The Food and Drug Administration has issued a final guidance to assist companies submitting cosmetic product facility registrations and cosmetic product listings to the agency. The guidance covers a broad range of items such as makeup products, nail polishes, shaving creams and other grooming products, perfumes, face and body cleansers, haircare products, moisturizers, and other skincare products.
Under the Modernization Of Cosmetics Regulation Act of 2022, cosmetic product manufacturers and processors must register their facilities with the FDA, update content within 60 days of any changes, and renew their registrations every two years. In addition, each marketed cosmetic product (including its ingredients) must be listed with the FDA and updates must be provided annually. There are exemptions to these requirement for certain small businesses as well as certain products and facilities that are subject to requirements for drugs and medical devices.
The FDA can suspend a facility’s registration if it determines that a cosmetic product manufactured or processed by that facility and distributed in the U.S. has a reasonable probability of causing serious adverse health consequences or death to humans and it has a reasonable belief that other products manufactured or processed by that facility may be similarly affected because of a failure that cannot be isolated to a product or products or is sufficiently pervasive to raise concerns about other products manufactured in the facility. If a facility’s registration is suspended, it is a prohibited act to distribute or sell (or otherwise introduce or deliver into commerce) in the U.S. cosmetic products from that facility.
However, the FDA announced recently that it does not intend to enforce the facility registration and product listing requirements until July 1, 2024. This deadline applies to all facility registrations and product listings, regardless of when the facilities first engaged in manufacturing or processing or when the products were first marketed.
The FDA’s final guidance explains these requirements, what key terms mean, who is responsible for making submissions, what information to include in submissions, and how and when to make submissions. It also contains information about a new electronic submission portal (though the FDA is also developing paper forms – FDA 5066 and 5067 – and expects them to be available soon).
The FDA notes that changes from a draft guidance issued earlier this year include additional information on the facility registration number, U.S. agent, and electronic and paper submissions, as well as a new section of frequently-asked questions and answers.
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.
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