Toy Association Alerts Members About Newly Proposed FDA Cosmetics Compliance Guidelines & Upcoming Registration Deadline

kid-scientistAugust 14, 2023 | The Toy Association™ is alerting members that the Food and Drug Administration (FDA) has recently released a draft guidance document titled “Registration and Listing of Cosmetic Product Facilities and Products,” which provides more information on the newly required compliance deadlines under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA is a major change to the FDA’s current regulatory framework for cosmetics with key provisions taking effect on or by December 29, 2023. The new regulations will affect all cosmetics and will include any toymakers that produce, import, or sell items such as DIY makeup and fragrance kits, temporary tattoos, face paint, play cosmetics, and more.

The newly released draft guidance document addresses:

  • The statutory requirement to submit cosmetic product facility registrations & product listings;
  • definitions;
  • who is responsible for making the submissions;
  • what information to include in the submissions;
  • how to make the submissions; and
  • when to make the submissions.

The draft guidance document is the first time the FDA is addressing the framework for registration and compliance for this new law and is soliciting comments with a September 7 deadline. The Toy Association has been monitoring regulation updates related to MoCRA since they were announced; staff is reviewing the Federal Notice and the guidance document.

It is important to note that, due to the statutory December 29 deadline, it is likely that the FDA will put the draft guidance into effect as-presented since there is very little time for any requested changes to be assessed and implemented. The FDA intends for the new submission portal to be online in October, giving regulated parties only two months to register all applicable facilities and products.

While there are some exemptions available for small businesses, registration and listing requirements may still apply depending on specific product types.

Toy manufacturers that will be impacted by the new regulations are encouraged to contact The Toy Association so that their concerns can be included in any comments. Feedback may be sent directly to Jos Huxley, senior vice president of technical affairs at The Toy Association.

The Toy Association will continue to monitor any updates and will keep members apprised of new developments. Members may reach out to Jos Huxley with any questions on this topic.