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Section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) sets out the requirements for imports and exports of products regulated by the Food and Drug Administration (FDA).

Imports

Shipments of products regulated by the FDA are subject to examination whenever they are offered for entry into the United States. Products found to be in violation of the laws and regulations administered by FDA will be detained. Products that cannot be brought into compliance will ultimately be refused. Products subject to refusal must either be exported or destroyed under U.S. Customs and Border Protection supervision. Products not examined at the time of entry are still subject to all the laws and requirements administered by FDA while in U.S. commercial channels.

Animal food imported into the United States must be composed entirely of ingredients judged acceptable for use in such products. Sections 402 and 403 of the FD&C Act require that human and animal foods be safe and wholesome, contain no deleterious, harmful, or unapproved substances, and be truthfully labeled. Federal animal food labeling regulations are found under Title 21 Code of Federal Regulations Part 501 [21 CFR 501].

Although there is no pre-market approval requirement for animal foods, their ingredients must be either approved food additives [21 CFR 573], generally recognized as safe (GRAS) [21 CFR 582], or the subject of an ingredient definition published in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO). FDA recognizes the ingredient names and definitions in the AAFCO OP, which has the most comprehensive list of ingredients acceptable for use in animal feed, as the common or usual name of the ingredients. Animal food ingredients include all component parts of an animal food, its constituents, or any combination, or mixture thereof, added to, and comprising, the food. Note that numerous herbs and other substances have not been approved for use in animal food in the US, and it is incorrect to assume GRAS substances approved for use in human food are also acceptable and safe for use in animal food.

More information on both the regulation of animal food products and food additives used in animal food is available from the following links:

Imported animal food, like human food, is subject to the requirements of The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). This Act requires the registration of human/animal food producing facilities with the FDA and for "prior notice" to be provided to FDA for each shipment of imported food before arrival in the U.S.

Additional information regarding facility registration and the prior notice requirements can be found on the following webpages:

Generally, a USDA APHIS Veterinary Services (VS) permit is required for the importation of any animal food, animal drug, or component (such as livestock feed, pet food/chews/treats, aquaculture feed, or ingredients thereof) that contain animal origin material (including dairy products, rendered materials, and raw or processed meat, for example) from countries with livestock diseases exotic to the United States. Import permit applications for animal-derived materials or regulated plant products are submitted to USDA using the APHIS eFile system.

Information regarding USDA APHIS VS import permits can be found on the following webpage or by contacting:

USDA APHIS Import Animal Products
Phone: (301) 851-3300, option 4
Email: APIE@USDA.GOV

Information regarding USDA APHIS plants and plant products import permits can be found on the following webpage or by contacting:

USDA APHIS Plants and Plant Products Permits
Phone: (877) 770-5990
Email: PlantProducts.Permits@USDA.GOV

Additional Information