II 

Calendar No. 372 

117TH CONGRESS 

2D SESSION S. 4261 

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 SENATE OF THE UNITED STATES 

MAY 19 (legislative day, MAY 17), 2022 

Mr. LEE (for himself, Mr. WICKER, Mr. DAINES, Mr. CASSIDY, and Mr. 

GRASSLEY) introduced the following bill; which was read the first time 

MAY 19, 2022 

Read the second time and placed on the calendar 

A BILL 

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. 

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 ‘‘Fixing Our Regulatory 

5 Mayhem Upsetting Little Americans Act’’ or the ‘‘FOR6 MULA Act’’. 


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1 SEC. 2. SUSPENSION OF RESTRICTIONS ON IMPORTATION 

2 OF INFANT FORMULA TO ADDRESS SHORT3 AGE. 

4 (a) DUTY-FREE TREATMENT OF INFANT FORMULA

5 IMPORTED FROM CERTAIN COUNTRIES.— 

6 (1) IN GENERAL.—During the 180-day period 

7 beginning on the date of the enactment of this Act, 

8 infant formula described in paragraph (2) shall 

9 enter the United States free of duty and free of 

10 quantitative limitation. 

11 (2) INFANT FORMULA DESCRIBED.—Infant for12 mula is described in this paragraph if the infant for13 mula— 

14 (A) is classified under heading 1901.10 of 

15 the Harmonized Tariff Schedule of the United 

16 States; 

17 (B) is imported from a country described 

18 in paragraph (3); and 

19 (C) was approved by the agency of the gov20 ernment of that country that regulates infant 

21 formula. 

22 (3) COUNTRIES DESCRIBED.—A country de23 scribed in this paragraph is any of the following: 

24 (A) Australia. 

25 (B) Israel. 

26 (C) Japan. 


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1 (D) New Zealand. 

2 (E) Switzerland. 

3 (F) South Africa. 

4 (G) The United Kingdom. 

5 (H) A member country of the European 

6 Union. 

7 (I) A member country of the European 

8 Economic Area. 

9 (b) TEMPORARY EXEMPTIONS FROM FDA REQUIRE10 MENTS.— 

11 (1) IN GENERAL.—With respect to any infant 

12 formula introduced or delivered for introduction into 

13 interstate commerce pursuant to subsection (a) dur14 ing the 180-day period beginning on the date of the 

15 enactment of this Act— 

16 (A) the requirements under section 412 of 

17 the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 350a) shall not apply; 

19 (B) such infant formula may be manufac20 tured, processed, packed, or held in a domestic 

21 or foreign facility that is not registered under 

22 section 415 of such Act (21 U.S.C. 350d); 

23 (C) the requirements under parts 106 and 

24 107 of title 21, Code of Federal Regulations, 

25 shall not apply; and 


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1 (D) such infant formula shall not be con2 sidered to be misbranded or adulterated solely 

3 on the basis of not being in compliance with the 

4 requirements of such section 412 or 415, or 

5 such part 106 or 107. 

6 (2) NOTIFICATION REQUIREMENT.— 

7 (A) IN GENERAL.—A person who intro8 duces or delivers for introduction into interstate 

9 commerce an infant formula pursuant to sub10 section (a) shall notify the Secretary of Health 

11 and Human Services (referred to in this sub12 section as the ‘‘Secretary’’) if such person has 

13 knowledge which reasonably supports the con14 clusion that such infant formula— 

15 (i) may not provide the nutrients re16 quired by section 412(i) of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 

18 350a(i)); or 

19 (ii) is a product that meets any cri20 terion under section 402(a) of such Act 

21 (21 U.S.C. 342(a)), or which otherwise 

22 may be unsafe for infant consumption. 

23 (B) KNOWLEDGE DEFINED.—For purposes 

24 of subparagraph (A), the term ‘‘knowledge’’ as 


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1 applied to a person subject to such subpara2 graph means— 

3 (i) the actual knowledge that the man4 ufacturer had; or 

5 (ii) the knowledge which a reasonable 

6 person would have had under like cir7 cumstances or which would have been ob8 tained upon the exercise of due care. 

9 (3) RECALL AUTHORITY.—If the Secretary de10 termines that infant formula introduced or delivered 

11 for introduction into interstate commerce pursuant 

12 to subsection (a) is a product described in paragraph 

13 (2)(A)(ii), the manufacturer or importer shall imme14 diately take all actions necessary to recall shipments 

15 of such infant formula from all wholesale and retail 

16 establishments, consistent with recall regulations 

17 and guidelines issued by the Secretary. 

18 (4) CLARIFICATION.—Section 801(j) of the 

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

20 381(j)) shall apply with respect to any infant for21 mula introduced or delivered for introduction into 

22 interstate commerce pursuant to subsection (a) dur23 ing the 180-day period beginning on the date of the 

24 enactment of this Act. 


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1 (c) SPECIAL SUPPLEMENTAL NUTRITION PROGRAM

2 FOR WOMEN, INFANTS, AND CHILDREN.— 

3 (1) ACCESS FOR WIC BENEFICIARIES.—Not4 withstanding any other provision of law, any infant 

5 formula introduced or delivered for introduction into 

6 interstate commerce pursuant to subsection (a) dur7 ing the 180-day period beginning on the date of en8 actment of this Act is eligible for purchase using 

9 benefits received under the special supplemental nu10 trition program for women, infants, and children es11 tablished by section 17 of the Child Nutrition Act of 

12 1966 (42 U.S.C. 1786). 

13 (2) WAIVERS.— 

14 (A) DEFINITION OF COVERED DOCU15 MENT.—In this paragraph, the term ‘‘covered 

16 document’’ means the attachment entitled 

17 ‘‘Process for State Agency Waiver Requests Re18 lated to Shortages’’ to the letter of the Sec19 retary of Agriculture dated February 18, 2022, 

20 entitled ‘‘Voluntary Recall of Certain Abbott 

21 Powder Formulas, including Similac, 

22 Alimentum and EleCare’’. 

23 (B) WAIVERS.—During the 180-day period 

24 beginning on the date of enactment of this Act, 

25 the Secretary of Agriculture may grant any 


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1 waiver described in the covered document, in2 cluding with respect to the exchange or 

3 issuance, as applicable, of infant formula intro4 duced or delivered for introduction into inter5 state commerce pursuant to subsection (a). 

6 (d) LIST OF IMPORTED INFANT FORMULA.—The 

7 Secretary of Agriculture, in conjunction with the Secretary 

8 of Health and Human Services, shall— 

9 (1) maintain a list of all infant formula intro10 duced or delivered for introduction into interstate 

11 commerce pursuant to subsection (a) during the 

12 180-day period beginning on the date of enactment 

13 of this Act, which shall include, for each infant for14 mula— 

15 (A) the country of origin; 

16 (B) the recommended measurements for 

17 mixing or otherwise preparing the infant for18 mula; and 

19 (C) the approved use and marketing status 

20 of the infant formula in the country of origin 

21 according to the applicable government entity 

22 that regulates infant formula in that country; 

23 and 

24 (2) make the list maintained under paragraph 

25 (1) publicly available on the websites of each of the 


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1 Department of Agriculture and the Food and Drug 

2 Administration. 

3 (e) INFANT FORMULA DEFINED.—In this section, 

4 the term ‘‘infant formula’’ has the meaning given that 

5 term in section 201(z) of the Federal Food, Drug, and 

6 Cosmetic Act (21 U.S.C. 321(z)). 


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Calendar No. 372 

117TH CONGRESS 

2D SESSION S. 4261 

A BILL 

To suspend duties and other restrictions on the imfor other purposes. age of infant formula in the United States, and portation of infant formula to address the shortMAY 19, 2022 

Read the second time and placed on the calendar 


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