II 

117TH CONGRESS 

2D SESSION S. 4256 

To amend the Federal Food, Drug, and Cosmetic Act to prevent food 

shortages, including shortages of infant formula and certain medical foods. 

IN THE SENATE OF THE UNITED STATES 

MAY 18 (legislative day, MAY 17), 2022 

Mr. CASEY (for himself, Mr. BROWN, Ms. DUCKWORTH, Mrs. GILLIBRAND, 

and Ms. WARREN) introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

prevent food shortages, including shortages of infant formula and certain medical foods. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Infants 

5 from Formula Shortages Act of 2022’’. 


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1 SEC. 2. DISCONTINUANCE OR INTERRUPTION IN THE PRO2 DUCTION OF ESSENTIAL SOURCES OF NUTRI3 TION. 

4 (a) DISCONTINUANCE OR INTERRUPTION IN THE

5 PRODUCTION OF ESSENTIAL FOOD.—The Federal Food, 

6 Drug, and Cosmetic Act is amended by inserting after sec7 tion 412 (21 U.S.C. 350a) the following new section: 

8 ‘‘SEC. 412A. DISCONTINUANCE OR INTERRUPTION IN THE 

9 PRODUCTION OF FOOD, INCLUDING INFANT 

10 FORMULA AND CERTAIN MEDICAL FOODS 

11 FOR INBORN ERRORS OF METABOLISM. 

12 ‘‘(a) IN GENERAL.—A manufacturer of an essential 

13 source of nutrition shall notify the Secretary, in accord14 ance with subsection (b), of a permanent discontinuance 

15 in the manufacture of such food or an interruption of the 

16 manufacture of an essential source of nutrition or any 

17 other circumstance that is likely to lead to a meaningful 

18 disruption in the supply of such food in the United States, 

19 and the reasons for such discontinuance or interruption. 

20 ‘‘(b) TIMING.—Except as provided in subsection (g), 

21 a notice required under subsection (a) shall be submitted 

22 to the Secretary— 

23 ‘‘(1) at least 6 months prior to the date of the 

24 discontinuance or interruption; or 

25 ‘‘(2) if compliance with paragraph (1) is not 

26 possible, as soon as practicable. 


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1 ‘‘(c) DISTRIBUTION.—To the maximum extent prac2 ticable, the Secretary shall distribute, to the Secretary of 

3 Agriculture and to appropriate organizations, as deter4 mined by the Secretary, through such means as the Sec5 retary determines appropriate, information on the dis6 continuance or interruption of the manufacture of an es7 sential source of nutrition, or other circumstance, reported 

8 under subsection (a). 

9 ‘‘(d) CONFIDENTIALITY.—Nothing in this section au10 thorizes the Secretary to disclose any information that is 

11 a trade secret or confidential information subject to sec12 tion 552(b)(4) of title 5, United States Code, or section 

13 1905 of title 18, United States Code. 

14 ‘‘(e) FAILURE TO MEET REQUIREMENTS.—If a per15 son fails to submit information required under subsection 

16 (a) in accordance with subsection (b)— 

17 ‘‘(1) the Secretary shall issue to such person a 

18 letter that— 

19 ‘‘(A) informs such person of the failure to 

20 comply; 

21 ‘‘(B) describes the basis for noncompli22 ance; and 

23 ‘‘(C) requires the person to comply not 

24 later than 30 calendar days after the date on 

25 which the letter was issued; 


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1 ‘‘(2) not later than 30 calendar days after the 

2 issuance of a letter under paragraph (1), the person 

3 who receives such letter shall submit to the Sec4 retary a written response to such letter that provides 

5 the information required under subsection (a); and 

6 ‘‘(3) not later than 45 calendar days after the 

7 issuance of a letter under paragraph (1), the Sec8 retary shall make such letter and any response to 

9 such letter under paragraph (2) available to the pub10 lic on the website of the Food and Drug Administra11 tion, with appropriate redactions made to protect in12 formation described in subsection (d), except that, if 

13 the Secretary determines that the letter under para14 graph (1) was issued in error or, after review of 

15 such response, the person had a reasonable basis for 

16 not notifying as required under subsection (a), the 

17 requirements of this paragraph shall not apply. 

18 ‘‘(f) REGULATIONS.— 

19 ‘‘(1) IN GENERAL.—Not later than 1 year after 

20 the date of enactment of the Protecting Infants from 

21 Formula Shortages Act of 2022, the Secretary shall 

22 promulgate regulations regarding the requirements 

23 under this section. 

24 ‘‘(2) CONTENTS.—Such regulations— 


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1 ‘‘(A) shall include a list of each category of 

2 food for which a manufacturer is required to 

3 notify the Secretary in accordance with sub4 section (a); and 

5 ‘‘(B) may— 

6 ‘‘(i) designate foods not otherwise de7 fined as an essential source of nutrition, 

8 giving special consideration to foods— 

9 ‘‘(I) upon which individuals with 

10 certain diseases or conditions may be 

11 particularly reliant; or 

12 ‘‘(II) that are administered under 

13 medical supervision; 

14 ‘‘(ii) designate additional categories of 

15 foods for which the Secretary determines 

16 notification described in subsection (a) is 

17 appropriate during a public health emer18 gency declared under section 319 of the 

19 Public Health Service Act; and 

20 ‘‘(iii) prescribe additional conditions 

21 on the timing and manner of such notifica22 tions as are reasonable and appropriate 

23 during such a public health emergency. 

24 ‘‘(g) ORDER.—During a public health emergency de25 clared under section 319 of the Public Health Service Act, 


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1 the Secretary may order any manufacturer of an essential 

2 source of nutrition to provide notification required by this 

3 section. Such order may— 

4 ‘‘(1) impose additional conditions on the timing 

5 and manner of notification as are reasonable and ap6 propriate in light of the circumstances of the public 

7 health emergency; and 

8 ‘‘(2) designate additional categories of food for 

9 which the Secretary determines notification is appro10 priate during the public health emergency. 

11 ‘‘(h) RISK MANAGEMENT PLANS.—Each manufac12 turer of an essential source of nutrition shall develop, 

13 maintain, and, as appropriate, implement a redundancy 

14 risk management plan that identifies and evaluates risks 

15 to the supply of the food, as applicable, for each establish16 ment in which such food is manufactured. A risk manage17 ment plan under this subsection— 

18 ‘‘(1) may identify and evaluate risks to the sup19 ply of more than one food, or food category, manu20 factured at the same establishment; and 

21 ‘‘(2) shall be subject to inspection and copying 

22 by the Secretary pursuant to section 704 or at the 

23 request of the Secretary. 

24 ‘‘(i) DEFINITIONS.—In this section: 


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1 ‘‘(1) ESSENTIAL SOURCE OF NUTRITION.—The 

2 term ‘essential source of nutrition’ means— 

3 ‘‘(A) an infant formula; 

4 ‘‘(B) a food that— 

5 ‘‘(i) meets the definition of ‘medical 

6 food’ in section 5(b) of the Orphan Drug 

7 Act; and 

8 ‘‘(ii) is intended for use by individuals 

9 with— 

10 ‘‘(I) certain inborn errors of me11 tabolism; or 

12 ‘‘(II) other conditions requiring a 

13 medical food, as determined by the 

14 Secretary in guidance issued under 

15 subsection (f); or 

16 ‘‘(C) a food so designated pursuant to sub17 section (f). 

18 ‘‘(2) MEANINGFUL DISRUPTION.—The term 

19 ‘meaningful disruption’— 

20 ‘‘(A) means a change in production that is 

21 reasonably likely to lead to a reduction in the 

22 supply of an essential source of nutrition by a 

23 manufacturer that is more than negligible and 

24 affects the ability of the manufacturer to fulfill 


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1 contractual obligations or meet expected de2 mand for its product; and 

3 ‘‘(B) does not include interruptions in 

4 manufacturing due to matters such as routine 

5 maintenance or insignificant changes in manu6 facturing so long as the manufacturer expects 

7 to resume operations in a short period of 

8 time.’’. 

9 (b) PROHIBITED ACTS.—Section 301 of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend11 ed by adding at the end the following new subsection: 

12 ‘‘(fff) The failure to provide information as required 

13 under section 412A after receipt of a letter from the Sec14 retary under subsection (e) of such section.’’. 

15 SEC. 3. REMOTE RECORDS ASSESSMENT FOR ESSENTIAL 

16 SOURCES OF NUTRITION. 

17 (a) FACTORY INSPECTION.—Section 704(a)(4)(A) of 

18 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

19 374(a)(4)(A)) is amended in the first sentence by insert20 ing ‘‘or the manufacturing, processing, packing, or holding 

21 of an essential source of nutrition (as defined in section 

22 412A)’’ after ‘‘processing of a drug’’. 

23 (b) REGULATIONS.—Not later than 1 year after the 

24 date of enactment of this Act, the Secretary of Health and 

25 Human Services (referred to in this section as the ‘‘SecVerDate Sep 11 2014 22:43 May 24, 2022 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4256.IS S4256

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1 retary’’) shall promulgate regulations describing cir2 cumstances in which the Secretary may issue requests for 

3 records or other information in advance of, or in lieu of, 

4 an inspection pursuant to section 704(a)(4)(A) of the Fed5 eral Food, Drug, and Cosmetic Act, as amended by sub6 section (a), processes for responding to such requests elec7 tronically or in physical form, and factors the Secretary 

8 may consider in evaluating whether such records are pro9 vided within a reasonable timeframe, within reasonable 

10 limits, and in a reasonable manner, accounting for re11 source and other limitations that may exist, including for 

12 small businesses. 

Æ 


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