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NDIN or FDA GRAS Certification? Which is Better in 2023?

Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is considered approved (and the product will not be considered adulterated upon formulation) for use, you have a decision to make: Do you wish to obtain ingredient approval through GRAS (Generally Recognized As Safe) or via NDI (New Dietary Ingredient)?

This blog will explore the concepts and requirements surrounding both GRAS and NDI to help you navigate your ingredients into the US food supply. We will discuss each pathway and reasons why your company may want to favour one over the other.

What Does Generally Recognized as Safe (GRAS) stand for?

GRAS stands for “Generally Recognized As Safe”. GRAS is the more flexible option as these decisions allow use in foods and dietary supplements no additional processing is applied to the ingredient. 

How Do I Classify my Ingredient as GRAS?

Ingredients can be self-affirmed GRAS or submitted via notification to the FDA for approval

Self-Affirmed GRASThe ingredient must be widely used in the food supply to meet the self-affirmed criteria. GRAS assessments require the substantiation/evidence to be made available to the public upon approval, thus limiting discretion. The requirement for proof is use in conventional foods for a long period of time and/or the food is considered safe by experts. Essentially you need to prove safe historical use. 

GRAS Notification to the FDA – FDA reserves the right to take 180 days or longer to evaluate a GRAS notification. Once an ingredient is approved via the GRAS route, it can be used in both food and dietary supplements. GRAS ingredients must meet the safety standard: reasonable certainty of no harm under the intended use conditions. GRAS ingredients must meet the lower GMP standards set out in 21 CFR 110. To summarize, this notification process takes longer to obtain but allows for use of the ingredient in food and dietary supplements.

What Does New Dietary Ingredient (NDI) Stand For?

NDI stands for “New Dietary Ingredient”. Unless considered an ‘old dietary ingredient’ (used in dietary supplement products prior to October 15, 1994), an NDIN (New Dietary Ingredient Notification) must be sent to and approved by the FDA. NDI approved ingredients are only approved for use within Dietary Supplements, thus limiting applications and uses of your ingredient. 

The NDI notification process will keep your submitted documentation largely between you and the regulator and is a good option for proprietary research/documentation. The NDI review standard is within 75 days, a considerably shorter timeline. NDI ingredients must meet the safety standard: does not present a significant or unreasonable risk of illness or injury. NDI ingredients must meet the higher GMP standards set out in 21 CFR 111. To summarize, this notification process is shorter in overall length, but only allows your ingredient to be used in dietary supplements. 

Summary

In conclusion, although the GRAS notification process takes longer on average it allows the most flexibility for end use (ie. use in dietary supplements and in food). NDI allows you to keep your documentation private, has a shorter review period but only allows you to market your ingredient within Dietary Supplements. There are pros and cons to each. Ultimately, how you wish to position your finished goods is the best deciding factor to choose GRAS or NDIN. The self-affirmed pathway allows for the quickest pathway to market, but you are still required to have significant evidence/proof. 

How Quality Smart Solutions can help:

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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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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