Title 21 — Food and DrugsRelease 119-73not60

§350m Requirements for Critical Food

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter IV— FOOD › § 350m

Last updated Apr 5, 2026|Official source

Summary

Manufacturers of a critical food must tell the Secretary right away if they stop or pause making that food in a way that could cause a real drop in supply. They must report this as soon as they can, but no later than 5 business days after the stoppage or pause. Within 5 calendar days of getting that notice, the Secretary will decide if a shortage is likely and, if so, share information with the Secretary of Agriculture and other appropriate groups. The Secretary will not reveal trade secrets or other protected confidential information. Each manufacturer must have a written plan for reducing supply risks at every plant that makes the food. The plan can cover more than one food and can include backup sites, alternate suppliers, stockpiles, or other fixes. The Secretary can inspect and copy these plans. If a manufacturer fails to report, the Secretary will send a warning letter and, unless the Secretary finds good reason not to, will post that letter and any company response on the FDA website within 45 calendar days with confidential parts redacted.

Full Legal Text

Title 21, §350m

Food and Drugs — Source: USLM XML via OLRC

(a)(1)A manufacturer of a critical food (as defined in section 321(ss) of this title) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption.

(2)Not later than 5 calendar days after receiving a notification under paragraph (1), if the Secretary has determined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such critical food, the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on such shortage.

(3)Nothing in this subsection authorizes the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.

(4)In this subsection, the term “meaningful disruption”—

(A)means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and

(B)does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.

(b)Each manufacturer of a critical food shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured. A risk management plan under this subsection—

(1)may identify and evaluate risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment;

(2)may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means; and

(3)shall be subject to inspection and copying by the Secretary pursuant to an inspection under section 374 of this title.

(c)(1)If a person fails to submit information required under, and in accordance with, subsection (a)—

(A)the Secretary shall issue a letter to such person informing such person of such failure; and

(B)not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)—

(i)the letter issued under subparagraph (A); and

(ii)at the request of such person, any response to such letter such person submitted to the Secretary.

(2)If the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not submitting a notification as required under subsection (a), the requirements of paragraph (1)(B) shall not apply.

Reference

Citations & Metadata

Citation

21 U.S.C. § 350m

Title 21 — Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60