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Title 21 — Food and DrugsRelease 119-73not60

§344 Emergency Permit Control

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD › § 344

Last updated Apr 5, 2026|Official source

Summary

When the Secretary finds that a certain kind of food made, processed, or packed in a specific area might be unsafe because of germs, and the danger can't be checked after the food is shipped across state lines, the Secretary must make rules that require permits for the makers, processors, or packers in that area. The permits will set conditions for how the food is handled and will last only as long as needed to protect public health. Once the rules begin, no one may ship that food across state lines from that area without a permit. The Secretary can immediately suspend a permit if its conditions are broken. The permit holder can ask to get it back, and after a quick hearing and an inspection the Secretary must reinstate it if the problems are fixed. Inspectors the Secretary names may enter any permitted plant to check compliance, and refusing entry can lead to suspension until access is allowed.

Full Legal Text

Title 21, §344

Food and Drugs — Source: USLM XML via OLRC

(a)Whenever the Secretary finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he then, and in such case only, shall promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health; and after the effective date of such regulations, and during such temporary period, no person shall introduce or deliver for introduction into interstate commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless such manufacturer, processor, or packer holds a permit issued by the Secretary as provided by such regulations.
(b)The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit, and the Secretary shall, immediately after prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued or as amended.
(c)Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.

Legislative History

Notes & Related Subsidiaries

Executive Documents

Transfer of Functions

For

Transfer of Functions

of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 344

Title 21 — Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60