II 

117TH CONGRESS 

2D SESSION S. 4350 

To provide for the expedited and duty-free importation of infant formula 

that may be lawfully marketed in the European Union, Canada, Japan, 

or the United Kingdom, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 6, 2022 

Mrs. GILLIBRAND introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for the expedited and duty-free importation of 

infant formula that may be lawfully marketed in the 

European Union, Canada, Japan, or the United Kingdom, 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 ‘‘Emergency Infant For5 mula Act’’. 

6 SEC. 2. EXPEDITED IMPORTATION OF INFANT FORMULA. 

7 (a) AUTHORIZATION FOR IMPORTATION AND SALE.— 


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1 (1) DECLARATION OF SHORTAGE.—The Presi2 dent may declare, in consultation with the Commis3 sioner of Food and Drugs and through Executive 

4 order, that a shortage exists in the United States of 

5 infant formula with respect to any period specified 

6 in such order. 

7 (2) AUTHORIZATION FOR IMPORTATION AND

8 SALE.—The President, in consultation with the 

9 Commissioner of Food and Drugs, may authorize 

10 the importation, distribution, and sale of any cov11 ered infant formula, notwithstanding the provisions 

12 of the Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 301 et seq.), if the applicable brand, manu14 facturer, or manufacturing plant, or the specific in15 fant formula product, is included in the Executive 

16 order promulgated pursuant to the authority pro17 vided by paragraph (1). Such Executive order may 

18 further specify, with respect to such authorized 

19 products, specific requirements with respect to the 

20 labeling or usage guidance to be eligible for importa21 tion, distribution, and sale pursuant to the authority 

22 provided by this paragraph. 

23 (3) LABELING REQUIREMENTS.— 

24 (A) EXEMPTION FROM UNITED STATES LA25 BELING REQUIREMENTS.—Any provision of the 


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1 Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 301 et seq.) relating to labeling require3 ments for infant formula products imported 

4 into the United States shall not apply with re5 spect to such products imported pursuant to 

6 the authority provided by paragraph (2). 

7 (B) REQUIREMENT WITH RESPECT TO

8 FOREIGN MARKETING ELIGIBILITY.—Notwith9 standing subparagraph (A), the Commissioner 

10 of Food and Drugs shall require any retailer of 

11 covered infant formula imported subject to the 

12 authority provided by paragraph (2), including 

13 an online retailer, to include in an appropriate 

14 and conspicuous place next to the product or 

15 description of the product, as applicable, a 

16 label— 

17 (i) that indicates that such product 

18 has not been approved for importation, dis19 tribution, or sale by the Commissioner of 

20 Food and Drugs and is authorized for sale 

21 only subject to the provisions of this Act; 

22 and 

23 (ii) that may additionally indicate the 

24 foreign country or countries where such 

25 product may be lawfully marketed. 


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1 (4) TERMINATION OF SHORTAGE.—The Presi2 dent may, upon determining that a shortage no 

3 longer exists in the United States of infant formula, 

4 terminate a declaration described in paragraph (1). 

5 (b) DUTY-FREE TREATMENT.—Notwithstanding any 

6 other provision of law, the President may, during any pe7 riod in which an infant formula shortage is declared in 

8 accordance with subsection (a)(1), reduce or suspend any 

9 duties imposed— 

10 (1) with respect to the importation of covered 

11 infant formula; or 

12 (2) with respect to any other article used in the 

13 production of infant formula that the importer cer14 tifies is being imported for such production. 

15 (c) PRIORITY HANDLING OF ENTRIES.—During any 

16 period in which an infant formula shortage is declared in 

17 accordance with subsection (a)(1), the Commissioner of 

18 U.S. Customs and Border Patrol shall give the highest pri19 ority and take any steps as may be necessary to expedite 

20 the processing of all entries of covered infant formula and 

21 articles used in the production of infant formula (as de22 scribed in subsection (b)(2)). 

23 (d) COVERED INFANT FORMULA.—In this Act: 

24 (1) COVERED INFANT FORMULA.— 


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1 (A) IN GENERAL.—Subject to subpara2 graph (B), the term ‘‘covered infant formula’’ 

3 means any infant formula that is lawfully mar4 keted in the European Union, Canada, Japan, 

5 the United Kingdom, and any country the 

6 President determines to have sufficient health 

7 and safety standards with respect to infant for8 mula. 

9 (B) EXCEPTION.—The President may ex10 clude from the definition of ‘‘covered infant for11 mula’’ products that— 

12 (i) are not labeled in English or an13 other language specified by the President; 

14 (ii) do not include instructions for the 

15 use of the product which incorporate the 

16 imperial system of measurement; or 

17 (iii) include any potential allergen 

18 identified by the President. 

19 (2) INFANT FORMULA.—In paragraph (1), the 

20 term ‘‘infant formula’’ has the meaning given to 

21 such term in section 201 of the Federal Food, Drug, 

22 and Cosmetic Act (21 U.S.C. 321). 

23 (e) USE OF DEFENSE PRODUCTION ACT AUTHORI24 TIES.—During any period in which an infant formula 

25 shortage is declared in accordance with subsection (a)(1); 


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1 (1) the President may use authorities provided 

2 by the Defense Production Act of 1950 (50 U.S.C. 

3 4501 et seq.) in the production of infant formula; 

4 and 

5 (2) infant formula shall be deemed to meet the 

6 criteria specified in section 101(b) of such Act. 

7 (f) SUNSET.—This Act shall cease to be effective on 

8 the date that is 5 years after the date of enactment of 

9 this Act. 

Æ 


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