This page provides an overview of cosmetics and the requirements that FDA verifies/enforces at the time they are imported or offered for import into the United States. FDA's Office of Cosmetics and Colors is responsible for overseeing the cosmetic program. Visit the cosmetics webpage for more information.
- What is a cosmetic?
- What cosmetic product requirements are verified at the time of importation?
- What cosmetic labeling requirements does FDA review at the time of importation?
- How can I determine if my cosmetic product is listed on an import alert?
- How does FDA Verify Compliance with the Cosmetic Requirements?
- Color Additives
- Voluntary Cosmetic Registration Program
- Affirmation of Compliance Codes
FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Cosmetics offered for import into the United States must comply with the same FDA laws and regulations as those that are produced domestically in the United States.
FDA routinely conducts field examinations and collects samples of cosmetics to verify that the ingredients (such as color additives) are suitable and safe for use in cosmetics, and verifies the color additives declared on the labeling have been approved by FDA for the intended use. Additionally, the product labeling is reviewed to ensure it complies with labeling requirements.
FDA reviews the import alert database to determine if the manufacturer or product is subject to detention without physical exam (DWPE). For example, import alert 53-06 Detention without Physical Examination of Cosmetics Containing Illegal Colors lists cosmetics that have been found to contain illegal colors.
Certified color additives used in cosmetic products require use of the color identification number (CIN) affirmation of compliance. FDA will verify the CIN at the time of importation for certified colors used in cosmetic products.
Cosmetic registration is voluntary and if supplied FDA will verify the firm’s voluntary cosmetic registration. See below for more information on cosmetic registration.
For more information visit the information for cosmetics importers page.
FDA conducts label examinations and reviews cosmetic labeling to ensure it is labeled according to FDA laws and regulations. FDA reviews the labeling and packaging to ensure it is informative and truthful, with the labeling information in English (or Spanish in Puerto Rico).
If the label includes claims to treat or prevent disease or otherwise affect the structure or any function of the body, it could cause the product to be considered a drug. For more information on drug claims, refer to Is It a Drug, a Cosmetic, or Both? (Or Is It Soap?) page. For more information on required cosmetic labeling information please visit the Labeling Regulations page.
FDA provides a list of import alerts by industry. To view the list of import alerts related to cosmetic products visit the import alert for cosmetics page.
FDA entry reviewers are trained to verify compliance with cosmetic requirements using the information provided to FDA in the importer’s entry transmission such as:
- Declared Manufacturer
- Declared Importer/Consignee
- Product Description
- Affirmations of Compliance (A of C)
These entry declarations are compared to information in FDA’s internal databases. The reviewer uses these internal databases to determine if the product is subject to DWPE, if the pure color additive is FDA certified, and verifies voluntary cosmetic registration information when supplied.
The submission of correct and accurate entry data along with the relevant A of C codes will help expedite the entry review process. Supplying this information accurately increases the likelihood that your shipment will be processed electronically and not held for manual review because FDA’s screening tool, PREDICT, can verify the declared information against FDAs internal data systems.
Note: Submitting inaccurate or incomplete information may delay the review of your entry.
Color additives are permitted in cosmetics only if FDA has approved those additives for the intended use. If your product contains a color additive, you must adhere to FDA’s laws and requirements for approval, certification, identity and specification, and use and restrictions. FDA separates approved color additives into two categories: colors subject to certification and colors not subject to certification.
Please visit the Color Additives and Cosmetics page for more information on color additives in cosmetics.
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 assists FDA in the regulation of cosmetics by providing information about cosmetic products and ingredients, their frequency of use, and firms involved in their manufacture and distribution to evaluate cosmetic products on the market.
For more information on VCRP please visit the Voluntary Cosmetic Registration Program page.
Affirmation of Compliance codes (A of C) are three letter codes that can be provided at the time of import to facilitate FDA review. FDA uses A of C codes to assist in verifying that your product meets the appropriate requirements. Providing the correct A of C codes reduces the likelihood that your shipment will be held for further FDA entry review during FDA’s import screening process. Submission of A of C codes is only mandatory in some instances and is not required for all scenarios. Submitting voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and review of your entry.
For information on cosmetic A of C codes as well as descriptions and examples of the cosmetic affirmation of compliance codes refer to the “Affirmation Of Compliance References” on the affirmation of compliance codes page.