Emergency Infant Formula Act

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. Short title This Act may be cited as the Emergency Infant Formula Act 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. (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. (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 (B) Exception The President may exclude from the definition of covered infant formula (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 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. (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.

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.