[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4350 Introduced in Senate (IS)]
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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.
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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