I 
117TH CONGRESS 
2D SESSION 
H. R. 8038 
To authorize the Food and Drug Administration to require manufacturers 
of infant formula to warn about a discontinuance or interruption in 
the production of infant formula, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 13, 2022 
Mr. JOHNSON of South Dakota (for himself, Ms. SPANBERGER, Mrs. BICE of 
Oklahoma, and Ms. SCHRIER) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce 
A BILL 
To authorize the Food and Drug Administration to require 
manufacturers of infant formula to warn about a dis-
continuance or interruption in the production of infant 
formula, and for other purposes. 
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 ‘‘Formula Shortage Re-
porting Act of 2022’’. 
VerDate Sep 11 2014 
22:00 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H8038.IH
H8038
pbinns on DSKJLVW7X2PROD with $$_JOB
SEC. 2. REQUIREMENT TO WARN ABOUT DISCONTINUANCE 
OR INTERRUPTION IN THE PRODUCTION OF 
INFANT FORMULA. 
(a) IN GENERAL.—Section 412 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350a) is amended by 
adding at the end the following: 
‘‘(j)(1) A manufacturer of infant formula shall notify 
the Secretary, in accordance with paragraph (2), of a per-
manent discontinuance in the manufacture of the infant 
formula or an interruption of the manufacture of the in-
fant formula that is likely to lead to a meaningful disrup-
tion in the supply of that infant formula in the United 
States, or a permanent discontinuance in the manufacture 
of an infant formula component or an interruption in the 
manufacture of an infant formula component that is likely 
to lead to a meaningful disruption in the supply of the 
infant formula component, and the reasons for such dis-
continuance or interruption. Notification under this sub-
section shall include disclosure of— 
‘‘(A) reasons for the discontinuance or interrup-
tion; 
‘‘(B) if an infant formula component is a rea-
son for, or a risk factor in, such discontinuance or 
interruption, the source of the infant formula com-
ponent and any alternative sources for the infant 
formula component known by the manufacturer; 
VerDate Sep 11 2014 
22:00 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H8038.IH
H8038
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(C) whether any associated device used for 
preparation or administration included in the infant 
formula is a reason for, or a risk factor in, such dis-
continuance or interruption; 
‘‘(D) in the case of an interruption, the ex-
pected duration of the interruption; and 
‘‘(E) such other information as the Secretary 
may require. 
‘‘(2) A notice required under paragraph (1) shall be 
submitted to the Secretary— 
‘‘(A) at least 72 hours prior to the date of the 
discontinuance or interruption; or 
‘‘(B) if compliance with subparagraph (A) is 
not possible, as soon as practicable. 
‘‘(3) If a manufacturer of infant formula determines 
that compliance with paragraph (2)(A) is not possible, the 
manufacturer shall submit such determination in writing 
to the Secretary and the justification for such determina-
tion. 
‘‘(4) To the maximum extent practicable, the Sec-
retary shall distribute to health care providers who treat 
pregnant women and children under the age of 2, and 
make publicly available on the website of the Food and 
Drug Administration, information on the discontinuance 
VerDate Sep 11 2014 
22:00 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H8038.IH
H8038
pbinns on DSKJLVW7X2PROD with $$_JOB
or interruption of the manufacture of the infant formula 
described in paragraph (1). 
‘‘(5) Nothing in this subsection shall be construed as 
authorizing the Secretary to disclose any information that 
is a trade secret or confidential information subject to sec-
tion 552(b)(4) of title 5, United States Code, or section 
1905 of title 18, United States Code. 
‘‘(6) The Secretary shall find a manufacturer of in-
fant formula to be in violation of this section if— 
‘‘(A) the Secretary determines that— 
‘‘(i) the manufacturer has failed to submit 
the notice required by paragraph (2) and the 
determination and justification required by 
paragraph (3); or 
‘‘(ii) the determination and justification 
submitted by the manufacturer are insufficient; 
‘‘(B) the Secretary issues a letter to such man-
ufacturer— 
‘‘(i) informing such manufacturer of such 
failure or insufficiency; and 
‘‘(ii) giving such manufacturer a period of 
not more than 30 calendar days to correct such 
failure or insufficiency; and 
VerDate Sep 11 2014 
22:00 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H8038.IH
H8038
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(C) the Secretary determines such manufac-
turer has failed to correct such failure or insuffi-
ciency by the end of such period. 
‘‘(7) For purposes of this subsection— 
‘‘(A) the term ‘infant formula component’ 
means a raw or in-process material, ingredient, con-
tainer, or closure used in the manufacturing or proc-
essing of infant formula; 
‘‘(B) the term ‘infant formula shortage’ or 
‘shortage’, with respect to an infant formula, means 
a period of time when the demand or projected de-
mand for the infant formula within the United 
States exceeds the supply of the infant formula; and 
‘‘(C) the term ‘meaningful disruption’— 
‘‘(i) means a change in production that is 
reasonably likely to lead to a reduction in the 
supply of an infant formula by a manufacturer 
that is more than negligible and affects the 
ability of the manufacturer to fill orders or 
meet expected demand for its product; and 
‘‘(ii) does not include interruptions in man-
ufacturing due to matters such as routine main-
tenance or insignificant changes in manufac-
turing so long as the manufacturer expects to 
resume operations in a short period of time.’’. 
VerDate Sep 11 2014 
22:00 Jun 14, 2022
Jkt 029200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H8038.IH
H8038
pbinns on DSKJLVW7X2PROD with $$_JOB