Resources for You
Voluntary Cosmetic Registration Program (VCRP)
- Registering cosmetic manufacturing and/or packaging establishments
- Filing Cosmetic Product Ingredient Statements (CPIS)
- Amending or Discontinuing a Product Formulation
The Voluntary Cosmetic Registration Program (VCRP) is an FDA reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the
The VCRP applies only to cosmetic products being sold to consumers in the
Benefits of VCRP participation
There are legal differences between cosmetics and drugs. The VCRP applies to products that are cosmetics as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 201(i). Drugs are subject to different requirements, including those for registering establishments and listing products with FDA (FD&C Act, sec. 510; 21 CFR 207). Some cosmetic products may also be drugs. Additional information on these types of products is available elsewhere on FDA's website. For example, you may wish to refer to “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).” If your products are drugs, or both cosmetics and drugs, see “Drug Registration and Listing System (DRLS & eDRLS)” and “Electronic Drug Registration and Listing Instructions.”
The VCRP is not a cosmetic approval program or a promotional tool. Cosmetics are not subject to FDA premarket approval. It is the firm's responsibility to ensure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law. Registration of a cosmetic establishment, assignment of an establishment registration number, filing a cosmetic product, or assignment of a CPIS number does not mean that FDA has approved the firm or its products (21 CFR 710.8 and 720.9) or that a product is a cosmetic as defined in the FD&C Act. Any representation in labeling or advertising that creates an impression of official approval because of registration or possession of a registration number is considered misleading (21 CFR 710.8 and 720.9). Misleading labeling makes a cosmetic misbranded (FD&C Act, 602(a)), and marketing a misbranded cosmetic is against the law (FD&C Act, 301(a)).
The VCRP is not part of an import notification system. Firms importing products considered to be solely cosmetics in the United States are not required to register with FDA, and a registration number is not required for importing cosmetics into the United States.
Certain information from the VCRP database is available through the Freedom of Information Act (FOIA). For example, FDA sometimes receives such requests from consumers or healthcare providers who wish to identify products that do or do not contain certain ingredients. Proprietary business information, however, is not releasable under FOIA. Firms may submit written requests for confidentiality of a cosmetic ingredient in accordance with 21 CFR 720.8, which also states how FDA handles such requests.
How to Participate:
3) Amending or Discontinuing a Product Formulation. CPIS numbers do not have expiration dates, so it is important for you to follow the procedures in 21 CFR 720.6 to amend a filed formulation or to discontinue a filed product that is no longer in commercial distribution. If you are filing via Internet, use Form FDA 2512 to amend or discontinue a CPIS. If you are using paper forms, use Form FDA 2512 to amend a formulation and Form FDA 2514 to discontinue a formulation.