I 
117TH CONGRESS 
2D SESSION 
H. R. 7808 
To suspend duties and other restrictions on the importation of infant formula 
to address the shortage of infant formula in the United States, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 17, 2022 
Mr. STEWART introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committees on 
Ways and Means, and Education and Labor, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To suspend duties and other restrictions on the importation 
of infant formula to address the shortage of infant for-
mula in the United States, 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 ‘‘Fixing Our Regulatory 
Mayhem Upsetting Little Americans Act’’ or the ‘‘FOR-
MULA Act’’. 
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SEC. 2. SUSPENSION OF RESTRICTIONS ON IMPORTATION 
OF INFANT FORMULA TO ADDRESS SHORT-
AGE. 
(a) DUTY-FREE TREATMENT OF INFANT FORMULA 
IMPORTED FROM CERTAIN COUNTRIES.— 
(1) IN GENERAL.—During the 180-day period 
beginning on the date of the enactment of this Act, 
infant formula described in paragraph (2) shall 
enter the United States free of duty and free of 
quantitative limitation. 
(2) INFANT FORMULA DESCRIBED.—Infant for-
mula is described in this paragraph if the infant for-
mula— 
(A) is classified under heading 1901.10 of 
the Harmonized Tariff Schedule of the United 
States; 
(B) is imported from a country described 
in paragraph (3); and 
(C) was approved by the agency of the gov-
ernment of that country that regulates infant 
formula. 
(3) COUNTRIES
DESCRIBED.—A country de-
scribed in this paragraph is any of the following: 
(A) Australia. 
(B) Israel. 
(C) Japan. 
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(D) New Zealand. 
(E) Switzerland. 
(F) South Africa. 
(G) The United Kingdom. 
(H) A member country of the European 
Union. 
(I) A member country of the European 
Economic Area. 
(b) TEMPORARY EXEMPTIONS FROM FDA REQUIRE-
MENTS.— 
(1) IN GENERAL.—With respect to any infant 
formula introduced or delivered for introduction into 
interstate commerce pursuant to subsection (a) dur-
ing the 180-day period beginning on the date of the 
enactment of this Act— 
(A) the requirements under section 412 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350a) shall not apply; 
(B) such infant formula may be manufac-
tured, processed, packed, or held in a domestic 
or foreign facility that is not registered under 
section 415 of such Act (21 U.S.C. 350d); 
(C) the requirements under parts 106 and 
107 of title 21, Code of Federal Regulations, 
shall not apply; and 
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(D) such infant formula shall not be con-
sidered to be misbranded or adulterated solely 
on the basis of not being in compliance with the 
requirements of such section 412 or 415, or 
such part 106 or 107. 
(2) NOTIFICATION REQUIREMENT.— 
(A) IN
GENERAL.—A person who intro-
duces or delivers for introduction into interstate 
commerce an infant formula pursuant to sub-
section (a) shall notify the Secretary of Health 
and Human Services (referred to in this sub-
section as the ‘‘Secretary’’) if such person has 
knowledge which reasonably supports the con-
clusion that such infant formula— 
(i) may not provide the nutrients re-
quired by section 412(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
350a(i)); or 
(ii) is a product that meets any cri-
terion under section 402(a) of such Act 
(21 U.S.C. 342(a)), or which otherwise 
may be unsafe for infant consumption. 
(B) KNOWLEDGE DEFINED.—For purposes 
of subparagraph (A), the term ‘‘knowledge’’ as 
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applied to a person subject to such subpara-
graph means— 
(i) the actual knowledge that the man-
ufacturer had; or 
(ii) the knowledge which a reasonable 
person would have had under like cir-
cumstances or which would have been ob-
tained upon the exercise of due care. 
(3) RECALL AUTHORITY.—If the Secretary de-
termines that infant formula introduced or delivered 
for introduction into interstate commerce pursuant 
to subsection (a) is a product described in paragraph 
(2)(A)(ii), the manufacturer or importer shall imme-
diately take all actions necessary to recall shipments 
of such infant formula from all wholesale and retail 
establishments, consistent with recall regulations 
and guidelines issued by the Secretary. 
(4) CLARIFICATION.—Section 801(j) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381(j)) shall apply with respect to any infant for-
mula introduced or delivered for introduction into 
interstate commerce pursuant to subsection (a) dur-
ing the 180-day period beginning on the date of the 
enactment of this Act. 
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(c) SPECIAL SUPPLEMENTAL NUTRITION PROGRAM 
FOR WOMEN, INFANTS, AND CHILDREN.— 
(1) ACCESS
FOR
WIC
BENEFICIARIES.—Not-
withstanding any other provision of law, any infant 
formula introduced or delivered for introduction into 
interstate commerce pursuant to subsection (a) dur-
ing the 180-day period beginning on the date of en-
actment of this Act is eligible for purchase using 
benefits received under the special supplemental nu-
trition program for women, infants, and children es-
tablished by section 17 of the Child Nutrition Act of 
1966 (42 U.S.C. 1786). 
(2) WAIVERS.— 
(A) DEFINITION
OF
COVERED
DOCU-
MENT.—In this paragraph, the term ‘‘covered 
document’’ means the attachment entitled 
‘‘Process for State Agency Waiver Requests Re-
lated to Shortages’’ to the letter of the Sec-
retary of Agriculture dated February 18, 2022, 
entitled ‘‘Voluntary Recall of Certain Abbott 
Powder 
Formulas, 
including 
Similac, 
Alimentum and EleCare’’. 
(B) WAIVERS.—During the 180-day period 
beginning on the date of enactment of this Act, 
the Secretary of Agriculture may grant any 
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waiver described in the covered document, in-
cluding with respect to the exchange or 
issuance, as applicable, of infant formula intro-
duced or delivered for introduction into inter-
state commerce pursuant to subsection (a). 
(d) LIST
OF IMPORTED INFANT FORMULA.—The 
Secretary of Agriculture shall— 
(1) maintain a list of all infant formula intro-
duced or delivered for introduction into interstate 
commerce pursuant to subsection (a) during the 
180-day period beginning on the date of enactment 
of this Act, which shall include, for each infant for-
mula— 
(A) the country of origin; 
(B) the recommended measurements for 
mixing or otherwise preparing the infant for-
mula; and 
(C) the approved use and marketing status 
of the infant formula in the country of origin 
according to the applicable government entity 
that regulates infant formula in that country; 
and 
(2) make the list maintained under paragraph 
(1) publicly available on the websites of each of the 
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Department of Agriculture and the Food and Drug 
Administration. 
(e) INFANT FORMULA DEFINED.—In this section, 
the term ‘‘infant formula’’ has the meaning given that 
term in section 201(z) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(z)). 
Æ 
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