---
kind: "section"
citation: "21 U.S.C. § 350m"
title: "21"
title_heading: "Food and Drugs"
number: "350m"
heading: "Requirements for critical food"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/350m"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IV — Food"
---

# §350m. Requirements for critical food

- (a) **Notification of meaningful disruption for critical food—**
  - (1) **In general—** A [manufacturer](/usc/21/360hh.md?p=3) of a [critical food](/usc/21/321.md?p=ss) (as defined in [section 321(ss) of this title](/usc/21/321.md?p=ss)) shall notify the [Secretary](/usc/21/321.md?p=d) of a permanent discontinuance in the manufacture or an interruption of the manufacture of such [food](/usc/21/321.md?p=f) that is likely to lead to a meaningful disruption in the supply of such [food](/usc/21/321.md?p=f) 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)](#a-1), if the [Secretary](/usc/21/321.md?p=d) has determined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such [critical food](/usc/21/321.md?p=ss), the [Secretary](/usc/21/321.md?p=d) shall [distribute](/usc/21/360eee.md?p=5), to the [Secretary](/usc/21/321.md?p=d) of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the [Secretary](/usc/21/321.md?p=d) through such means as the [Secretary](/usc/21/321.md?p=d) determines appropriate, information on such shortage.
  - (3) **Confidentiality—** Nothing in this subsection authorizes the [Secretary](/usc/21/321.md?p=d) to disclose any information that is a trade secret or confidential information subject to [section 552(b)(4) of title 5](/usc/5/552.md?p=b-4) or [section 1905 of title 18](/usc/18/1905.md).
  - (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](/usc/21/321.md?p=ss) by a [manufacturer](/usc/21/360hh.md?p=3) that affects the ability of the [manufacturer](/usc/21/360hh.md?p=3) to meet expected demand for its [product](/usc/21/360eee.md?p=13); and
    - (B) does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, [colors](/usc/21/321.md?p=t-2), or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the [manufacturer](/usc/21/360hh.md?p=3) expects to resume operations in a short period of time.
- (b) **Risk management plans—** Each [manufacturer](/usc/21/360hh.md?p=3) of a [critical food](/usc/21/321.md?p=ss) shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the [food](/usc/21/321.md?p=f), as applicable, for each establishment in which such [food](/usc/21/321.md?p=f) is manufactured. A risk management plan under this subsection—
  - (1) may identify and evaluate risks to the supply of more than one [critical food](/usc/21/321.md?p=ss), or [critical food](/usc/21/321.md?p=ss) category, manufactured at the same establishment;
  - (2) may identify mechanisms by which the [manufacturer](/usc/21/360hh.md?p=3) 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](/usc/21/321.md?p=d) pursuant to an inspection under [section 374 of this title](/usc/21/374.md).
- (c) **Failure to meet requirements—**
  - (1) **In general—** If a [person](/usc/21/321.md?p=e) fails to submit information required under, and in accordance with, [subsection (a)](#a)—
    - (A) the [Secretary](/usc/21/321.md?p=d) shall issue a letter to such [person](/usc/21/321.md?p=e) informing such [person](/usc/21/321.md?p=e) of such failure; and
    - (B) not later than 45 calendar days after the issuance of a letter under [subparagraph (A)](#c-1-A), subject to [paragraph (2)](#c-2), the [Secretary](/usc/21/321.md?p=d) shall make available to the public on the website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, with appropriate redactions made to protect the information described in [subsection (a)(3)](#a-3)—
      - (i) the letter issued under [subparagraph (A)](#c-1-A); and
      - (ii) at the request of such [person](/usc/21/321.md?p=e), any response to such letter such [person](/usc/21/321.md?p=e) submitted to the [Secretary](/usc/21/321.md?p=d).
  - (2) **Exception—** If the [Secretary](/usc/21/321.md?p=d) determines that the letter under [paragraph (1)](#c-1) was issued in error or, after review of such response, the [person](/usc/21/321.md?p=e) had a reasonable basis for not submitting a notification as required under [subsection (a)](#a), the requirements of [paragraph (1)(B)](#c-1-B) shall not apply.

## Source credit

(June 25, 1938, ch. 675, § 424, as added Pub. L. 117–328, div. FF, title III, § 3401(k), Dec. 29, 2022, 136 Stat. 5844.)