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U.S. Department of Health and Human Services

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Import Procedures - Background

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Sections 801(a) and 536(a) of the Federal Food, Drug, and Cosmetic Act authorize FDA to examine foods, drugs, cosmetics, tobacco products, devices, and radiation-emitting products offered for import into the United States.  As part of the importation process, importers must file information about the product with the United States Customs and Border Protection (CBP), and other agencies with jurisdiction.  Importers can file this information themselves, or may use the services of a licensed customhouse broker to facilitate submission of the required documentation.  FDA conducts evaluations of filers who participate in FDA’s electronic entry processing program to determine if filers are submitting accurate data to FDA. 

FDA can refuse admission into the U.S. of imported products if, among other reasons, the product appears to be adulterated or misbranded.  As an initial step, FDA issues a notice to the owner or consignee informing them that their shipment has been detained and the basis of the detention.  The owner or consignee is provided an opportunity to provide testimony regarding the admissibility of the product or, in some circumstances, to submit a proposal to recondition the product to bring it into compliance with applicable laws.    If the owner fails to show that the product is in compliance or fails to bring the product into compliance, FDA will issue a notice to the owner or consignee that the product was refused admission into the U.S.  The product then has to be exported no later than 90 days after receipt of the notice, or it is subject to being destroyed by CBP. 

FDA discloses the name of the foreign manufacturer responsible for the refused product, the date of refusal, and the description of the product, as provided by the manufacturer, on the FDA Web site.   This information is updated monthly and can be searched by country of origin or product. 

FDA works closely with CBP to prevent the importation of adulterated, misbranded, or otherwise violative products into the country.