Title: FORMULA Act
Policy area: Foreign Trade and International Finance

Summary:
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]
[S. 4261 Placed on Calendar Senate (PCS)]

<DOC>





                                                       Calendar No. 372
117th CONGRESS
  2d Session
                                S. 4261

 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 SENATE OF THE UNITED STATES

                 May 19 (legislative day, May 17), 2022

  Mr. Lee (for himself, Mr. Wicker, Mr. Daines, Mr. Cassidy, and Mr. 
 Grassley) introduced the following bill; which was read the first time

                              May 19, 2022

            Read the second time and placed on the calendar

_______________________________________________________________________

                                 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, 
in conjunction with the Secretary of Health and Human Services, 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)).
                                                       Calendar No. 372

117th CONGRESS

  2d Session

                                S. 4261

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                              May 19, 2022

            Read the second time and placed on the calendar