Resources for You
Color Additives and Cosmetics Cosmetic Labeling
- Guidance, Compliance and Regulatory Information
Ingredients Prohibited & Restricted by FDA Regulations Voluntary Cosmetic Registration Program (VCRP)
- FDA's Import Program
U.S. Customs and Border Protection: Importing into the United States: A Guide for Commercial Importers
Information for Cosmetics Importers
June 22, 2001; updated December 13, 2006, October 29, 2009, and March 29, 2013
FDA often receives questions about requirements for importing cosmetics into this country. The following are some commonly asked questions and our responses.
- How does FDA monitor imports?
- Can FDA answer my questions about U.S. Customs?
- Are all imported cosmetics sampled and examined?
- Do imported and domestically produced cosmetics need to meet the same requirements?
- Is it necessary to receive FDA approval before importing cosmetics?
- Do I need to register with FDA in order to import cosmetics?
- What are the international differences in the definitions of cosmetics and drugs?
- What are some of the reasons cosmetics offered for import are refused entry into the United States?
- What ingredients are prohibited or restricted?
- Are “natural” or “organic” cosmetics required to receive certification?
- What are the labeling requirements for cosmetics?
While not all imported products are examined at the time of entry, those not examined are still subject to all the legal requirements of the laws we enforce.
- FDA Authority Over Cosmetics
- Three Legal Concepts: Interstate Commerce, Adulterated, and Misbranded
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
- Cosmetic Labeling and Label Claims
- Color Additives and Cosmetics
- Guidance, Compliance and Regulatory Information
- Resources for You: Cosmetics Manufacturers, Packagers, and Distributors
Remember, however, that some “personal care products” are drugs, or both cosmetics and drugs, under U.S. law. If your product is a drug under U.S. law, it is subject to the requirements for drugs, such as premarket approval. To learn more, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).”
If your products are drugs, or both cosmetics and drugs, under U.S. law, however, they are subject to requirements for drug registration. Similarly, importers of cosmetic ingredients that are also classified as food products are required to meet the registration requirements of the Bioterrorism Act of 2002.
Drugs are regulated by FDA’s Center for Drug Evaluation and Research (CDER). Please direct questions about drugs to CDER at CDERSmallBusiness@fda.hhs.gov or email@example.com.
- Ingredients or contaminants that cause the product to be unsafe.
- Color additive violations: All color additives must be approved by FDA for the intended use; some must not be used unless they are batch-certified in FDA's own laboratories. Misuse of color additives makes a product adulterated. To learn more, see “Color Additives and Cosmetics” and the additional resources listed on that page.
- Prohibited and restricted ingredients: Violating the restrictions on the use of these substances makes a cosmetic adulterated.
- Microbial contamination: Sterility is not required for cosmetic products, but microbial contamination can pose a health hazard and therefore make a product adulterated.
- Labeling violations, such as deficiencies in the ingredient declaration, or failure to include all required labeling information in English (or Spanish, in Puerto Rico).
- Claims that cause a product marketed as a cosmetic to be subject to regulation as a drug under U.S. law.
Remember, these are just some common violations. Any violation of applicable U.S. laws and related regulations may result in a cosmetic being detained.
Also, remember that all cosmetics are required to be safe, regardless of the sources of their ingredients. An ingredient’s source does not determine its safety. To learn more, see “'Organic’ Cosmetics.”
- Must all labeling be in English?
All required label information must be in English. However, if the product is marketed only in Puerto Rico, it must be labeled in Spanish. If some labeling information appears in another language, all required label information must also appear in that language.
Can common or usual names of ingredients used in the country of origin be used on cosmetic labels?
Under the Fair Packaging and Labeling Act, ingredients must be identified by their "common or usual names" in the United States. Terms such as “aqua,” “mel,” or “parfum” are permitted only in parentheses following their common or usual names in English, such as “water,” “honey,” and “fragrance.”
Is INCI nomenclature acceptable for identifying botanical ingredients?
INCI (International Nomenclature Cosmetic Ingredient) names for botanical ingredients typically use Latin names for genus and species to identify botanical ingredients. U.S. regulations require the use of common or usual names. Latin terms may be included parenthetically following the common or usual name of an ingredient. Example: Aloe (Aloe Barbadensis) Extract. See “FDA Response to CTFA Requests Regarding Harmonization of Ingredient Names (Color Additives, Denatured Alcohol, and Plant Extracts).”
Are C.I. numbers acceptable for identifying color additives on cosmetic labeling?
C.I. numbers are not acceptable on product labeling unless they are preceded by the color additive names accepted in the U.S. followed by the C.I. number in parentheses. In addition, C.I. numbers do not indicate FDA approval or FDA color certification. To learn more, see “Color Additives and Cosmetics” and the additional resources listed on that page.
I want to import cosmetics without labeling, and label them in the United States before marketing them. Is this permitted?
There is an exemption from ingredient labeling that may apply in such cases. Bulk cosmetics do not have to comply with the cosmetic labeling regulations if the person introducing the shipment is the operator of the establishment where the powder is going to be repackaged and labeled, or, in a case where someone else is going to introduce the shipment into the United States, if a written agreement signed by the establishment operator is available for customs officials at the time the shipment is offered for import. The labeling exemption will be void, however, if the product is moved from the establishment without the required labeling. For complete information, see the regulation at 21 CFR 701.9.