Food, Drug, Cosmetic, and Device Safety Amendments of 1992

Summary

Food, Drug, Cosmetic, and Device Enforcement Amendments of 1991 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to authorize any U.S. district court to order the recall of a food, drug, device, or cosmetic if the court finds a reasonable probability that the food, drug, device, or cosmetic will cause serious adverse health consequences or death. Defines "recall" to: (1) include retrieval, repair, or replacement of a product; and (2) exclude a stock recovery or market withdrawal which is unrelated to health consequences of the product involved and to any violation of the FDCA. Authorizes the Secretary of Health and Human Services, for the same reasons, to order cessation of distribution and to recall it from commercial distribution and use. Declares a recall order by the Secretary to be a final agency action. Requires such an order to: (1) not recall a food, drug, or cosmetic from individuals; and (2) provide for notice to individuals subject to risks associated with the food, drug, or cosmetic. Requires manufacturers, distributors, and importers of foods, drugs, devices, or cosmetics to report to the Secretary any recall initiated by the manufacturer, distributor, or importer. Adds failure to take certain actions required by this Act to the list of prohibited acts. Authorizes seizure and detention of any food, drug, device, or cosmetic that is in violation of the FDCA. (Current law authorizes seizure of any food, drug, or cosmetic for specified reasons and detention of any device for specified reasons.) Modifies certain procedures regarding detention. Makes a detention order a final agency action. Grants the Commissioner of the Food and Drug Administration subpoena power with regard to proceedings and investigations regarding a violation under the FDCA. Limits delegation of the subpoena authority. Provides for civil monetary penalties for various acts, including violating any provision of the FDCA, making false statements, bribes, and obstruction of investigations. Modifies the authority of the Secretary to inspect establishments and vehicles with regard to violations of the FDCA concerning food, drugs, devices, or cosmetics or packaging, labeling, or containers for such products, including adding authority to retain samples and to copy records. Declares that an inspection shall extend to all things bearing on whether articles are in violation of the FDCA. (Current law declares that an inspection relating to drugs or devices extends to all things bearing on violation of the FDCA.) Specifies items excluded from inspection under these provisions. Requires each manufacturer, importer, and distributor of products regulated under the FDCA and each owner, operator, or agent in charge of an establishment subject to inspection under certain provisions of the FDCA to maintain records and make reports as the Secretary determines to be necessary. Extends to all officers and employees of the Department of Health and Human Services conducting examinations, investigations, or inspections relating to the illegal distribution of steroids or certain acts prohibited under the FDCA the enforcement powers currently granted to those involved with counterfeit drug matters. Requires refusal of admission for import of any article which is in violation of the FDCA. (Current law requires refusal of admission if adulterated, misbranded, or in violation of provisions relating to new drugs.) Replaces provisions requiring the destruction or exporting of articles refused admission with provisions requiring refused articles to be marked, before export, as refused entry into the United States. Directs the Secretary of the Treasury to notify the Secretary of Health and Human Services of food, drugs, devices, and cosmetics being imported into the United States. Requires that the bond which is required, pending decision on the admission of an article, in order to release the article to the owner or consignee, be at least three times the invoice value of the article. Requires the destruction of an article if the Secretary of Health and Human Services finds that there is a reasonable probability that use of or exposure to the article will cause significant adverse health consequences or death. Directs the Secretary of the Treasury, on request of the Secretary of Health and Human Services, to refuse to authorize delivery of an article to the owner or consignee. Prohibits the owner or consignee of an article, a sample of which was delivered or examined, from making a claim for payment for the sample. Presumes the existence of the connection with interstate commerce required for jurisdiction in any action to enforce the FDCA respecting a food, drug, device, or cosmetic. (Current law presumes such existence in an action respecting a device.) Transfers provisions of the Public Health Service Act relating to regulation of biological products to the FDCA and removes from the transferred material provisions relating to recalls and penalties for offenses. Adds violation of the transferred provisions to the FDCA list of prohibited acts.

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4 official files

• Reported in House (text)

  Reported in House · EN

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• Introduced in House (text)

  Introduced in House · EN

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• Reported to House with amendment(s)

  summary · EN · 5 October 1992

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• Introduced in House

  summary · EN · 24 October 1991

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