Cosmetics Registration in
USA
Regulatory Authority:
US Food and Drug Administration
Link for RA:
Local regulation:
U.S. Food, Drug, and Cosmetic Act (FD&C Act)
Who can register :
- Manufacturers
- Distributors
- Packers
Data to be communicated :
To complete Form 2512, the following information is required:
- Labeller information
- Information from the manufacturer
- Information about the packer
- Indicate whether the filed product is already available in the United States.
- Information on the product
- Select product category
- Choose a product category.
- Code of the product
- Name of a brand or a specific product
- Website for the product
- Label photos should be uploaded.
- Ingredient Information
- You have the option of entering a CAS/ VCRP code number or a common, everyday chemical name.
- Authorised individual name
Process:
Declaration of the Ingredients in Cosmetic Products (CPIS).
A cosmetics manufacturer, packer, or distributor can submit a statement for each product commercially distributed in the United States. For each formulation, use a separate FDA 2512 form. (You’ll need Form FDA 2512 and Form FDA 2512a if you’re utilising printed documents.) The FDA assigns each formulation filed in the VCRP a CPIS number.
Making changes to a product’s formulation or discontinuing it.
Form FDA 2512 and continuation Form FDA 2512a can change or terminate a CPIS. Within 60 days of the product’s commercial distribution, changes to the brand name or ingredients must be submitted. You should stop using a CPIS within 180 days of learning about the end of retail distribution.
Timeframe and fees:
Additional information:
The FDA is responsible for cosmetic labelling under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labelling Act (FPLA). Pre-market approval of cosmetic product labelling is not possible since the FDA lacks the resources and authority required by law. The manufacturer and distributor must ensure that products are properly labelled. Failure to adhere to labelling regulations may result in a misbranded product. All information on the labels must be written in English.