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What Is an FDA Import?

Any product brought into the country over which the Food and Drug Administration has jurisdiction is an FDA import. The FDA monitors standards of foreign products to ensure the safety and health of the consumers. FDA imports include almost all foods (except meat and poultry), drugs, biologics, cosmetics, medical devices, electronic products that emit radiation, animal feed, veterinary drugs and tobacco products.

  1. Foods

    • Foods imported into the U.S. have to be as safe as local products and free of all substances considered as adulterants by the FDA. Foreign food facilities exporting foods to the U.S. must be registered with the FDA and provide notice of all incoming food shipments.

    Drugs

    • Drugs imported into the U.S. must have FDA approval. Any drug not meeting this requirement is adulterated and illegal. To ensure the safety, quality, potency and effectiveness of imported drugs, FDA requires registration of both the imported drugs and their manufacturing facilities. Over-the-counter drugs are also FDA imports and should comply with OTC monographs.

    Cosmetics

    • Cosmetics imported into the U.S. must be safe for their intended use and properly labeled. Color additives in cosmetics must be FDA approved. Labeling should be in accordance to FDA requirements.

    Medical Devices

    • Medical devices include all in vitro diagnostic products, medical and surgical instruments. Medical devices must be FDA approved before being imported. Foreign medical device manufacturers must register their establishment with the FDA and follow the quality system regulations.

    Products that Emit Radiation

    • These products include medical devices (therapeutic, diagnostic, surgical) scientific equipment, baggage x-rays and household products (microwave ovens, televisions, laser toys). All imports that emit radiation have to meet performance and labeling standards and submit reports of radiation safety to the FDA.

    Biologics

    • Imported biologics (blood and blood products, vaccines, tissues and cellular and gene therapies) must have FDA approval before being imported. In addition, foreign manufacturers must follow FDA regulations before, during and after the product is imported.

    Veterinary Drugs and Animal Feed

    • Similar to drugs imported for human use, all veterinary drugs imported into the U.S. have to be FDA approved. Inspection occurs at the port of entry for all imported animal feed, and the FDA destroys or re-exports all adulterated products.

    Tobacco Products

    • Importers of tobacco products must submit documents to the FDA listing the ingredients contained in the product. They also must submit tobacco health documents that include the names of the manufacturer and importer, as well as the health effects due to its use.

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