Cosmetic products imported into the United States are subject to the same laws and regulations as those produced in the United States. They must be safe for their intended uses and contain no prohibited ingredients, and all labeling and packaging must be informative and truthful, with the labeling information in English (or Spanish in Puerto Rico). All color additives must be approved by FDA; many cannot be used unless certified in FDA's own laboratories. If the product has an intended use that causes it to be considered a drug, it must comply with the requirements for drugs.
If the product has an intended use that causes it to be considered a drug, it must comply with the requirements for drugs, including establishment registration and drug listing.
Cosmetic firms are encouraged to register their establishments and file Cosmetic Product Ingredient Statements with FDA's Voluntary Cosmetic Registration Program (VCRP). However, 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.
Among the most common reasons for import refusals of cosmetics are labeling violations, the illegal use of color additives, and the presence of poisonous or deleterious substances, such as pathogenic microorganisms. FDA has several Import Alerts for cosmetics that do not comply with U.S. laws and regulations governing cosmetics and color additives. In addition, two of FDA's Import Alerts for drugs address cosmetic-type products marketed with therapeutic claims that cause them to be considered unapproved new drugs under the law: one for certain skin care products labeled as anti-aging creams and another for various unapproved new drugs promoted in the U.S.
FDA urges cosmetic importers to consult our Information for Industry for further resources.