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Is it a cosmetic or a drug?

If the cosmetic is classified as a medicinal product or medical device, you must follow the FDA rules for drugs and medical devices

There is no need to obtain FDA approval to import cosmetic products into America

However, FDA clearance may be required if the product is intended for therapeutic purposes and is therefore categorized in the U.S. as a drug

Cosmetic products also classified as medicinal products for the purpose of their importation into the US

In this case, the FDA rules regarding the importation and sale of drugs in America must be followed

It is possible for a product to be classified as both a cosmetic and a drug (e.g. an anti-dandruff shampoo), in which case the product will be required to simultaneously comply with the laws regarding the importation of drugs and cosmetics. The problem is more delicate than you can imagine. We had the case of a customer who had the importation of anti-cellulite creams blocked in America because the components of the cosmetic product were listed as "Active Ingredients" and the wording "Active Ingredients" is typically used for drugs. In that case, it was enough to show up in person during the FDA import inspection at the US customs and explain the situation to the inspector. Another time we had the case of an importation of hand creams to America, bearing labels that claimed they "cure skin redness". Since the only products that "cure" are medicines, the product in question could not be classified as a cosmetic according to FDA rules and was instead subject to the regulations of prior approval and import permits, typically applicable to drugs. In this case, the import was refused, the container was refused entry at customs and sent back to Italy, and the manufacturer was blacklisted by the FDA. The requirements for importation would change further if the article in question were to be categorized as soap.

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FDA Compliance

ExportUSA takes care of ensuring that your products adhere to FDA standards. We make sure that all food products, cosmetics, medical devices, and dietary supplements comply with FDA regulations.