Fixing Our Regulatory Mayhem Upsetting Little Americans Act or the FORMULA Act
This bill provides duty-free treatment to infant formula imported from certain countries.
Specifically, the bill provides, for 180 days beginning on this bill's enactment, duty-free treatment to infant formula if the formula (1) is imported from specified countries (e.g., Australia, Japan, and the United Kingdom), and (2) was approved by the government of that country regulating such formula.
The bill temporarily waives certain Food and Drug Administration regulations and requirements under the Federal Food, Drug, and Cosmetic Act for formula imported under this bill.
A person who manufactures or imports formula must notify the Department of Health and Human Services (HHS) if the person has knowledge that such formula may not provide required nutrients or may be unsafe for infant consumption. If HHS determines the formula is unsafe for infant consumption, then the manufacturer or importer must immediately recall shipments from all wholesale and retail establishments.
The bill makes formula imported under this bill eligible for purchase using benefits received under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
The Department of Agriculture must maintain and publicize a list of imported formula approved for use and marketing within the country of origin and the recommended measurements for mixing or otherwise preparing the formula.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7808 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 7808
To suspend duties and other restrictions on the importation of infant
formula to address the shortage of infant formula in the United States,
and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 17, 2022
Mr. Stewart introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
Ways and Means, and Education and Labor, 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
concerned
_______________________________________________________________________
A BILL
To suspend duties and other restrictions on the importation of infant
formula to address the shortage of infant formula in the United States,
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 ``Fixing Our Regulatory Mayhem
Upsetting Little Americans Act'' or the ``FORMULA Act''.
SEC. 2. SUSPENSION OF RESTRICTIONS ON IMPORTATION OF INFANT FORMULA TO
ADDRESS SHORTAGE.
(a) Duty-Free Treatment of Infant Formula Imported From Certain
Countries.--
(1) In general.--During the 180-day period beginning on the
date of the enactment of this Act, infant formula described in
paragraph (2) shall enter the United States free of duty and
free of quantitative limitation.
(2) Infant formula described.--Infant formula is described
in this paragraph if the infant formula--
(A) is classified under heading 1901.10 of the
Harmonized Tariff Schedule of the United States;
(B) is imported from a country described in
paragraph (3); and
(C) was approved by the agency of the government of
that country that regulates infant formula.
(3) Countries described.--A country described in this
paragraph is any of the following:
(A) Australia.
(B) Israel.
(C) Japan.
(D) New Zealand.
(E) Switzerland.
(F) South Africa.
(G) The United Kingdom.
(H) A member country of the European Union.
(I) A member country of the European Economic Area.
(b) Temporary Exemptions From FDA Requirements.--
(1) In general.--With respect to any infant formula
introduced or delivered for introduction into interstate
commerce pursuant to subsection (a) during the 180-day period
beginning on the date of the enactment of this Act--
(A) the requirements under section 412 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a)
shall not apply;
(B) such infant formula may be manufactured,
processed, packed, or held in a domestic or foreign
facility that is not registered under section 415 of
such Act (21 U.S.C. 350d);
(C) the requirements under parts 106 and 107 of
title 21, Code of Federal Regulations, shall not apply;
and
(D) such infant formula shall not be considered to
be misbranded or adulterated solely on the basis of not
being in compliance with the requirements of such
section 412 or 415, or such part 106 or 107.
(2) Notification requirement.--
(A) In general.--A person who introduces or
delivers for introduction into interstate commerce an
infant formula pursuant to subsection (a) shall notify
the Secretary of Health and Human Services (referred to
in this subsection as the ``Secretary'') if such person
has knowledge which reasonably supports the conclusion
that such infant formula--
(i) may not provide the nutrients required
by section 412(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350a(i)); or
(ii) is a product that meets any criterion
under section 402(a) of such Act (21 U.S.C.
342(a)), or which otherwise may be unsafe for
infant consumption.
(B) Knowledge defined.--For purposes of
subparagraph (A), the term ``knowledge'' as applied to
a person subject to such subparagraph means--
(i) the actual knowledge that the
manufacturer had; or
(ii) the knowledge which a reasonable
person would have had under like circumstances
or which would have been obtained upon the
exercise of due care.
(3) Recall authority.--If the Secretary determines that
infant formula introduced or delivered for introduction into
interstate commerce pursuant to subsection (a) is a product
described in paragraph (2)(A)(ii), the manufacturer or importer
shall immediately take all actions necessary to recall
shipments of such infant formula from all wholesale and retail
establishments, consistent with recall regulations and
guidelines issued by the Secretary.
(4) Clarification.--Section 801(j) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(j)) shall apply with
respect to any infant formula introduced or delivered for
introduction into interstate commerce pursuant to subsection
(a) during the 180-day period beginning on the date of the
enactment of this Act.
(c) Special Supplemental Nutrition Program for Women, Infants, and
Children.--
(1) Access for wic beneficiaries.--Notwithstanding any
other provision of law, any infant formula introduced or
delivered for introduction into interstate commerce pursuant to
subsection (a) during the 180-day period beginning on the date
of enactment of this Act is eligible for purchase using
benefits received under the special supplemental nutrition
program for women, infants, and children established by section
17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786).
(2) Waivers.--
(A) Definition of covered document.--In this
paragraph, the term ``covered document'' means the
attachment entitled ``Process for State Agency Waiver
Requests Related to Shortages'' to the letter of the
Secretary of Agriculture dated February 18, 2022,
entitled ``Voluntary Recall of Certain Abbott Powder
Formulas, including Similac, Alimentum and EleCare''.
(B) Waivers.--During the 180-day period beginning
on the date of enactment of this Act, the Secretary of
Agriculture may grant any waiver described in the
covered document, including with respect to the
exchange or issuance, as applicable, of infant formula
introduced or delivered for introduction into
interstate commerce pursuant to subsection (a).
(d) List of Imported Infant Formula.--The Secretary of Agriculture
shall--
(1) maintain a list of all infant formula introduced or
delivered for introduction into interstate commerce pursuant to
subsection (a) during the 180-day period beginning on the date
of enactment of this Act, which shall include, for each infant
formula--
(A) the country of origin;
(B) the recommended measurements for mixing or
otherwise preparing the infant formula; and
(C) the approved use and marketing status of the
infant formula in the country of origin according to
the applicable government entity that regulates infant
formula in that country; and
(2) make the list maintained under paragraph (1) publicly
available on the websites of each of the Department of
Agriculture and the Food and Drug Administration.
(e) Infant Formula Defined.--In this section, the term ``infant
formula'' has the meaning given that term in section 201(z) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)).
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, 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 concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, 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 concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, 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 concerned.
Referred to the Subcommittee on Trade.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line