II 

117TH CONGRESS 

2D SESSION S. 4262 

To temporarily allow the importation of infant formula free of duty and 

free of quantitative limitation, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 19 (legislative day, MAY 17), 2022 

Mr. LEE introduced the following bill; which was read twice and referred to 

the Committee on Health, Education, Labor, and Pensions 

A BILL 

To temporarily allow the importation of infant formula free 

of duty and free of quantitative limitation, 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 ‘‘Formula Act of 2022’’. 

5 SEC. 2. INCREASING THE SUPPLY OF INFANT FORMULA. 

6 (a) IN GENERAL.—During the 180 day period begin7 ning on the date of the enactment of this Act, infant for8 mula classified under heading 1901.10 of the Harmonized 

9 Tariff Schedule of the United States shall enter the 


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1 United States free of duty and free of quantitative limita2 tion, if such formula— 

3 (1) is imported from a country on the list pub4 lished by the Secretary of Health and Human Serv5 ices under subsection (c)(1) or a member country of 

6 the European Union; and 

7 (2) is lawfully marketed in the country of ori8 gin. 

9 (b) GUIDANCE.— 

10 (1) IN GENERAL.—The Secretary of Health and 

11 Human Services (referred to in this subsection and 

12 in subsection (c) as the ‘‘Secretary’’) shall, not later 

13 than 7 days after the date of enactment of this Act, 

14 issue, and periodically update, as appropriate, guid15 ance for domestic and foreign manufacturers of in16 fant formula in order to increase availability of such 

17 formula in the United States that is safe and nutri18 tionally adequate. 

19 (2) ELEMENTS OF THE GUIDANCE.—The guid20 ance under paragraph (1) shall address the fol21 lowing: 

22 (A) Information to be submitted to the 

23 Secretary by foreign and domestic manufactur24 ers of infant formula for consideration with re25 gard to the introduction into interstate comVerDate Sep 11 2014 15:48 May 25, 2022 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4262.IS S4262

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1 merce (including importation) of infant formula 

2 that is safe and nutritionally adequate but that 

3 may not comply with all applicable statutory 

4 and regulatory requirements. Such information 

5 shall include— 

6 (i) safety and nutritional adequacy of 

7 the infant formula; 

8 (ii) product identification information; 

9 (iii) the quantity of the infant formula 

10 intended for introduction into interstate 

11 commerce; 

12 (iv) a copy of the label for the infant 

13 formula (with information on any allergens 

14 present on the product label and adequate 

15 instructions for safe product preparation 

16 and use) and description of the packaging 

17 of the infant formula; and 

18 (v) manufacturing information, in19 cluding test results, and facility compliance 

20 and inspection history. 

21 (B) Information for manufacturers plan22 ning to increase domestic production of infant 

23 formula for purposes of addressing the ongoing 

24 shortage. 


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1 (3) PRIORITY.—The guidance under paragraph 

2 (1) shall provide for priority consideration for manu3 facturers that are able to produce large volumes of 

4 such infant formula quickly. 

5 (c) IMPORTATION FROM COUNTRIES MEETING CER6 TAIN STANDARDS.— 

7 (1) IN GENERAL.—Not later than 7 days after 

8 the date of enactment of this Act, the Secretary 

9 shall publish a list of countries the Secretary deter10 mines to have manufacturing and safety standards 

11 for infant formula that are similar, equivalent, or 

12 otherwise suitable, as compared to United States 

13 standards. 

14 (2) PERSONAL AND COMMERCIAL IMPORTA15 TION.—Beginning on the date on which the list of 

16 countries is published under paragraph (1), for a pe17 riod not to exceed 180 days, the Secretary shall 

18 allow personal and commercial importation of infant 

19 formula from any country on such list, as well as 

20 from any member country of the European Union, 

21 without regard to the guidance under subsection 

22 (b)(2) and the requirements of section 412 of the 

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

24 350a), section 415 of such Act (21 U.S.C. 350d), 


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1 and parts 106 and 107 of title 21, Code of Federal 

2 Regulations. 

3 (d) DEFINITION.—In this section, the term ‘‘infant 

4 formula’’ has the meaning given such term in section 

5 201(z) of the Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 321(z)). 

7 SEC. 3. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM 

8 FOR WOMEN, INFANTS, AND CHILDREN. 

9 (a) ACCESS FOR WIC BENEFICIARIES.—Notwith10 standing any other provision of law, any infant formula 

11 (as defined in section 2(d)) imported into the United 

12 States pursuant to section 2(c)(2) is eligible for purchase 

13 using benefits received under the special supplemental nu14 trition program for women, infants, and children estab15 lished by section 17 of the Child Nutrition Act of 1966 

16 (42 U.S.C. 1786). 

17 (b) PRODUCT RECALLS AND SUPPLY CHAIN DISRUP18 TIONS.—Section 17 of the Child Nutrition Act of 1966 

19 (42 U.S.C. 1786) is amended— 

20 (1) in subsection (b), by adding at the end the 

21 following: 

22 ‘‘(24) SUPPLY CHAIN DISRUPTION.—The term 

23 ‘supply chain disruption’ means a shortage of sup24 plemental foods that impedes the redemption of food 

25 instruments, as determined by the Secretary.’’; and 


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1 (2) by adding at the end the following: 

2 ‘‘(r) PRODUCT RECALLS AND SUPPLY CHAIN DIS3 RUPTIONS.— 

4 ‘‘(1) DEFINITION OF QUALIFIED ADMINISTRA5 TIVE REQUIREMENT.—In this subsection, the term 

6 ‘qualified administrative requirement’ means— 

7 ‘‘(A) a requirement under this section; and 

8 ‘‘(B) any regulatory requirement promul9 gated pursuant to this section. 

10 ‘‘(2) MODIFICATION OR WAIVER OF REQUIRE11 MENTS.—Notwithstanding any other provision of 

12 law, the Secretary shall modify or waive a qualified 

13 administrative requirement to allow 1 or more State 

14 agencies— 

15 ‘‘(A) to permit vendors authorized to par16 ticipate in the program under this section to ex17 change or substitute authorized supplemental 

18 foods obtained with food instruments with food 

19 items that are not identical (including in brand 

20 and size); 

21 ‘‘(B) to modify or waive any requirement 

22 with respect to medical documentation for the 

23 issuance of noncontract brand infant formula, 

24 except the requirements for participants receiv25 ing Food Package III (as defined in section 


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1 246.10(e)(3) of title 7, Code of Federal Regula2 tions (as in effect on the date of enactment of 

3 this subsection)); 

4 ‘‘(C) to modify or waive the maximum 

5 monthly allowance for infant formula; 

6 ‘‘(D) to modify or waive any additional re7 quirement with respect to supplemental food 

8 products provided under the program under 

9 this section if the modification or waiver— 

10 ‘‘(i) may facilitate increased access to 

11 those products; 

12 ‘‘(ii) does not substantially weaken the 

13 nutritional quality of those products; and 

14 ‘‘(iii) is in accordance with any appli15 cable guidance or directive from the Ad16 ministrator of Food and Drugs determined 

17 to be applicable by the Secretary. 

18 ‘‘(3) DURATION.—A modification or waiver 

19 under paragraph (2)— 

20 ‘‘(A) shall be available for a period of not 

21 more than 180 days beginning on the date of 

22 enactment of this subsection; and 

23 ‘‘(B) may be renewed, subject to the condi24 tion that the Secretary shall provide notice of 


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1 the renewal not less than 15 days before the re2 newal shall take effect.’’. 

Æ 


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