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H.R. 7808House117th Congress (2021-2023)In Committee

FORMULA Act

Sponsored by Chris StewartRep. Chris Stewart (R-UT)
Introduced May 17, 2022

AI-Generated Summary

Updated February 8, 2026 at 3:30 PM UTC

The FORMULA Act temporarily lifts tariffs and many FDA requirements on imported infant formula for 180 days to help ease the current U.S. shortage. It applies to formula from a list of approved countries and lets the product be sold through the WIC program. The law also sets up notification, recall, and reporting rules to protect infant safety during this period.

Key Provisions

  • For 180 days, infant formula from Australia, Israel, Japan, New Zealand, Switzerland, South Africa, the United Kingdom, EU and EEA members can be imported duty‑free and without quantitative limits.
  • During that time, FDA requirements for labeling, registration, and manufacturing facilities are waived, but importers must notify HHS if they suspect the formula lacks required nutrients or is unsafe.
  • If HHS determines a product is unsafe, the importer must immediately recall it from all retailers.
  • Formula imported under the act can be purchased with WIC benefits, and the USDA can grant waivers related to state agency requests for shortages.
  • The USDA must keep a public list of all imported formulas, showing country of origin, preparation instructions, and the product’s approval status in its home country.

Legislative Activity

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2 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Trade.

Trade Subcommittee

May 17, 2022

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HouseIntro Referral

Introduced in House

May 17, 2022

HouseIntro Referral

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.

Energy and Commerce Committee

May 17, 2022

HouseCommittee

Referred to the Subcommittee on Trade.

Trade Subcommittee

May 17, 2022

Bill Text

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Introduced in HouseIssued May 17, 2022

I

117th CONGRESS

2d Session

H. R. 7808

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.

1.

Short title

This Act may be cited as the Fixing Our Regulatory Mayhem Upsetting Little Americans Act or the FORMULA Act.

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)).