Emergency Infant Formula Act
Bill: S.4350 | Sponsor: Sen. Gillibrand, Kirsten E. (D-NY)
Policy area: Foreign Trade and International Finance

Summary:
Emergency Infant Formula Act
This bill addresses the shortage of infant formula in the United States, including by authorizing the President to take certain actions to expedite the importation of such formula.
Specifically, the bill authorizes the President to declare through an executive order that a shortage of infant formula exists in the United States. The President may use authorities provided under the Defense Production Act of 1950 in the production of infant formula.
Additionally, the President may authorize the importation, distribution, and sale of any covered infant formula if the applicable brand, manufacturer, manufacturing plant, or the specific infant formula product is included in the executive order. Covered infant formula generally refers to any infant formula that is lawfully marketed in the European Union, Canada, Japan, the United Kingdom, or any country the President determines has sufficient health and safety standards with respect to infant formula.
The bill exempts imported infant formula from U.S. labeling requirements. The Food and Drug Administration (FDA) must require retailers of imported infant formula to place a label on the product indicating it has not been approved by the FDA.
The bill also authorizes the President to reduce or suspend any duties on the importation of covered infant formula or articles used in the production of infant formula.
U.S. Customs and Border Protection must give the highest priority and take steps as necessary to expedite the processing of all entries of covered infant formula and articles used in the production of infant formula.

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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Emergency Infant Formula Act''.

SEC. 2. EXPEDITED IMPORTATION OF INFANT FORMULA.

    (a) Authorization for Importation and Sale.--
            (1) Declaration of shortage.--The President may declare, in 
        consultation with the Commissioner of Food and Drugs and 
        through Executive order, that a shortage exists in the United 
        States of infant formula with respect to any period specified 
        in such order.
            (2) Authorization for importation and sale.--The President, 
        in consultation with the Commissioner of Food and Drugs, may 
        authorize the importation, distribution, and sale of any 
        covered infant formula, notwithstanding the provisions of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
        if the applicable brand, manufacturer, or manufacturing plant, 
        or the specific infant formula product, is included in the 
        Executive order promulgated pursuant to the authority provided 
        by paragraph (1). Such Executive order may further specify, 
        with respect to such authorized products, specific requirements 
        with respect to the labeling or usage guidance to be eligible 
        for importation, distribution, and sale pursuant to the 
        authority provided by this paragraph.
            (3) Labeling requirements.--
                    (A) Exemption from united states labeling 
                requirements.--Any provision of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 301 et seq.) relating to 
                labeling requirements for infant formula products 
                imported into the United States shall not apply with 
                respect to such products imported pursuant to the 
                authority provided by paragraph (2).
                    (B) Requirement with respect to foreign marketing 
                eligibility.--Notwithstanding subparagraph (A), the 
                Commissioner of Food and Drugs shall require any 
                retailer of covered infant formula imported subject to 
                the authority provided by paragraph (2), including an 
                online retailer, to include in an appropriate and 
                conspicuous place next to the product or description of 
                the product, as applicable, a label--
                            (i) that indicates that such product has 
                        not been approved for importation, 
                        distribution, or sale by the Commissioner of 
                        Food and Drugs and is authorized for sale only 
                        subject to the provisions of this Act; and
                            (ii) that may additionally indicate the 
                        foreign country or countries where such product 
                        may be lawfully marketed.
            (4) Termination of shortage.--The President may, upon 
        determining that a shortage no longer exists in the United 
        States of infant formula, terminate a declaration described in 
        paragraph (1).
    (b) Duty-Free Treatment.--Notwithstanding any other provision of 
law, the President may, during any period in which an infant formula 
shortage is declared in accordance with subsection (a)(1), reduce or 
suspend any duties imposed--
            (1) with respect to the importation of covered infant 
        formula; or
            (2) with respect to any other article used in the 
        production of infant formula that the importer certifies is 
        being imported for such production.
    (c) Priority Handling of Entries.--During any period in which an 
infant formula shortage is declared in accordance with subsection 
(a)(1), the Commissioner of U.S. Customs and Border Patrol shall give 
the highest priority and take any steps as may be necessary to expedite 
the processing of all entries of covered infant formula and articles 
used in the production of infant formula (as described in subsection 
(b)(2)).
    (d) Covered Infant Formula.--In this Act:
            (1) Covered infant formula.--
                    (A) In general.--Subject to subparagraph (B), the 
                term ``covered infant formula'' means any infant 
                formula that is lawfully marketed in the European 
                Union, Canada, Japan, the United Kingdom, and any 
                country the President determines to have sufficient 
                health and safety standards with respect to infant 
                formula.
                    (B) Exception.--The President may exclude from the 
                definition of ``covered infant formula'' products 
                that--
                            (i) are not labeled in English or another 
                        language specified by the President;
                            (ii) do not include instructions for the 
                        use of the product which incorporate the 
                        imperial system of measurement; or
                            (iii) include any potential allergen 
                        identified by the President.
            (2) Infant formula.--In paragraph (1), the term ``infant 
        formula'' has the meaning given to such term in section 201 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
    (e) Use of Defense Production Act Authorities.--During any period 
in which an infant formula shortage is declared in accordance with 
subsection (a)(1);
            (1) the President may use authorities provided by the 
        Defense Production Act of 1950 (50 U.S.C. 4501 et seq.) in the 
        production of infant formula; and
            (2) infant formula shall be deemed to meet the criteria 
        specified in section 101(b) of such Act.
    (f) Sunset.--This Act shall cease to be effective on the date that 
is 5 years after the date of enactment of this Act.
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