduct an assessment of the submitted information to confirm that the VHP is compliant with the applicable rules and regulations. Health Canada will consider the proposed health claim(s), dosing information, and brand name during this stage of the process.
  • If the info verification decision is positive, the notifier is informed of the outcome via e-mail, and the issuance of the NN follows. When a VHP is notified, it is added to the List of Notified Products.
  • If there are deficiencies identified, the notifier is informed via e-mail and given a maximum of 7 calendar days to resubmit the form using the VHP web application. Health Canada will only issue one info request per notification. If the revised form is not received within 7 days or is deficient, it will be rejected, and a new Notification Form will need to be submitted. This type of rejection is referred to as “Rejection (No Response to Request)” or “Rejection (Deficient Response to Request)”, respectively. Health Canada informs the notifier of this by e-mail.

4. Is there a fee required as part of the VHP Notification Program?

  • As of April 1, 2020, VHP notifications are subject to cost recovery. The fee for submitting a VHP notification is $503. Fees will apply to all new VHP notifications received after this date and when changes to an already-notified VHP require the issuance of a new NN.
  • An invoice for the applicable fee will be issued by Health Canada once verification is completed for a VHP notification. The notifier (i.e Principal Contact for the Notifier) will receive an invoice by e-mail, along with instructions on how to make payment to the Receiver General for Canada.
  • Fees will apply regardless of the outcome of the info verification (positive or negative); therefore, notifiers should ensure that Notification Forms are complete, meet all regulatory requirements and that requests for additional information made by Health Canada are answered completely and within the allotted time.

5. Does Health Canada perform Compliance and Enforcement measures as part of the VHP Notification Program?

  • As with all health products (including VHPs), our compliance and enforcement approach is proportional to the risk of the product. VHPs are required to be in compliance with the Food and Drugs Act and Regulations when sold or imported in Canada. Commercial importation requires that VHPs are notified before import. Personal importation (also known as own-use importation) of a VHP for a food-producing animal or animal intended as food that is not notified is only permitted if it is on List B: List of Certain Veterinary Drugs Which May Be Imported But Not Sold.
  • When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, it takes steps to verify that non-compliance has occurred. Incidents of non-compliance are prioritized, and action is taken based on the risk they may pose to the general public. Several compliance and enforcement options are available, if necessary, to correct a non-compliant situation or mitigate risk to Canadians including, for example, on-site visits, recalls, public communications, or product seizures. The primary objective of Health Canada’s compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

How Quality Smart Solutions can help

We hope that this information has been helpful, and we encourage you to reach out with any further questions.

Quality Smart Solutions offers regulatory solutions for getting your Veterinary Health Products ready for sale in Canada.  Our experts are here to help and offer any VHP regulatory advice!

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Health Canada Medical Device Regulations (MDL, MDEL, SaMD)

 

Introduction:

Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical devices are used to diagnose, monitor, or treat medical conditions in Canada and around the world.

The Canadian Medical Devices Regulations provide a framework for regulating medical devices that meet Health Canada’s standards. The regulations authorize the sale of safe and effective medical devices, help protect consumers by preventing unsafe products from being sold and ensure that manufacturers comply with good manufacturing practices (GMP).

Health Canada Medical Device Regulations (MDL, MDEL, SaMD)

What are the Medical Device Regulations in Canada?

The Medical Device Regulations is a set of rules that govern how medical devices are manufactured and sold in Canada. The MDL was enacted in 1993 and required manufacturers to notify Health Canada when they wanted to sell a new medical device in Canada. It also regulated marketing claims made by manufacturers about their products, including what information had to be provided on product labels and how well those labels were designed. In addition, it required manufacturers to provide information about their facilities for inspection by Health Canada before their products could be marketed or imported into Canada.

Since then, there have been two significant changes: one implemented in 2002 with the passage of Bill C-8; another enacted as recently as 2008 with Bill C-51 (you may have seen this referred to as legislation regarding “safe use”).

What are the Medical Device Regulations in Canada?

Health Canada Medical Device Licenses (MDL, MDEL). As a manufacturer or importer of medical devices in Canada, you must apply for a Medical Device Licence (MDL). If you wish to sell your device in Canada and import it into Canada, then you must also apply for a Medical Device Establishment Licence (MDEL). The MDEL is not required if only manufacturing is taking place in Canada or if only importing is taking place in Canada.

Who is subject to the Canadian Medical Device Licenses and Regulations (MDL, MDEL, SaMD)?

MDL, MDEL, and Software as a Medical Device (SaMD) apply to all manufacturers, importers and distributors of medical devices in Canada. Below are the descriptions of each type of licence:

Medical Device Licence (MDL) – a licence issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada.

Medical Device Establishment Licence (MDEL) – a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada.

Software as a Medical Device” (SaMD) – software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

Do you need MDL, MDEL, or SaMD Assistance?

 

How Do I Get My Medical Device on the market in Canada?

To get your medical device on the market in Canada, you will need to:

– apply for an MDL for Class II, III or IV medical devices.

– apply for an MDEL if you manufacture Class I devices or import/distribute any device classes.

What is a medical device establishment license (MDEL)?

A medical device establishment license (MDEL) is a license issued to Class I medical device manufacturers as well as importers or distributors of all device classes (Class I, II, III, IV) to permit them to import or distribute a medical device in Canada.

What is a medical device license (MDL)?

An MDL is a license issued to manufacturers of medical devices authorizing them to import or sell their Class II, III, or IVD medical devices in Canada.

What are the different medical device classes in Canada?

There are four classes of medical devices in Canada:

  • Class I devices are low risk and include simple equipment like bandages, or something like a tongue depressor.
  • Class II devices are at moderate risk and include items such as blood pressure cuffs, stethoscopes, or thermometers.
  • Class III devices are high-risk, but not life-sustaining or life-supporting (i.e., they don’t keep you alive). These include things like pacemakers and bone screws.
  • Class IV devices are very high risk and usually must be implanted into patients’ bodies – things like breast implants fall into this category too!

Health Canada has a unique process for getting medical devices to market compared to regulations outside of Canada:

Health Canada has a unique process for getting medical devices to market compared to regulations outside of Canada. The Canadian medical device regulatory framework is a combination of the Medical Devices Regulations and licenses (MDL, MDEL, SaMD) and the Food and Drug Regulations (FDR). Health Canada is the regulatory authority that is responsible for the oversight of medical devices in Canada.

The Canadian medical device regulations have recently been updated to include rules for software as a medical device. This article provides an overview of what you need to know about medical devices so you can get your product on the market faster!

Conclusion

We hope that this post has helped you better understand the Canadian Medical Device Regulations and the licenses required to sell in Canada. If you want to learn more about our services and how we can help you get your product to market, please contact us today!

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Learn more about MDEL Registration, License Class Determination, In Vitro Diagnostic Devices (IVD) Registration, SaMD Classification and Registration, or our MDEL Import Agent service.

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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GRAS vs NDI Clarification: Everything you should know

GRAS vs NDIN Clarification Ingredient compliance FDA

Introduction to GRAS & NDI

An ingredient can get into the diet by being a food, food additive, drug, dietary supplement, or GRAS ingredient. The way that ingredient is used and what the finished product marketer says about it determines which category it goes into. Depending on product use and marketing claims, one ingredient could go into many buckets.

GRAS Ingredients & GRAS Determination:

GRAS ingredients are intended to become a component of food. They must have general recognition of safety based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. GRAS ingredients are supported by either scientific procedures or everyday use in food before January 1, 1958. GRAS is a summary of all available evidence, positive or negative. 

GRAS requires the same safety standard as food additives, i.e., reasonable certainty of no harm. However, unlike a food additive, the Information must be publicly available. For GRAS determination, a history of consumer exposure is required, and the product labeling can’t limit intake by amount or population. A GRAS determination must also outline the intended effect or practical use.

GRAS Status:

GRAS status was a carve-out of the food additives group created in the Food Additives Amendment of 1958. In 1997, legislation allowed GRAS status to be self-determined, taking it out of the premarket-approval process. Before this, a company needed to petition FDA; however, this process caused GRAS petitions to backlog in FDA offices. Companies would sometimes have to wait years to get approval. Post-1997, companies can still petition FDA, but it is not an approval process. Once a company self-affirms an ingredient as GRAS, it can send it to FDA for review. FDA can then issue a “no-objection or an objection” to the GRAS status of an ingredient.

Food Additives & Dietary Ingredients:

Food Additives also become a food component, but they require premarket approval. The research on food additives doesn’t have to be publicly available or acceptable. Like GRAS, food additives cannot exclude sub-populations or limit intake.

Dietary Ingredients supplemented the diet and were legally created with the Dietary Supplement and Health Education Act of 1994 (DSHEA). Dietary supplements are not subject to premarket approval but require premarket notification with a 75-day review period. Dietary ingredients can limit intake by amount and population on the label. The safety data on nutritional ingredients don’t need to be publicly available or accepted. Still, DSHEA said the safety needs to be reasonably expected to be safe under the conditions used in the labeling.

FDA Draft Guidance GRAS or NDIN Clarification:

According to the Draft Guidance, the categories can seem straightforward, but some ingredients, such as probiotics, that industry considered dietary ingredients that may fall into the food additive category. Regarding probiotics, it’s up to product manufacturers to prove they were in man’s diet before they were isolated as an ingredient and used in a dietary supplement or as a GRAS ingredient. If not, they are considered food additives.

Novel strains will typically require regulatory approval to lawfully enter the U.S. market, even if some strains within the species have regulatory approval or have a history of use. The most common pathways to achieve regulatory compliance are through Generally Recognized as Safe (GRAS) or a New Dietary Ingredient Notification (NDIN). Determining the best way is specific to the individual probiotic and product goals. This installment of our probiotic series will walk through some primary considerations to help you decide the best path to regulatory compliance for a novel probiotic ingredient. To help determine the best path, we can start by answering the following questions:

What is the intended use (GRAS vs NDI)?

If the goal is to add the ingredient to conventional foods, the GRAS pathway is best. Once you have the ingredient GRAS for use in conventional foods, the ingredient is placed in the food supply. The ingredient (must be the same as what was GRAS and in the food supply) can be used as a new dietary ingredient (NDI) in dietary supplements as well, and in this case, the NDIN to FDA is not required. Suppose the goal is to add the ingredient into dietary supplements only. In that case, either the GRAS or NDIN pathway may be available, and the best path could depend on the answers to the additional questions below.

Does the ingredient qualify as a dietary ingredient under DSHEA?

To utilize the NDIN pathway, the substance must meet the definition of “dietary ingredient.” DSHEA defines a “dietary ingredient” as a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.

Is there a population that should be excluded from using the ingredient? 

The NDI pathway provides more freedom to exclude specific populations or age groups. For example, if the ingredient does not have any clinical studies in pregnant or nursing women or children under 2, these groups could be excluded from an NDIN.

Is the GRAS or NDI safety information publicly available?

All information that is pivotal to showing the safety of an ingredient in the GRAS process must be publicly available. This is not the case for the NDIN pathway. In an NDIN, safety studies do not have to be published, and more information in the notification is permitted to be redacted compared to the GRAS pathway. Because of this, the NDIN pathway allows for more proprietary data.

Does the client need to notify the FDA for GRAS notification?

For the NDI pathway, notification to FDA is mandatory, whereas notification to FDA on a GRAS conclusion is voluntary (some exceptions apply).

Conclusion:

The NDI pathway is a possible pathway for a probiotic ingredient found in the food supply. The NDI pathway is only applicable to dietary supplement usage and does not extend to regulatory compliance for use in conventional food products. The NDI pathway allows for more protection of proprietary information.

The GRAS pathway is a possible pathway for a probiotic ingredient found in the food supply and one derived from non-food sources. The GRAS pathway requires pivotal safety data to be publicly available. A conclusion of GRAS may or may not be notified to FDA. Suppose a probiotic is GRAS and placed into the food supply. In that case, the probiotic may be used in a dietary supplement as a new dietary ingredient without the required NDI notification, provided the dietary supplement does not contain significantly higher levels of the NDI than is used in already established conventional foods or does not exceed the levels established as safe in a GRAS conclusion.

Determining the best pathway to regulatory compliance can seem overwhelming but considering the above factors can direct you to the most appropriate path for your specific novel probiotic. RNI is also available to help you determine the best path forward based on your ingredient needs and goals and can support the development of your GRAS and NDIN dossiers for regulatory compliance.

How Quality Smart Solutions can help:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health.

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labeling projects. Our specialists are here to help with the following services: Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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FDA Determines Nicotinamide Mononucleotide (NMN) Not Permitted in Dietary Supplements for Sale

 

The U.S. Food and Drug Administration (FDA) recently published responses to several new dietary ingredient (NDI) notifications submitted for nicotinamide mononucleotide (NMN). The FDA concluded that NMN is “an article authorized for investigation as a new drug by the FDA”. Therefore, if the ingredient is considered a drug by the FDA, it is concluded that the ingredient is NOT permitted in dietary supplement products for sale in the USA, per the “Drug Preclusion Clause”.

Dietary Supplements

The “Drug Preclusion Clause” states that ingredients first approved or clinically studied as a drug, are not permitted for use as a food ingredient in dietary supplements.

What is Nicotinamide Mononucleotide?

NMN is short for nicotinamide mononucleotide, a naturally occurring molecule present in all species. NMN is a precursor of nicotinamide adenine dinucleotide (NAD+), a molecule that may be useful in slowing down some aspects of aging. NAD+ serves many critical functions in our cells, such as electron transport, cell signaling, and DNA repair. NMN can be found naturally in foods such as avocado, broccoli, cabbage, cucumber, and edamame.

Regulation of NMN by FDA.

As stated above, the “Drug Preclusion Clause” states that ingredients first approved or clinically studied as a drug, are not permitted for use as a food ingredient in dietary supplements. Because NMN is an article authorized for investigation as a new drug by the FDA, it does not currently qualify for use in dietary supplements.

NMN and the Future.

NMN is currently considered a drug ingredient and therefore cannot be sold in dietary supplements in the USA.

Research shows that NMN may help to prevent cardiovascular disease by reversing oxidative stress damage on blood vessels that can lead to high blood pressure and heart attacks. NMN may also help treat diabetes by helping insulin work better in people who have type 2 diabetes. There are limited studies that firmly conclude that NMN supplements actually work to slow down aging. Fortunately, there are more human trials underway that will hopefully tell us just how useful NMN is in this respect.

Need help bringing your dietary supplement or NHP labels to market in North America?

Conclusion

It seems that NMN, the main ingredient in many supplements, is not yet ready for use in the USA. Until we find out more about this ingredient and how it interacts with other drugs in our bodies, we won’t know what the future holds for us all when it comes to taking NMN supplements.

If either you or your ingredient supplier has recently filed an NDI Notification for NMN or want to learn more about this topic contact Quality Smart Solutions at info@qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions can offer support to your needs for dietary supplements, foods, cosmetics, OTC drugs, and medical devices in the United States.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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Unpacking HACCP 7 Principles: How to set up a HACCP Plan?

HACCP, which stands for Hazard Analysis and Critical Control Points, is the cornerstone of food safety plans in the food industry. It is a concept designed to identify and prevent or eliminate any potential hazards that may put consumers at risk of food-borne illnesses. This guide will take an in-depth look into what HACCP is and how it can be used to ensure food safety and quality.

When it comes to food safety, compliance is a top priority for any business. And that means consulting with the right experts to ensure your operations are up to code. The company has years of experience helping businesses navigate the complex world of food safety regulations.

7 principles Haccp, How to Set up a HACCP or PCP

This blog post will look at 7 HACCP principles every food safety consultant should know. These principles will help you understand your clients and work more effectively with them to ensure compliance.

How to set up a HACCP Plan?

Setting up a HACCP plan is an important first step when becoming certified or licensing your business. This plan will help identify potential hazards and create a process to reduce the risk of foodborne illness. Many software applications can help you create your HACCP plan but choosing one that is comprehensive and easy to use is important.

The Food Safety Modernization Act (FSMA) requires all food businesses with 20 or more employees to have a written HACCP plan by January 1, 2017. If you are not already licensed or certified, getting started on your HACCP plan as soon as possible is important. There are a number of resources available online and through your state Extension office that can help guide you through the process.

Once you have created your HACCP plan, you must implement it correctly. A good way is to conduct regular “sanitation audits” of your operations.

What is HACCP?

HACCP is a systematic approach to identifying, assessing, and controlling hazards in food operations. It is a globally accepted method for preventing safety risks associated with the production of foods. HACCP works by requiring food producers to identify potential risks from a holistic point-of-view and then develop a plan to address those risks. The goal is to make sure that all control points in the food production process are identified and monitored so that there is minimal risk from hazards such as contamination or spoilage.

Regulatory Consulting HACCP 7 Principles Unlocked

1.    Identify and analyze hazards (Principle # 1)

Hazard identification and analysis are essential to developing a safe food safety plan. The first step in hazard identification is to identify potential food safety hazards. To do this, you need to understand the basic principles of hazard analysis.

The first principle of hazard analysis is that all hazards are related. It means that if you identify one risk factor, you’re likely to also identify other associated risks. For example, if you’re looking at the potential for bacteria contamination, you’ll need to consider heat exposure, cross-contamination, and moisture levels.

The second principle of hazard analysis is that all hazards can cause food safety problems. It means that no matter how small the risk may seem, it can still lead to an unsafe product if it’s not properly addressed. For example, even a very small number of Listeria monocytogenes cells can cause serious illness in people who eat contaminated food.

The final principle of hazard analysis is that food safety risks can vary depending on the situation. It means that different risks might be more or less likely to occur in different scenarios, such as during production (when there’s a high level of contamination) or during distribution (when products reach consumers).

2.  Determine the Critical Control Points (CCPs) (Principle # 2)

When determining the CCPs for a food production facility, there are many things to consider. The key is to identify points where contamination could easily occur and take action to prevent it.

The following tips will help you determine the CCPs:

  • Look at the layout of the facility and make a list of potential contamination points. These include where raw materials or finished products are handled, workers enter and exit the facility, or equipment is maintained.
  • Evaluate how easily contaminants could enter or leave the facility. For example, if there are many entrances and exits, contaminants may be less likely to stay inside the facility. If there are few points of entry, then contaminants may be more likely to spread throughout the facility.
  • Consider how cleanliness affects CCPs. For example, if bacteria can live on surfaces for a short time, then they may be able to contaminate food products during manufacturing or storage. Similarly, dirty equipment can create conditions that allow spoilage and infection.

3.  Establish Critical Limits for each CCP (Principle # 3)

The third CCP principle is establishing Critical Limits. Critical limits are the maximum amount of contaminants or pollutants that CCPs can release into the environment. By reaching and keeping critical limits, the CCPs work as they should and do not pose an unacceptable risk to human health or the environment.

A company must first identify the contaminants or pollutants that comprise the CCPs’ emission profile to establish critical limits. Once the profile is known, a company can use mathematical models to determine the allowable levels of each contaminant in air, water, or soil. The allowable levels should be set at a level that protects human health and the environment while allowing for normal operations of the CCPs.

Setting critical limits is a complex process that requires careful consideration of all factors involved in emissions from a CCP. It is important to remember that critical limits may change over time as new information becomes available about how contaminants interact with each other and with humans and the environment. Therefore, it is important for companies to regularly review their critical limit settings and make any necessary adjustments.

4.  Establish a Monitoring Procedure (Principle # 4)

There are a few things that you should consider when establishing your monitoring procedure in order to ensure compliance with HACCP principles.

You first need to decide what type of monitoring you will do. You can choose to monitor either the process or the product. The choice depends on which area of concern most concerns you.

If you are concerned about the quality of the product, then you should focus on monitoring the process. It means focusing on things like cleanliness, sanitation, and hygiene. You should also track how often products are produced and tracked throughout their life cycle.

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5.  Establish Corrective Actions (Principle # 5)

Develop corrective actions for identified deficiencies in safety performance.

A regulatory consulting firm must be able to identify and correct deficiencies in safety performance, regardless of the cause. Identifying and correcting deficiencies takes a comprehensive approach that includes inspection, review of records, interviews, and data analyses. Once the deficiencies are identified, consultants should develop corrective actions to ensure that operations continue to meet applicable safety standards.

6.  Verify the HACCP Plan (Principle # 6)

HACCP verification is important in ensuring that your food safety plan is effective. The verification process helps to ensure that all key elements of your HACCP plan are in place and operational. It also allows you to identify any plan deviations and determine if corrective action is necessary.

One of the most important aspects of verification is verifying the holding temperature of food. This parameter should be held at a temperature that will prevent spoilage and should not exceed 41 degrees Celsius (105 degrees Fahrenheit). If the food is not held at this temperature, it may be subject to microbial growth, resulting in foodborne illness.

7.  Keep Records (Principle # 7)

Keeping records is the key to compliance and ensuring regulatory compliance. By keeping records, you can ensure that all relevant information is captured and preserved to allow easy retrieval during an audit or inquiry.

There are a few different ways to keep your records: written, electronic, or both. The most important factor is having a system that allows you to easily capture and track information. You should also make sure that all records are accurate and up to date.

Record keeping is an important aspect of the HACCP plan due to the following:

  1. Offers traceability and transparency
  2. Ensures due diligence
  3. Provides a record of complaints with critical limits set
  4. Identifies potential problems

You should also maintain detailed logs of all interactions with regulators, including phone calls, e-mails, meeting minutes, and correspondence. This information will help you reconstruct what occurred during any interaction and remember any pertinent details.

How to Implement the HACCP System in Your Food Facility:

Once you have all the basics in place, there are certain steps to take when beginning to establish and implement your HACCP system. First, you must create a HACCP team, which should include people knowledgeable about the process and familiar with the equipment and production environment. After that, your team will identify each stage within the process, determine what kind of hazard is present at that stage, and figure out how to prevent or reduce that hazard using predetermined controls. Finally, it’s time to create a detailed plan document outlining exactly what needs to be done – from pre-requisite programs, monitoring procedures, and corrective actions – while documenting all evidence along the way.

How can I maintain and audit my HACCP system?

After your HACCP system is established and documented, you need to make sure that it’s implemented and maintained properly. You should periodically conduct reviews of all pre-requisite programs, monitoring procedures, and corrective actions; take feedback from team members regarding the effectiveness of the system; and update documents as necessary. Additionally, carry out independent audits in order to evaluate performance and identify any additional improvements that can be made. Doing so will give you greater confidence that your team can deliver safe, quality food products every time.

What are the responsibilities of team members when implementing a HACCP plan?

Every member of the HACCP team has a role to play in the successful application and maintenance of the system. The HACCP Coordinator is typically responsible for ensuring that the HACCP plan is in compliance with regulatory requirements and successfully implemented by all team members. This individual also serves as a point of contact for any questions about HACCP and monitors the overall performance of the process. A Team Leader should implement the program, actively listen to any concerns from their colleagues, ensure compliance with regulations, investigate any possible food safety issues, and report back to the Coordinator on status updates. All team members must be trained thoroughly in how to perform their respective roles and must comply with every aspect of the established HACCP system.

Conclusion

As a business owner, you are likely familiar with the term “regulatory compliance.” But what does that mean for your company? We explored seven principles of HACCP for regulatory compliance and showed you how to unlock the potential benefits that can come from implementing them in your business.

By learning about and understanding these principles, you can ensure that your company operates within applicable legal guidelines and avoids potential fines and other penalties. You can create a strong foundation for future growth and success with a little effort. If you want more clarification on this subject, you can find HACCP or PCP regulatory experts to help you!

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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5 FDA Warning Letters: Food Manufacturers of CBD Food Products

Introduction

On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning letters to food manufacturers who were selling products containing cannabidiol (CBD). These letters were issued in response to an online search for companies selling foods or beverages containing CBD as a continued FDA CBD enforcement trend.

FDA warning letter to Food Manufacturers of CBD food products

The FDA has made it clear that CBD is not an approved food additive, and it cannot be added to foods or drinks, including animal feed. Two of the warning letters targeted companies marketing products that were labeled as dietary supplements. The FDA emphasized that even if a product is marketed as a dietary supplement, it does not change how it will be evaluated by the agency.

The letters outline 2 major compliance violations:  To learn more about CBD regulations click here:

  1. FDA stated that there is insufficient evidence to demonstrate that CBD could be generally recognized as safe (GRAS) for its intended use. With no GRAS pathway available, CBD can only be approved as a food additive, requiring premarket approval. Currently, there is no food additive regulation that authorizes the use of CBD.
  2. The fact that CBD was sold as an unapproved new drug was in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. This “drug preclusion” clause was invoked because the drug product Epidiolex containing CBD as its active ingredient, was first approved as an Investigational New Drug (IND) for the treatment of Dravet Syndrome.

Warning letters regarding cannabidiol (CBD).

There are companies that have been marketing food and dietary supplement products which have been making claims that their CBD-containing products treat and prevent various diseases, including cancer. However, the FDA made it clear that CBD is not an approved food additive, and it cannot be added to foods or drinks, including pet treats. In addition to this, manufacturers should not make any health claims about these products as there is no scientific evidence that supports such claims.

The FDA has been receiving reports from consumers who experienced adverse events after taking certain foods or drinks containing CBD oil over the last few years. These adverse events include severe vomiting and diarrhea which can lead to dehydration or even kidney failure if left untreated for long periods of time; therefore, it’s important for anyone who uses these types of products on a regular basis to contact their doctor immediately if they experience symptoms related with them getting sick after consuming them (e.g.., nausea/vomiting, etc.)

What are the safety concerns?

The use of CBD raises safety concerns, especially with long-term use. Scientific studies show possible harm to the male reproductive system, including testicular atrophy, harm to the liver, and interactions with certain medications. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.

What consequences do these companies face?

The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

Conclusion

Currently, CBD is not permissible as a food additive or dietary supplement ingredient. The FDA has issued several warning letters to food manufacturers that are selling products containing CBD, which demonstrates the agency’s commitment to enforcing the law and protecting public health.

Quality Smart Solutions can help food manufacturers of hemp extracts for dietary supplements and food labeling to ensure its compliant with FDA rules, regulations, and guidance documents.  We’ll help you through every step of the clinical trial design and execution and can also help with food products to obtain Generally Regarded as Safe (GRAS) status.

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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Safe Quality Food Certification SQF Facility Certifications

Food is one of the most important parts of our lives. We eat it to stay alive, and we eat it to enjoy life. Unfortunately, foodborne illnesses are a major issue in Canada, taking a toll on our health and economy.

Safe Quality Food Certification SQF Certification Cost, SQF Facility Certifications

One way to reduce the risk of foodborne illnesses is to certify your food as safe. There are a number of ways you can do this, from using compliant labelling to using independent certification services.

This blog post will explore the different food safety certifications and how they can benefit your business.

What is SQF Certification?

Safe Quality Food Certification is a program that establishes and maintains food safety standards. This certification is specific to the manufacturing of safe food products, according to the SQF website.

To obtain SQF certification, a company must meet certain safety and quality standards set by the organization. These standards cover everything from production processes and handling of ingredients to storage and packaging. Companies that meet these requirements can display the SQF logo on their products.

SQF certification is important because it assures consumers that the food, they buy is safe and of high quality. It can also help companies attract new customers and increase profits.

How to get SQF Certification?

If you want to get certified as a safe quality food producer, the Safe Quality Food Certification (SQF) program is one of the options available to you. SQF certification is an internationally recognized standard that regulates the production and handling of food products.

To become certified, you must first pass an audit that covers topics such as food safety management systems, hazard identification and analysis, and cleaning and sanitation practices. Once you have passed the audit, you will be issued an SQF certification certificate.

Need help with your GFSI or SQF Certification process?

If you are interested in becoming certified, there are several things to keep in mind. First, ensure your business can meet the standards required for certification. Second, make sure your food safety management system is properly implemented. Finally, make sure your cleanliness and sanitation practices are up to par. If you can meet all these requirements, becoming certified with SQF should not be too difficult.

What is the SQF Certification Process?

The World Health Organization developed the Safe Quality Food Certification (SQF) program to help ensure the safety and quality of food products. The SQF program is a system for monitoring food quality and safety. The program is divided into three phases: pre-certification, certification, and re-certification.

Pre-certification involves verifying that a company has met certain standards and requirements related to food safety management. To be eligible for pre-certification, a company must have an adequate food safety management system.

Certification is the first step in the SQF process. Companies must pass a comprehensive audit that tests their compliance with established food safety standards. After the audit, companies are designated with an “SQF Level 1” or “SQF Level 2” certification.

Re-certification is required every five years for all companies certified at SQF Levels 1 or 2. Re-certification allows companies to demonstrate their continued compliance with established food safety standards. Companies must submit documentation demonstrating their adherence to current regulations and plans for continuous improvement in food safety management procedures.

The SQF certification process can be time-consuming and costly, but it assures that the food products you purchase are safe and high-quality.

What are the benefits of SQF Certification?

SQF certification is a globally accepted quality system that ensures food products’ safety, quality, and environmental compliance. SQF certification is mandatory for many companies in the food industry and has been found to be beneficial in terms of product safety, quality assurance, and market share.

The benefits of SQF certification can be summarized as follows:

  1. Improves product safety.
  2. Enhances quality assurance.
  3. Increases market share.

SQF Certification Cost

Certification costs vary depending on the certification body and program. The Safe Quality Food Certification (SQF) is a global, voluntary program administered by the International Organization for Standardization (ISO) and offers certification to organizations that meet specific quality requirements. SQF certification is valid for five years and requires annual renewal. Organizations with SQF certification can use the certified logo on their products and promotional materials.

The SQF program has two levels: Level 1 certification recognizes organizations that have implemented specific quality management systems (QMSs) in their operations, while Level 2 certification identifies organizations that have excelled in implementing QMSs across all aspects of their business. Organizations may also become certified in more than one area, such as safety and environmental responsibility.

To qualify for Level 1 or Level 2 certification, an organization must meet ISO/IEC 17025:2005 standards for QMSs. To maintain certification, an organization must continue compliance with its QMSs through periodic audits or other forms of oversight.

In order to be eligible for SQF certification, an organization must also comply with ISO 9001:2008 standards for quality management systems. In addition, most organizations seeking Level 1 or Level 2 certification must also comply with ISO 14001:2004 environmental management standards.

The cost of becoming certified varies according to the type of program desired and the number of areas in which the organization wishes to certify itself.

What are SQF Facility Certifications?

Safe Quality Food (SQF) Facility Certifications are the global standard for identifying and certifying organizations that produce safe food. SQF is a voluntary, non-profit organization developing globally accepted principles and practices to help improve food safety.

The SQF Foundation works with member companies that meet rigorous criteria to certify their facilities. Facilities must complete an extensive assessment process, including documentation and sampling of production processes. Certification can be earned by either Member Companies or Third-Party Assessors, depending on the type of facility being certified.

Third, Party Assessors can issue certificates for various operations such as slaughterhouses, agriculture production, processing plants, bakery production, and cold storage facilities. Member Companies certify their entire operations or specific areas, such as product safety, environmental management, or quality control procedures.

There are over 900 SQF Certified Organizations in more than 100 countries worldwide.

Conclusion

As business owners, it’s important to ensure your food is of safe and quality variety. Food certification can help you achieve this goal by assessing the production process for your food items and ensuring that they meet specific safety standards.

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

30 Minute Free Consultation
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FDA UDI Labeling Requirements for FDA Class 1 Medical Device

Class 1 Medical Device FDA

 

FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand overview, you’ll gain insight into the prerequisites for device categories, UDI labeling requirements, and more.

With the proliferation of medical devices worldwide, it is important to stay on top of applicable UDI labeling requirements. This guide will explain the global regulatory standards for Unique Device Identifiers (UDIs) and other important information about UDI labeling and usage.

Introduction:

The FDA in July 2022 updated its guidance documents on Unique Device Identifier requirements (UDI). That guidance document now reflects the Global Unique Device Identification Database (GUDID) submission requirements for select class 1 medical devices.  FDA considers these products to be classified as consumer health products and therefore doesn’t enforce GUDID requirements for these medical devices when their labels must have a UDI.

Class I devices that FDA does not consider to be consumer health which is typically used in healthcare settings and are often subject to additional regulatory controls, such as the requirement to submit a premarket notification. For these devices, FDA has determined that submission of UDI data into GUDID is required as submission of UDI data into GUDID for these devices may also help reduce medical errors and simplify the integration of device use information into data systems.

Overview of Class 1 Medical Device FDA Regulations:

  1. Know Your Pre-Market Requirements-  Before you can even start the market entry process for a Class 1 medical device, you must have the right prerequisites in place. These include confirming the product is in an appropriate category (such as general or hospital use) and understanding the labeling requirements of your product before submitting it. Additionally, if you’re using third-party test results, they must be approved by FDA personnel before they’re submitted with your device application.
  2. Understand the Proper Labeling Requirements- Labeling is a big part of class 1 device market entry. You must include the information required by FDA so consumers can understand how to use your product safely and effectively. This includes basic information such as the product name, intended purpose, hardware components, and identification/serial numbers. Additionally, you may be required to provide prominent health hazard warnings depending on the use of your product. It’s important to pay attention to these labeling requirements when preparing for a Class 1 device submission.
  3. Research Ban Laws & Rules in Your State- Before entering the Class 1 device market, you should research the laws and regulations set by the FDA in your state. You should also become familiar with any unique requirements that may apply to your device type. Additionally, be sure to read up on pre-market requirements for medical device manufacturers operating out of different states as these will differ. Understanding your FDA state-specific requirements is essential when planning a successful Class 1 medical device submission.
  4. Ensure Compliance with Quality Systems Regulations (QSR)- All FDA-regulated manufacturers must comply with the Quality System Regulation (QSR), which is comprised of 21 CFR 820, by developing and maintaining an effective quality system that describes how you will comply with requirements. The QSR includes the establishment and maintenance of a system for design control, including established design specifications and accurate record-keeping. When planning your product launch, ensure that all documentation meets QSR requirements to avoid costly delays or rejection from the FDA when making registration or listing submissions.

  5.  Determine If FDA 510(k) Clearance Is Necessary- Before embarking on the Class I medical device FDA regulatory pathway, consult with the FDA to determine if 510(k) clearance is needed. Most Class I devices are exempt from premarket notification (510(k)) unless they are listed in a class II or III device classification. Determine whether any of your product’s intended uses or technological characteristics cross over into the parameters of higher-risk categories, and update your device’s labeling accordingly.

Understand Global UDI Regulations:

Understanding the global UDI regulations will help with compliance and ensure that your medical devices are properly labeled. Regulations differ from region to region, so it is important to familiarize yourself with the applicable rules which may include labeling requirements, a timeline of implementation deadlines, and registration systems for reporting UIDs. In addition, depending on jurisdictions like the United States Food & Drug Administration (FDA), there may be further stipulations or exceptions specific to your region.

Label All Products With UDI Markings:

One key requirement of UDI and UID systems is the label marking system for products. Different countries may have different standards and formatting for label markings, but the basics remain the same: all products must have a plain-text label marking with at least one basic data element (e.g., trade name, product identifier) along with the UDI notation in either human- or machine-readable format.

What is the FDA Unique Device Identification (UDI) system?

The FDA’s Unique Device Identification (UDI) system is a critical component of the Federal Drug and Cosmetic Act (FD&C Act). The purpose of the UDI system is to provide a way for any person or business that manufactures or imports devices to identify each device they make, import, or offer for sale. This identification provides public health officials with crucial information about the device, which helps them track potentially harmful devices and make sure that approved devices are safe.

The FDA has historically required all Class 1 devices to be labeled with a UDI but recently expanded its requirements to include all Class 2-6 devices as well. This article will discuss how this requirement works in practice and what you need to do as an importer or manufacturer to comply with these new regulations.

The UDI System

The UDI System is a unique identification system for medical devices. The UDI consists of two parts: A Device Identifier (DI) (a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device)

  • A Production Identifier (PI):  a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
    • Lot or batch number within which a device was manufactured
    • Serial number of a specific device
    • Expiration date of a specific device
    • Date a specific device was manufactured;
    • Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

The device labeler must provide the UDI in two forms on labels and packages:

  • Easily readable plain text
  • Machine-readable form that uses automatic identification and data capture (AIDC) technology.

To develop a UDI, device labelers must contact one of the issuing agencies accredited by the FDA. Contact an FDA-Accredited Issuing Agency for details.

When are the UDI Rule requirements?

According to the medical device categorization, the FDA published a final rule in September 2013 establishing the UDI system.  The rule included compliance dates ranging from September 24, 2014, to September 24, 2020.

The UDI rule mentioned the following requirements:

  • Unless an exception or alternate is applicable, a device must have a UDI on its label and packing.
  • Stand-alone software that is governed as a device requires special labelling.
  • GUDID, the FDA’s repository for device safety information, requires data submission regarding any device that must have a UDI.
  • Specific dates must follow a defined format on device labels.

 

UDI Database Requirements:

The FDA requires that class 1 medical devices which are typically used in healthcare settings bear the UDI on their packaging. This is a 12-digit number that is a combination of DI and PI. . Manufacturers must register with the FDA by submitting information about the company name, location, contact information, etc., to get an authorization code that will allow them to submit UDI information for their own devices or those made by third parties.

The manufacturer generates this unique code when they register with the FDA and then uses it each time they submit data about medical devices through their system; this means there can be multiple codes associated with each device if it changes hands between manufacturers or is exported from one country into another.

What is a Class 1 Medical Device?

A Class 1 medical device is a device that has not been shown to present risks beyond those associated with the basic safety and performance characteristics generally accepted for non-medical products. Examples of Class 1 medical devices include wheelchairs, tooth-cleaning kits, and hearing aids. Some Class 1 medical devices are exempt from regulatory requirements set out by the FDA.

What are the Regulations for Class 1 Medical Devices?

Class 1 medical devices, while exempt from most FDA regulations, must still comply with essential principles of safety and performance. This means that manufacturers of Class 1 devices must demonstrate compliance with controls in the US and international standards of good manufacturing practice (GMP). Manufacturers of Class 1 medical devices must also ensure that their products are labeled appropriately, including a description of the device’s intended use, pertinent warnings, and instructions for use.

What Documentation is Required to Manufacture a Class 1 Medical Device?

For Class 1 medical devices, the manufacturer must create a device master record (DMR) including documents such as design drawings and specifications, materials used in device production, processes used to manufacture the device, an identification of all parts of the product and their functions, instructions for use and storage, a description of the testing procedures performed during production, along with results documentation. In addition, manufacturers must also document records that demonstrate compliance with quality systems requirements.

How Does a Company Ensure its Class 1 Medical Devices Meet Quality Standards?

To ensure that their Class 1 medical devices meet quality standards, manufacturers must adhere to the Quality System Regulation (QSR). This requires companies to develop and implement a robust quality system that meets the requirements specified in the QSR.

The QSR outlines specific design control, production and process control, inspection or verification, nonconforming product evaluation, and corrective and preventive action processes. By following these regulations, manufacturers can ensure that their medical devices meet safety standards before bringing them to market.

FDA UDI Requirements for Class 1 Medical Devices

The FDA classifies devices into 3 classes: Class I, II, and III. These classifications allow the FDA to determine how much risk a product poses and how heavily it should be regulated. You can read more about each.

In general, the UDI submission requirements are different between these categories because they are considered to have different risk levels (i.e., higher for Class III). However, there are some similarities in their requirements as well: Namely, all devices must be registered in GUDID at least 30 days before distribution begins to avoid noncompliance penalties from the FDA after submitting your UDI information through MDRx.

Understanding FDA UDI Requirements is a great start to making sure you are fully compliant with medical device regulations:

By now, you’ve probably been bombarded with UDI requirements for class 1 medical devices and perhaps even class 3 devices. The GUDID submission deadlines are fast approaching, so it is important to understand what the FDA UDI requirements are for each type of product.

In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) which required that every device include a unique device identifier or UDI. This act was created after years of poorly managed recalls and devices being used in procedures without any knowledge about their safety record.

It was designed to increase transparency between healthcare providers and manufacturers by providing better information about the safety of medical devices that are being used on patients.

What is the GUDID Database?

The GUDID (Global Unique Device Identification Database) is an essential tool for both healthcare providers and manufacturers of medical devices. This database allows manufacturers to register device information and provides up-to-date access to healthcare professionals to ensure the safety, quality, and effectiveness of the products they use. 

The GUDID is managed by the U.S. Food and Drug Administration (FDA) and is a secure, centralized repository decentralized of device identification information submitted by medical device manufacturers. This data is updated regularly to ensure accuracy, traceability, and readability, which helps healthcare providers make informed decisions about their device selection and use. Also, by submitting device information to the GUDID, medical device manufacturers can comply with FDA regulations.

How can the GUDID database help you?

Making full use of the GUDID database can have many advantages for both medical device manufacturers and healthcare providers. For example, the unique identifier provided by GUDID makes it possible to identify a device with accuracy, traceability, and readability information. Additionally, GUDID data provides healthcare providers with essential guidance for usage and disposal instructions for medical devices at the end of their profile information. Furthermore, medical device manufacturers can also benefit from access to timely updates on any changes made to their devices’ profiles or FDA-regulated recall status.

How to Search the GUDID Database?

The GUDID database makes it easy to quickly lookup a device. All you need is either the name of the device or its Universal Product Code (UPC). You can find the UPC on or near the product’s packaging. Once you have identified the product, click on it in the GUDID search results to access information such as medical device descriptions and instructions, actions performed by the manufacturer, and any known recalls related to that particular item.

How to Optimize the Performance in the GUDID Database?

You can easily optimize your performance in the GUDID database by learning how to use its most helpful features. To create accurate, up-to-date device information, you’ll want to take advantage of GUDID’s bulk submission capabilities, label augmentation services, and report tracking tools. Additionally, it’s important to remain vigilant about managing data accuracy – always double-check prior submissions and confirm current device versions are accurately listed within the system.

GUDID Submission Timelines

The GUDID submission timeline and process have been designed to ensure that the UDI is assigned within 12 hours of the time of submission and that a labeler has access to all relevant information in one place at all times.

The steps are as follows:

  • Submit your device record (DR) or modification to FDA’s Global Unique Device Identification Database (GUDID).
  • Within 12 hours after submitting your DR/modification, check the status of your DR/modification on the GUDID portal and review any errors reported by FDA for resolution. Once resolved, please upload your corrected version of your DR/modification. If no corrections are needed, proceed directly to Step 4 below: Labeler Notification Reassignment Letter (LRARL) generation.
  • Upon successful completion of these activities outlined above, you will receive an LRARL from FDA via email with instructions for downloading labels from our CDRH Labeling Information Management System website—the same site where labels were previously downloaded using CDRH’s legacy Labeling Information Management System (LIMS).

Submitting Information to the Global Unique Device Identification Database (GUDID):

Device labelers are required to submit information to the FDA-administered Global Unique Device Identification Database (GUDID). GUDID includes a standard set of basic identifying elements for each device with a UDI and contains ONLY the device identifier (DI), which serves as the key to obtaining device information in the database. GUDID does not include the production identifier (PI).

To submit information to GUDID, the device labeler must first request a GUDID account.

Conclusion

The UDI system is a great way to make sure that medical devices are properly tracked and identified. It helps ensure that they are not misbranded or adulterated, which could lead to serious harm or injury to patients. The FDA has made it clear that all Class 1 Medical Devices must be registered before being sold in the US. You should always be aware of your responsibility as a manufacturer when dealing with UDI requirements for any class of device, as well as understand how FDA UDI regulations apply specifically for each class level.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information: 

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Canadian Medical Device Classification (MDALL, MDL & MDEL Listing)

medical device classification in canada

How Medical Devices are Classified in Canada

Regulatory Classification Basics for your Medical Device: 

There are certain rules that apply to a medical device classification, and it varies between different regulatory agencies. The classifications are related to the perceived risk of the product type. Medical device manufacturers selling internationally need to familiarize themselves with the applicable regulations within the Canadian market.

Why does Regulatory Classification even matter for my Medical Device?

Knowing how your medical device is classified matters so that we can determine what is required to be done before the medical device is sold in Canada. Furthermore, the classification determines how the product is to be designed and what controls are required. Lastly, timelines around what it would take to bring your device to market and costs can be estimated once the device class is determined.

Medical Device Classification in Canada (MDALL, MDL, MDEL)

The medical devices regulations in Canada are established by the Government of Canada and regulated by Health Canada. There is a risk-based classification system defined by Health Canada for non-in vitro diagnostic (non-IVDDs) medical devices:

  1. Invasive Devices (Rules 1-3)
  2. Non-Invasive Devices (Rules 4-7)
  3. Active Devices (Rules 8-12)
  4. Special Rules (Rules 13-16)

For each of the broad categories, there are a set of rules that apply.  Manufacturers should follow these rules to determine the risk classification of their medical devices. For example, you are interested in marketing a percutaneous catheter in Canada. After reviewing the Risk-Based Classification System for non-IVDDs, we would determine for you that the percutaneous catheter is an invasive device. To classify the device, we’d review all the options and conclude that Rule 1 applies for you. Further, based on the intent of use, the medical device is classified as a Class II medical device in Canada. There are similar risk-based classification systems for in vitro diagnostic medical devices and Software as a Medical Device (SaMD).

Medical Device Licence (MDL) in Canada

Overall, there are four levels of medical device classifications based on the level of risk (low to high) in Canada: Class I, Class II, Class III, and Class IV.  Before going to market in Canada, a manufacturer must first apply for a medical device license (MDL).

Class, I medical devices do not require a license. There are different applications for Class II, Class III, and Class IV medical devices, and the application complexity increases as the risk classification increases.

There is a keyword index document available to assist manufacturers in verifying the class of medical devices is an alphabetical listing of all the short descriptors for devices that are entered into the medical devices system. This document contains synonyms and industry words that are used to describe these devices, along with their respective classifications.

Need MDALL, MDL, MDEL Registration & Listing Health Canada Assistance

 

Manufacturers of Class II, III, and Class IV medical devices can receive their MDL license by submitting a premarket application.  This can be in either the ToC or Health Canada formats, for entering the Canadian market. Additionally, the manufacturers should obtain an ISO 13485 certification with Medical Device Single Audit Program (MDSAP).

Medical Device Active Licence Listing (MDALL)

Once Health Canada approves the Medical Device Licence, the device information is maintained in the Medical Devices Bureau database for Class II, Class III, and Class IV devices. Class I medical devices do not require an MDL as they are monitored by the Health Products and Food Branch Inspectorate through establishment licensing.

The MDALL online query allows you to search for medical devices with an active MDL. A search can be done by company name, company ID, license name, license number, device name, and device identifier.  A device identifier is a unique series of letters or numbers or a combination of both, assigned by the manufacturer to identify the device. The catalog number of the device is often selected for this purpose.

Medical Device Licence Renewal in Canada

The medical device license renewal process in Canada has two purposes.  The first is to confirm whether the medical device will continue to be sold in Canada and whether the medical device license will remain active.  The second is to collect information that must be assessed prior to invoicing for market authorization.

Manufacturers of medical devices that are licensed for sale in Canada are required to inform Health Canada each year before November 1 that the information submitted with their license application and any subsequent amendments have not changed. This is referred to as the medical device license renewal process. Manufacturers of licensed Class II, III, and IV medical devices are charged an annual fee, payable at the time of license renewal, for the right to sell their devices in Canada. The fee is charged annually for the twelve-month period beginning on November 1 of each year. Manufacturers must notify Health Canada if there is a change regarding the regulatory correspondent or contact information previously submitted. Failure to do so may result in the cancellation of your medical license.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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Medical Device License (MDL MDEL SaMD) Under the Microscope

 

The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence (MDL) and the Medical Device Establishment Licence (MDEL) are the licenses issued by Health Canada, the Health Agency that regulates the medical devices sold in the Canadian market.

Medical Device License MDL MDEL SaMD

These licences are referred to as “medical device” and “medical device establishment,” respectively. In the Canadian market, medical devices are separated into four different classes: Class I, Class II, Class III, and Class IV.

Devices that fall into Classes II, III, and IV are eligible to receive Medical Device Licenses (MDL). In contrast, establishments that manufacture Class I medical devices are eligible to receive Medical Device Establishment Licenses (MDEL). In addition, the MDEL is granted to importers and distributors of all device classes.

A medical device license is a type of intellectual property (IP) license issued by Health Canada to authorize a manufacturer to sell its medical device in Canada.

Medical Device License (MDL) – Common License

It is a license required for a company to manufacture, import, distribute and sell medical devices in Canada.

A medical Device License (MDL) is a permit or license to sell medical devices. Health Canada issues this license. Furthermore, it is a requirement for all medical device manufacturing. Getting MDL becomes easy when you proceed with a reliable platform.

Medical Device Establishment License (MDEL)

Medical Device Establishment License (MDEL) is the document that provides evidence of compliance with the Medical Devices Regulations. The Medical Device Establishment Licence (MDEL) is an authorization issued by Health Canada under the authority of the Food and Drugs Act, which authorizes an establishment to manufacture or import/distribute a medical device.

The MDEL also authorizes an establishment to manufacture or import/distribute software that performs medical functions (SaMD). Health Canada regulates all medical devices that are marketed in Canada.

Renewal of MDEL and MDL

Before April 1 of each year, the MDEL goes through an annual review, and before November 1 of each year, the MDL for each device class goes through a renewal process. The application for the initial licence and the application for renewing an existing licence are both different from one another.

It is imperative to select the appropriate application in order to prevent any potential delays in the review process by Health Canada. Quality Smart Solutions has the knowledge and experience to successfully manage and complete the projects required by the Canadian Medical Device Regulator.

Do you need MDL, MDEL, or SaMD Assistance?

 

Software as a Medical Device (SaMD)

The software industry contributes significantly to the advancement of the healthcare sector. Any software product’s functionality, as well as the manner in which it is represented or labelled for use, determines whether it can be considered a medical device in accordance with the regulations set forth by Health Canada.

Software as a Medical Device (SaMD) is software that monitors or treats human health. Software as a Medical Device (SaMD) is software that has been demonstrated to meet the regulatory requirements of Health Canada’s Medical Devices Program. It can be used instead of an MDL but not in addition to an MDL.

Software as a medical device (SaMD) is a regulatory term used in Canada to describe the approval process for the software that performs medical functions. SaMD is also used as an electronic device offering healthcare services. SaMDs can be used to diagnose, treat, or prevent illness or injury.

Health Canada Medical Device and Quality Management System Requirements

It is essential to get a basic understanding of the whole procedure. It will not only make things easier for you but it will also save you time and money.

When applying for an MDL, you will also be required to demonstrate that you have a quality management system that is certified to ISO 13485 and is in compliance with the Medical Device Single Audit Program (MDSAP).

This demonstrates that your organization is able to fulfill the specific requirements outlined in the Canadian Medical Devices Regulations (CMDR).

Difference

Knowing the difference between MDL, MDEL, and SaMD licenses is essential because they are not interchangeable. However, these terms and licenses are required for different purposes.

The MDL is a license that is required for medical devices. It enables the manufacture, distribution, and sale of medical devices in the United States. This article will explain what the MDL is and what it does.

The MDEL is a Health Canada regulatory classification for medical device establishments. The MDEL licence is an establishment licence, which means that the holder of this licence is permitted to manufacture, import, and distribute medical devices within their specific establishment. This licence is usually granted to businesses that are involved in the production or distribution of medical devices.

The MDEL licence is an important qualification for businesses who want to produce or distribute medical devices. It allows these businesses to operate under strict safety and quality guidelines, and it also allows them to sell their products in a regulated market.

SAMDs are software that act as a medical device. The creation of software for medical devices is one of the areas of the healthcare industry that is expanding at the quickest rate.

Does Canada require that international producers have a local representative in the country?

No. In the case of medical devices, Health Canada does not mandate that a local representative be present. Applications for medical device registration can be submitted by foreign producers, and those applications can be held.

My device has FDA authorization; is there a fast-track for additional markets?

The approvals obtained in other countries are not recognized by Health Canada, and as a result, they do not provide you with any major advantages throughout the approval process. On the other hand, if an application is turned down in another jurisdiction, it can hurt the chances of getting it approved in Canada.

Because a significant portion of the material that must be provided for submissions to Health Canada is the same as that which must be provided for an EU technical file or a US 510(k), having these could potentially reduce the amount of time spent.

Conclusion

The MDL vs MDEL vs SaMD landscape is a complex one, but hopefully this article has given you a better understanding of the differences between these three types of medical devices licences available in Canada.

All medical devices imported into or offered for sale in Canada are subject to the Medical Devices Regulations (the Regulations). These were written with authority granted by the Food and Drugs Act (the Act). The Regulations outline the requirements that must be met for medical devices to be legally imported into Canada, sold there, or advertised there.

We hope you have now grasped the idea of all three terms (MDL, MDEL & SAMD). If you still have questions, feel free to ask the experts now.

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Learn more about MDEL Registration, License Class Determination, In Vitro Diagnostic Devices (IVD) Registration, SaMD Classification and Registration, or our MDEL Import Agent service.

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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CFIA Enforcement of Nutrition Facts Table & Food Labelling

 

The Canadian Food Inspection Agency (CFIA) is responsible for protecting Canadians’ health and safety by ensuring that food that reaches customers is safe, nutritious, and correctly labeled. The CFIA’s responsibilities also include enforcing federal food safety and nutrition regulations.

Nutrition Facts Table CFIA

As of July 1, 2016, the CFIA has begun to enforce the new Nutrition Facts Table (NFT) and food labeling regulations. It means that all food products sold in Canada must now comply with these new rules.

If you are a food manufacturer, importer, or retailer, it is important to understand these changes and how food labeling links your business with your customers. This blog post will provide an overview of the new NFT and food labeling requirements, as well as some tips on how to comply with them.

Overview of the CFIA’s Enforcement Process

The Canadian Food Inspection Agency (CFIA) ensures that food products sold in Canada are safe and properly labeled. The CFIA enforces federal food safety and labeling laws, such as the Food and Drugs Act and the Safe Food for Canadians Act.

The CFIA’s enforcement process begins when it receives a complaint or information about a possible violation. The CFIA will then investigate to determine if there is a federal law violation. If a violation is found, the CFIA will take appropriate enforcement action, including issuing a warning, recalling a seizure order, or prosecuting the offender.

The CFIA takes food safety and labeling violations seriously and will not hesitate to take enforcement action when necessary. However, the CFIA also recognizes that many unintentional violations can be corrected quickly and easily. In these cases, the CFIA may provide guidance to help businesses comply with the law.

Nutrition Facts Table and CFIA Changes

The Nutrition Facts table is a mandatory component of food labels in Canada. It must be easy to read and understand and provide information on the following nutrients: calories, fat, saturated, trans fat, cholesterol, sodium, carbohydrates, fiber, sugars, and protein. The table must also include each nutrient’s percent daily value (%DV).

The %DV tells you the percentage of each nutrient in a single serving in terms of the daily recommended intake. For example, if the %DV for sodium is 4%, then one serving of that food contains 4% of the daily recommended intake for sodium.

 

Recently, Canadian officials have made many changes to the nutrition fact table. Some of them are the following.

  1. Potassium has been included in the previously mentioned list of nutrients because of its significance in maintaining normal blood pressure. The majority of people in Canada do not consume sufficient amounts of this essential nutrient.
  2. Omit vitamin A and vitamin C because the diets of most individuals in Canada provide an adequate amount of these nutrients.
  3. Adding the levels of potassium, calcium, and iron that are measured in milligrams (mg)
  4. Including a footnote at the table’s bottom regarding the percentage of the daily value
  5. Consumers will have an easier time understanding how much sugar and other nutrients (like sodium) are in their meals if this information is provided, and it will explain that: A little amount would be 5% or less.
  6. The Nutrition Facts table can help you make wise and informed choices about the foods you eat. Use it to compare similar products and choose the one that best meets your nutritional needs.

Food Labelling

According to the Canadian Food Inspection Agency (CFIA), food labels must include certain information to help consumers make informed choices about the foods they purchase. The CFIA is responsible for enforcing these requirements and ensuring that food labels are accurate and up-to-date.

The Nutrition Facts table is one of the most important parts of a food label, as it provides information on the nutrient content of a food. The CFIA requires that all packaged foods sold in Canada include a Nutrition Facts table on their label.

The CFIA also regulates other aspects of food labeling, such as claims about a product’s benefits, ingredient lists, and nutrition claims. For example, claims such as “low fat” or “high in fiber” must meet specific criteria for a food label.

The CFIA has published several resources to help the industry comply with food labeling requirements, including a Guide to Food Labelling and Advertising and a toolkit for small businesses.

How does the CFIA Enforces the Regulations?

The Safe Food for Canadians Act and Regulations have rules about how food labels should look. The Canadian Food Inspection Agency (CFIA) makes sure these rules are followed. The CFIA verifies that the industry complies with the regulations through various activities, such as inspections, audits, and investigations. Food Labelling Links consumers with safe food.

If the CFIA finds that a company is not in compliance with the food labeling regulations, it may take enforcement action. Enforcement actions can range from issuing a warning to ordering a recall of the products in question. The CFIA also has the authority to issue fines and prosecute companies that do not comply with the law.

The CFIA takes food labeling violations seriously and will not hesitate to take enforcement action when necessary. The industry should be aware of the Safe Food for

Conclusion

The CFIA’s enforcement of the Nutrition Facts Table and food labeling is important in ensuring Canadians have access to accurate and up-to-date information about the foods they eat. This will help them make informed choices about the foods they purchase and ultimately lead to healthier eating habits.

How Quality Smart Solutions can help

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent.  Unlock your FSVP Certification with these 7 steps.

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FSVP Compliance: Regulatory Assessment Record Keeping

 

U.S.A RRA FDA Draft Guidance:

In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation of Remote Regulatory Assessments (RRAs). Questions and answers outlined the regulatory oversight during and after the COVID-19 pandemic. 

FSVP Compliance Record Reviews

The draft, “Conducting Remote Regulatory Assessments: Questions and Answers,” outlines the FDA’s use of RRAs to continue regulatory oversight in the short and long term. The draft guidance states that RRAs, which allowed FDA to assess an establishment’s compliance while there were travel restrictions, have been proven.  The FDA has determined that continued use of RRAs will benefit the post-pandemic world and across all FDA-regulated industries.

Remote Regulatory Assessments:

RRAs are optional in some situations, while they are required in others. For American food importers participating in the Foreign Supplier Verification Program (FSVP), RRAs are required. Establishments must make sure that the necessary FSVP documents are kept properly, in English, and easily accessible to FDA when it is implementing RRAs to evaluate their compliance because record-keeping is a crucial component of FSVP compliance.

Businesses that only import products are not regarded as facilities unless they also manufacture, process, pack, or store food. However, rather than FSVP for US importers, FDA would instead examine for compliance with the Supply Chain Program under 117 (like FSVP for food facilities).

FDA FSVP Record Reviews (FSVP Rule):

A range of activities for which the FDA may use multiple terminologies, but that are all deemed to be forms of RRAs, including remote interactive evaluations and remote record reviews, according to the FDA.

According to the FSVP rule, each imported product from each supplier must be supported by paperwork that shows FDA food safety compliance.

The FSVP needs to be updated at least every three years, or if important supplier/product information changes, such as the facility’s address, or when a new ingredient or procedure is added that has an impact on the hazard analysis or other FSVP evaluations.

Do you need help getting your FSVP certification?

 

FDA Timeframes for Establishment FSVP Records:

FDA assesses each situation individually before determining the required timeframe for an institution to submit records for a required RRA. However, importers are required by the Federal Food, Drug, and Cosmetics (FD&C) Act to deliver FSVP records “promptly to the FDA upon request.” The records must be supplied electronically or in another way that enables fast delivery when the FDA makes a written request for them.

The FDA Compliance Officer will ask for the records to be submitted using the FSVP Importer Portal for FSVP Records Submission during RRAs. The portal will ask importers to register for an account and upload the required FSVP information.

The documents need to be arranged and identified correctly. They might also be emailed in at other times. FDA is a legally recognized organization and will request physical records at the importer’s business headquarters.

What are the FSVP Non-Compliance penalties?

FDA may refuse a U.S. importer’s food imports at the U.S. port of entry (21 CFR 1.514(a)), and the importer may be in violation of section 805 of the FD&C Act if they don’t answer to the FDA’s request for FSVP reports. Among the behaviors that FDA may deem as declining to engage in a mandatory RRA are actions like withdrawing participation and refusing to give FDA access to records.

Additionally, FDA will issue a Form 483, summarising the inspectional observations, if violations are discovered during an FSVP inspection. FDA will publicly issue a Warning Letter, which can progress to issuing a public Import Alert 99-41 if an importer does not respond and take corrective steps within 15 days.

Once an Import Alert is issued, the FDA will detain an importer’s violative food shipments without the need for physical examination. This effectively can shut down an importer’s business.  Therefore, it is critical that your FSVP certification is done properly to avoid non-compliance penalties.

How Quality Smart Solutions can help

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent.  Unlock your FSVP Certification with these 7 steps.

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Canada Cosmetic Regulations: Cosmetic Notification Form (CNF)

 

Top Canada Cosmetic Regulations Cosmetic Notification Form (CNF)

Canada is one of the most popular tourist destinations in the world, and it’s no surprise that the country has some of the most stringent cosmetic regulations in the world.

Cosmetic Notification Form (CNF)

In this blog post, we’ll look at some of the top Canadian cosmetic regulations and what you need to do if you want to sell products in Canada. From ingredient lists to packaging, read on to learn everything you need to know about selling products in Canada.

What is a Cosmetic Notification Form?

A Cosmetic Notification Form (CNF) is a document that must be submitted to Health Canada before you commence the distribution of a cosmetic product in Canada. The person responsible for distributing the product must be listed on the cosmetic notification form. You must also include information about the product, such as its name, ingredients, and intended use.

To ensure that your cosmetic products are safe and meet Canadian safety standards, you must first submit a CNF to Health Canada. It will help Health Canada to ensure that your products are safe before they’re released to the market.

The CNF is important because it allows Health Canada to track any safety issues with your product. If Health Canada identifies any issues, they will reach out to you with corrective actions that will be required prior to continuing the sale of your cosmetic products.

If you want to distribute a cosmetic product in Canada, you must first submit a CNF to Health Canada.

What are the Cosmetic Notification Form Requirements?

The cosmetic notification form (CNF) is a document that cosmetics manufacturers in Canada must submit to Health Canada before they market their products. The CNF is an electronic registration form that must be submitted to the department prior to sale in Canada.

The CNF requires information such as the name and address of the manufacturer, the product ingredients, the product name, product form, and area of intended use.

The Cosmetic Notification Form requirements became effective on January 1, 2009. All cosmetic manufacturers wishing to market their products in Canada must register with Health Canada using the CNF.

How to File a Cosmetic Notification Form?

If you are selling a cosmetic product in Canada, you must file a Cosmetic Notification Form (CNF). You can file the form with the government agency that regulates cosmetics in Canada. The form requires information about the product, ingredients, and any manufacturers/distributors.

The CNF is used to:

  • Stop non-compliant products from being released into the environment
  • Check for safety issues with cosmetic products
  • Track products and their ingredients

You can find more information about filing a CNF on the Health Canada website.

Who Must File a Cosmetic Notification Form?

Cosmetic manufacturers and distributors must file a Cosmetic Notification Form (CNF) if they import, distribute or sell any cosmetic product in Canada that is not currently authorized for sale in Canada. The Cosmetic Notification Form must be filed with Health Canada before the cosmetic product can be sold in Canada.

The Cosmetic Notification Form must include the following information:

  • The name of the cosmetic product
  • The company name and address of the cosmetic manufacturer or distributor
  • The ingredients of the cosmetic product
  • The country of origin for the cosmetic product

Where Can I File a Cosmetic Notification Form in Canada?

A cosmetic Notification Form (CNF) is a form that must be filed with Health Canada in order to notify the regulator of any changes or updates to the cosmetic product’s ingredients, manufacturing processes, or labeling. The CNF must be filed for all cosmetic products, including personal care products.

To file a CNF, you must fulfil all the requirements. You need someone to help you out on the legal front. Only experts can help and guide you effectively throughout the process. It will make things a lot easier for you.

How long will it take for Health Canada to Process My Cosmetic Notification Form?

Cosmetic products that do not contain any restricted or prohibited ingredients will be processed immediately and a cosmetic number will be issued in 24 – 48 hours. Cosmetics that contain restricted ingredients will follow manual processing by Health Canada. A service standard for manual processing has not been established. 

Conclusion

The Cosmetic Notification Form (CNF) is a document that cosmetic companies must submit to Health Canada before marketing a new cosmetic product in Canada. The CNF includes details about the product, such as its ingredients and intended use, and information on how it will be marketed.

By law, all cosmetics products must contain safe ingredients in order to be sold in Canada.  For tips on how to complete your cosmetic notification form (CNF) click here:

CNF Infographic

How Quality Smart Solutions can help

QSS offers regulatory services from registering your cosmetic products to reviewing your cosmetic labels and submitting a cosmetic notification application to Health Canada.

We also offer FDA cosmetic product compliance solutions for USA Cosmetic Regulations.

Our experts are here to help and offer any cosmetic-related regulatory advice!

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Food Labelling & Health Canada Packaging Update 2022-12-15

 

Health Canada Announcement:

The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and they will apply to packaged foods high in saturated fat, sugars, and salt. A front-of-package emblem will need to be shown on these prepackaged foods in order to comply with the new requirements.

Food products carrying these new symbols are ones that meet or exceed daily amounts of saturated fat, carbohydrates, and salt. It is required that the sign, which is a magnifying glass in black and white with accompanying text, be visible on the front of all packages, that it be situated on the upper right side of the label, and that it be printed in both English and French.

Food Labelling Health Canada Packaging Updates

These new changes represent a significant cost investment for specific businesses operating in various food product segments specifically targeted by the regulations.

The food industry has been given until January 1, 2026, to make this change. However, you may start seeing the front-of-package nutrition symbol earlier.

Compliance Enforcement

The CFIA will begin to check compliance on December 15, 2022, and will use enforcement discretion when non-compliant enterprises have documented plans outlining how they intend to satisfy the new rules as soon as is humanly practicable.

Food labels have updated the list of ingredients and the nutrition data table to reflect these changes. Because of these revisions, the nutrition facts table and the list of ingredients will be improved so that they are simpler to comprehend.

This will assist the people in Canada in making decisions based on accurate information. It was decided to give the industry five years to make the necessary changes to their labels and use up any labels that had already been printed to meet the current requirements.

Despite this, because of the difficulties created by COVID-19, the Canadian Food Inspection Agency (CFIA) has decided that, for the first year, up to December 14, 2022, they would concentrate their efforts on education and the promotion of compliance.

Main sectors affected by these changes.

The changes that have been made to the nutrition facts table are subjected to help make healthier food choices. Now people will have access to more accurate information, and they will be able to know and decide what is good for them.

This transparency will develop trust between consumers and manufacturers as well.

  • Changes to the nutrition facts table
  • Changes to the serving size
  • Changes to the information on sugars
  • Changes to the information on sweeteners
  • Changes to the list of ingredients
  • Front-of-package nutrition labeling

Do you need help with the new Health Canada food labeling and packaging updates?

 

Food items that require symbols and those that do not:

The following are examples of foods that will need to display the symbol:

  1. Generally, prepackaged foods that reach or surpass 15 percent of the recommended value for saturated fat, carbohydrates, or salt are prefabricated (such as deli meats, soups, frozen desserts, or puddings).
  2. Foods sold in a pre-packaged form that includes 10 percent or more of the recommended value for saturated fat, carbohydrates, or salt and have a tiny reference quantity (meaning the amount of food a person generally takes in one sitting) are considered to be high in these nutrients (such as pickles, salad dressings, cookies or breakfast cereals).
  3. Main meals sold in a pre-packaged form with a reference quantity larger than or equal to 200 grams and that meets or exceeds 30 percent of the recommended value for saturated fat, sugars, or salt (such as frozen lasagna, meat pie, or pizza).

A few food items are excluded from this rule:

  1. Foods that are beneficial to one’s health, such as fresh, frozen, canned, or dried fruits and vegetables; 2% or whole milk; eggs; foods that contain a healthy fat profile, such as vegetable oils, nuts, and fatty fish; and any combination of these foods so long as they do not contain ingredients that contain saturated fat, sugars, and sodium.
  2. Foods that provide a source of nutrients that are not commonly accessible in other foods and that most Canadians do not receive enough of, such as cheese and yogurt, which include calcium and are manufactured from dairy products. These are examples of foods that fall into this category.
  3. Foods that are developed specifically to fulfill the requirements of a particular demographic, such as rations for usage by members of the armed forces.

Standard Format Details

Changes are introduced for the following standard formats

  • Language
  • Location
  • Orientation
  • Visibility
  • Order
  • Type
  • Leading
  • Rules
  • Indents
  • Colour in the Nutrition Facts Table
  • Crowding of Information and Narrowing the Nutrition Facts Table
  • Adjusting the Nutrition Facts Table Rectangle
  • Dividing the Nutrition Facts Table
  • Destruction of the Nutrition Facts Table Upon Opening of the Package
  • Abbreviations and Symbols in the Nutrition Facts Table
  • Presentation of Certain Additional Information in the NFT
  • Tailoring of the Linear format and Language Specifications

Abbreviations and Symbols in the Nutrition Facts Table

Consultations with members of the public back up the idea that readers often have trouble understanding what is meant when abbreviations are used. The following are the only acronyms that can be used in the Nutrition Facts table (NFT) because of this restriction on the number of allowed abbreviations:

  • “% Daily Value” or “% DV” for “Percent Daily Value” (English expression)
  • “% valeur quotidienne” or “% VQ” “pourcentage de la valeur quotidienne” (French expression)
  • “Vit” for vitamin
  • “kJ” for kilojoules

The shortened forms “% DV” or “% VQ” should be limited to the particular NFt figures they are authorized, as stated in the Directory of Nutrition Facts Table Formats. This will ensure that the information presented is accurate.

When the abbreviated form “% DV” and “% VQ” subheading is used within the NFt rather than the long form “% Daily Value” and “% valeur quotidienne,” the asterisk (*) that follows it also links the abbreviation to an explanation of its meaning, elsewhere within the table (i.e., * DV = Daily Value; * VQ = valeur quotidienne), as demonstrated in the example that follows.

Conclusion

The Canadian government has changed the information available on food and nutrition items. The information on the list of ingredients seen on food labels has been improved due to input from consumers and stakeholders.

Now customers will have more access to more information and can decide what is better for them and their children.

How Quality Smart Solutions can help

At Quality Smart Solutions, we have a team of experts who are skilled in Health Canada Food & Beverage Compliance.

We can assist you with your food label and packaging compliance/translation, Nutrition Facts Table creation, TMA License, Novel Food Notification, SFCR License, HACCP, or PCP setup.

We also offer GRAS Notification and Supplement Food Compliance Solutions.

Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

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Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023

The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments.

The fiscal year will begin on October 1st, 2022, and end on September 30th, 2023. All medical device facilities will have to pay these fees to remain FDA-compliant.

In this blog, we’re going to elaborate on everything that you should know going into 2023 and which we’ll elaborate on everything you should know including which fees may apply in 2023.

FDA Medical Device MDUFA Fees in 2023

Medical Devices and Establishments:

  • Certain medical device applications 
  • Periodic reporting on class III devices 
  • Annual registration of establishments 

All businesses that have sales that are less than $100 million in the most recent tax year can qualify as small businesses and pay a reduced fee on their applications.  If your business has sales of less than $30 million you can receive a waiver for your first premarket application or reports.

These Medical Device Establishment registration fees are consistent no matter the business size and must be paid to complete registrations.  There are no waivers or reductions for small businesses, establishments, or groups when it comes to this establishment registration fee.  This fee must be paid for every physical location a company owns that handles applicable medical device functions.  All medical device fees have increased to deal with inflation over the last year as a result of FDA suggestions.

What is the purpose of Medical Device User Fees:

  • User fees are used to fund FDA’s medical device regulatory programs
  • MDUFA fees are used to fund the medical device user fee program
  • FDA uses these fees to review new medical devices and monitor the safety of existing devices
  • FDA has a budget for these fees

FDA’s Medical Device User Fee Programs:

  • MDUFA VI is the sixth amendment to the Medical Device User Fee and Modernization Act (MDUFMA)
  • MDUFA VI was signed into law in December 2017
  • MDUFA VI will go into effect on October 1, 2022

FDA’s Proposed FY 2023 Medical Device User Fee Rates:

  • increase in fees for the first time since 2017
  • MDUFA VI rates are based on the number of submissions and inspections
  • MDUFA VI rates are based on inflation and volume
  • MDUFA VI rates are lower than the proposed FY 2023 MDUFA VI rates

FY 2023 MDUFMA Financial Highlights:

  • FDA is proposing to refund 50% of the user fee for 510(k) applications filed in 2023
  • FDA is proposing to refund 50% of the user fee for Premarket Reports filed in 2023

FDA’s Proposed FY 2023 Refund Policy for the Premarket Application User Fee and the Premarket Report User Fee:

  • FDA is proposing to refund 50% of the user fee for 510(k) applications filed in 2023
  • FDA is proposing to refund 50% of the user fee for Premarket Reports filed in 2023

How Quality Smart Solutions can help

FDA won’t consider medical device registrations to be complete until all required payments have been paid and the deadline for renewal is December 31st, 2022.  If not paid, the FDA can remove your registration from its database.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device licenses and registrations.  We can help you by responding to potential information requests, keeping your licenses and registrations updated, and reviewing your device labels. 

Contact us today to learn more about how we can support your compliance needs during and after licensing! For more assistance with FDA regulatory requirements call 1-800-396-5144, email: info@qualitysmartsolutions.com, or book a FREE regulatory consultation with one of our experts using the form.

How Quality Smart Solutions can help

How can Quality Smart Solutions help you ensure your 510k medical devices are FDA-compliant? We offer medical device license application services that consist of preparing and submitting applications, as well as handling communication with the FDA. Our team of experts can handle all medical licensing matters and are happy to help you with future projects or questions! Please find our contact information here:

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Top Natural Health Product Regulations in Canada

Natural Health Product Regulations

 

The Canadian government has a set of regulations in place for natural health products (NHPs). These regulations help to ensure the safety and quality of NHPs sold in the country. If you’re planning on selling NHPs in Canada, it’s important to be aware of these regulations.

Note: The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) after expanding its mandate to encompass non-prescription and disinfection medications (NHPs).

In this blog post, we will go over the top natural health product regulations in Canada. We’ll also provide some tips on how to comply with these regulations.

 

What is a Natural Health Product?

A natural health product (NHP) is a product that has been specifically designed to support and promote human health. They are often made from natural ingredients and can include vitamins, minerals, herbs, and other botanicals. NHPs are regulated by Health Canada and must meet specific safety and quality standards before they can be sold in Canada.

Natural health products have been used for centuries to support overall health and well-being. Today, they are an important part of many people’s lives and are used to treat a variety of conditions. Natural health products can be found in a variety of forms including tablets, capsules, tinctures, creams, and teas.

If you are considering taking a natural health product, it is important to speak with your healthcare provider first. This is especially important if you have any underlying health conditions or take any medications as NHPs can interact with these. Once you have decided that an NHP is right for you, be sure to purchase it from a reputable source and look for the Natural Product Number (NPN) on the front panel of the product label. This ensures that the product has been through Health Canada’s approval process and meets all safety and quality standards.

About the Regulations

Following extensive consultation with industry stakeholders, health care professionals, academics, and consumers in Canada, the Natural Health Products Regulations were drafted. They address the concerns of Canadians regarding the availability and safety of natural health products (NHPs), as well as the 53 recommendations made by the House of Commons Standing Committee on Health regarding the regulation of NHPs in Canada.

Every non-prescription health product (NHP) that is sold in Canada is required to have a product licence, and the facilities in Canada that produce, package, label, and import NHPs are also required to have site licences.

In order to get product and site licences, certain labelling and packaging standards need to be satisfied. Additionally, acceptable manufacturing procedures need to be adhered to, and appropriate evidence of safety and efficacy needs to be presented.

Do you need help with your NHP compliance?

 

What are the top natural health product regulations in Canada?

There are many different regulations that govern the production and sale of natural health products in Canada. The following is a brief overview of the main regulations governing these products:

Health Canada regulates the safety, quality, and labeling of natural health products. This includes ensuring that products meet safety standards set out in the Food and Drugs Act and Health Canada’s Regulations. Health Canada also reserves the right to refuse to register a product’s registration. It is done in the case if it believes that it is unsafe or not in compliance with applicable regulations.

The Natural Product Association of Canada (NPA) is a voluntary association of manufacturers, distributors, retailers, and consumers of natural health products. NPA operates an online marketplace where members can buy, sell and trade natural health products.

The Canadian Food Inspection Agency (CFIA) is responsible for regulating the food industry in Canada. Among other things, the CFIA oversees product safety, working with provincial/territorial agricultural regulators to ensure that food sold in Canada is safe to eat. The CFIA also regulates natural health products under its jurisdiction, including through its Registration and Approval Program for herbal medications and dietary supplements.

How to Obtain a Natural Health Product License

In order to obtain a natural health product (NHP) license in Canada, you must submit a complete application to Health Canada. This application must include:

  • A description of the product
  • Information on the ingredients, including a list of all medicinal ingredients and their amounts
  • The intended use(s) of the product
  • Any safety information, including any warnings or precautions
  • Any clinical information supporting the safety and efficacy of the product

After your application is received, it will be reviewed by Health Canada to determine whether the product meets the requirements for licensing. If your product is approved for licensing, you will be issued a Natural Product Number (NPN) which must be included on all labelling and advertising for your product.

Health Canada’s Regulatory Framework

In order to ensure the safety and efficacy of natural health products (NHPs) in Canada, Health Canada has established a comprehensive regulatory framework.

This framework includes:

  1. The Natural Health Products Regulations
  2. The Food and Drugs Act
  3. The Controlled Substances Act
  4. The Pest Control Products Act
  5. The Radiation Emitting Devices Act

The Natural Health Products Regulations (NHPR) are the primary piece of legislation governing NHPs in Canada. The NHPR sets out requirements for products that are to be sold as NHPs, including Good Manufacturing Practices (GMPs), labelling requirements, and product licensing.

Products that fall under the scope of the NHPR must obtain a product licence from Health Canada before they can be marketed in Canada. To obtain a licence, manufacturers must provide evidence that their products meet the requirements of the NHPR. Once licensed, manufacturers must comply with all applicable provisions of the NHPR, including GMPs and labelling requirements.

The Food and Drugs Act (FDA) is the primary piece of legislation governing food, drugs, and cosmetics in Canada. The FDA prohibits the sale of any food, drug, or cosmetic that is unsafe for human use. The term “drug” includes any substance or mixture of substances manufactured, sold, or represented for use in: diagnosing, treating, or preventing disease in humans; restoring, correcting or modifying organic functions in humans.

Requirements for Selling Natural Health Products

In order to sell natural health products (NHPs) in Canada, you must comply with the Natural Health Products Regulations. These regulations are designed to demonstrate the safety, efficacy, and quality of NHPs.

All NHPs must have a product licence before they can be sold in Canada. To obtain a licence, manufacturers and importers must submit a product licence application to Health Canada. The application must include evidence that the NHP meets specific requirements for safety, efficacy and quality.

Health Canada assesses all applications for NHPs on a case-by-case basis. In general, the department looks at three main factors when considering whether or not to issue a licence:

  1. Does the NHP pose any safety risks?
  2. Is there scientific evidence to support the claims made about the NHP’s efficacy?
  3. Does the NHP meet good manufacturing practices?

If you are planning on selling NHPs in Canada, it is important that you are familiar with these requirements. Failure to comply with the Natural Health Products Regulations could result in fines and/or jail time.

Conclusion

The top natural health product regulations in Canada are designed to protect consumers and ensure that they are getting safe and effective products. The natural health product regulations Canada regulations are constantly evolving, so it is important to stay up-to-date on the latest changes.

Get In Touch with Experts for FREE Consultation

By familiarizing yourself with the regulatory landscape, you can be confident that you are using natural health products that meet the highest standards of safety and quality.

For 6 important things to know about your NPN and the  NHPID click here:

How Quality Smart Solutions can help

At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

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Unlock 7 Steps to Verifying Your FSVP

 

Foreign Supplier Verification Program (FSVP)

Due to the increasingly global nature of today’s industry, an increasing number of businesses are searching for their suppliers overseas. Even though foreign sourcing has traditionally been difficult, the Foreign Supplier Verification Program (FSVP) established under the FSMA does not make the process any less difficult.

The obligation for guaranteeing that imported food items are safe has been transferred from the government to the corporations in accordance with the FSVP rule. In addition, the Food and Drug Administration (FDA) holds importers responsible for ensuring that food brought into the United States and Canada meets the requirements set out by the agency.

FDA FSVP Certification

We have listed the following seven steps for businesses that want to get their FSVP certification.

What is FSVP?

Importers put in place a program known as an FSVP Plan in order to ensure that their international suppliers produce food in a way that is safe for the general public’s health. These plans demonstrate that foreign suppliers export food that has not been adulterated, that allergies are properly identified, and that U.S. preventative controls or safety laws are met.

All food and drinks, food and color additives introduced during processing, nutritional supplements, packaging, and food contact substances are considered part of an FSVP Plan’s definition of “food.”

Follow the FSVP checklist to ensure timely results.

Step 1: Review Compliance Status

The Quality Inspector will initially make contact with a foreign supplier to investigate the latter’s present level of compliance. Additionally, the compliance history of the supplier is taken into consideration by the QI.

This is done by looking at warning letters from Customs, import warnings, and requirements for certification issued by the FDA in accordance with section 801(q) of the Food, Drug, and Cosmetic Act (FD&C Act).

Step 2: Perform Hazard Analysis

Importers are obligated to do a risk assessment on each and every food they bring into the country, evaluating not just the possible dangers but also the likelihood and severity of such dangers. The majority of the time, a danger analysis has already been carried out by a foreign provider. The QI will analyze the pre-existing hazard assessment and write their findings in these circumstances.

If a supplier does not have a hazard analysis, it is the obligation of importers to investigate the firm’s activities and seek for dangers that need to be controlled. If the investigation does not uncover any potential hazards, there will be no need for further product verification. Nevertheless, an importer is required to preserve a copy of the hazard study in their records as verification.

Do you need help getting your FSVP certification?

 

Step 3: Verify Suppliers     

Importers can check suppliers in several ways. On-site audits, frequent sampling, testing, and reviewing of food safety records and documentation are examples of verification procedures. Importers can do their own on-site audits or employ a third-party auditor to verify a foreign supplier’s activities. According to CFR Title 21, importers don’t need on-site audits unless a danger may cause significant health repercussions or death.

Importers who rely on product sampling and testing for verification must keep detailed records.

  • Sample kinds and numbers
  • Sample lot numbers
  • Tests
  • Corrective measures for dangers
  • Laboratory information
  • QI test documentation

FSVP importers can check food safety records. If so, they must keep track of the documents they evaluated, when they reviewed them, and what they were. They must also document their findings and remedial measures.

Step 4: Take Corrective Action

When necessary, importers have the authority to demand remedial steps from their suppliers. During verification efforts, it is possible to discover that a firm is not storing a product at the required temperature to prevent it from going wrong or that a company is picking lettuce after applying organic manure.

Both of these violations are considered fraudulent. It is possible that the investigation will determine that a corporation needs to provide bathrooms for its field personnel. Each of these cases calls for a unique course of action to be taken, illustrating how solutions will be unique to both individual businesses and individual products.

Step 5: Provide Importer Identification Upon Entry

A Data Universal Numbering System, or DUNS, the number is required for every business that deals in international trade. When submitting an entry form with Customs and Border Protection, importers are required to supply both their name and their DUNS number.  For an update on the DUNS requirement for 2022 Food Facility Registrations click here:

Step 6: Maintain accurate records over time

Additionally essential is the maintenance of extensive records. Importers are required by the FDA to keep documents relating to compliance status, foreign supplier verification efforts, hazard analyses, investigations, and remedial measures in accordance with the FSVP regulation.

Additionally, importers are required to undergo FSVP reassessments. Unless otherwise instructed, importers must preserve their records in either their original form, a photocopy, or digital format for at least two years. Additionally, the records must be made available to the FDA whenever they request them.

Step 7:  Reassess the FSVP plan consistently

After the verification process, an importer is free to purchase items from a supplier who has been approved. Nevertheless, a continuous focus on assessment and upkeep is necessary for an effective FSVP plan. According to the law, importers are required to conduct a reevaluation of their FSVP Plans every three years. An earlier evaluation is required to take place in the event that an importer becomes aware of new dangers associated with imported goods, such as a changed product formulation or a different source of raw materials.

FSVP Importers are required to take corrective measures if the evaluation determines that an imported food no longer satisfies the standards of the FSVP. Their actions may consist of deciding to update their FSVP Plan to guarantee that they screen suppliers in a more comprehensive manner or refraining from engaging with a supplier until that party has addressed any identified risks.

Before bringing food into the United States, importers must perform their own research as part of the Food Safety and Voluntary Program (FSVP). When it comes to compliance, taking a preventative stance is the best way to avoid difficulties in the future. Even if the food is safe and the overseas supplier is complying with regulations, the FDA has the authority to prevent shipments from entering the nation if it determines that a company’s FSVP efforts are deficient. Importers may better protect themselves and the food supply of the United States at the same time by following the FSVP checklist.

Conclusion

Due to the increasingly global nature of today’s industry, an increasing number of businesses are searching for their suppliers overseas. Even though foreign sourcing has traditionally been difficult, the Foreign Supplier Verification Program (FSVP) established under the FSMA does not make the process any less difficult.

The obligation for guaranteeing that imported food items are safe has been transferred from the government to the corporations in accordance with the FSVP rule. FSVP certification is essential to operate your business. If you are an FSVP importer, follow the above-mentioned FSVP checklist to get the desired results.

If you are busy, you can contact an expert to guide you further and make these steps of getting FSVP certification easier for you.

How Quality Smart Solutions can help

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent.  

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Inside Scoop MDL VS MDEL & SAMD: Medical Device License Unlocked

 

The Medical Device License is a legal document that is required for the manufacture, sale, and distribution of medical devices. A medical device license is a type of intellectual property (IP) license that is issued by the FDA to authorize a manufacturer to sell its medical device in the United States.  The MDL is the most comprehensive and stringent of these licenses.

Medical Device License SaMD, MDL, MDEL

There are three types of Medical Device Licenses: MDL MDEL and SAMD. The first type, the MDL – or “full” medical device license – is the most comprehensive and stringent of these licenses.

It is important to know the difference between MDEL and SAMD licenses because they are not interchangeable, and they are both required for different purposes.

Differences between MDL, MDEL & SAMD:

The MDL is a license that is required for medical devices. It enables the manufacture, distribution, and sale of medical devices in the United States. This article will explain what the MDL is and what it does.

The MDEL is an FDA regulatory classification for medical device products. It was created to provide a more accurate description of a product’s risk profile to help FDA staff determine how to handle the device’s regulation.  We can also operate as your MDEL Import Agent to ensure your products are successfully imported into Canada.

SAMDs are Medical Device Submissions submitted by manufacturers of Class II or III devices to comply with FDA regulations.

Let’s know more about each of them in detail while particularly focusing on the key differences.

Medical Device License (MDL) – Common License

It is a license that is required for a company to manufacture, import, distribute and sell medical devices in Canada.

A medical Device License (MDL) is a permit or license to sell medical devices. It is issued by Health Canada, and it is a requirement for all medical device manufacturers.

The MDL is a regulatory classification for class I, II, and III devices in the US and Canada. It is not a classification of the device itself but instead of the FDA’s regulatory authority over the device. The MDL was created in 1976 and updated in 1990 to include class III devices.

– A Class I device is defined as a device that does not require premarket approval from FDA, while Class II devices are those that require premarket notification to FDA before marketing.

Do you need MDL, MDEL or SaMD Regulatory Assistance?

 

Class III devices are those for which there is insufficient information about their safety and effectiveness to permit them to be marketed without premarket approval from FDA. 

Getting MDL is possible when you proceed with a reliable and authentic platform that has a 0% failure rate. The experts at reliable platforms always guide you about the right procedures and provide compliance solutions.

Medical Device Establishment License (MDEL)

Medical Device Establishment License (MDEL) is the document that provides evidence of compliance with the Medical Devices Regulations. The Medical Device Establishment License (MDEL) is an authorization issued by Health Canada under the authority of the Food and Drugs Act, which authorizes an establishment to manufacture or import a medical device.

The MDEL Health Canada SAMD is an authorization issued by Health Canada under the authority of the Medical Devices Regulations, which authorizes an establishment to manufacture or import software that performs medical functions. Medical devices are regulated by the FDA and Health Canada. The FDA regulates devices that are marketed in the United States, while Health Canada regulates devices that are marketed in Canada.

Software as a Medical Device (SAMD)

Software as a Medical Device (SAMD) is software that monitors or treats human health. It is not regulated by the FDA and does not require any type of licensing. The FDA has no jurisdiction over software as a medical device.

Software as a Medical Device (SAMD) is a software that has been demonstrated to meet the regulatory requirements of Health Canada’s Medical Devices Program. It can be used in lieu of an MDL, but not in addition to an MDL.

Software as a medical device (SAMD) is a regulatory term used in Canada to describe the approval process for the software that performs medical functions. The term SAMD is also used for an electronic device that offers healthcare services. SaMD’s can be used for diagnosis, treatment, or prevention of illness or injury.

MDL vs MDEL vs SAMD Under The Microscope

In order to import medical devices into Canada, the device must be approved by Health Canada. This approval is done through an MDEL license.

There are different types of licenses for medical devices:

MDL: Designated medical device license (MDL) for importing designated medical devices into Canada

MDEL: Medical device establishment license (MDEL) for manufacturing or importing medical devices in Canada

SAMD: Software as a designated medical device license

The software license is an MDEL Health Canada SAMD, while the MDL and the MDEL are specific subsets of this type of license.

MDEL is an abbreviated name for Medical Device Establishment License. This is a license issued by the Canadian government to authorize a medical device establishment to put their devices into commercial distribution. MDEL is mainly required when releasing new devices or when adding new technologies to existing devices.

Medical Device License Health Canada:

In Canada, there are two versions of the MDEL: SAMD and MDEL-H. The latter enables companies with established facilities to add new technologies without having to start from scratch with a whole new facility and provides easier access for small enterprises while still maintaining strict regulations. A company can have both types of licenses at the same time, but they will differ in what they cover or what kind of work can be done under each license.

A medical device can be licensed by Health Canada and Health Canada will then assign a Medical Device Establishment License (MDEL) to the company. The MDEL is given to the company to be able to import, wholesale, or lease devices for use in Canada.

The US FDA classifies software as a device. A Software as a Medical Device (SAMD) is considered similar to MDEL which requires certification from the FDA.

We hope that you have now clearly grasped the idea of all three terms (MDL, MDEL & SAMD). If you still have questions, feel free to ask the experts now.

If you need FDA Medical Device compliance assistance we can help with that as well!

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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Drug Identification Number (DIN) Unlocked Inside Scoop

How to obtain your Drug Identification Number (DIN)

 

Many drug industries are working in every country. To sell any OTC drug in Canada is not possible without its legal authorization. A computer-generated eight-digit number is issued to every drug in Canada from Health Canada before it comes to market. This eight-digit number is known as Drug Identification Number (DIN).

Drug Identification Number (DIN)

A Drug Identification Number indicates the information about the drug and whether it meets all the Food and Drug Act criteria and its Regulation. It gives a favorable risk/benefit profile of drugs. DIN is on the label of prescription or over-the-counter drug products evaluated and authorized for sale in Canada.

DIN is a unique number for every drug according to its quality, safety, dosage, and effect. Manufacturers must meet these criteria; then, DIN is issued to the drug. Such measures provide surety about the medicines that have been assessed and are safe for use. It must appear like DIN: 123456, for example. Avoid purchasing and using products that lack a DIN. It is a property of Health Canada.

Aim of DIN

The primary purpose of DIN is to protect the health and safety of Canadians from taking unsafe and unauthorized drugs. And to provide them with reliable, timely, and 100% accurate information on the availability of drugs in Canada.

Objectives

A DIN identifies the following characteristics:

  • Manufacturer
  • Product Name
  • Active Ingredients
  • Strengths of active ingredients
  • Pharmaceutical form
  • Route of administration
  • Guidance document

Need help obtaining your (DIN) Drug Identification Number?

The Guidance Document

For all the drugs that have been issued a DIN number, there is a guidance document that is applied (i.e., human and veterinary drugs, biologics, disinfectants, and radiopharmaceuticals. The change in this document is limited if that affects the status of DIN.

This document covers by Health Canada to the manufacturer the following activities:

  • Issuance of a DIN
  • Issuance of revised Drug notification
  • Market notifications’ filing
  • 12 months of sale without notifications’ filing
  • Discontinuation of sale notifications’ filing

This document does not include management of drug submission, reporting adverse reactions, user and the right to sell drug fees, licensing, and annual drug notification processes.

Medical devices, veterinary health products, natural health products, experimental treatments for humans and animals, pest control products, and cannabis for medical purposes regulated under Part 14 of the Cannabis Regulations are also not included.

A DIN must be obtained by the Manufacturers of prescription and non-prescription drugs before they market their products in Canada. A Notice of Compliance (NOC) may also be required for the market authorization of a drug.

Issuance of DIN

Drug DIN is issued to the manufacturer; he acts as an agent on behalf of Health Canada. Because of this association, a person or any partner sells a drug using their name or trade name. After providing all the details and satisfying Health Canada, DIN is issued.

Cancellation of DIN

DIN can be canceled if the person fails to provide the required information for the safety and efficiency of the drug for its recommended use or on notice of noncompliance. Every year manufacturers must provide a signed copy of their Annual Drug Notification Form to Health Canada. Their DIN will be canceled if they fail to provide it before October 1st.

Drug Notification Form (DNF)

Every manufacturer must fill out this form before October 1st so that all information supplied before is correct about the drug. For more information on ADNF, consult the Guidance Document- Fees for the Rights to Sell Drugs. This form contains all the information about drugs and DIN that Health Canada has authorized.

According to the Food and Drug Regulations, the manufacturer, within the 30 days after the drug has been sold first, its date and sign the completed DNF. Please return it to Health Canada with a statement that all the information is correct and identifies the first sale date.

Product Name

The product name of a drug is named by the manufacturer so that they can sell and advertise it. If a manufacturer wants to sell his drug (already assigned DIN) under two or more product names, then he must file an application for this purpose- a separate DIN will be assigned for a separate product name. No other DIN is issued to the same product but to different retailers. This means manufacturers can sell drugs privately, but the DIN of the same product and manufacturer name will remain the same regardless of the retailer’s separate stores.

Health Canada assigns only one DIN to the products with unfamiliar flavors, colors, and fragrances but has all other same characteristics as drug formulation, dosage, route, manufacturer, and product name.

Separate DINs will be issued to sugar and sugar-free drugs with the same manufacturer. Also, preservation and preservation-free formulations will be issued as separate DINs.

Expiry of Drug

The expiry date of the drug should be mentioned on the label. Drug expiry should contain its potency, purity, and physical characteristics. It should also mention when the medicine cannot be used. The expiry should be a minimum of a month or a year.

Label

A label can be any separate package inserted in the packaged drug or written on the container. Facts sheets, consumer/patient leaflets, product monograph, or any other material that contain information related to the drug. These labels may be included in the package or sent to the consumer at the time of sending.

New Drugs

The new drug that meets all the criteria Health Canada gives must have NOC and DIN for authorization of sale in Canada. Drugs before June 2018 were not given DIN, so they were offered to apply for DIN after June via the application. Manufacturers send a direct email of application (DNF) to Health Canada.

No new DINs are issued until the NOC is granted or other requirements are left. DIN is issued when the NOC is granted to the manufacturer. The original Din is given to the manufacturer if they mention any change in the process of the drug. Application for this purpose must be submitted as well. The DNF shows the market authorization, so no NOC is required.

The Bottom Line

No drug in Canada can be sold without issuing the Drug Identification Number (DIN). This is very important for the safety of every person in Canada. They take legal and authorized drugs that have benefits. Also, for the drugs that got DIN but are not sold by the manufacturer for 12 consecutive months (due to low market demand or any other reason), the manufacturer must write an application to Health Canada so that after proper roots, they consider the DIN of that drug dormant.

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How Quality Smart Solutions can help

Are you looking to have your drug product registered with Health Canada? Quality Smart Solutions has a team of experts who are skilled with DIN applications. If you need help with your Drug Establishment License (DEL) Registration we can help with that as well. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

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FSVP Plan: What you should know about FSMA-FSVP Certification

FSMA-FSVP Certification and FSVP Plan

The FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company to develop and maintain a plan that outlines how it will verify the safety of its food supply chain.

The FSVP-FSMA certification is required for all companies that want to export food products to other countries. It ensures that these companies are following the regulations set by the Food Safety Modernization Act, which was signed into law in 2011. The Foreign Supplier Verification Program (FSVP) provides this certification, which has been updated since its inception in 2012.

FSMA-FSVP Certification is a certification that is awarded to companies and organizations that have met the requirements of the FSVP Plan. The FSVP Plan was introduced by the Food Safety Modernization Act in 2011.

FSVP Program:

The FSVP Program is a voluntary program for food facilities to verify they are meeting FDA standards. This certification allows them to export their products with reduced inspections.

A company or organization can be awarded this certification if they follow the requirements of FSMP-FSMA and have successfully completed an FDA audit.

FSVP-FSMA – An Overview

FSVP stands for Food Safety Verification Program and FSMA stands for Food Safety Modernization Act. The FSVP Plan is a set of requirements to demonstrate that a company is compliant with the FSMA. A company can comply with the FSMA by either being certified or having an approved plan.

Need help with your FSVP Plan FSMA-FSVP Certification?

What is an FSVP Plan?

On May 30, 2017, the Foreign Supplier Verification Programs (FSVP) rule went into effect in the United States. The FDA Food Safety Modernization Act requires FSVP (FSMA). No matter where the food is produced, FSMA mandates that the same preventative food safety requirements apply to food eaten in the United States.

Importers are required by FSVP to confirm that the food they receive from overseas vendors meets all relevant FDA safety criteria. As your FSVP agent, Quality Smart Solutions is available. To find out more, call them right away.

FSVP Plans are required by the FDA for all food manufacturers. FSVP Plan ensures that you have a plan in place to prevent, detect, and respond to food safety hazards.

The FSVP Plan must include:

  • A written HACCP plan
  • A written preventive controls plan
  • An employee training program on the prevention of hazards and how to reduce or eliminate them

What Is FSVP certification?

FSVP certification is issued by the FDA for the “Food Safety and Veterinary Medicine” field. The FSVP Association is a non-profit organization that was founded in 2002. They offer this certification to food safety professionals and veterinarians who want to work in food safety.

This certification can be obtained by passing an exam and fulfilling a certain set of requirements. It is a voluntary program that helps to establish competency in food safety and veterinary medicine.

The FSMA-FSVP Certification program consists of three levels: Level 1 (basic), Level 2 (Enhanced), and Level 3 (Advanced). Companies can take advantage of the program based on their needs. For example, if a company just wants to register as an importer or as a foreign supplier, then they only need to complete Level 1 or Level 2. On the other hand, if they want to register as both an importer and a foreign supplier then they need to complete all 3 levels.

The FSVP Plan Certification is designed to help companies in the food industry comply with Food Safety Modernization Act (FSMA) rules, which are enforced by the FDA. The FSVP Plan Certification offers businesses a way to demonstrate their commitment to food safety, which may make them more attractive customers for other companies with similar interests.

Levels of FSVP Certification

The FSMA-FSVP Certification is a professional certification for food safety managers and supervisors. The FSVP stands for Food Safety and Quality Professionals. The FSMA-FSVP Certification is recognized as a valuable credential by employers and organizations that require food safety training.

The FSMA-FSVP Certification is recognized as a valuable credential by employers and organizations that require food safety training. There are three levels of certification: Basic, Enhanced, and Advanced.

Basic Certification

The basic certification is based on the FDA Guidance Document that was published on July 17, 2016. The Basic level of certification requires 30 hours of continuing education credits. It is designed to provide a general overview of the food safety and quality management system in the workplace with an emphasis on the fundamentals of the system.

Enhanced Certification

An enhanced certification includes additional requirements to demonstrate compliance with FSMA. The Enhanced level is more in-depth than the Basic Level. It includes an in-depth look at food safety regulations and practices, including HACCP principles, risk assessment, sanitation principles, personal hygiene practices, etc., as well as an understanding of how to apply these concepts to specific industries such as restaurants or grocery stores.

Advanced Certification

An advanced certification includes additional requirements to demonstrate compliance with the FDA Guidance Document and other guidelines such as HACCP and ISO 22000 standards. The advanced level requires 60 hours of continuing education credits. The FSMA-FSVP exam is a challenging test. The goal of the test is to evaluate your knowledge of food safety and quality assurance concepts, principles, regulations, and good practices. The advanced FSMA-FSVP certification also includes an evaluation of your ability to apply these concepts in the workplace.

This certification will provide you with the knowledge necessary to work as a food safety professional in the industry.

Want to know where to get FSMA-FSVP Certification? 

Quality Smart Solutions is a global consulting firm that provides strategic support for products, NHPs, pharmaceuticals, and medical devices. They are trusted by many clients in the industry to provide them with guidance on quality standards and regulations.

The FSMA-FSVP Certification training course will equip you with knowledge on the importance of food safety, how to be compliant with the regulations set by FSMA-FSVP and how to implement food safety best practices in your workplace. The certification process at Quality Smart Solutions is designed to help companies comply with the FDA’s Food Safety Modernization Act (FSMA) and the Foreign Supplier Verification Program (FSVP) requirements.

Get In Touch With Experts To Know Which Level Of Certification You Need!

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

30 Minute Free Consultation
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How Does FDA Classify Software As A Medical Device (SaMD)?

 

Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. The use of the software is fully incorporated into digital services for both medical and non-medical uses. One of three forms of software connected to medical devices is software that, on its own, qualifies as a medical device.

SaMD Software as a Medical Device

Software that is a part of a medical device (software in a medical device) and software used in the creation or upkeep of a medical device are the other two categories of software connected to medical devices. Due to this reason, FDA classifies software as a medical device (SaMD).

Let’s know about software as a medical device (SaMD) and why FDA classifies software as a medical device.

What is Software as a medical device (SaMD)?

Software is recognized as a medical device when it aids the healthcare system in a way that positively impacts one or two sectors or parts of the healthcare system without the usage of any hardware medical tools. This method demonstrates the benefits of using cutting-edge technological instruments that work as a software and don’t require any kind of physical setup.

The term Software as a Medical Device is very well defined and explained by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

The use of software as a medical device is on the rise, and we can see and comprehend the advantages it offers, particularly in emergencies or when patients want quick assistance. It can be applied to a wide variety of online activities, including VLANs, medical device operating systems, and industrial “off-the-shelf” platforms, to name a few. Previously, such software was regarded as “single-player software,” “healthcare industry software,” and/or “health operating systems” by businesses, global authorities, and healthcare professionals.

Why has the FDA classified Software as a Medical Device (SaMD)?

It is no secret that many nations throughout the world are still unaware of the enormous and significant benefits linked to the use of software for healthcare systems. Because of this, there is a need to raise public knowledge of its significance, importance, and overall influence of it on the healthcare system. The benefits of this software need to be made clear to the general public because they go well beyond those of conventional medical equipment. Harmonizing medical device regulations will be made easier with an understanding of these facts. FDA has classified software as a medical device to observe even further benefits of it in the future. IMDRF develops internationally agreed-upon documents related to a wide variety of topics affecting medical devices. In 2013, IMDRF formed the Software as a Medical Device Working Group (WG) to develop guidance supporting innovation and timely access to safe and effective SaMD globally.

 

Seeking Medical Device 510K or Software as a Medical Device (SaMD) Registration & Licensing?

How to know if your product is a part of the FDA? 

The definitions of Software as a Medical Device (SaMD) provided by IMDRF, and the FDA are essentially the same. It is also another supporting information that the FDA is also a member of IMDRF so when your product is approved by FDA, your software product can achieve the status of SaMD.

Firstly, it is important to know the quality of your product and whether it has the potential to be regarded as a medical device. The quality and the ability of the intended product can easily be evaluated in the light of the definition by IMDRF which says, “intended for one or more medical purposes”. FDA cites the FD&C act’s section 181(h) definition of a device, which reads as follows:

An item that is a tool, machine, implement, implant, contraption, in vitro reagent, or another similar or related item, including a component or accessory.

It must be:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Note: The term “device” does not include software functions excluded according to section 520(o).

Here it is worth mentioning that the term “intended use” refers to the actual use for which that particular software is designed and which particular problem it will address as a medical device.

How does SaMD qualify for 510k Registration?

The FDA is the regulatory body that sets out the standards for medical device registration. It reviews and approves any new medical device before it can be sold in the United States. The FDA is responsible for ensuring that these devices are safe and effective, as well as meeting certain requirements set out by law. A 510(k) clearance refers to a notification of a substantially equivalent device to an already cleared device. This notification allows the company to market its product without additional testing, providing that they abide by certain conditions set out by the FDA.

Final Verdict

Regulations and guidelines for SaMD still contain some ambiguities that will need to be clarified in the upcoming years. Concerning issues like cybersecurity, there is still considerable work to be done. The learning curve for software professionals transitioning into the medical device industry is very significant.

But this area also offers tremendous possibilities and excitement. We want you to reduce the effort required to create reliable software for medical devices by acquiring licenses so that your business can thrive through compliance and risk mitigation.

There is no reason why your organization can’t produce high-quality SaMD that enhances the quality of life for millions of patients with the appropriate tools and the finest available expert advice. One helpful platform in this regard is Quality Smart Solutions.

The time has arrived for you to realize your goal of having your software authorized as a medical device.

Need more information or want to know the SaMD licensing procedure?

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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FDA Facility Registration & Renewals (FDA Medical Device, Food & Drugs)

Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and Drug FDA domestic and foreign facilities!  With the facility renewal period fast approaching we’re going to touch upon the FDA Facility Registration and