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What is FDA's Voluntary Cosmetic Registration Program (VCRP)?
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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.
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 and products that are not for sale.
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.
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What is the purpose of VCRP participation?
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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.
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Can I use the FDA registration information in the product’s ads?
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No. 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 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. Misleading labeling makes a cosmetic misbranded.
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How to Participate?
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There are two parts to the VCRP filing. You may participate in both parts of the program or only one part.
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. 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.
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. The term commercial distribution of a cosmetic product means annual gross sales in excess of $1,000 for that product. FDA assigns a CPIS number to each formulation filed in the VCRP.
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