Recently, the FDA released the final guidelines for the listing of cosmetic facilities and products, and launched a new cosmetics portal called 'Cosmetic Direct'. And, the FDA announced mandatory requirements for cosmetic facility registration and product listing starting from July 1, 2024, to ensure regulated businesses have sufficient time to prepare and submit information.
1. Regulations
1)Modernization of Cosmetics Regulation Act of 2022, (MoCRA)
2)Federal Food, Drug and Cosmetic Act (FD&C Act)
3)Fair Packaging and Labelling Act (FPLA)
2. Scope of application
According to US law, cosmetics are defined as items that are applied, spread, sprayed, or otherwise used on the human body to clean, beautify, enhance attractiveness, or change appearance.
Specifically, it includes skin moisturizer, perfume, lipstick, nail polish, eye and facial cosmetics, cleaning shampoo, perm, hair dye and deodorant, as well as any substance used as a cosmetic ingredient. Soap does not belong to cosmetics.
3. Classification
According to MoCRA, the US cosmetics FDA classifies cosmetics into the following categories:
-Baby products: including baby shampoo, skin care talcum powder, face cream, oil and liquid.
-Bath products: including bath salt, oil, medicine, foam agent, bath gel, etc.
-Eye cosmetics: such as eyebrow pencil, eyeliner, eye shadow, eye wash, eye makeup remover, eye black, etc.
Cosmetics with special effects, such as anti wrinkle, whitening, weight loss, etc., need to be registered as OTC drugs at the same time. It should be noted that these new regulations apply to cosmetics exported to the US market.
FDA registration
MoCRA has not only added the following new requirements, including the establishment of the cosmetics responsible person system, mandatory reporting of serious adverse reactions, compliance with Good Manufacturing Practice (GMP), factory facility registration and product listing registration, providing sufficient safety certificates, but also required the label to be marked with the responsible person information, essence allergens, professional use of product statements, the development and release of asbestos detection methods in cosmetics containing talcum powder, and the safety risk assessment and animal phase out test of PFAS in cosmetics.
Prior to the implementation of MOCRA, cosmetic manufacturers/packers may register their factory facilities with the FDA through the US FDA's Voluntary Cosmetic Registration Program (VCRP), and the FDA does not have mandatory requirements for this.
But with the implementation of MOCRA and the approaching mandatory deadline, all companies selling cosmetics in the United States must register their manufacturing facilities with the FDA and update their registration information every two years, including name, contact information, etc. Facilities located outside the United States are also required to provide information and contact details of agents within the United States. There are also some supplementary information that need to be filled in, such as parent company information, enterprise type, packaging pictures, product webpage links, whether it is a professional cosmetics, the responsible person's Dun&Bradstreet code, etc. It is not mandatory to fill in. Existing cosmetic facilities must register with the FDA within one year after the new regulations are issued, and the registration period for new cosmetic facilities is within 60 days of engaging in cosmetic processing and production.
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FDA testing report
Post time: Aug-21-2024
