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Title 21, Food and DrugsRelease 119-110

§344 Emergency Permit Control

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER IV — FOOD › § 344

Last updated Sep 22, 2026|Official source

Summary

If the Secretary investigates and finds that a certain type of food made in a particular place might be unsafe because germs may get in during making, processing, or packing, and that danger cannot be spotted after the food is shipped, the Secretary must make rules that require the makers, processors, or packers in that place to get permits. The permits will include conditions on how the food must be made or packed for a short time to protect public health. Once those rules start, no one may ship that food across state lines unless the maker has the required permit. The Secretary can suspend a permit right away if its conditions are broken. The permit holder can ask to get it back; after a quick hearing and an inspection, the permit must be restored if the problems are fixed. People chosen by the Secretary may inspect any permitted factory, and refusing them entry can lead to suspension until access is allowed.

Full Legal Text

Title 21, §344

Food and Drugs, Source: USLM XML via OLRC

(a)Conditions on manufacturing, processing, etc., as health measure
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)Violation of permit; suspension and reinstatement
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)Inspection of permit-holding establishments
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

Sep 22, 2026

Release point: 119-110