Cosmetic products placed on the market in the USA do not need product registration/FDA pre-market approval, with the exception of colour additives. However, the FDA can pursue enforcement actions against products that are not compliant with the legislation, either when products are already on the market or when cosmetic products are imported into the country.
Cosmetic products have to be safe for their intended use but the legislation does not require a specific set of tests or documents to demonstrate the safety of individual products or ingredients. It is up to the cosmetics’ manufacturer to determine how they will prove the safety of their products.
Cosmetic products must also comply with the ingredient restrictions, prohibitions and allowable colourants.
Labelling, including cosmetic product claims, is a very important part of ensuring compliance with the relevant legislation. Products that are improperly labelled, deceptively packaged or otherwise misbranded are prohibited and can be removed from the market.
As mentioned, there is no pre-market approval for cosmetic products. The cosmetic firms are, however, encouraged to participate in the FDA’s Voluntary Cosmetic Registration Program (VCRP), which is an online registration system where manufacturers, distributors and packers can register their facility and provide certain information about the cosmetic products they are selling in the USA.