Summary: H.R.5170 — 94th Congress (1975-1976)All Information (Except Text)

There is one summary for H.R.5170. Bill summaries are authored by CRS.

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Introduced in House (03/19/1975)

Food and Drug Recall and Remedy Act - Requires, under the Federal Food, Drug, and Cosmetic Act, that every processor of any article which is a food, drug, device, or cosmetic develop and maintain recall systems adequate to enable effective removal from the market of any article which has left the control of such processor, and which article the processor knows, or has reason to know, is adulterated or misbranded or otherwise fails to comply with the requirements of that Act.

Empowers the Secretary of Health, Education, and Welfare to promulgate regulations for the maintenance of records and reports necessary to enable the identification and removal from the market of adulterated or misbranded articles.

Requires processors to notify the Secretary indicating the actions planned, if any, to assure effective removal of adulterated or misbranded articles from the market. Requires processors to immediately notify the Secretary of any recall, whether or not such notification is otherwise required under this Act.

Provides that if the Secretary determines that any article is adulterated or misbranded he may: (1) notify the appropriate processor of such determination and the basis for it; and (2) issue orders to assure that adequate notification of such determination is provided to all persons (including manufacturers, distributors, retailers, health professionals, and consumers) who should properly receive such notification..

Provides that if the Secretary determines that any article which is a food, drug, device, or cosmetic is adulterated or misbranded, he may issue a removal order. States that such a removal order may include requirements that production or distribution of the article be ceased, processing procedures be corrected, articles be recalled to the wholesale, retail, or consumer level, and other measures be taken to protect consumers.

Provides that a removal order may also include requirements that: (1) the processor reimburse the Secretary for any expenses incurred due to the processor's failure to diligently assure effective removal from the market of articles which are adulterated or misbranded; (2) articles be destroyed or, if possible, brought into compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, under the supervision of an authorized representative of the Secretary, with expenses borne by the claimant or person seeking release of the article; or (3) any processor to whom it applies refund the purchase price of an article subject to a removal order to purchasers.

Stipulates that such a removal order may be issued only after the Secretary has afforded the processor or processors to whom such order is directed an opportunity for an informal hearing. Defines "informal hearing".

Provides that whenever any article which is a food, drug, device, or cosmetic is found by a representative of the Secretary in interstate commerce, such article may be detained for a reasonable period, (not to exceed 20 days), if there is a reasonable basis to show that such article is adulterated or misbranded.

Provides that any person who would be entitled to claim such article if it were seized may appeal a detention to a superior official. Requires that such official provide an opportunity for such person to present his views on the matter and confirm or revoke such detention within five days.

Provides that in the case of actual controversy as to the validity of any final order of the Secretary under this Act, any person who is adversely affected may obtain review in the appropriate United States court of appeals. Stipulates that no such appeal shall operate as a stay of the Secretary's order.

Increases the criminal penalty for violations of the Federal Food, Drug, and Cosmetic Act from a fine of $1,000 to a fine of $5,000.

Repeals the present prohibition against multiple seizure of misbranded articles in violation of the Federal Food, Drug, and Cosmetic Act.

Requires that any regulations that the Secretary of Health, Education, and Welfare is required to promulgate under this Act be issued within six months of the effective date of this Act.