Food and Drug Administration's Program for Regulating Imported Products Needs Improving

HRD-77-72: Published: Jul 5, 1977. Publicly Released: Jul 5, 1977.

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Lack of information on products entering the United States limits the effectiveness of the Food and Drug Administration's (FDA) efforts to regulate imported products before they are sold to the American public.

FDA does not maintain enough specific information on the types and volume of imports to know whether all the various imported products are inspected. Without such data, the agency cannot determine how effective its import surveillance is nor can it assess the extent that imports comply with regulations.

Recommendation for Executive Action

  1. Status: Closed

    Comments: Please call 202/512-6100 for additional information.

    Recommendation: The Secretary of Health, Education, and Welfare should direct the Commissioner of FDA to: establish a system to provide comprehensive information on specific products showing volume imported, volume inspected, and inspection results; evaluate the effectiveness of the compliance program; provide Customs with updated lists of products subject to FDA regulation and periodically review Customs entry documents to identify products under FDA jurisdiction which were not referred for regulatory action; develop uniform criteria for district offices to follow in recommending the penalty that should be imposed when importers violate Customs redelivery bonds; more aggressively develop cooperative agreements with those countries that export violative products to the United States and which can implement such agreements; and require importers to certify that imported products meet the requirements of the Federal Food, Drug, and Cosmetic Act.

    Agency Affected:


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