I 
117TH CONGRESS 
2D SESSION 
H. R. 7989 
To amend the Federal Food, Drug, and Cosmetic Act to prevent food 
shortages, including shortages of infant formula and certain medical foods. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 8, 2022 
Ms. SCHRIER (for herself, Mrs. HAYES, and Ms. WASSERMAN SCHULTZ) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
prevent food shortages, including shortages of infant for-
mula and certain medical foods. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Protecting Infants 
from Formula Shortages Act of 2022’’. 
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SEC. 2. DISCONTINUANCE OR INTERRUPTION IN THE PRO-
DUCTION OF ESSENTIAL SOURCES OF NUTRI-
TION. 
(a) DISCONTINUANCE
OR INTERRUPTION
IN
THE 
PRODUCTION OF ESSENTIAL FOOD.—The Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 412 (21 U.S.C. 350a) the following new section: 
‘‘SEC. 412A. DISCONTINUANCE OR INTERRUPTION IN THE 
PRODUCTION OF FOOD, INCLUDING INFANT 
FORMULA AND CERTAIN MEDICAL FOODS 
FOR INBORN ERRORS OF METABOLISM. 
‘‘(a) IN GENERAL.—A manufacturer of an essential 
source of nutrition shall notify the Secretary, in accord-
ance with subsection (b), of a permanent discontinuance 
in the manufacture of such food or an interruption of the 
manufacture of an essential source of nutrition or any 
other circumstance 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. 
‘‘(b) TIMING.—Except as provided in subsection (g), 
a notice required under subsection (a) shall be submitted 
to the Secretary— 
‘‘(1) at least 6 months prior to the date of the 
discontinuance or interruption; or 
‘‘(2) if compliance with paragraph (1) is not 
possible, as soon as practicable. 
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‘‘(c) DISTRIBUTION.—To the maximum extent prac-
ticable, the Secretary shall distribute, to the Secretary of 
Agriculture and to appropriate organizations, as deter-
mined by the Secretary, through such means as the Sec-
retary determines appropriate, information on the dis-
continuance or interruption of the manufacture of an es-
sential source of nutrition, or other circumstance, reported 
under subsection (a). 
‘‘(d) CONFIDENTIALITY.—Nothing in this section au-
thorizes the Secretary to disclose any information that is 
a trade secret or confidential information subject to sec-
tion 552(b)(4) of title 5, United States Code, or section 
1905 of title 18, United States Code. 
‘‘(e) FAILURE TO MEET REQUIREMENTS.—If a per-
son fails to submit information required under subsection 
(a) in accordance with subsection (b)— 
‘‘(1) the Secretary shall issue to such person a 
letter that— 
‘‘(A) informs such person of the failure to 
comply; 
‘‘(B) describes the basis for noncompli-
ance; and 
‘‘(C) requires the person to comply not 
later than 30 calendar days after the date on 
which the letter was issued; 
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‘‘(2) not later than 30 calendar days after the 
issuance of a letter under paragraph (1), the person 
who receives such letter shall submit to the Sec-
retary a written response to such letter that provides 
the information required under subsection (a); and 
‘‘(3) not later than 45 calendar days after the 
issuance of a letter under paragraph (1), the Sec-
retary shall make such letter and any response to 
such letter under paragraph (2) available to the pub-
lic on the website of the Food and Drug Administra-
tion, with appropriate redactions made to protect in-
formation described in subsection (d), except that, if 
the Secretary determines that the letter under para-
graph (1) was issued in error or, after review of 
such response, the person had a reasonable basis for 
not notifying as required under subsection (a), the 
requirements of this paragraph shall not apply. 
‘‘(f) REGULATIONS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of the Protecting Infants from 
Formula Shortages Act of 2022, the Secretary shall 
promulgate regulations regarding the requirements 
under this section. 
‘‘(2) CONTENTS.—Such regulations— 
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‘‘(A) shall include a list of each category of 
food for which a manufacturer is required to 
notify the Secretary in accordance with sub-
section (a); and 
‘‘(B) may— 
‘‘(i) designate foods not otherwise de-
fined as an essential source of nutrition, 
giving special consideration to foods— 
‘‘(I) upon which individuals with 
certain diseases or conditions may be 
particularly reliant; or 
‘‘(II) that are administered under 
medical supervision; 
‘‘(ii) designate additional categories of 
foods for which the Secretary determines 
notification described in subsection (a) is 
appropriate during a public health emer-
gency declared under section 319 of the 
Public Health Service Act; and 
‘‘(iii) prescribe additional conditions 
on the timing and manner of such notifica-
tions as are reasonable and appropriate 
during such a public health emergency. 
‘‘(g) ORDER.—During a public health emergency de-
clared under section 319 of the Public Health Service Act, 
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the Secretary may order any manufacturer of an essential 
source of nutrition to provide notification required by this 
section. Such order may— 
‘‘(1) impose additional conditions on the timing 
and manner of notification as are reasonable and ap-
propriate in light of the circumstances of the public 
health emergency; and 
‘‘(2) designate additional categories of food for 
which the Secretary determines notification is appro-
priate during the public health emergency. 
‘‘(h) RISK MANAGEMENT PLANS.—Each manufac-
turer of an essential source of nutrition shall develop, 
maintain, and, as appropriate, implement a redundancy 
risk management plan that identifies and evaluates risks 
to the supply of the food, as applicable, for each establish-
ment in which such food is manufactured. A risk manage-
ment plan under this subsection— 
‘‘(1) may identify and evaluate risks to the sup-
ply of more than one food, or food category, manu-
factured at the same establishment; and 
‘‘(2) shall be subject to inspection and copying 
by the Secretary pursuant to section 704 or at the 
request of the Secretary. 
‘‘(i) DEFINITIONS.—In this section: 
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‘‘(1) ESSENTIAL SOURCE OF NUTRITION.—The 
term ‘essential source of nutrition’ means— 
‘‘(A) an infant formula; 
‘‘(B) a food that— 
‘‘(i) meets the definition of ‘medical 
food’ in section 5(b) of the Orphan Drug 
Act; and 
‘‘(ii) is intended for use by individuals 
with— 
‘‘(I) certain inborn errors of me-
tabolism; or 
‘‘(II) other conditions requiring a 
medical food, as determined by the 
Secretary in guidance issued under 
subsection (f); or 
‘‘(C) a food so designated pursuant to sub-
section (f). 
‘‘(2) MEANINGFUL
DISRUPTION.—The term 
‘meaningful disruption’— 
‘‘(A) means a change in production that is 
reasonably likely to lead to a reduction in the 
supply of an essential source of nutrition by a 
manufacturer that is more than negligible and 
affects the ability of the manufacturer to fulfill 
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contractual obligations or meet expected de-
mand for its product; and 
‘‘(B) does not include interruptions in 
manufacturing due to matters such as routine 
maintenance or insignificant changes in manu-
facturing so long as the manufacturer expects 
to resume operations in a short period of 
time.’’. 
(b) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following new subsection: 
‘‘(fff) The failure to provide information as required 
under section 412A after receipt of a letter from the Sec-
retary under subsection (e) of such section.’’. 
SEC. 3. REMOTE RECORDS ASSESSMENT FOR ESSENTIAL 
SOURCES OF NUTRITION. 
(a) FACTORY INSPECTION.—Section 704(a)(4)(A) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
374(a)(4)(A)) is amended in the first sentence by insert-
ing ‘‘or the manufacturing, processing, packing, or holding 
of an essential source of nutrition (as defined in section 
412A)’’ after ‘‘processing of a drug’’. 
(b) REGULATIONS.—Not later than 1 year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
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retary’’) shall promulgate regulations describing cir-
cumstances in which the Secretary may issue requests for 
records or other information in advance of, or in lieu of, 
an inspection pursuant to section 704(a)(4)(A) of the Fed-
eral Food, Drug, and Cosmetic Act, as amended by sub-
section (a), processes for responding to such requests elec-
tronically or in physical form, and factors the Secretary 
may consider in evaluating whether such records are pro-
vided within a reasonable timeframe, within reasonable 
limits, and in a reasonable manner, accounting for re-
source and other limitations that may exist, including for 
small businesses. 
Æ 
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