Title 21, Food and DrugsRelease 119-110

§350m Requirements for Critical Food

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

Last updated Sep 22, 2026|Official source

Summary

Manufacturers of critical foods must tell the Secretary when they stop or interrupt making a product in a way that could cause a meaningful disruption in U.S. supply. That notice must be given as soon as possible, and no later than 5 business days after the stoppage or interruption. Within 5 calendar days of getting that notice, if the Secretary thinks a shortage is likely, the Secretary must share information about the shortage with the Secretary of Agriculture and other appropriate parties. The Secretary cannot reveal trade secrets or other confidential commercial information protected by law. Meaningful disruption means a production change likely to cause a significant drop in supply that keeps the maker from meeting expected demand; it does not include routine maintenance, switching flavors or colors, or short pauses expected to end quickly. Each manufacturer must keep a redundancy risk management plan for every place it makes a critical food. The plan must identify and evaluate supply risks, can cover several foods made at the same site, and can describe ways to reduce impact (for example, other production sites, different suppliers, or stockpiles). The Secretary may inspect and copy these plans. If a maker fails to notify as required, the Secretary will send a warning letter and, unless the Secretary finds the letter was wrong or the maker had a reasonable excuse, will post the letter and any response on the FDA website within 45 calendar days, with confidential information removed.

Full Legal Text

Title 21, §350m

Food and Drugs, Source: USLM XML via OLRC

(a)Notification of meaningful disruption for critical food

(1)In general

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)Distribution of information

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)Confidentiality

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)Meaningful disruption

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)Risk management plans

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)

(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)Failure to meet requirements

(1)In general

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)Exception

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

Sep 22, 2026

Release point: 119-110