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.
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
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.
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.
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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