The FDA's Voluntary Cosmetic Registration Program (VCRP) is a notification system used by manufacturers, packagers and retailers of cosmetic products that are commercially available in the United States.
There are two parts to the VCRP filing, described in detail in the sections below. You may participate in both parts of the program or only one part. The VCRP regulations can be found in 21 CFR, parts 710 and 720.
The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics. It also does not apply to products that are not for sale, such as hotel samples, free gifts, or cosmetic products you make in your home to give to your friends.
The VCRP assists FDA in carrying out its responsibility to regulate cosmetics marketed in the United States. Because product filings and establishment registrations are not mandatory, voluntary submissions provide FDA with the best estimate of information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution (Federal Register, vol. 73, p. 76360, and vol. 69, p. 9339).
Information from the VCRP database also has been used by the Cosmetic Ingredient Review (CIR), an independent, industry-funded panel of scientific experts, to assist the CIR Expert Panel in establishing their priorities for assessing ingredient safety as part of their ingredient safety review (Federal Register, vol. 73, p. 76360).
The VCRP is a voluntary registration system for cosmetic products as defined by the Federal Food, Drug, and Cosmetic Act (FD&C Act), section 201(i); 21 USC 321(i). Drugs are subject to different FDA registration and marketing requirements (FD&C Act, sec. 510; 21 CFR 207). Depending on the claims made, some cosmetic products may also be drugs. If a cosmetic product is also a drug, it must comply with the requirements for both cosmetics and 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 (21 USC 362(a)).
The VCRP is not part of a prior notice system for imported cosmetics. Firms importing products considered to be solely cosmetics in the United States are not required to register with FDA.
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. Please note, in late 2018, certain registration information from the VCRP, that is currently available to the public through FOIA, will be posted on the VCRP Registration Reports webpage.
The regulations authorizing this program are found in 21 CFR, parts 710 and 720.
1) Registering cosmetic manufacturing and/or packaging establishments. Cosmetic establishments are facilities where cosmetics are manufactured and/or packaged, not locations that house only business operations. Only owners or operators of cosmetic manufacturing or packing facilities can register their establishments, using a separate Form FDA 2511 for each facility location. Distributors cannot register an establishment (21 CFR 710.1). Domestic firms that have begun operations can register their establishments before or after their products are entered into commercial distribution and for sale to U.S. consumers. Foreign firms may voluntarily register their establishments after their products are exported for sale in the U.S. FDA assigns a registration number to each establishment location.
2) Filing Cosmetic Product Ingredient Statements (CPIS). A cosmetic manufacturer, packer, or distributor can file a statement for each product the firm has entered into commercial distribution in the United States. Use a separate Form FDA 2512 for each formulation. (If you are using printed forms, you will need both Form FDA 2512 and 2512a.) FDA assigns a CPIS number to each formulation filed in the VCRP.
3) Amending or Discontinuing a Product Formulation. A CPIS can be amended or discontinued by filing Form FDA 2512 and continuation Form FDA 2512a. Changes to a brand name or ingredients should be submitted within 60 days after the product enters commercial distribution. A CPIS should be discontinued within 180 days after discontinuance of commercial distribution becomes known to you.