I 
117TH CONGRESS 
2D SESSION 
H. R. 7933 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
and supply of infant formula, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 3, 2022 
Ms. DELAURO (for herself, Mr. BISHOP of Georgia, Ms. BARRAGA´N, Ms. 
PRESSLEY, Mr. SAN NICOLAS, Mr. LARSON of Connecticut, Mr. THOMP-
SON of California, Ms. WILD, Ms. NORTON, Mr. NADLER, Mr. LAWSON 
of Florida, Mr. SARBANES, Mrs. BUSTOS, Ms. TLAIB, Mrs. NAPOLITANO, 
Ms. WILSON of Florida, Mr. COOPER, Mr. BLUMENAUER, Mr. CARBAJAL, 
Mr. EVANS, Mrs. TRAHAN, Mr. POCAN, Mr. TRONE, Mr. TORRES of New 
York, Mr. CICILLINE, Mr. DANNY K. DAVIS of Illinois, Ms. SPEIER, Ms. 
UNDERWOOD, Mr. DESAULNIER, Mrs. CAROLYN B. MALONEY of New 
York, Mr. CARSON, Mrs. HAYES, Ms. PINGREE, Ms. BONAMICI, Mr. 
LEVIN of California, Mr. COURTNEY, Ms. MENG, Mr. PERLMUTTER, Ms. 
CHU, Mr. BOWMAN, Ms. TITUS, Ms. DEAN, Ms. SCHAKOWSKY, Ms. BASS, 
Ms. LEE of California, Mrs. DEMINGS, Mr. KRISHNAMOORTHI, Mr. 
RASKIN, Ms. SCHRIER, Mr. PAPPAS, Ms. BLUNT ROCHESTER, Mr. KIL-
MER, Mr. CASTEN, Ms. ROSS, Ms. STEVENS, Mrs. LAWRENCE, Ms. 
SPANBERGER, Mr. COHEN, Mr. PANETTA, Ms. PORTER, Mrs. WATSON 
COLEMAN, Mr. MICHAEL F. DOYLE of Pennsylvania, Mr. CONNOLLY, Ms. 
CASTOR of Florida, Mr. HIMES, Ms. MCCOLLUM, Mr. CROW, Mr. 
GALLEGO, Mr. SWALWELL, Ms. SCANLON, Mr. WELCH, Ms. CLARK of 
Massachusetts, Ms. ROYBAL-ALLARD, Mr. SOTO, Mr. CASE, Mr. 
CA´RDENAS, Ms. JACKSON LEE, Ms. KUSTER, Mr. LANGEVIN, and Ms. 
LOIS FRANKEL of Florida) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce, and in addition to 
the Committees on Financial Services, Education and Labor, and Agri-
culture, for a period to be subsequently determined by the Speaker, in 
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned 
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A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
improve the safety and supply 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 ‘‘Keep Infant Formula 
Safe and On the Shelves Act of 2022’’. 
SEC. 2. PRODUCT SAFETY. 
(a) INSPECTIONS AND AUDITS.—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) INSPECTIONS AND AUDITS.— 
‘‘(1) IN
GENERAL.—Not less than every 6 
months, the Secretary shall inspect the facilities of 
each manufacturer of infant formula registered 
under subsection (c). 
‘‘(2) UNANNOUNCED INSPECTIONS.—Not later 
than 6 months after the date of enactment of the 
Keep Infant Formula Safe and On the Shelves Act 
of 2022, and not less than once per calendar year 
thereafter, the Secretary shall conduct unannounced 
inspections of the facilities of each manufacturer of 
infant formula registered under subsection (c), in-
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cluding such facilities with no history of notable reg-
ulatory findings. 
‘‘(3) AUTOMATIC COMPREHENSIVE FOOD SAFE-
TY AUDIT.—If the Secretary makes a notable regu-
latory finding at any facility of a manufacturer of 
infant formula during an inspection or audit, the 
Secretary shall require such facility to undergo a 
comprehensive food safety audit that includes— 
‘‘(A) a root cause analysis; 
‘‘(B) enhanced testing; and 
‘‘(C) comprehensive environmental samples 
throughout the facility. 
‘‘(4) AUDITS.—The Secretary shall increase the 
frequency of comprehensive food safety audits of a 
facility of a manufacturer of infant formula reg-
istered under subsection (c) if there are persistent 
notable regulatory findings at such facility. 
‘‘(5) MICROBIAL TEST RESULTS.— 
‘‘(A) IN GENERAL.—During any inspection 
or audit by the Secretary of a facility of a man-
ufacturer of infant formula, the manufacturer 
shall provide to the Secretary the results of all 
microbial tests conducted by or for the facility 
during the period of 15 years preceding the 
date of the inspection or audit. 
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‘‘(B) FINES.—If the Secretary finds that a 
facility is in violation of subparagraph (A), such 
violation shall be treated as an infraction for 
purposes of imposing a fine in accordance with 
title 18, United States Code.’’. 
(b) CRONOBACTER SAKAZAKII.—The Secretary of 
Health and Human Services, acting through the Director 
of the Centers for Disease Control and Prevention, and 
in consultation with the Council of State and Territorial 
Epidemiologists, 
shall 
consider 
adding 
cronobacter 
sakazakii to the list of nationally notifiable diseases and 
conditions under the National Notifiable Diseases Surveil-
lance System. 
SEC. 3. SUPPLY. 
(a) STRATEGIC NATIONAL STOCKPILE.—Not later 
than 90 days after the date of enactment of this Act, the 
Secretary of Agriculture, in consultation with the Assist-
ant Secretary for Preparedness and Response of the De-
partment of Health and Human Services and the Adminis-
trator of the Federal Emergency Management Agency, 
shall— 
(1) perform an assessment of— 
(A) short- and long-term storage of infant 
formula, including the possibility of storage of 
infant formula in a Federal stockpile; and 
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(B) models for distribution of infant for-
mula during shortages; and 
(2) submit a report to the Congress on the re-
sults of such assessment. 
(b) NOTIFICATION
BY MANUFACTURERS
OF CIR-
CUMSTANCES THAT COULD LEAD TO A SHORTAGE OF IN-
FANT FORMULA OR ESSENTIAL MEDICAL FOOD.— 
(1) REQUIREMENT.—Chapter IV of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 341 et 
seq.) is amended by adding the following at the end: 
‘‘SEC. 424. NOTICE OF CIRCUMSTANCES THAT COULD LEAD 
TO A SHORTAGE. 
‘‘(a) NOTICE REQUIREMENT.—Not later than 5 busi-
ness days after a manufacturer of infant formula or essen-
tial medical food becomes aware of circumstances that 
could lead to a shortage of infant formula or essential 
medical food in the United States, such manufacturer 
shall give written notice of such circumstances to the Sec-
retary. 
‘‘(b) DEFINITION.—In this section, the term ‘essen-
tial medical food’ means a food that— 
‘‘(1) is formulated to be consumed or adminis-
tered enterally under the supervision of a physician; 
‘‘(2) is intended for the specific dietary man-
agement of a disease or condition for which distinc-
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