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The agency focal point for international issues that cut across product lines is FDA's Office of International Programs.
U.S. imports reached over 6 million shipments, worth $80 billion, in 2000, and they are rising sharply. FDA lacks the resources to inspect a meaningful proportion of these products when they arrive at the more than 150 U.S. ports of entry. (Although FDA inspectors review 100 percent of entry documents, they physically inspect less than one percent of all imports.) The agency therefore uses several approaches to ensure that imports meet the high U.S. public health standards before they leave the exporting country:
In addition to protecting American consumers, FDA oversight contributes significantly to the worldwide acceptance of foods, pharmaceuticals, medical devices and other FDA-regulated products.
By imparting a clear explanation of FDA requirements to all nations and firms that export FDA-regulated products to the United States, the agency is able to assist in facilitating exports of products that meet its requirements and discouraging those that are violative. Therefore, FDA assists foreign (and domestic) manufacturers in understanding how to comply with FDA's Current Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, known as Hazard Analysis and Critical Control Point (HACCP), and other regulations.
As a global leader and the world's premier consumer protection regulatory agency, a strong FDA is essential to continued protection of the health of American consumers, and to improving public health worldwide.