Food, Drug, Cosmetic, and Device Enforcement Authorities Act

Summary

Food, Drug, Cosmetic, and Device Enforcement Authorities Act - 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 which is in violation of the FDCA. Authorizes the Secretary of Health and Human Services, upon finding that there is a reasonable probability that a food, drug, or cosmetic would cause serious, adverse health consequences or death, to issue an order requiring the appropriate person (including the manufacturer, importer, distributor, or retailer) to immediately cease any distribution of the food, drug, or cosmetic. Provides an opportunity for an informal hearing for the person subject to such order, on whether the order should be amended to require a recall of such items. Declares any recall order to be a final agency action. Requires manufacturers and distributors 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. Requires the promulgation of regulations with respect to such seizure and detention. Grants the Commissioner of the Food and Drug Administration subpoena power with regard to proceedings and investigations (other than a rulemaking) under the FDCA. 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 or cosmetics, including adding authority to retain samples and to copy records. Declares that an inspection shall extend to all things, including equipment, finished and unfinished materials, containers, labeling, processes, controls, and facilities, 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.) Sets forth similar authority with respect to drugs and devices. Sets forth inspection procedures with respect to infant formulas. Limits inspection at certain sites and for certain records. Requires inspectors to give a written report to the owner, operator, or agent in charge after the inspection of an establishment. Sets forth requirements for inspectors where samples are necessary from any inspection. 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 under the FDCA the enforcement powers currently granted to those involved with counterfeit drug matters. Includes the illegal distribution of steroids or steroid substitutes and violations of prohibited acts under the purview of such employees. 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. 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. 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.) 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. 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. Requires destruction within ten days, without option to relabel or export, of any article that will cause significant adverse health consequences or death. Affords the owner an informal hearing prior to such action. Includes as prohibited acts: (1) the failure to mark an article as required by the FDCA or the removal or alteration of such a mark and the failure to export an article bearing such mark through the port through which the owner or consignee attempted to import it; and (2) the importation or introduction or delivery for introduction into interstate commerce of an article which has been refused admission. Includes in the definition of "interstate commerce," as used in the FDCA, commerce involving an article or activity which affects interstate commerce. Makes a similar inclusion in definitional provisions relating to electronic product radiation control. 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.)

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

2 official files

• Introduced in Senate (text)

  Introduced in Senate · EN

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 27 November 1991

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.