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  1. International Programs

Imports and Exports

Laws, regulations and policies applicable to imports and exports, domestic and overseas inspections for compliance, fraud deterrence.

All FDA-regulated products imported into the United States are required to meet the same laws and regulations as domestic goods. Imported foods must be pure, wholesome, safe to eat and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe for their intended use and properly labeled; radiation-emitting devices must meet established standards; tobacco products must meet U.S. requirements, and all products must contain informative and truthful labeling in English.

FDA-regulated products are subject to inspection when offered for import into the United States. Products may be refused entry if they appear, from examination or otherwise, to violate FDA requirements. Some products are subject to certification and/or testing requirements due to a past history of violations; these are identified in import alerts and in certain international cooperative arrangements.

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FDA is responsible for enforcing the Federal Food, Drug, and Cosmetic Act (FD&C Act), including those provisions concerning FDA-regulated products that are exported from the United States.  Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§321-397, and other statutes FDA administers.

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