Cosmetics manufacturers, packers and distributors that operate in the USA are encouraged to use the FDA’s Voluntary Cosmetic Registration Program (VCRP).
The VCRP applies only to cosmetic products that are sold to end-consumers in the USA. The VCRP does not apply to products that are not intended for sale, such as hotel samples or free gifts, and is not intended for cosmetics that are only for professional use, such as products used in spas or salons.
The VCRP does not result in FDA pre-market approval for a particular product. The FDA uses the information obtained through the VCRP to evaluate the cosmetic products that are on the market. Information from the VCRP is also used by the Cosmetic Ingredient Review (CIR) to assist its expert panel in assessing ingredient safety and determining priorities for ingredient safety reviews.
The VCRP can be used to register cosmetic manufacturing and/or packaging establishments and for registering finished cosmetic products. Owners or operators who engage in the manufacture or packaging of a cosmetic product can register their establishments either before or after their products have entered commercial distribution. This registration does not apply to distributors such as beauty shops, retailers, pharmacies, physicians, hospitals, clinics, etc. The FDA assigns a registration number to each establishment location.
The product manufacturer, packer or distributor can take responsibility for the finished product “registration”—Voluntary Filing of Cosmetic Product Ingredient Statements (CPIS). The filing must be done within 60 days after commercial distribution has begun. The CPIS can also be filed to amend an earlier submission if the formulation of the product changes. The FDA assigns a CPIS number to each formulation file in the VCRP.
