Cosmetics

Voluntary Cosmetic Registration Program

FDA’s Voluntary Cosmetic Registration Program (VCRP) is a reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.

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About VCRP

There are two parts to the VCRP, described in detail in the sections below. You may participate in both parts of the program or only one part. No fees are required to participate in this voluntary program.

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 (Title 21, Code of Federal Regulations (CFR), part 710.9), such as hotel samples, free gifts, or cosmetic products you make in your home to give to your friends.

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Benefits of VCRP Participation

The VCRP assists FDA in carrying out its responsibility to regulate cosmetics. FDA uses the information to evaluate cosmetic products on the market. Because product filings and establishment registrations are not mandatory, voluntary submissions provide FDA with the best 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 assessing ingredient safety and determining priorities for ingredient safety review (Federal Register, vol. 73, p. 76360). FDA representatives attend CIR meetings in a non-voting capacity. By participating in the VCRP you are supporting these safety review processes.

Cosmetic companies gain one additional benefit from VCRP participation. Filers can use the database as back-up storage for product information because the FDA server is secured and off-site.

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Some Important Things to Know

  • 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.
  • The regulations authorizing this program are found in 21 CFR, parts 710 and 720.

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How to Participate

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). Firms can register their establishments before or after their products are entered into commercial distribution and for sale to U.S. consumers. FDA assigns a registration number to each establishment location and returns a copy of your Form FDA 2511 to you, listing the number assigned to the location as a receipt.

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.) You also may file a CPIS to amend an earlier submission if you change the formulation. FDA assigns a Cosmetic Product Ingredient Statement Number (CPIS NO.) to each formulation filed in the VCRP and returns an OFFICIAL RECEIPT to you marked COMPLETE, listing the CPIS NO. assigned to the submission.

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.

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Page Last Updated: 09/10/2014
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