Cosmetics are not subject to FDA premarket approval or mandatory establishment registration or ingredient reporting. It is the firm’s responsibility to assure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the US FDA regulations.
The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US. There are two parts in FDA Voluntary Cosmetic Registration Program ; you may participate in both parts of the program or only one part.
- Cosmetic manufacturing establishment registration with the US FDA
Cosmetic manufacturers or packers whose products are in commercial distribution in the US should register their cosmetic establishments with the US FDA, using a separate Form for each cosmetic manufacturing location. Only cosmetic manufacturers and packers should register, not cosmetic distributors. FDA assigns a registration number to each cosmetic establishment registered and sends you a receipt.
- Cosmetic Product Ingredient Statements (CPIS) Filing with the US FDA
A cosmetic manufacturer, packer, or distributor should file a statement for each cosmetic product the firm has entered into commercial distribution in the US. With the distributor’s permission, a private labeler or packer also may file these forms.
ALN can assist you in
- Voluntary Cosmetic Registration with the US FDA
- Cosmetic Product Ingredient Statement Filing with the US FDA