FDA began enforcing MoCRA’s facility registration and product listing requirements on July 1, 2024, so your cosmetic company must now comply with the law. But is it?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.
The new law helps to ensure the safety of cosmetic products. In November 2023, the US Food and Drug Administration (FDA) announced that it would delay enforcement of certain requirements under the Modernization of Cosmetics Regulation Act (MoCRA) until July 1, 2024, to give the industry more time to comply with pending deadlines.
To support brands still in the process of registering, we have included some helpful resources, such as this FDA article which contains links to submission guides and their electronic submission portal.
In their recent blog “What Cosmetics Companies Need to Know About MoCRA’s July 1 Deadlines” CEW breaks down some common misconceptions about how the new law is applied, including rules around FEI numbers, foreign facility registration requirements, and who should assume the role of “Responsible Person”. They also list the potential ramifications of not complying with the new registration. Click here to read the blog.
Finally, here is a helpful guide, produced by the FDA, to support brands using the Cosmetics Direct electronic submissions portal for registering and listing cosmetic product facilities and the products themselves.
It is important to note that some small businesses are exempt from the MoCRA rules. To learn more about which companies are considered exempt click here.
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Frequently asked questions
What is MoCRA?
MoCRA is the Modernization of Cosmetics Regulation Act of 2022. It is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938, and it is designed to help ensure the safety of cosmetic products.
When did MoCRA enforcement start?
The FDA delayed enforcement of certain MoCRA requirements until July 1, 2024, to give the industry more time to meet pending deadlines. That date has passed, so cosmetics companies are now expected to comply, including registering their facilities and listing their products with the FDA.
How do I register a cosmetics facility and list products under MoCRA?
Use the FDA’s Cosmetics Direct electronic submissions portal. The FDA has published an article with links to submission guides and the portal, plus a separate guide on using Cosmetics Direct to register cosmetic product facilities and list the products themselves. Both are linked in the post’s resources.
Are small businesses exempt from MoCRA?
Some are. Certain small businesses are exempt from the MoCRA rules, and the FDA has published guidance explaining which companies are considered exempt. Check that guidance before deciding whether the registration and listing requirements apply to your business.
Sources
- Consolidated Appropriations Act, 2023 (H.R. 2617, enrolled bill), which contains the Modernization of Cosmetics Regulation Act of 2022, U.S. Congress
- Deadline for Registration and Listing of Cosmetic Product Facilities and Products: What Does the Deadline Mean?, U.S. Food and Drug Administration
- What Cosmetics Companies Need to Know About MoCRA’s July 1 Deadlines, Cosmetic Executive Women (CEW)
- Guide to using the Cosmetics Direct electronic submissions portal for facility registration and product listing, U.S. Food and Drug Administration
- FDA guidance on small business exemptions under MoCRA, U.S. Food and Drug Administration
