Cosmetics Importers

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FDA often receives questions from cosmetics firms about requirements for importing cosmetics into the United States. Here are some commonly asked questions and our responses.

To learn about exporting cosmetics from the United States to other countries, see Information for Exporters: FAQs.

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?

How does FDA monitor imports?

FDA works closely with U.S. Customs and Border Protection (CBP) to monitor imports. Imported cosmetics are subject to examination by CBP at the time of entry. Foreign cosmetics that appear to be adulterated or misbranded may be refused entry into the United States. They must be brought into compliance, destroyed, or re-exported. Import refusals are listed on FDA’s website and are updated monthly.

Can FDA answer my questions about U.S. Customs requirements?

No. You will need to contact U.S. Customs and Border Protection (CBP)directly to learn what Customs requirements apply to your imports. Useful resources on the CBP website include, for example, "Importing into the United States: A Guide for Commercial Importers."

Are all imported cosmetics sampled and examined?

Not all cosmetics are inspected or sampled upon entry into this country. In order to focus inspection efforts most efficiently, FDA issues Import Alerts to advise inspectors of trends in violations. Among the products addressed in Import Alerts are cosmetic-type products marketed with therapeutic claims that cause them to be considered unapproved new drugs under the law, cosmetics that are adulterated because of microbial contamination, failure to meet U.S. requirements for color additives, and bulk shipments of high-risk bovine tissue from BSE (bovine spongiform encephalopathy) countries. For a complete list, see Import Alerts for Industry: Cosmetics.

However, examination of imported cosmetics is not limited to the types of products specified in Import Alerts. Also, the fact that a product has not been detained previously does not protect it from being detained in the future, if it appears to be in violation of U.S. law.

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.

Do imported and domestically produced cosmetics need to meet the same requirements?

Imported cosmetics must comply with the same laws and regulations that apply to those produced domestically. Cosmetic products and ingredients are not subject to premarket approval by FDA, with the exception of color additives. However, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled. Color additives must be approved for the intended use; some must be from batches certified by FDA. Firms and individuals who manufacture or market cosmetics are responsible for ensuring that their products are in compliance with U.S. law. To learn more, see:

and the related resources listed on those pages.

Is it necessary to receive FDA approval before importing cosmetics?

Cosmetic products and ingredients, other than color additives, do not need FDA approval before they go on the market. However, they must not be adulterated or misbranded. This means that they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled. With the exception of color additives and those ingredients that are prohibited or restricted by FDA regulations, a cosmetic firm may use any ingredient, as long as it does not cause the product to be adulterated in any way. Companies and individuals who manufacture or market cosmetics have a legal responsibility for the safety and labeling of their products.

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?).”

Do I need to register with FDA in order to import cosmetics?

No. 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 this country. FDA encourages both domestic and foreign cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with our Voluntary Cosmetic Registration Program (VCRP), but as its name indicates, participation in this program is voluntary, not mandatory. Please note that the VCRP can only accept Cosmetic Product Ingredient Statements for cosmetics that are already on the market in the United States (21 CFR 720.2).

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.

What are the international differences in the definitions of cosmetics and drugs?

Many countries define drugs and cosmetics differently from the United States. For example, in some countries, sunscreens are regulated as cosmetics. In the United States, they are regulated as drugs. Hair restoration, skin protectant, pain relief, anti-aging effects that involve the structure or function of the skin, and treatment of acne, dandruff, eczema, or irritated skin are other examples of claims that would cause products to be regulated as drugs (or in some cases, both cosmetics and drugs) in the United States. Cosmetics and drugs are subject to different requirements. To learn more about the differences between cosmetics and drugs under U.S. law, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)” and the additional resources listed on that page.

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 druginfo@fda.hhs.gov.

What are some of the reasons cosmetics offered for import are refused entry into the United States?

A cosmetic may be refused entry into the United States if it appears not to comply with applicable U.S. laws and regulations in any way. The following are just some of the most common reasons:

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.

What ingredients are prohibited or restricted?

If you are an importer, it is essential for you to verify that the products you import comply with regulations that prohibit or restrict the use of certain ingredients. The country of origin may not have the same ingredient prohibitions and restrictions as the United States. But remember, any ingredient is prohibited if it causes the finished cosmetic product to be unsafe for consumers under labeled or customary conditions for use, even if there is no regulation specifically prohibiting or restricting its use in cosmetics. To learn more, see “Ingredients Prohibited or Restricted by FDA Regulations.”

Are “natural” or “organic” cosmetics required to receive certification?

FDA does not define or regulate terms such as “organic” and “natural.” However, the U.S. Department of Agriculture (USDA) does regulate the use of the term “organic” when used in terms of agricultural ingredient marketing. Questions about the use of organic agricultural ingredients should be directed to USDA. There are also private organizations that certify “natural” and other claims; however, these organizations are in no way affiliated with FDA.

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.”

What are the labeling requirements for cosmetics?

To learn about cosmetic labeling, see “Labeling” and the additional resources listed on that page, such as the “Cosmetic Labeling Guide.” The following are some of the more common labeling concerns affecting importers:

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 shipment 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.

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