This release is a key step in implementing the Modernization of Cosmetics Regulation Act (MoCRA), aimed at providing the industry with clarity regarding the FDA’s new mandatory recall authority.

What the Guidance Covers

The draft document outlines the specifics of how and when the FDA will exercise its power to force a recall. Key areas of focus include:

Decision Criteria: The specific criteria the FDA will use to determine if a mandatory recall is necessary.

The Process: A step-by-step look at the procedure the FDA will follow when implementing a mandatory recall.

Industry Expectations: Clear guidelines on what is expected from companies regarding compliance with these orders.

Call to Action

Industry stakeholders are encouraged to review the document to understand their new obligations. The draft guidance is currently open for public comment.

Deadline: You must submit your comments by February 17.

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A 2021 study revealed that the detected fluorine levels in cosmetics could be a case of trace amounts derived from materials naturally occurring in the environment or resulting from the manufacturing process. This naturally occurring or unintentional presence of trace materials is recognized by the FDA and they offer guidance on the allowable levels. FDA plans to review such compounds and assures to publish a complete report on PFAs in cosmetics by Dec 29, 2025 as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

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The portal is designed to simplify and expedite the registration process for facilities engaged in cosmetic businesses and for listing of products sold in the US. By providing a centralized platform, the FDA aims to enhance the efficiency of regulatory procedures, making it easier for industry professionals to comply with industry standards and guidelines.

The FDA has also extended the deadline for submissions, moving the compliance date from Dec. 29, 2023, to July 1, 2024.  If you require any assistance with filing your submissions via the Cosmetics Direct portal, please reach out to us. Our team is here to guide and support you through the process, ensuring a smooth experience for all stakeholders involved.

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New Requirements for Cosmetics:

1. Adverse Event Record keeping and Serious Adverse Event Reporting:

• Must report to FDA no more than 15 business days of event awareness
• Must maintain all related records
• Cosmetic product labels must list contact information for consumers to report side effects

2. Mandatory Facility Registration and Product and Ingredient Listing:

• Facility Registration by December 29, 2023 – All existing facilities (domestic and foreign) that engage in the manufacturing or processing of a cosmetic product for distribution in the United States must register with the FDA
• Must be renewed every 2 years
• Product Listing must be submitted within 120 days of market launch and it must be renewed annually

3. Cosmetic Safety Substantiation

• Adequate substantiation of safety is required for all cosmetics

4. Cosmetic Labeling and Fragrance Allergen Transparency

• Product labels must be updated to include fragrance allergens
• June 29, 2024 – List of allergens to be declared will be proposed by FDA and finalized within 180 days of the comment period ending
• Labeling must be updated by December 29, 2025

5. Current Good Manufacturing Practices:

• Manufacturers must meet GMP by 2025
• FDA is expected to publish a proposed regulation before December 29, 2024 and finalize it by December 29, 2025

6. Talc rule:

• FDA to publish a proposed test protocol for asbestos in Talc by December 29, 2023
• To be finalized 180 days after comment period ends

7. PFAS Report:

• FDA to assess the use of per- and polyfluoralkyl substances (“PFAS”) in cosmetic products and the scientific evidence regarding the safety of their use in cosmetics products
• FDA will publish the results of this assessment in a public report no later than December 29, 2025

8. Animal testing

• No requirements specific to testing involving animals, but animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances

MoCRA EXEMPTIONS:

• Small business exemptions apply – average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000 AND
• Do not engage in the manufacturing or processing of the cosmetic products listed below:
  • Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
  • Cosmetic products that are injected.
  • Cosmetic products that are intended for internal use.
  • Cosmetic products that are intended to alter appearance for more than 24 hours.

If you have any questions or would like further information, please contact us.

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