Section 801 of the Federal Food, Drug, and Cosmetic Act (FFDCA) sets out the requirements for imports and exports of FDA regulated products.
The adulteration and misbranding standards for feed and feed ingredients of foreign origin are the same as for those of domestic origin. A notable difference is the burden of proof that FDA must meet to refuse the entry of products of foreign origin. Under Section 801(a), the agency must only establish that the product “appears” to be violative under the FFDCA. This is a lesser standard than that to establish a domestic product as violative.
The U.S. Customs and Border Protection informs FDA when regulated products are offered for entry into the United States. FDA has the option of releasing the product, requesting the owner to hold the merchandise intact pending FDA examination, or detention if the product has a violative history. Ordinarily these decisions are made at the District level but, at times, District personnel may consult with headquarters to determine the admissibility of a product. To assist field personnel in making these decisions, they have access to resources, which alert them to potential problems, or items that should be sampled. Some of these resources and other information on imports are available on the Internet from the FDA’s Office of Regulatory Affairs (ORA), Office of Regional Operations.
The legal requirements that must be met are the same for imported and domestic products, including feed mill licensing and new animal drug approval requirements. However, the enforcement procedures are different. Imported products regulated by FDA are subject to inspection at the time of entry. Shipments found not to comply with our laws and regulations are subject to detention. They must be brought into compliance, otherwise, they are subject to refusal. Refused articles must be either destroyed, or re-exported.
Generally, an USDA permit is required for imported materials derived from animals and plants. Animal products, which require permits, include dairy products and meat products (e.g., meat meal and bone meal) from countries with livestock diseases exotic to the United States. Import permit applications for animal products may be obtained through the Automated Document Retrieval by calling (301) 734-4952, or writing to the USDA-APHIS-VS at:
USDA, APHIS, VS, NCIE
4700 River Road, Unit 40
Riverdale, MD 20737-1231
Import permit applications for plant products may be obtained by calling (877) 770-5990, fax (301) 734-5786, or writing to the USDA-APHIS-PPQ at:
USDA, APHIS, PPQ
4700 River Road, Unit 136
Riverdale, MD 20737-1236
Importing Food Products into the United States USDA-APHIS-VS USDA-APHIS-PPQ About the Office of Regulatory Affairs Supplementary Information Certificate to Foreign Government Requests (PDF)(PDF - 837KB) FDA Export Certificates
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