Today, FDA issued long-awaited draft guidance on cosmetic facility registrations and product listings, as required under the Modernization of Cosmetics Act Regulation of 2022 (MoCRA). The draft guidance, when finalized, will assist cosmetic companies with cosmetic product facility registration and product listing submissions including ingredients, to FDA. Cosmetic facility registration and product listing will be required before December 29, 2023. The registration and listing requirements apply to a wide range of cosmetic products including makeup products, nail polishes, shaving creams and other grooming products, perfumes, face and body cleansers, haircare products, moisturizers, and other skincare products.
Linda Katz, FDA Director of the FDA’s Office of Cosmetics and Colors, said “The agency will rely on registration and listing information to accomplish several objectives, such as identifying facilities producing products potentially causing adverse events, facilitating the recall of unsanitary products, administering product testing and surveillance programs, planning inspections and identifying products marketed in violation of the law.”
As we discussed in our June 26th News & Insights Article “Prep + Prime for MoCRA,” MoCRA requires the following:
- Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
- Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
A Responsible Person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of the cosmetic product.
Exemptions from Facility Registration/Product Listing Requirements
MoCRA exempts certain small businesses from facility registration and product listing requirements. However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:
- Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use
- Products that are injected
- Products that are intended for internal use
- Products that are intended to alter the appearance for more than 24 hours under customary or usual conditions of use, and removal by the consumer is not part of such conditions of use
Additionally, other businesses and uses may be exempt such as trade shows, hotel and airline services that provide complimentary cosmetic products, and hospitals, physicians’ officers and health care clinics. There are also exemptions for certain products and facilities that are subject to requirements for drugs and devices.
Importantly, FDA is advising of a new electronic submission portal that will be available in October 2023 for cosmetic facility registrations and product listings. The Agency is encouraging registration submissions through this portal. However, the FDA is developing a paper form as an alternative.
As outlined in the draft guidance, FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. We recommend businesses obtain an FEI number now, if you do not already have one, to facilitate registration.
FDA is accepting comments on the draft guidance by September 7, 2023.
Garg Law will be developing a system to assist cosmetic businesses with cosmetic facility registration and product listing, similar to our service offerings for food facility registration and medical device registration. Stay tuned to our News & Insights to learn more, or email us at info@garg-law.com to assist you with submitting comments to FDA’s draft guidance, or any cosmetics compliance questions.
