---
kind: "section"
citation: "21 U.S.C. § 350a–1"
title: "21"
title_heading: "Food and Drugs"
number: "350a–1"
heading: "Protecting infants and improving formula supply"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/350a-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IV — Food"
---

# §350a–1. Protecting infants and improving formula supply

- (a) **Definitions—**
  - (1) **In general—** In this section, the term “[infant formula](/usc/21/321.md?p=z)” has the meaning given such term in [section 201(z)](/usc/21/201.md) of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act ([21 U.S.C. 321(z)](/usc/21/321.md?p=z)).
  - (2) **Omitted—**
- (b) **Office of Critical Foods—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall establish within the Center for [Food](/usc/21/321.md?p=f) Safety and Applied Nutrition an office to be known as the Office of [Critical Foods](/usc/21/321.md?p=ss). The [Secretary](/usc/21/321.md?p=d) shall appoint a Director to lead such Office.
  - (2) **Duties—** The Office of [Critical Foods](/usc/21/321.md?p=ss) shall be responsible for oversight, coordination, and facilitation of activities related to [critical foods](/usc/21/321.md?p=ss), as defined in [section 201(ss)](/usc/21/201.md) of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 321(ss)](/usc/21/321.md?p=ss)], as added by [subsection (a)(2)](#a-2).
- (c) **Omitted—**
- (d) **Report—** Not later than one year after December 29, 2022, the [Secretary](/usc/21/321.md?p=d) shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives that includes—
  - (1) the number of premarket submissions for new [infant formula](/usc/21/321.md?p=z) the [Secretary](/usc/21/321.md?p=d) has received under section 412(d) of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act ([21 U.S.C. 350a(d)](/usc/21/350a.md?p=d)) each year since 2012;
  - (2) how many of such submissions received requests from the [Secretary](/usc/21/321.md?p=d) for additional information;
  - (3) how long after receiving such submissions the [Secretary](/usc/21/321.md?p=d) sent such requests for additional information;
  - (4) what additional information the [Secretary](/usc/21/321.md?p=d) requested of the [persons](/usc/21/321.md?p=e) submitting such submissions; and
  - (5) the date each new [infant formula](/usc/21/321.md?p=z) described in subparagraph (A)[^1] was first marketed, if available.
- (e) **Infant formula flexibilities—** The [Secretary](/usc/21/321.md?p=d) shall publish a list on the website of the [Department](/usc/21/321.md?p=c) of Health and Human Services providing information on how to identify appropriate substitutes for [infant formula](/usc/21/321.md?p=z) [products](/usc/21/360eee.md?p=13) in shortage that are relied upon by infants and other individuals with inborn errors of metabolism or other serious health conditions.
- (f) **International harmonization of infant formula requirements—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d)—
    - (A) shall participate in meetings with representatives from other countries to discuss methods and approaches to harmonizing regulatory requirements for [infant formula](/usc/21/321.md?p=z), including with respect to inspections, [labeling](/usc/21/321.md?p=m), and nutritional requirements; and
    - (B) may enter into arrangements or agreements regarding such requirements with other countries, as appropriate, including arrangements or agreements with a foreign government or agency of a foreign government to recognize the inspection of foreign establishments that manufacture [infant formula](/usc/21/321.md?p=z) for export to the United States.
  - (2) **Study on infant formula—**
    - (A) **In general—** Not later than 60 days after December 29, 2022, the [Secretary](/usc/21/321.md?p=d) shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this paragraph as the “National Academies”) to examine and report on challenges in supply, market competition, and regulation of [infant formula](/usc/21/321.md?p=z) in the United States.
    - (B) **Contents of the report—** The report developed pursuant to the agreement under [subparagraph (A)](#f-2-A) shall—
      - (i) assess and evaluate—
        - (I) [infant formula](/usc/21/321.md?p=z) marketed in the United States;
        - (II) any challenges in supply, or market competition with respect to such [infant formula](/usc/21/321.md?p=z); and
        - (III) any differences between [infant formula](/usc/21/321.md?p=z) marketed in the United States and [infant formula](/usc/21/321.md?p=z) marketed in the European Union, including with respect to nutritional content and applicable [labeling](/usc/21/321.md?p=m) and other regulatory requirements; and
      - (ii) include recommendations, including for [infant formula](/usc/21/321.md?p=z) [manufacturers](/usc/21/360hh.md?p=3), on measures to address supply and market competition in the United States.
    - (C) **Final report—** The agreement under [subparagraph (A)](#f-2-A) shall specify that the National Academies shall, not later than 1 year after December 29, 2022, complete such study and submit a report on the results of such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives.
- (g) **Transparency and accountability to support infant formula innovation—**
  - (1) **to (4) Omitted—**
  - (5) **Guidance—** Not later than 1 year after December 29, 2022, the [Secretary](/usc/21/321.md?p=d) shall issue guidance regarding information [sponsors](/usc/21/360fff.md?p=8) may consider including in submissions required under section 412(d) of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act ([21 U.S.C. 350a(d)](/usc/21/350a.md?p=d)), including considerations for meeting each of the requirements of paragraphs [(1)](#d-1), [(2)](#d-2), and [(3)](#d-3) of subsection (d).
  - (6) **Omitted—**
- (h) **Response to recall—**
  - (1) **Manufacturer submission—**
    - (A) **In general—** Promptly after the initiation of a recall of [infant formula](/usc/21/321.md?p=z), the [manufacturer](/usc/21/360hh.md?p=3) of the recalled [infant formula](/usc/21/321.md?p=z) shall submit information to the [Secretary](/usc/21/321.md?p=d) regarding such recall.
    - (B) **Contents—** A submission under [subparagraph (A)](#h-1-A) shall include the following:
      - (i) A plan (including an estimated timeline, as applicable) of actions the [manufacturer](/usc/21/360hh.md?p=3) will take, suited to the individual circumstances of the particular recall, including—
        - (I) to identify and address any cause of, and contributing factor in, known or suspected adulteration or known or suspected misbranding; and
        - (II) if appropriate, to restore operation of the impacted facilities.
      - (ii) In the case that a recall of the [manufacturer](/usc/21/360hh.md?p=3)’s [infant formula](/usc/21/321.md?p=z) [products](/usc/21/360eee.md?p=13), and subsequent actions to respond to such recall, impacts over 10 percent of the production of the [infant formula](/usc/21/321.md?p=z) intended for sale in the United States, a plan to backfill the supply of the [manufacturer](/usc/21/360hh.md?p=3)’s [infant formula](/usc/21/321.md?p=z) supply if the current domestic supply of such [infant formula](/usc/21/321.md?p=z) has fallen, or is expected to fall, below the expected demand for the formula.
  - (2) **Report to Congress—**
    - (A) **In general—** Promptly after a submission under [paragraph (1)](#h-1) is received, the [Secretary](/usc/21/321.md?p=d) shall provide such submission, together with the information specified in [subparagraph (B)](#h-2-B), in a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives.
    - (B) **Contents—** A report under [subparagraph (A)](#h-2-A) shall include the following:
      - (i) Information concerning the current domestic supply of [infant formula](/usc/21/321.md?p=z), including—
        - (I) a breakdown of the specific types of formula involved; and
        - (II) an estimate of how long current supplies will last.
      - (ii) If a submission or submissions under [paragraph (1)](#h-1) show that the recall and subsequent actions to respond to the recall impact over 10 percent of the domestic production of [infant formula](/usc/21/321.md?p=z) intended for sale in the United States—
        - (I) actions to work with the impacted [manufacturer](/usc/21/360hh.md?p=3) or other [manufacturers](/usc/21/360hh.md?p=3) to increase production; and
        - (II) specification of—
          - (aa) any additional authorities needed regarding production or importation to fill a supply gap; and
          - (bb) any supplemental funding necessary to address the shortage.
  - (3) **Sunset—** This subsection shall cease to have force or effect on September 30, 2026.
- (i) **Coordination with manufacturer—**
  - (1) **In general—**
    - (A) **Communication following inspection—** Upon completing an inspection of an [infant formula](/usc/21/321.md?p=z) manufacturing facility impacted by a recall, the [Secretary](/usc/21/321.md?p=d), acting through the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1), shall provide the [manufacturer](/usc/21/360hh.md?p=3) involved a list of any actions necessary to—
      - (i) address deficiencies contributing to the potential adulteration or misbranding of [product](/usc/21/360eee.md?p=13) at the facility; and
      - (ii) safely restart production at the facility.
    - (B) **Response to manufacturer—** Not later than 7 days after receiving a written communication from a [manufacturer](/usc/21/360hh.md?p=3) of [infant formula](/usc/21/321.md?p=z) containing corrective actions to address manufacturing deficiencies identified during an inspection of a facility engaged in the manufacturing of an [infant formula](/usc/21/321.md?p=z) impacted by a recall, the [Secretary](/usc/21/321.md?p=d), acting through the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1), shall provide a substantive response to such communication concerning the sufficiency of the proposed corrective actions.
  - (2) **Inspections—** The [Secretary](/usc/21/321.md?p=d) shall ensure timely communication with a [manufacturer](/usc/21/360hh.md?p=3) of [infant formula](/usc/21/321.md?p=z) following an inspection of a facility engaged in the manufacturing of [infant formula](/usc/21/321.md?p=z) for consumption in the United States. If a reinspection of a [manufacturer](/usc/21/360hh.md?p=3) of an [infant formula](/usc/21/321.md?p=z) is required to ensure that such [manufacturer](/usc/21/360hh.md?p=3) completed any remediation actions or addressed any deficiencies, the [Secretary](/usc/21/321.md?p=d) shall reinspect such facility in a timely manner. The [Secretary](/usc/21/321.md?p=d) shall prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent a shortage of an [infant formula](/usc/21/321.md?p=z).
  - (3) **Annual inspections—** Not later than 6 months after December 29, 2022, and not less than once per calendar year thereafter, the [Secretary](/usc/21/321.md?p=d) shall conduct inspections, including unannounced inspections, of the facilities (including foreign facilities) of each [manufacturer](/usc/21/360hh.md?p=3) of an [infant formula](/usc/21/321.md?p=z) required to be registered under section 412(c)(1)(A) of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act ([21 U.S.C. 350a(c)(1)(A)](/usc/21/350a.md?p=c-1-A)), in accordance with a risk-based approach and ensure timely and effective internal coordination and alignment among the Office of Regulatory Affairs and the Center for [Food](/usc/21/321.md?p=f) Safety and Applied Nutrition. In meeting the inspection requirements under this subsection, the [Secretary](/usc/21/321.md?p=d) may rely on inspections conducted by foreign regulatory authorities, under arrangements or agreements, and conducted by [State](/usc/21/321.md?p=a-1) agencies under contract, memoranda of understanding, or any other obligation.
- (j) **National strategy on infant formula—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d), in consultation with the [Secretary](/usc/21/321.md?p=d) of Agriculture and other heads of relevant [departments](/usc/21/321.md?p=c) and agencies, shall develop and issue, not later than 90 days after December 29, 2022, a national strategy on [infant formula](/usc/21/321.md?p=z) to increase the resiliency of the [infant formula](/usc/21/321.md?p=z) supply chain, protect against future contamination and other potential causes of supply disruptions and shortages, and ensure parents and caregivers have access to [infant formula](/usc/21/321.md?p=z) and information they need.
  - (2) **Immediate national strategy—** The national strategy under [paragraph (1)](#j-1) shall include efforts—
    - (A) to increase the resiliency of the [infant formula](/usc/21/321.md?p=z) supply chain in the short-term by—
      - (i) assessing causes of any supply disruption or shortage of [infant formula](/usc/21/321.md?p=z) in existence as of December 29, 2022, and potential causes of future supply disruptions and shortages;
      - (ii) assessing and addressing immediate [infant formula](/usc/21/321.md?p=z) needs associated with the shortage; and
      - (iii) developing a plan to increase [infant formula](/usc/21/321.md?p=z) supply, including through increased competition; and
    - (B) to ensure the development and updating of education and communication materials for parents and caregivers that cover—
      - (i) where and how to find [infant formula](/usc/21/321.md?p=z);
      - (ii) comparable [infant formulas](/usc/21/321.md?p=z) on the market;
      - (iii) what to do if a specialty [infant formula](/usc/21/321.md?p=z) is unavailable;
      - (iv) [safe](/usc/21/321.md?p=u) practices for handling [infant formula](/usc/21/321.md?p=z); and
      - (v) other topics, as appropriate.
  - (3) **Long-term strategy—** Not later than 90 days after the submission of the report described in [subsection (f)(2)](#f-2), the [Secretary](/usc/21/321.md?p=d) shall update the national strategy under [paragraph (1)](#j-1) to include efforts to improve preparedness against [infant formula](/usc/21/321.md?p=z) shortages in the long-term by—
    - (A) outlining methods to improve information-sharing between the Federal Government and [State](/usc/21/321.md?p=a-1) and local governments, and other entities as appropriate, regarding shortages;
    - (B) recommending measures for protecting the integrity of the [infant formula](/usc/21/321.md?p=z) supply and preventing contamination;
    - (C) outlining methods to incentivize new [infant formula](/usc/21/321.md?p=z) [manufacturers](/usc/21/360hh.md?p=3) to increase supply and mitigate future shortages; and
    - (D) recommending other necessary authorities to gain insight into the supply chain and risk for shortages, and to incentivize new [infant formula](/usc/21/321.md?p=z) [manufacturers](/usc/21/360hh.md?p=3).
- (k) **, (l) Omitted—**
- (m) **Importation for personal use—**
  - (1) **In general—** Notwithstanding any provision of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act ([21 U.S.C. 301](/usc/21/301.md) et seq.), during the 90-day period beginning on December 29, 2022, an individual may, without prior notice to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, import up to a 3-month supply of [infant formula](/usc/21/321.md?p=z) for personal use from—
    - (A) Canada;
    - (B) any country in the European Union; or
    - (C) any other country that is determined by the [Secretary](/usc/21/321.md?p=d) to be implementing and enforcing requirements for [infant formula](/usc/21/321.md?p=z) that provide a similar assurance of safety and nutritional adequacy as the requirements of the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act ([21 U.S.C. 301](/usc/21/301.md) et seq.).
  - (2) **Limitations—** [Infant formula](/usc/21/321.md?p=z) may be imported pursuant to [paragraph (1)](#m-1) only if the [infant formula](/usc/21/321.md?p=z)—
    - (A) is exclusively for personal use and will not be commercialized or promoted; and
    - (B) does not present an unreasonable risk to human health.
  - (3) **Reporting of adverse events—** If a health care provider becomes aware of any adverse event which the health care provider reasonably suspects to be associated with [infant formula](/usc/21/321.md?p=z) imported pursuant to [paragraph (1)](#m-1), the health care provider shall report such adverse event to the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1).
  - (4) **Public notice—** The [Secretary](/usc/21/321.md?p=d), acting through the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1), shall post on the public website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration notice that—
    - (A) [infant formula](/usc/21/321.md?p=z) imported pursuant to [paragraph (1)](#m-1) may not have been manufactured in a facility that has been inspected by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration;
    - (B) the [labeling](/usc/21/321.md?p=m) of such [infant formula](/usc/21/321.md?p=z) may not meet the standards and other requirements applicable with respect to [infant formula](/usc/21/321.md?p=z) under the Federal [Food](/usc/21/321.md?p=f), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act ([21 U.S.C. 301](/usc/21/301.md) et seq.); and
    - (C) the nutritional content of [infant formula](/usc/21/321.md?p=z) imported pursuant to [paragraph (1)](#m-1) may vary from that of [infant formula](/usc/21/321.md?p=z) meeting such standards and other requirements.
  - (5) **Sense of Congress—** It is the sense of Congress that [persons](/usc/21/321.md?p=e) considering the personal importation of [infant formula](/usc/21/321.md?p=z) should consult with their pediatrician about such importation.

## Footnotes

[^1]: So in original. There is no subparagraph (A).

## Source credit

(Pub. L. 117–328, div. FF, title III, § 3401, Dec. 29, 2022, 136 Stat. 5838.)

## Notes

### Editorial Notes

### References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (m)(1), (4)(B), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.

### Codification

Section was enacted as part of the Food and Drug Omnibus Reform Act of 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Section is comprised of section 3401 of div. FF of Pub. L. 117–328. Subsec. (a)(2) of section 3401 of div. FF of Pub. L. 117–328 amended section 321 of this title. Subsecs. (c), (g)(1)–(4), (6), and (l) of such section 3401 amended section 350a of this title. Subsec. (k) of such section 3401 enacted section 350m of this title.

### Statutory Notes and Related Subsidiaries

### Definition of “Secretary”

Pub. L. 117–328, div. FF, title III, § 3002, Dec. 29, 2022, 136 Stat. 5807, provided that: “In this title [see Short Title of 2022 Amendment note set out under section 301 of this title], except as otherwise specified, the term ‘Secretary’ means the Secretary of Health and Human Services.”