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Everything you should know about Cosmetic Labelling

Cosmetic Labelling

 

Introduction:

Cosmetic labelling is an essential part of developing and marketing cosmetics. Companies must meet government requirements for labelling, including ingredient listings, cautions and warnings, cosmetic claims, directions for use and other information needed for safety and consumer understanding. This guide outlines the necessary requirements of cosmetic labelling in Canada.

Understanding Cosmetic Labelling Regulations and Requirements:

Labelling requirements for cosmetics are outlined in legislation like the Cosmetic Regulations, the Consumer Packaging and Labeling Act and the Food and Drugs Act. It’s important to familiarize yourself with these regulations to ensure your labels meet all the necessary requirements. In addition, it is also essential that your labels are truthful, easy to understand, and provide adequate information to the consumer, including ingredient lists and product warnings.

Learn More About Ingredient Listings and Cosmetic Claims:

Cosmetic labels must list ingredients by their International Nomenclature Cosmetic Ingredient (INCI) name and in order of how much is present in the product from most to least. Ingredients must also be checked to ensure they are not present on the Cosmetic Ingredient Hotlist (Prohibited List), or that they comply with the restrictions per the Hotlist (Restricted List). Additionally, cosmetic labels may make certain claims about the product, such as “moisturizes” or “cleanses skin” so it’s important to be familiar with the regulations around these types of statements, and at what point they become unacceptable.

 

Understand Cautions & Warnings and Special Packaging Guidelines:

Labels that could be considered a possible health hazard must include appropriate caution and warning statements, such as ” “CAUTION: This product contains ingredients that may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made.” Special packaging guidelines must also be followed for any cosmetics packaged in a pressurized container (e.g., aerosol deodorant). Safety data sheets should be maintained for cosmetic products and should be kept on file until the product has been sold or disposed of.

Determine the Right Way to Display Safety Information and Expiration Dates on Labels:

Cosmetic products are not required to display an expiration date, however it may be ideal to include a “Best Before” date, to ensure product freshness and quality. This should be located near the name and address information, to clearly indicate when the product may no longer be safe to use. Safety symbols (e.g., pressurized container, flammable symbols) should also be included on labels where appropriate, to concisely communicate potential risks associated with the product. It is important to adhere to established labelling regulations in order for your products to remain in compliance with applicable industry standards.

Evaluation of Cosmetic Label Claims:

When formulating a cosmetic product with purposeful ingredients, it’s important to closely evaluate the claims being made on the label. Cosmetics cannot contain “active” or “medicinal” ingredients, therefore any claims that are made for the product must be generalized and cosmetic in nature. Cosmetic claims may refer to the product performance, but only without attributing a therapeutic effect. They may only describe effects in the context of appearance/scent. For example, “Our shampoo makes your hair soft and healthy looking.” would be an acceptable cosmetic claim. The nuances of cosmetic vs. health claims can sometimes be tricky, so it’s important to evaluate your cosmetic claims to ensure they are compliant with the regulations.

CNF Infographic

The importance of accurate cosmetic labelling: A guide for brands

When it comes to cosmetic products, accurate labeling is crucial for both consumer safety and regulatory compliance. This section will provide all the information you need to understand cosmetic labeling requirements, including the types of information that must be included on product labels and the regulations governing cosmetic labeling.

Understand the regulations and requirements for cosmetic labeling


Before creating your product labels, it’s essential to understand the regulations and requirements for cosmetic labeling. In the United States, the Food and Drug Administration (FDA) regulates cosmetic labeling under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These regulations require that cosmetic labels include specific information, such as the product’s name, net weight or volume, and a list of ingredients in descending order of predominance. It’s vital to ensure that your product labels comply with these regulations to avoid legal issues and ensure consumer safety.

Use clear and concise language on your labels


When creating cosmetic labels, it’s essential to use clear and concise language that consumers can easily understand. Avoid using technical jargon or complicated language that may confuse or mislead consumers. Use simple language to describe the product’s benefits, ingredients, and usage instructions. Additionally, include any necessary warnings or precautions to ensure consumer safety. Clear and concise language on your labels can help build consumer trust and improve the overall user experience.
Include all necessary information, such as ingredients and warnings.

Accurate cosmetic labeling is crucial for brands to ensure consumer safety and regulatory compliance


It’s essential to include all necessary information on your labels, such as a list of ingredients, usage instructions, and any vital warnings or precautions. This information not only helps consumers make informed decisions about the products they use, but it also helps to build trust with your brand. Make sure to use clear and concise language that is easy for consumers to understand, and avoid using technical jargon or complicated language that may confuse or mislead them.

Ensure accurate and consistent labeling across all products


It’s crucial to ensure that all your products are accurately and consistently labeled, regardless of size or packaging. This includes ensuring that all necessary information is included on the label, such as the product name, list of ingredients, usage instructions, and any essential warnings or precautions. It’s also important to ensure that the font size and style are consistent across all products and that the label is easy to read and understand. By maintaining accurate and consistent labeling, you can help to build trust with your customers and ensure their safety when using your products.

Regularly review and update your labeling to stay compliant with changing regulations


Regulations surrounding cosmetic labeling can change frequently, so it’s crucial to stay up-to-date and ensure your labeling remains compliant. This may involve regularly reviewing and updating your labeling to reflect regulations or industry standard changes. It’s also essential to ensure that your labeling is consistent across all products and that any changes are communicated clearly to your customers. By staying compliant with regulations and maintaining accurate labeling, you can help protect your brand’s reputation and ensure the safety of your customers.

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FDA Draft Guidance Labeling Plant Based Milk Alternatives in 2023

Labeling Plant Based Milk Alternatives

Introduction:

The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of plant-based products marketed and sold as alternatives to milk (plant-based milk alternatives, or PBMA).

This draft guidance will provide industry with recommendations that will result in clear labelling, allowing consumers to make more informed purchasing decisions. It also clarifies that some PBMA’s common or usual names have been established by common usage, such as “soy milk” and “almond milk.” 

Purpose of the Guidance:

The purpose of this guidance is to provide FDA’s current position on the naming of plant-based foods marketed and sold as milk substitutes (plant-based milk substitutes) in accordance with sections 403(a)(1) and 403(i)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(a)(1) and 343(i)(1)). Our recommendations on the use of voluntary nutrient statements are also included in the guidance. The use of these voluntary nutrient statements by the industry would provide consumers with additional nutrition information to assist them in understanding certain nutritional differences between these products and milk and making informed dietary choices.

Background:

In 2018, the FDA issued a notice seeking public feedback on how consumers use PBMA products and how they understand the term “milk” when it appears in the names of products made from soy, peas, and nuts. More than 13,000 comments were received by the agency.

FDA Comment Review:

Following a review of these comments and focus group studies with consumers, the FDA concluded that consumers generally understand that PBMA do not contain milk and choose PBMA because they are not milk. Many consumers, however, may be unaware of the nutritional differences between milk and PBMA products.

Almond or oat-based PBMA products, for example, may contain some calcium and be consumed as a source of calcium, but their overall nutritional content is not comparable to milk and fortified soy beverages, and thus they are not included in the dairy group in the Dietary Guidelines, 2020-2025. Both public comments and focus groups assisted the agency in developing its recommendations in this draft guidance.

FDA Recommendations:

The FDA recommends that PBMA products with the term “milk” in their names, such as “soy milk” or “almond milk,” and with a nutrient composition that differs from milk include a voluntary nutrient statement that conveys how the product compares to milk based on USDA’s Food and Nutrition Service (FNS) fluid milk substitutes nutrient criteria.

How will this assist customers?

These statements will assist consumers in making informed dietary choices by explaining certain nutritional differences between plant-based products labelled with “milk” in their names and milk. If a PBMA does not have “milk” in its name but is labelled with another term such as “beverage” or “drink” and does not make a claim comparing the product to milk, then the voluntary nutrient statement recommendations in the draft guidance do not apply.

To Submit Comments:

Comments on the draft guidance should be submitted within 60 days after publication in the Federal Register. You may submit electronic comments to Regulations.gov. All written comments should be identified with the docket number FDA-2023-D-0451 and with the title of the guidance document.

For More Information:

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Health Canada Latest Draft Guidance (Biologic Regulations, Drug Labelling, NDS/ANDS & Drug Submissions Rolling Reviews)

Health Canada Drug Draft Guidance

 

Introduction:

Submitting a new drug to Health Canada can be a complex and time-consuming process. This post will provide essential information about the regulations, legal requirements, and specific steps involved in the submission process for new drugs in Canada.

Health Canada has been busy lately releasing several draft guidance documents related to drug compliance in Canada. In this blog, we’re going to summarize all the following guidance documents for your convenience.

What is NDS Health Canada?

NDS Health Canada stands for Natural Health Products Directorate, a division of Health Canada responsible for regulating natural health products in Canada. Natural health products include vitamins, minerals, herbal remedies, homeopathic and traditional medicines. The NDS Health Canada ensures that these products are safe, effective, and of high quality before they are sold to the public. They also provide guidance and support to manufacturers and distributors of natural health products to ensure compliance with regulations.

What are the requirements for obtaining NDS Health Canada approval?

A drug must undergo a rigorous review process to obtain NDS Health Canada approval. This process includes pre-clinical testing, clinical trials, and a thorough evaluation of the drug’s safety and effectiveness. The drug must also meet all regulatory requirements and be manufactured in a facility that meets Health Canada’s standards. Once a drug has been approved, it is closely monitored for any potential safety concerns.

What is the process for applying to NDS Health Canada?

The process for applying to NDS Health Canada can be lengthy and complex. It typically involves several stages, including pre-submission consultations, the submission of a New Drug Submission (NDS) or Supplemental New Drug Submission (SNDS), and a review and evaluation process by Health Canada. The application must include detailed information about the drug’s safety, efficacy, quality, manufacturing process, and potential risks or side effects. It is important to work closely with Health Canada throughout the application process to ensure all requirements are met and the drug is approved promptly.

How to Prepare for a New Drug Submission?

Before submitting a new drug to Health Canada, it is important to make sure all clinical trials and other research related to the product have been completed. This includes testing for safety and efficacy, as well as documenting the manufacturing process for the drug. Additionally, it’s important to create documentation that explains how the drug works and its potential side effects. All this information must be submitted with the application for approval.

Who Can Apply for New Drug Submissions?

According to regulations set forth by Health Canada, only drug manufacturers and those with exclusive rights can submit a new drug for approval. Drug company owners and officers, research scientists, pharmacists, as well as individuals who have law degrees and specialized knowledge of pharmaceuticals, are all eligible to apply for approval. Alternatively, companies that market drugs on behalf of drug makers are also authorized to apply for approval.

What are the regulatory framework rules for new drug submissions in Canada?

Health Canada regulates the approval and sale of all drugs in Canada. The regulatory framework for new drug submissions is outlined in the Food and Drugs Act and Regulations. The process involves several stages, including pre-clinical testing, clinical trials, and a thorough review of the drug’s safety and efficacy data. The submission must also include information on the drug’s manufacturing process, labeling, and packaging. Once the submission is complete, Health Canada will review the data and decide on whether to approve the drug for sale in Canada.

Why are NDS pre-clinical and clinical studies important to gather data on safety and efficacy?

Pre-clinical and clinical studies are important to gather data on the safety and efficacy of a new drug. Pre-clinical studies are conducted in the laboratory and involve testing the drug on cells and animals to determine its potential toxicity and effectiveness. Clinical studies involve testing the drug on humans to determine its safety and efficacy in treating the targeted disease or condition. These studies are crucial in providing evidence to support the safety and efficacy of the drug and are required by Health Canada for a successful new drug submission.

How to prepare a New Drug Submission (NDS) package?

To prepare a successful New Drug Submission (NDS) package for Health Canada, it is important to follow the guidelines and regulations set forth by the agency. The package should include detailed information on the drug’s safety and efficacy, including pre-clinical and clinical study data. It should also include information on the drug’s manufacturing process, labeling, and packaging. It is important to work closely with Health Canada throughout the submission process to ensure all requirements are met and any questions or concerns are addressed promptly.

How to submit the NDS to Health Canada and respond to any requests for additional information?

Once the NDS package is complete, it can be submitted to Health Canada for review. The agency will then conduct a thorough review of the package and may request additional information or clarification if needed. It is important to respond to these requests promptly and provide all requested information to ensure a successful review process. It is also important to work closely with Health Canada throughout the review process and address any concerns or questions they may have. Once the review is complete and the drug is approved, it can be marketed and sold in Canada.

Health Canada’s Latest Draft Guidance for Drugs in Canada:

  1. Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use
  2. Update Regulations for Biologic Drugs
  3. New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
  4. Management of Rolling Reviews for Drug Submissions

1. Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use:

Health Canada launched a consultation on a proposal to amend the labeling of pharmaceutical drugs for a human use guidance document on December 21, 2022. The proposed changes were to sections C.01.004(1)(a) and C.01.011 of the Food and Drug Regulations.

What are the Proposed Changes?

We have summarized the proposed regulatory amendments for your convenience:

2.1.1 Principal Display Panel

“The standard for the drug product, if any;” will no longer need to be displayed on the principal display panel.

3.4.2.1 Proper Name

It will no longer be a requirement to list the standard of manufacture near the proper name of the drug, instead, Health Canada proposes leaving it up to the discretion of the sponsor whether or not they “would like to include the standard of manufacture”, but if they do, should still include it near the proper name.

3.4.3 Standard of Manufacture

Health Canada is proposing removing “Under subsection C.01.004 (1) of the Regulations” from Under subsection C.01.004 (1) of the Regulations, where a standard prescribed by the Regulations exists (see Section 3.4.3.1, “Prescribed Standard”) and it applies to the specific drug product, it shall be included on the principal display (main) panel of the inner and outer labels. Additionally, the proposed changes “it shall be included” to “it may be included” from the above statement.

3.4.3.1 Prescribed Standard

It will no longer be required to include on the label the CSD standard, however, the drug substance must still conform in all aspects to that standard.

3.4.3.3 Manufacturer’s Standard

The proposal removes both references to sections C.01.011 & C.01.011 (4) of the Regulations:

By section C.01.011 of the Regulations, no person shall use a manufacturer’s standard for a drug that provides (a) a lesser degree of purity than the highest degree of purity, or (b) a greater variation in potency than the least variation of potency, provided for that drug in any publication mentioned in Schedule B to the Act.

3.4.3.5 Placement of Standard on Labelling

The proposal removes “(see subsections 10(1) and (2) of the Act)”, and “this standard” from Where a standard of manufacture is to be shown on a label (see subsections 10(1) and (2) of the Act), this standard should be declared near the prescribed or proper name of the drug product. The quantitative amounts may be indicated before or after the prescribed or proper name (e.g., Conjugated Estrogen Tablets CSD 1.25 mg, Acetaminophen Tablets USP, 325 mg).

3.5.5 Declaration of Medicinal Ingredients

The proposal removes the footnote from “However, when a standard exists for the entire combination, then this standard must normally 10 be declared on the main panel of the label” and also changes “must” to “may”.

5.4.5 Prescribing Information

The proposal removes “Standard of manufacture where required by the Regulations;” from the prescribing information (or professional information) for new drug products not conforming to the Product Monograph format or not subject to Division 8 of the Regulations.

2. Update to Health Canada Regulations for Biologic Drugs:

Health Canada issued a notice to stakeholders on December 16, 2022, regarding their proposal to amend the regulations for biologic drugs (Schedule D drugs) in Division 4, Part C of the Food and Drug Regulations.

This notice is for businesses that manufacture, package/label, test, store, import, distribute, and/or wholesale biologic drugs.

The goal of this proposal is to:

  • support current biological drug practices.
  • and better address scientific and technological advances.

Scope

This is true for drugs on Schedule D of the Food and Drug Act (FDA)

  • Division 4 of Part C of the Food and Drugs Regulations applies to biologic drugs.
  • The FDA’s Schedule D contains legislation for biologic drugs to which Division 4 applies.

What are the changes?

The amendments to Division 4 propose to:

  • Replace existing Division 4 regulations (from C.04.001-C.04.683 to C.04.001-C.04.010)
  • Add a new regulation to Division 2 (C.02.012.1)
  • Amend a regulation in Division 8 (C.08.003.1)

Need help navigating the latest Health Canada draft guidance for OYTC drugs?

3. Proposed changes in New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs):

On December 22, 2022, Health Canada opened a consultation on a proposal to amend the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)

S.3.1 Structure and Other Characteristics Elucidation

Confirmation of structure should be provided based on the synthetic route and spectral analyses. Information such as the potential for isomerism, stereochemistry identification, and the ability to form polymorphs should also be included.

To: Confirmation of the molecular structure of the drug substance should be provided using spectroscopic and other relevant techniques. Data addressing potential isomerism, including absolute and relative stereochemistry, should be provided where applicable. The characterization should use appropriate techniques when elucidating the internal structure of the drug substance (such as amorphous or alternative crystalline forms) (such as single crystal and powder x-ray diffraction). Use samples that are representative of the proposed manufacturing process.

S.3.2 Impurities – Determining Potential and Actual Impurities

From: Potential impurities should be investigated for structural alert(s). When appropriate, any potentially mutagenic impurities should be assessed and controlled by ICH M7.

To: Potential impurities should be investigated for structural alertness (s). When appropriate, assess and control any potentially mutagenic impurities, including the potential formation or introduction of high-potency mutagenic carcinogens identified in the ICH M7 guideline as the cohort of concern (aflatoxin-like, N-nitroso, and alkyl-azoxy compounds).

S.4.1 Specification – Specifications

From: If a Schedule B compendial monograph applies to the drug substance, a sponsor may declare a Manufacturer’s Standard on the label (which indicates that the material may differ in some respect from the compendial standard). However, under section C.01.011 (4) of the Food and Drug Regulations, no one shall use a manufacturer’s standard for a drug that provides (a) a lesser degree of purity than the highest degree of purity and (b) a greater variation in potency than the least variation in potency provided for that drug in any publication mentioned in Schedule B to the Act.

To: If a Schedule B compendial monograph applies to the drug substance, a sponsor can choose to declare a Manufacturer’s Standard on the labelling (which indicates that the material may differ in some respect from the compendial standard).

Added: The drug substance specification should include routine testing for nitrosamine impurities when the risk for presence is high or the concentration of any nitrosamine is at significant levels (for example, greater than 30% of the acceptable intake limit).

P.2 Pharmaceutical Development – Dosage and Administration

Added: The measures are taken during development to reduce the presence of high-potency mutagenic carcinogens (aflatoxin-like, N-nitroso, and alkyl-azoxy compounds) identified in the ICH M7 guideline as the cohort of concern in the drug product and its components

Sections 2.3 and 3.2.P.2 of the drug application include a risk assessment for the potential presence of nitrosamine impurities in the drug product.

Analytical data, procedures, and proposed controls should be included in the appropriate sections of the drug application (e.g., 3.2.S.2, 3.2.S.4, 3.2.S.7, 3.2.P.3, 3.2.P.4, 3.2.P.5, 3.2.P.7, 3.2.P.8)

P.5.1 Control of Drug Product: Specification(s)

From: If a Schedule B compendial monograph applies to the drug product, a sponsor can choose to declare a Manufacturer’s Standard on the labelling which indicates that the material may differ in some respect from the compendial standard. However, according to section C.01.011 of the Food and Drug Regulations, no person shall use a manufacturer’s standard for a drug that provides (a) less purity than the highest degree of purity and (b) a greater variance in potency than the least variation in potency, provided for that drug in any publication mentioned in Schedule B to the Act.

To: If a Schedule B compendial monograph applies to the drug product, a sponsor can choose to declare a Manufacturer’s Standard on the labelling which indicates that the material may differ in some respect from the compendial standard. However, the specifications must be acceptable to the Minister.

Added: Routine testing for nitrosamine impurities should be included in the drug product specification when:

  • the potential for nitrosamine introduction during drug product manufacturing, packaging, and storage is identified or
  • a nitrosamine impurity is detected in the drug product during confirmatory testing and the root cause of its presence is unknown.
  • Where such a risk is identified, a test and acceptance criteria for both release and shelf-life specifications should be included in the drug application.

4. Management of Rolling Reviews for Drug Submissions:

New amendments to the Food and Drug Regulations are being proposed by Health Canada. “New provisions that enable the rolling review of a new drug submission (NDS) or supplement to a new drug submission (SNDS) that meets specific eligibility conditions” are among the amendments.

If a sponsor meets certain eligibility criteria, the amendments will allow them to apply for rolling review status for future drug submissions.

This rolling review status will allow a sponsor to file a drug submission to Health Canada without providing all of the necessary information about the drug’s safety, efficacy, and quality. Once a drug submission has been filed, the sponsor will have a certain amount of time to provide the missing information. Eligibility for a rolling review will not change the safety, efficacy, and quality requirements outlined in Part C of the associated regulations.

Scope and Application:

This draft guidance document is intended for sponsors who want to apply for rolling review status for a future drug submission as well as sponsors who have already filed a submission that has been granted rolling review status.

The document also applies to rolling reviews of drug submissions that are related to vaccines under the “List of Influenza Vaccines for Which Supplements to New Drug Submissions Can be Filled”.

The Health Products and Food Branch is responsible for regulating drugs for human and veterinary use by the Food and Drugs Act (act) and its regulations.

This guidance document does not apply to the following submissions:

  • drug submissions eligible for a rolling review for a public health emergency drug for COVID-19 or a condition described in the List of conditions that threaten public health in Canada.
  • veterinary drug submissions undergoing joint or simultaneous reviews with foreign regulatory authorities.

The rolling review option does not apply to the following:

  • abbreviated new drug submission (ANDS) pathway.
  • supplement to an abbreviated new drug submission (SANDS) pathway.
  • submission classes with a performance standard of 120 days or less.

Objectives of the Policy:

The goal of this change is to give Health Canada the option of receiving information for an eligible new drug submission or supplement to a new drug submission (SNDS) after the submission has already been filed. Furthermore, this change will aid in the resolution of issues earlier in the rolling review process and provide more opportunities for interactions between Health Canada and the sponsor. All of this will help to expedite access to the Canadian market if evidence of safety, efficacy, and quality is presented.

1. What are Health Canada’s drug labeling requirements for new drug submissions?

Health Canada has specific requirements for drug labeling, including details on product names, ingredients, dosage, warnings, and more. Manufacturers must comply with these regulations when submitting a new drug application.

2. Do drug manufacturers need to provide bilingual labeling for their products in Canada?

Yes, Health Canada mandates bilingual labeling for drug products, meaning labels must be in English and French to cater to the bilingual population.

3. What information should be included on drug labels for new submissions?

Drug labels should include essential information such as the drug’s name, active ingredients, dosage instructions, contraindications, warnings, and special handling instructions.

4. How do I ensure accurate translations for the French portion of drug labels?

Manufacturers should work with professional translators who are well-versed in medical terminology to ensure accurate translations for the French portion of drug labels.

5. Are there specific font size and legibility requirements for drug labels?

Health Canada has guidelines on font size and legibility to ensure that drug labels are easily readable by consumers and healthcare professionals.

6. Can drug manufacturers use a standardized template for labeling in new drug submissions?

While there are industry-standard labeling templates, manufacturers must customize them to meet the specific requirements of their new drug submissions.

7. What is the timeline for reviewing drug labeling in new submissions by Health Canada?

The review timeline can vary, but Health Canada aims to review new drug submissions efficiently to ensure drug labels meet regulatory standards.

8. What happens if a drug label does not meet Health Canada’s requirements?

Non-compliance with drug labeling requirements can delay the approval process for new drug submissions. Manufacturers may need to make necessary revisions to meet regulatory standards.

9. Are there any exemptions or special considerations for certain types of drugs or manufacturers?

Health Canada guides exemptions and special considerations for specific drug categories or unique situations. Manufacturers should consult Health Canada’s resources for details.

10. Where can drug manufacturers find comprehensive guidance on drug labeling for new submissions to Health Canada? 

Drug manufacturers can access detailed guidance documents and resources on Health Canada’s official website to ensure compliance with drug labeling requirements in new submissions.

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When & how to File Your Medical Device 510k Submission?

When to File Your 510k Submission

Introduction:

A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market a new device that is substantially equivalent to a legally market device.

Submitting a 510k to the FDA is an important step for any business or healthcare product that needs to be approved for sale. Knowing when the time is right to submit can be tricky, but with this guide, you’ll be able to prepare yourself and submit your 510k with confidence.

Become Familiar with relevant FDA Medical Device Regulations:

It is important to be familiar with the specific regulations that apply to your product and its type so that you know when it is time to file a 510k submission. Understanding deadlines, required documentation and what must be included in the submission are all key components of filing successfully. Take the initiative to research and understand the requirements associated with submitting a 510k.

Demonstrate the Substantial Equivalence between Your Device and Predicate Devices:

Identifying a predicate device that is substantially equivalent to your device is very critical to the success of your 510(k) application. It is also essential to analyze any similarities and differences between your device and the predicate device(s) before you submit a 510k. This will help you determine if you are subject to certain regulations or not.

In determining if a product is considered substantially equivalent to a chosen predicate device, the FDA has set specific criteria, including: the device has the same intended use and technological characteristics as the predicate device; or the product has the same intended use as the predicate device, yet has different technological characteristics and does not raise any new questions regarding safety and effectiveness; and the data submitted to the FDA can demonstrate that the device is at least as safe and effective for use in patients as the marketed device.

Analyze the Differences between Your Medical Device and Predicate Devices:

It is essential to analyze any difference between your device and the predicate devices before you submit a 510k. Analyzing similarities and differences can help you determine if you are subject to certain regulations or not. When reviewing differences, focus on major characteristics such as structure, function, materials, physical properties, chemical composition, and performance data. Make sure to have a clear understanding of the differences for your submission to be successful.

Consider Your Type of Medical Device 510k Submission:

Before you submit your 510k, it’s important to consider the type of submission that best describes your device and its intended use. There are three types, including: traditional 510k, abbreviated 510K and special 510K. The Special 510(k) and Abbreviated 510(k) submission types can be used when a 510(k) submission meets certain factors, however, the Traditional 510(k) can be used under any circumstance to seek marketing authorization of a device. In a Traditional 510(k), the submitter provides descriptive information about the indications for use and technology and results of performance testing to demonstrate substantial equivalence.

Meanwhile, Abbreviated 510(k) application relies on “summary reports” that briefly describe and summarize the testing performed to support the submission as recommended in relevant guidance document(s). These reports summarize the device description, the manufacturer’s device design requirements, risk management information, and a description of test methods used to address performance characteristics.

Research Any Significant Design Changes to Your Medical Device or Manufacturing Process:

As you prepare to submit your 510k, consider any design changes to either the device or its manufacturing process. Significant design changes could require you to file a traditional 510k instead of an abbreviated one. Research the differences between the predicate devices used in similar submissions and gather data to demonstrate your device’s safety and effectiveness if needed. Additionally, research any labeling updates or clinical studies that may be necessary before submitting your application.

Know the Use of Clinical Data Requirements in the Submission Process, if Applicable:

The FDA may require clinical data with your submission to demonstrate the safety and effectiveness of the device. The FDA considers this data when determining whether a device poses risks, so understanding these requirements is essential. A few common scenarios where clinical data is necessary include a novel technology, changes in an existing device’s indications for use, or any changes that could result in increased safety risks for patients. Gather all relevant population, usage, and performance studies to include with your submission.

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

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5 Tips to find the best FDA Medical Device Regulatory Consultant

FDA Medical Device Consultant

 

Introduction:

Navigating the intricate web of medical device regulations can be daunting for businesses unfamiliar with the regulatory landscape. Hiring a professional medical device regulatory consultant can provide the expertise and knowledge necessary to ensure compliance with both federal and international laws.

Selecting the ideal FDA medical device regulatory consultant is crucial, particularly given regulatory compliance and quality assurance complexities. When choosing the right consultant for your US FDA medical device requirements, it’s imperative to consider various factors, including experience, regulatory proficiency, cost, and turnaround time expectations.

Understanding Your Regulatory Requirements

Before embarking on the search for a regulatory consultant, it is essential to have a clear understanding of your regulatory requirements. This preliminary step will help you identify the consulting firm that best fits your needs. Different firms specialize in distinct areas and levels of expertise, so a grasp of your requirements is paramount. Determine which regulations your product must adhere to and whether additional services like simulation studies or testing are necessary to ensure compliance.

Researching Different Consulting Options

During your search for the right regulatory consulting firm, take the time to research your options and compare them thoroughly. Evaluate the qualifications of their staff, their experience with similar medical device projects, and any specialized expertise that could benefit your needs. Reading reviews from current and past clients can also provide valuable insights into the level of service a company offers, helping you make an informed decision.

Analyzing Their Track Record of Success

A consultant’s track record of success and reputation should weigh heavily in your decision-making process. Before engaging a consultant, review their portfolio and success rate. Request client references to gain firsthand insights into their working relationship. This step will instill confidence in their ability to deliver valuable results, making them the ideal consultant for your project.

Seeking Testimonials and Referrals

Pay attention to available testimonials and referrals to ensure you’ve chosen the right consultant. These sources can offer valuable information about a consultant’s adherence to cost, quality, and timeliness standards. Additionally, they shed light on the consultant’s proficiency in understanding technical concepts and their problem-solving approach.

Evaluating Cost, Experience, and Expertise

In selecting a consultant, consider not only their cost but also their overall value. Experience is paramount; inquire about the number of FDA-registered medical devices they’ve consulted on, including development and 510(k) submissions. Ensure they are well-versed in recent regulations affecting your product and deeply understand other FDA regulations relevant to the medical device sector.

Considering Partnerships or Subcontractors

Consider whether a more prominent consulting firm is more advantageous than an individual consultant. Many larger firms offer subcontractors with specialized skills, providing extra support that can prove valuable during the consultation process. While larger firms may have a higher price tag, they often excel at navigating the unique challenges of FDA-regulated products. They have valuable connections with industry players, such as testing labs, which can facilitate product development and meet specific regulatory requirements.

Checking for Certifications

Before finalizing your choice of an FDA medical device consultant, verify their credentials and certifications. The FDA mandates that consultants offering guidance on regulated products hold relevant certifications, including Medical Device Quality System Regulation (QSR) and Quality System Standard for Medical Devices (QSd). Additionally, consider ISO 13485 certification for quality management system requirements and IEC/EN 62304 certification for software life cycle processes, if applicable to your product or production process.

Ensuring Proven Compliance Techniques and Supportive Resources

Hiring a consulting service should guarantee up-to-date regulations and assurance of device compliance. Ensure the consulting firm employs established techniques for streamlining submissions, obtaining timely approvals, and understanding international markets. Confirm the availability of supportive resources, such as project management teams and expertise in geographic markets, to facilitate your compliance journey.

Benefits of Hiring a Medical Device Regulatory Consulting Firm

1. Updated Regulatory Know-how: Regulatory consultants stay informed about ever-changing medical device regulations, ensuring your company complies with the latest industry developments and legal requirements.

2. Efficient and Cost-saving Strategies: These firms offer cost-effective strategies and help identify potential cost savings by optimizing processes and finding alternatives for product innovation.

3. Comprehensive Advice and Guidance: Specialized consultants provide various services, including regulatory strategy, market access consulting, compliance activities, and training programs, ensuring organizations remain compliant.

4. Time-saving Analysis of Regulations: Consultants simplify the complex task of researching and understanding regulatory requirements, allowing your company to focus on core activities.

5. Maximized Opportunity for Success: By relying on experienced consultants, you can quickly adapt to changes and seize opportunities in this highly regulated industry.

In conclusion, selecting the right medical device regulatory consultant is a critical decision that requires careful consideration of numerous factors. By conducting thorough research, evaluating experience and expertise, and ensuring compliance with certifications and regulations, you can make an informed choice that will help your business navigate the challenging regulatory landscape and achieve success in the medical device industry.

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The ultimate Generally Recognized As Safe GRAS Guide Unlocked

Food Regulations Food ComplianceIntroduction:

If you are wondering what foods and substances the FDA considers to be Generally Recognized As Safe (GRAS), you have come to the right place. This guide will explain the critical safety standards for GRAS regulation and provide an overview of what products are deemed safe by the FDA.

“Generally Regarded As Safe” (GRAS) is a category of food ingredients used in the United States. The FDA’s GRAS program allows companies to formulate, market, and sell their products without submitting safety data to the agency. The program helps speed up the regulatory process by making it easier for businesses to bring new products to market.

The FDA’s Generally Regarded as Safe (GRAS) regulations are essential to ensuring food additives’ safety in the United States. These regulations help to determine which substances are safe for use in food and which are not. In this article, we’ll take a closer look at the “Generally Regarded as Safe” GRAS regulations and how they work.

The role of the FDA in food safety regulation

The FDA plays a crucial role in ensuring the food’s safety. Its primary responsibility is to protect public health by regulating the production, distribution, and labeling of food products. The FDA’s authority extends to all food products except meat, poultry, and certain egg products, which the U.S. Department of Agriculture (USDA) regulates.

One of the key ways the FDA ensures food safety is by evaluating food ingredients. The FDA assesses the safety of food ingredients based on scientific evidence, industry data, and expert opinions. This evaluation process helps the FDA determine which ingredients are safe for consumption and which may pose a public health risk.

The History and Development of GRAS Regulations

The concept of GRAS has been around for decades, evolving and adapting to the changing landscape of the food industry. The initial regulations for GRAS were established in the 1950s by the U.S. Food and Drug Administration (FDA). These regulations aimed to provide a framework for determining the safety of food ingredients based on their common use in food before 1958 or their long history of safe consumption.

Over the years, the regulations surrounding GRAS have undergone revisions and updates to keep up with scientific advancements and changing dietary patterns. The FDA has been actively involved in evaluating and approving substances for GRAS status, ensuring that they meet the necessary safety criteria.

The criteria for achieving GRAS Status

To be considered GRAS, a substance must meet certain criteria that demonstrate its safety for consumption. These criteria are based on scientific evidence and are evaluated using a rigorous process. The primary factors considered when determining GRAS status include:

1. History of safe use: A substance must have a long history of safe consumption by a significant number of people. This history provides evidence of the substance’s safety over time.

2. Expert consensus: The scientific community should widely agree that the substance is safe for consumption. This consensus is reached through extensive research, studies, and peer-reviewed publications.

3. Scientific data: Scientific data, including toxicological studies, animal testing, and human trials, are essential in assessing the safety of a substance. This data helps determine the substance’s potential risks and any adverse effects it may have.

These criteria ensure that substances considered for GRAS status undergo a thorough evaluation process, leaving no room for ambiguity when it comes to consumer safety.

The process of self-determination and voluntary GRAS notification

One of the unique aspects of the GRAS program is the concept of self-determination. Under this concept, the responsibility for determining the safety of an ingredient lies with the manufacturer or supplier. Suppose a company believes that an ingredient meets the criteria for GRAS. In that case, it can make self-determination and use the ingredient in its products without seeking FDA approval.
 
However, the FDA encourages manufacturers to notify the agency of their GRAS determinations voluntarily. This allows the FDA to review the safety evaluation conducted by the manufacturer and provide feedback if necessary. While voluntary, this notification process helps ensure transparency and accountability in the GRAS determination process.
 
It’s important to note that the FDA does not approve or endorse GRAS determinations made by manufacturers. The agency’s role is to assess the safety of ingredients based on the available scientific evidence and expert opinions. The voluntary notification process allows the FDA to review and comment on the manufacturer’s safety evaluation.

 

The Process of Self-Determination and Expert Review for GRAS Status

Obtaining GRAS status involves a comprehensive evaluation process that includes self-determination and expert review. In the self-determination phase, the manufacturer or supplier of the substance conducts a thorough assessment of its safety based on scientific data and historical use. This assessment is documented and submitted to the FDA for review.

The FDA then conducts its review, which involves evaluating the submitted data, analyzing the scientific literature, and consulting with external experts. The expert review is a critical step in ensuring the credibility and accuracy of the self-determination process. The FDA may request additional information or studies if deemed necessary during this review.

Once the FDA is satisfied with the safety and supporting evidence, the substance is granted GRAS status. It is important to note that the FDA’s review process is transparent, allowing for public scrutiny and input.

How Does the FDA Determine if a Food Ingredient is Safe_ Generally Regarded as Safe or Generally Recognized as Safe How Does the FDA Determine if a Food Ingredient is Safe_ Generally Regarded as Safe or Generally Recognized as Safe How Does the FDA Determine if a Food Ingredient is Safe_ Generally Regarded as Safe or Generally Recognized as Safe

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The regulatory framework and oversight of GRAS Substances

GRAS substances are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act. The FDA is responsible for ensuring the safety and integrity of food products, including those with GRAS status. The regulatory framework for GRAS substances includes several key elements:

1. Notification process: Manufacturers or suppliers must notify the FDA about their determination of GRAS status for a substance. This notification includes detailed information about the substance, its intended use, and the basis for its safety.

2. Publicly available records: The FDA maintains a database of GRAS notifications, which is accessible to the public. This transparency allows for public scrutiny and helps maintain accountability.

3. Continuous monitoring: Once a substance is granted GRAS status, it is subject to ongoing monitoring by the FDA. This includes reviewing new scientific data, conducting inspections, and taking appropriate action if safety concerns arise.

The regulatory framework ensures that GRAS substances are held to high standards of safety and undergo regular evaluation to maintain their status.

Controversies and challenges surrounding the GRAS determination process

While the GRAS program plays a vital role in ensuring food safety, it has its controversies and challenges. One of the main concerns is the role of industry self-determination in the GRAS process. Critics argue that the current system allows manufacturers to make self-serving determinations without sufficient oversight from the FDA.

Another challenge is the need for transparent guidelines for making GRAS determinations. The FDA provides general criteria for determining GRAS status. Still, there needs to be more specific guidance on how to conduct safety evaluations. This lack of clear guidelines can lead to inconsistencies in the evaluation process and raise concerns about the reliability of GRAS determinations. Furthermore, there have been cases where ingredients initially considered GRAS were later found to pose health risks. This highlights the need for ongoing monitoring and reassessment of GRAS ingredients to ensure safety.

Case studies of popular food ingredients and their GRAS status

To better understand the practical application of the GRAS program, let’s examine a few case studies of popular food ingredients and their GRAS status.

1. Salt (Sodium Chloride): Salt is a commonly used ingredient in food and has a long history of everyday use. It is considered GRAS by the FDA, but excessive salt consumption has been linked to health issues such as high blood pressure. This highlights the importance of moderation even with GRAS ingredients.

2. Caffeine: Caffeine is another widely used ingredient in coffee, tea, and other beverages. It is considered GRAS, but excessive consumption can lead to adverse health effects, such as insomnia and increased heart rate. Again, moderation is key.

3. Artificial Sweeteners: Artificial sweeteners like aspartame and sucralose are used as sugar substitutes in many products. These ingredients have undergone extensive scientific testing and are considered GRAS. However, some studies have raised concerns about their long-term effects on health.

Frequently asked Generally Recognized as Safe Questions we receive from food manufacturers:

What is FDA generally recognized as safe GRAS?

“Generally Regarded as Safe” (GRAS) is a designation the FDA gives to substances considered safe for food use. This designation is based on qualified experts’ scientific evaluation of the substance’s safety. The GRAS designation is critical because it allows food manufacturers to use certain substances in their products without needing FDA approval. However, it’s important to note that the GRAS designation is not a guarantee of safety, and the FDA can still take action if new information suggests a substance may not be safe.

How are substances determined to be GRAS?

Substances are determined to be GRAS through a scientific evaluation process by qualified experts. These experts review all available data on its importance, including studies on its safety and toxicity, and decide whether it is safe for use in food. The evaluation process also considers the intended use of the substance, the amount that will be used, and the potential for exposure. If the experts determine the ingredient is safe, it can be designated GRAS and used in food products without FDA approval.

What are the requirements for GRAS substances?

A substance must meet specific requirements set forth by the FDA to be considered GRAS. These requirements include a history of safe use in food, a general recognition of safety by qualified experts, and a lack of scientific evidence to suggest that the substance is harmful when used in food. Additionally, the GRAS compound must be used according to good manufacturing practices and not exceed the levels deemed safe by the FDA.

How are GRAS substances monitored for safety?

While GRAS substances are not subject to pre-market approval by the FDA, they are still monitored for safety. The FDA relies on various sources to gather information about the safety of GRAS substances, including scientific literature, reports from industry, and adverse event reports. If new data suggests that a GRAS substance may no longer be safe, the FDA can take action to remove it from the list of GRAS substances or require additional safety testing. Additionally, manufacturers must notify the FDA if they become aware of new information suggesting their GRAS substance is no longer safe.

What is the role of the FDA in GRAS regulations?

The FDA plays a crucial role in ensuring the safety of food additives through its “Generally Regarded as Safe” (GRAS) regulations. While GRAS substances are not subject to pre-market approval, the FDA monitors them for safety and can take action if new information suggests they may no longer be safe. The FDA also requires manufacturers to notify them if they become aware of further details suggesting their GRAS substance is no longer safe. Overall, the FDA’s role in GRAS regulations is to protect public health by ensuring the safety of food additives.

How does GRAS status apply to food products?

GRAS status is granted to products judged to be safe through scientific procedures and accepted by the FDA for use in the market without undergoing formal pre-market approval. When a product meets this classification, food product formulators can draw reasonable conclusions about its safety based on solid science, scientific principles, and existing data. GRAS status can mean different things for different products, so understanding GRAS and its implications is essential when launching your new venture.

What does GRAS mean?

“Generally Recognized As Safe” (GRAS) is a U.S. food and drug safety designation given to certain substances that can be used in food and drugs without additional regulatory approval. When consumed at the levels outlined in FDA regulations, GRAS recipes are extensively investigated and determined by qualified experts as having safe use, no harm, and no side effects. Substances must be proven through scientific tests or an extensive review of published scientific data to be considered GRAS.

How does the FDA determine GRAS status?

Once qualified experts have evaluated a substance, the FDA reviews the data, conclusions, and scientific evidence to determine GRAS status. If the FDA determines sufficient proof that particular implications are safe for food, drugs, or cosmetics, it will issue an official GRAS notice in the Federal Register. The FDA also requires manufacturers of GRAS substances to maintain records to document the safety assessment of their ingredients and to ensure continuous product safety.

What are some examples of common GRAS food substances?

The FDA has identified hundreds of substances as GRAS, including common food ingredients such as baking soda, vinegar, citric acid, and specific colors and flavorings. Other commonly used GRAS ingredients are preservatives like sodium benzoate and potassium sorbate, sweeteners like stevia and xylitol, and spices like capsaicin and ginger. Additionally, some novel ingredients from natural sources, such as seaweed extract gums and starches, have been deemed GRAS by the FDA.

What are the Differences Between GRAS Status, FFC Classification, and Additives Declaring GRAS Status on a Product Label?

It’s essential to understand the differences between FFC classification, GRAS status, and additives when declaring your product’s GRAS classification. The FFC (Food and Food Contact) classification is used for food components made with an ingredient that may be consumed as-is without further processing and that contact food during normal handling. An additive is a substance added to enhance the flavor or preserve the shelf life of food. Finally, GRAS status implies that a product poses no known risk of harm when consumed at the levels normally expected.

How do I declare GRAS status on a food product label?

When preparing to declare GRAS status on a product label, consider taking the following steps: First, determine whether your product is composed of FFC-classified ingredients or meets the definition of an additive. Then, review information on toxicity levels and safe usage data to determine whether the substance meets standards for GRAS classification. Finally, submit all necessary paperwork to the FDA for pre-market certification.

What potential risks are associated with claiming GRAS status on a product label?

Considering the potential risks and consequences of claiming GRAS status for a product is crucial. For instance, if a manufacturer makes a false claim about their product, they may face civil or criminal liability as outlined in the False Claims Act. Additionally, incorrect assertions about GRAS status for products can lead to recalls and other enforcement actions from the FDA.

What is the safety assessment system (SGS) for new self-GRAS ingredients?

The FDA also allows companies to make their safety assessments for novel ingredients and submit a self-GRAS notification. This is called a “self-determination” process; the company assesses the ingredient’s safety and makes a case for why it should be accepted without further FDA review. In most cases, self-GRAS will be subject to future FDA audits or periodic inspections to verify that the ingredient is safe for consumption.

What is the importance of product safety testing in determining GRAS status?

Before an ingredient is deemed generally recognized as safe (GRAS) by the FDA, it must undergo rigorous testing to ensure it meets safety standards. Companies must submit comprehensive safety data, including toxicological profiles, clinical trials, and other scientific evidence, to show that an ingredient is not harmful or dangerous when consumed at specified levels. This includes testing for potential allergens, contaminants, and by-products from production. Product safety testing will help to ensure that any item classified as GRAS does not pose a risk of harm to consumers.

How does the GRAS program help speed up the regulatory process?

The program aims to reduce the regulatory burden on all stakeholders, including industry and regulators. Someone can achieve this through increased transparency in the regulatory process and by preventing unnecessary delays in getting products to market. The number of applications submitted under this program has been growing steadily since its inception in 1992, with more than 50% coming from small businesses or universities with fewer than 500 employees.

How do I distinguish GRAS ingredients from non-GRAS ingredients?

When assessing potential ingredients for a product, there are several key factors to consider to ensure that you are using a GRAS (generally recognized as safe) ingredient. It’s essential to research the ingredient’s history and ensure that it has been reviewed and approved by the FDA or that an independent panel of experts has declared it safe. It must also be able to meet specific criteria about its characteristics, composition, intended use, and safety concerns. If these criteria are met, an ingredient can be considered GRAS by designation.

What are some commonly used natural GRAS ingredients?

Natural GRAS ingredients are widely used in the food, health, and beauty industries to add nutrition and provide supplemental benefits. Commonly used natural GRAS ingredients include:

  • Oils like coconut, palm, and olive oil.
  • Plant-based starches like tapioca starch.
  • Vitamins, minerals, herbs, and spices are derived from natural sources.
  • Probiotics.
  • Sweeteners like honey and agave syrup
  • Raw food dyes such as carmine, turmeric, saffron, and annatto

What are some benefits of using natural GRAS ingredients in formulations?

Using natural GRAS ingredients in formulations is beneficial for many reasons. Natural GRAS ingredients can offer health benefits such as increased energy, improved digestion, enhanced cognitive function, improved skin and hair quality, and weight management assistance. Natural GRAS ingredients are also often easier to digest than artificial options, which makes them more accessible for the body to utilize. Additionally, natural GRAS ingredients generally have fewer side effects than synthetic options.

How can I avoid potential safety hazards with proper research and testing?

To ensure natural GRAS ingredients are safe for consumption, it’s essential to research and test each component thoroughly and correctly. Someone must identify the potential safety hazards before any raw GRAS ingredients can be validated. It’s also important to double-check the source of all elements before sourcing and ensure they meet the specifications set forth by governing bodies. Additionally, products made with natural GRAS ingredients should have good quality assurance processes to ensure compliance with applicable laws and regulations.

What does “Generally Regarded as Safe” (GRAS) mean in food regulations?

Generally Regarded as Safe” (GRAS) is a designation used in food regulations to indicate that a substance is considered safe for consumption based on a history of everyday use in food or scientific evidence, without formal approval as a food additive.

How is a substance determined to be GRAS?

To be considered GRAS, a substance must have a consensus among qualified experts that it is safe for its intended use in food. This determination can be based on historical usage, scientific studies, or both. The safety assessment should be publicly available for scrutiny.

Who determines if a substance is GRAS?

Determining whether a substance is food manufacturers or ingredient suppliers typically makes GRAS. They compile scientific data and expert opinions to support the substance’s safety. The U.S. Food and Drug Administration (FDA) can review and question these determinations.

Is GRAS status permanent?

No, GRAS status is not permanent. It can be subject to change if new scientific evidence emerges suggesting a safety concern. The FDA can reevaluate and challenge GRAS determinations if necessary.

Are all food additives required to go through the GRAS process?

No, not all food additives need to go through the GRAS process. Some substances are explicitly recognized as safe by the FDA and are exempt from the GRAS determination process. Others, especially new additives, may require formal approval.

Can consumers find information about GRAS substances on food labels?

Generally, GRAS status is not listed on food labels. However, food manufacturers must ensure that all ingredients used in their products, including those with GRAS status, meet safety standards set by regulatory authorities.

What are some common examples of GRAS substances?

Common examples of GRAS substances include salt (sodium chloride), sugar (sucrose), vinegar (acetic acid), and various vitamins and minerals when used under established guidelines.

Is GRAS status the same globally?

No, GRAS status and regulations can vary from one country to another. Each country or region may have its criteria and process for determining whether a substance is generally considered safe for food use.

Can individuals petition for a substance to be considered GRAS?

Yes, individuals or organizations can submit a GRAS notification to the FDA, providing scientific evidence and expert opinions supporting the safety of a substance. The FDA reviews these notifications and can respond with their evaluation.

Are there any controversies or concerns related to GRAS determinations?

Yes, concerns have been raised about the transparency and potential conflicts of interest in GRAS determinations, as some decisions are made by the same companies that produce the substances in question. Efforts have been made to address these issues and enhance the rigor of the process.

Additional Reading about GRAS:

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Unlocking the FDA Guidelines for NAC Supplements

NAC Supplements labeling Requirements

Introduction:

On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). NAC is a supplement form of cysteine, a semi-essential amino acid, which was approved by the FDA as a drug in 1963 to treat liver side effects from an overdose of Tylenol (acetaminophen) and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease.

The new guidance explains the FDA’s intent to exercise enforcement discretion concerning the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. This enforcement discretion policy applies to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

To learn about the FDA’s enforcement discretion for NAC supplements click here:

Know the requirements for marketing NAC Supplements:

The FDA requires that the manufacturer or distributor of an NAC supplement follows certain guidelines for labeling and safety. Make sure to read all labels carefully, as the label should detail everything you need to know about the product, including any warnings about potential side effects and contaminants. Additionally, ask your provider questions about NAC supplements before including them in your health regimen. This can help ensure you’re making informed decisions about what products are safe and beneficial for you.

Be aware of NAC Supplement labeling requirements:

When purchasing an NAC supplement, it’s important to be aware of certain labeling requirements as put forth by the FDA. These include both general and product-specific labeling, such as itemized ingredients, a description of what the product does, information about nutraceuticals, usage instructions and dosage information, safety warnings about potential side effects or adverse reactions due to drug interactions, and expiration date. Additionally, all NAC supplements must clearly state if they are dietary supplements.

Need help with your NAC supplement compliance?

Understand safety guidelines for NAC supplement products:

As with any supplement, it’s important to make sure that the NAC product you purchase meets safety guidelines. Look for reliable suppliers of high-quality NAC supplements and pay attention to any warning labels about potential drug interactions or side effects when taking them. Be sure to read the information carefully before taking a NAC supplement so that you can accurately understand the benefits, risks, and dosing instructions. Additionally, look for products that have been third-party tested for quality and purity.

Pay attention to current NAC Supplement updates:

Be sure to pay attention to current updates about NAC supplement regulations to ensure that you are fully aware of all FDA requirements. The FDA regularly evaluates supplements and issues updated guidelines or product recalls as necessary. Understanding and following the latest instructions related to dosing, labeling, ingredients, and manufacturing standards can help you stay informed.

Utilize FDA resources for guidance and advice:

Make sure you understand all relevant safety, labeling, and manufacturing standards for NAC supplements by taking advantage of FDA resources. The FDA provides helpful tips and guidance on its website as well as regulatory update alerts about any changes that have been made to the regulatory requirements. Additionally, you can contact the FDA directly with questions or comments regarding your products.

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Understanding the regulations for Class III Medical Devices

Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements. Understand the Regulatory Requirements of Class 3 Medical Devices. Class 3 medical devices have the most stringent regulatory requirements when compared to other device classes. To ensure they meet the specific standards set by regulators, manufacturers must thoroughly understand what their obligations are and how to meet them. This includes understanding device labeling, conducting necessary preclinical tests, and designing appropriate clinical trials as well as obtaining marketing authorization from local and international agencies. With little room for error, a company must pay ample attention to meeting these strict regulations. Step-by-Step Guide for Regulatory Compliance Process. A step-by-step guide for Class 3 medical device manufacturers to prepare for and meet regulatory requirements is provided below: 1. Understand the local and international standards and regulations that apply to your product. 2. Perform risk assessments, identify hazards, and assess safety risks. 3. Develop appropriate device labeling information including instructions, warnings, indications, and contraindications. 4. Prepare preclinical tests related to the identified safety risks of the medical device. 5. Run clinical trials by applicable regulations and obtain relevant certification of efficacy, performance, or other features as necessary. 6. Submit marketing authorization applications to local or international agencies if required by applicable regulations or laws. 7. Develop post-marketing surveillance plans as may be needed going forward to ensure continued compliance with standards and regulations applicable to your device. Strategies to Reduce Cost and Time in Compliance Testing. There are strategies to reduce the cost and time associated with compliance testing. For example, the development of a standardized quality manual helps to streamline the process, by providing step-by-step protocols that must be met to achieve conformity with regulatory requirements. Leveraging tools like automated data collection can help bring costs down for conducting tests and checks, where testing has been pre-certified as meeting standard requirements. Additionally, engaging external compliance teams or consultants early in the process can help identify any potential problems quickly and provide advice on which steps are critical to addressing quality management issues. Assessing the Role of Third-Party Certifiers in Regulating these Devices. Third-party certifiers are an invaluable tool in the regulation of Class 3 medical devices. Not only do they allow manufacturers to have a comprehensive overview of the entire product development cycle and all its stages, but they also aid in certifying that requirements have been met as outlined by regulatory authorities. Additionally, they can provide valuable insights into which materials must be considered during the production process that may not necessarily be required by regulations, but would improve safety or efficacy. Ultimately, certification from third-party entities is an essential component for Class 3 medical devices to fully comply with applicable standards and regulations. Guidelines for manufacturers for Managing Risk and Adverse Events. The risk of adverse events is an ever-present reality for medical device manufacturers. Therefore, it is important to have a robust management system in place for risk and adverse event assessment, reporting, and monitoring to minimize the potential impact these may have on safety and efficacy. Manufacturers should clearly define criteria within product development plans to ensure appropriate assessments are taken during each product’s entire life cycle. This includes a systematic approach to suspending, withdrawing, or replacing devices deemed unsafe or ineffective due to adverse events. Additionally, manufacturers should be prepared to respond quickly and effectively whenever an adverse event or complaint is reported.

Introduction:

Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements.

Class 3 medical devices are especially complex and pose the highest risk to patients. To ensure patient safety, manufacturers of class 3 medical devices must strictly follow guidelines issued by the FDA to achieve quality assurance during production. These guidelines include requirements related to design validation, process validation, labeling, sterilization, and more.

Understand the Regulatory Requirements of Class 3 Medical Devices:

Class 3 medical devices have the most stringent regulatory requirements when compared to other device classes. To ensure they meet the specific standards set by regulators, manufacturers must thoroughly understand what their obligations are and how to meet them. This includes understanding device labeling, conducting necessary preclinical tests, and designing appropriate clinical trials as well as obtaining marketing authorization from local and international agencies. With little room for error, a company must pay ample attention to meeting these strict regulations.

The regulatory requirements for Class III medical devices are outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act), which the FDA enforces. The FD&C Act defines the classification of medical devices based on their intended use, design, and potential risks. Class III medical devices are subject to the most stringent regulatory requirements, which include premarket approval (PMA), premarket notification (510(k)), post-market surveillance, and adverse event reporting.

The FDA also requires that Class III medical devices meet specific labeling requirements and have a unique device identification (UDI) system to facilitate tracking and reporting of adverse events. Failure to comply with these regulations can result in significant fines, legal action, and damage to your company’s reputation.

What is the FDA approval process for class III medical devices?

The FDA approval process for Class III medical devices is complex and lengthy, requiring significant resources, time, and expertise. The approval process ensures that medical devices are safe and effective for their intended use and meet the regulatory requirements outlined by the FDA.

The FDA approval process for Class III medical devices consists of several stages, including preclinical testing, clinical trials, and post-market surveillance. The preclinical testing stage involves testing the device in animal models and conducting bench studies to assess the device’s safety and effectiveness.

The clinical trial involves testing the device on human subjects to evaluate its safety and effectiveness. The clinical trial data is then submitted to the FDA for review and approval. Clinical trials are typically conducted in three phases, each involving more subjects and more rigorous testing.

Once the device has been approved, it must undergo post-market surveillance to monitor its safety and effectiveness in real-world settings. This involves tracking adverse events and conducting post-market studies to assess the device’s long-term safety and efficacy.

What is preclinical testing for class III medical devices?

Preclinical testing is critical to the FDA approval process for Class III medical devices. Preclinical testing involves conducting laboratory experiments and animal studies to evaluate the device’s safety and effectiveness before it is tested in humans.
Preclinical testing typically involves testing the device in animal models to assess its safety and efficacy.

This may include conducting toxicity studies, biocompatibility testing, and other tests to evaluate the device’s performance and potential adverse effects.

The results of preclinical testing are used to determine whether the device is safe to test in humans and to design the clinical trial protocol. Preclinical testing is a vital step in the approval process for Class III medical devices, and it helps to ensure that the device is safe and effective before it is tested in humans.

Why are clinical trials required for Class III medical devices?

Clinical trials are critical to the FDA’s approval process for Class III medical devices. Clinical trials involve testing the device on human subjects to evaluate its safety and effectiveness. Clinical trials typically involve more issues and more rigorous testing in three phases.

Why are there clinical trial phases for Class III medical devices?

Phase I clinical trials typically involve a small number of healthy volunteers. They are designed to assess the device’s safety and potential adverse effects.

Phase II clinical trials involve a more significant number of subjects. They are designed to evaluate the device’s effectiveness and safety in patients with the target condition.

Phase III clinical trials involve a more significant number of subjects. They are designed to confirm the device’s safety and effectiveness in a larger patient population. The results of the clinical trials are then submitted to the FDA for review and approval.

What are class III medical device post-market surveillance and adverse event reporting?

Post-market surveillance is critical to the FDA’s regulatory process for Class III medical devices. Post-market surveillance involves monitoring the device’s safety and effectiveness in real-world settings and tracking adverse events.

Medical device manufacturers must report adverse events to the FDA and maintain records of these events. The FDA uses this information to monitor the safety and effectiveness of medical devices and, if necessary, take action to protect public health.
Suppose a medical device manufacturer becomes aware of a problem with a device. In that case, they are required to report it to the FDA. Failure to report adverse events or maintain records can result in significant fines and legal action.

What are the labeling requirements for class III medical devices?

Class III medical devices are subject to specific labeling requirements designed to ensure that patients and healthcare providers have access to essential information about the device’s use, risks, and benefits.

The labeling requirements for Class III medical devices are outlined in the FDA’s Code of Federal Regulations (CFR) and include information such as the device’s intended use, indications for use, warnings, and precautions.

The labeling must also include a unique device identification (UDI) system, which facilitates tracking and reporting adverse events. The UDI system consists of a unique identifier assigned to each medical device, which must be included on the device’s label.

Why is the Unique Device Identification (UDI) system important for Class III medical devices?

The Unique Device Identification (UDI) system is critical to the FDA’s regulatory process for Class III medical devices. The UDI system facilitates tracking and reporting adverse events and improves patient safety.

The UDI system includes a unique identifier assigned to each medical device, which must be included on the device’s label. The UDI system also consists of a database that contains information about each medical device, including its manufacturer, model number, and expiration date.

The UDI system helps improve patient safety by facilitating the tracking and reporting of adverse events. It also helps to improve supply chain management by providing a standardized method for identifying and tracking medical devices.

Why are compliance and enforcement important for Class III medical devices?

Compliance and enforcement are critical components of the FDA’s regulatory process for Class III medical devices. Medical device manufacturers must comply with the FDA’s regulatory requirements, and failure to do so can result in significant fines and legal action.
The FDA has the authority to conduct inspections and audits of medical device manufacturers to ensure compliance with regulatory requirements. The FDA can also issue warning letters, fines, and legal action against companies that fail to comply with regulatory requirements.

Medical device manufacturers must understand and comply with the FDA’s regulatory requirements to avoid fines, legal action, and damage to their company’s reputation.

Step-by-Step Guide for Medical Device Regulatory Compliance Process:

A step-by-step guide for Class 3 medical device manufacturers to prepare for and meet regulatory requirements is provided below:
1. Understand the local and international standards and regulations that apply to your product.
2. Perform risk assessments, identify hazards, and assess safety risks.
3. Develop appropriate device labeling information including instructions, warnings, indications, and contraindications.
4. Prepare preclinical tests related to the identified safety risks of the medical device.
5. Run clinical trials by applicable regulations and obtain relevant certification of efficacy, performance, or other features as necessary.
6. Submit marketing authorization applications to local or international agencies if required by applicable regulations or laws.
7. Develop post-marketing surveillance plans as may be needed going forward to ensure continued compliance with standards and regulations applicable to your device.

Guidelines for manufacturers for Managing Risk and Adverse Events:

The risk of adverse events is an ever-present reality for medical device manufacturers. Therefore, it is important to have a robust management system in place for risk and adverse event assessment, reporting, and monitoring to minimize the potential impact these may have on safety and efficacy. Manufacturers should clearly define criteria within product development plans to ensure appropriate assessments are taken during each product’s entire life cycle. This includes a systematic approach to suspending, withdrawing, or replacing devices deemed unsafe or ineffective due to adverse events. Additionally, manufacturers should be prepared to respond quickly and effectively whenever an adverse event or complaint is reported.

Conclusion: Importance of following regulations for Class III Medical Devices

In conclusion, the FDA highly regulates Class III medical devices to ensure their safety and effectiveness. Understanding the regulations governing Class III medical devices is essential for medical device
manufacturers and aspiring entrepreneurs.

The FDA approval process for Class III medical devices is complex and lengthy, requiring significant resources, time, and expertise. The approval process ensures that medical devices are safe and effective for their intended use and meet the regulatory requirements outlined by the FDA.

Medical device manufacturers must also comply with specific labeling requirements and have a unique device identification (UDI) system to facilitate tracking and reporting of adverse events. Compliance and enforcement are critical components of the FDA regulatory process, and failure to comply with regulatory requirements can result in significant fines, legal action, and damage to your company’s reputation.

By following the regulations governing Class III medical devices, medical device manufacturers can ensure the safety and effectiveness of their devices and improve patient safety. Aspiring entrepreneurs can also navigate the complex world of medical device regulations and bring their innovative ideas to market.

Learn more about the class 3 medical devices application here:

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

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What Does It Mean to be GFSI Certified in an FSMA Environment?

GFSI Certified in an FSMA Environment

Introduction:

FSMA stands for the “Food Safety Modernization Act” which is a set of laws enacted by the US government to ensure food safety and decrease the risk of foodborne illness. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

What is the FSMA Act?

The Food Safety Modernization Act (FSMA) enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.

What does FSMA require of food facilities?

For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes:

  • Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise.
  • Mandatory produce safety standards: FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area, and water.
  • Authority to prevent intentional contamination: FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.

How does FSMA impact US food imports?

The FSMA gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include:

  • Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment)
  • Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for the FDA to recognize accreditation bodies is due 2 years after enactment)
  • Certification for high-risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third-party certification or other assurance of compliance as a condition of entry into the U.S.
  • Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)
  • Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.

What are GFSI Schemes?

A food safety scheme is recognized by GFSI when it meets the food safety requirements defined in the GFSI Guidance Documents. GFSI is an organization that benchmarks and approves different auditing standards. There isn’t technically any single audit called “The GFSI Audit,” but there are several standards that are GFSI-benchmarked. GFSI benchmarked schemes include:

  • Primus GFS
  • Global Aquaculture Alliance Seafood
  • Global Gap
  • FSSC 22000
  • Global Red Meat Standard
  • Canadagap
  • SQF
  • BRCGS Global Standard
  • IFS International Featured Standards
  • Japan Food Safety Management Association

If you are a food processor or manufacturer in the United States you can choose any of the applicable GFSI schemes, though, getting a GFSI audit will most likely mean getting a BRCGS or SQF audit.

What are the benefits of GFSI Certification?

GFSI certification is a way for companies to demonstrate that their products meet the highest standards of food safety. Food safety is a large part of GFSI’s mission, which is why they created this program. The GFSI sets out quality standards to create an environment where consumers can safely buy and consume products without worrying about whether or not they will become sick from eating them.

The benefits of using GFSI-certified raw materials are clear: you can be sure that your product will meet all requirements when it comes down to it. In turn, this reduces overall costs associated with making sure your goods are safe enough for consumption by users around the world.

Conclusion:

GFSI certification is a big deal and deserves some attention. As the world continues to look for ways to ensure food safety, GFSI certification will continue to be one of the most important standards in this industry.

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