117 HR 7875 IH: Emergency Infant Formula Act U.S. House of Representatives 2022-05-24 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I117th CONGRESS2d SessionH. R. 7875IN THE HOUSE OF REPRESENTATIVESMay 24, 2022Mr. Sherman (for himself, Mr. Bacon, Mr. Gottheimer, Ms. Manning, Mr. Thompson of California, Mr. Cohen, and Mrs. Demings) introduced the following bill; which was referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concernedA BILLTo 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. 201 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. 201 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)

Definitions

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, or 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 the term covered infant formula products whose label—(i)is not in English or another language specified by the President;(ii)does not include instructions for the use of the product which incorporate the imperial system of measurement; or(iii)does not identify all potential allergens that are contained in the product and appear on a list of potential allergens 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. 201).(e)

Sunset

This Act shall cease to be effective on the date that is 5 years after the date of enactment of this Act.