Protecting Infants from Formula Shortages Act of 2022
Bill: S.4256 | Sponsor: Sen. Casey, Robert P., Jr. (D-PA)
Policy area: Health

Summary:
Protecting Infants from Formula Shortages Act of 2022
This bill imposes requirements on manufacturers of infant formula and medical foods for individuals with inborn errors of metabolism.
A manufacturer of such a food must notify the Food and Drug Administration (FDA) of any circumstance that is likely to lead to a meaningful disruption of the U.S. supply of the food, including a discontinuance or interruption of manufacturing. The manufacturer must submit the notification at least six months prior to the cause of the disruption or, if that is not possible, as soon as practicable. The FDA must provide the Department of Agriculture and appropriate organizations information about the cause of the disruption.
The FDA must inform a person (an individual or entity) of their failure to comply with these notification requirements. If the failure continues for a certain time period, the person shall be subject to fines, imprisonment, or both.
During a public health emergency, the FDA may impose additional conditions for such notifications and designate additional categories of food that are subject to the notification requirements.
The bill also requires each manufacturer of such a food to develop and maintain a redundancy risk management plan that identifies and evaluates risks for each manufacturing establishment for the food.

To amend the Federal Food, Drug, and Cosmetic Act to prevent food 
 shortages, including shortages of infant formula and certain medical 
                                 foods.

    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 ``Protecting Infants from Formula 
Shortages Act of 2022''.

SEC. 2. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF ESSENTIAL 
              SOURCES OF NUTRITION.

    (a) Discontinuance or Interruption in the Production of Essential 
Food.--The Federal Food, Drug, and Cosmetic Act is amended by inserting 
after section 412 (21 U.S.C. 350a) the following new section:

``SEC. 412A. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF FOOD, 
              INCLUDING INFANT FORMULA AND CERTAIN MEDICAL FOODS FOR 
              INBORN ERRORS OF METABOLISM.

    ``(a) In General.--A manufacturer of an essential source of 
nutrition shall notify the Secretary, in accordance with subsection 
(b), of a permanent discontinuance in the manufacture of such food or 
an interruption of the manufacture of an essential source of nutrition 
or any other circumstance that is likely to lead to a meaningful 
disruption in the supply of such food in the United States, and the 
reasons for such discontinuance or interruption.
    ``(b) Timing.--Except as provided in subsection (g), a notice 
required under subsection (a) shall be submitted to the Secretary--
            ``(1) at least 6 months prior to the date of the 
        discontinuance or interruption; or
            ``(2) if compliance with paragraph (1) is not possible, as 
        soon as practicable.
    ``(c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute, to the Secretary of Agriculture and to 
appropriate organizations, as determined by the Secretary, through such 
means as the Secretary determines appropriate, information on the 
discontinuance or interruption of the manufacture of an essential 
source of nutrition, or other circumstance, reported under subsection 
(a).
    ``(d) Confidentiality.--Nothing in this section authorizes the 
Secretary to disclose any information that is a trade secret or 
confidential information subject to section 552(b)(4) of title 5, 
United States Code, or section 1905 of title 18, United States Code.
    ``(e) Failure To Meet Requirements.--If a person fails to submit 
information required under subsection (a) in accordance with subsection 
(b)--
            ``(1) the Secretary shall issue to such person a letter 
        that--
                    ``(A) informs such person of the failure to comply;
                    ``(B) describes the basis for noncompliance; and
                    ``(C) requires the person to comply not later than 
                30 calendar days after the date on which the letter was 
                issued;
            ``(2) not later than 30 calendar days after the issuance of 
        a letter under paragraph (1), the person who receives such 
        letter shall submit to the Secretary a written response to such 
        letter that provides the information required under subsection 
        (a); and
            ``(3) not later than 45 calendar days after the issuance of 
        a letter under paragraph (1), the Secretary shall make such 
        letter and any response to such letter under paragraph (2) 
        available to the public on the website of the Food and Drug 
        Administration, with appropriate redactions made to protect 
        information described in subsection (d), except that, if the 
        Secretary determines that the letter under paragraph (1) was 
        issued in error or, after review of such response, the person 
        had a reasonable basis for not notifying as required under 
        subsection (a), the requirements of this paragraph shall not 
        apply.
    ``(f) Regulations.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Protecting Infants from Formula Shortages Act 
        of 2022, the Secretary shall promulgate regulations regarding 
        the requirements under this section.
            ``(2) Contents.--Such regulations--
                    ``(A) shall include a list of each category of food 
                for which a manufacturer is required to notify the 
                Secretary in accordance with subsection (a); and
                    ``(B) may--
                            ``(i) designate foods not otherwise defined 
                        as an essential source of nutrition, giving 
                        special consideration to foods--
                                    ``(I) upon which individuals with 
                                certain diseases or conditions may be 
                                particularly reliant; or
                                    ``(II) that are administered under 
                                medical supervision;
                            ``(ii) designate additional categories of 
                        foods for which the Secretary determines 
                        notification described in subsection (a) is 
                        appropriate during a public health emergency 
                        declared under section 319 of the Public Health 
                        Service Act; and
                            ``(iii) prescribe additional conditions on 
                        the timing and manner of such notifications as 
                        are reasonable and appropriate during such a 
                        public health emergency.
    ``(g) Order.--During a public health emergency declared under 
section 319 of the Public Health Service Act, the Secretary may order 
any manufacturer of an essential source of nutrition to provide 
notification required by this section. Such order may--
            ``(1) impose additional conditions on the timing and manner 
        of notification as are reasonable and appropriate in light of 
        the circumstances of the public health emergency; and
            ``(2) designate additional categories of food for which the 
        Secretary determines notification is appropriate during the 
        public health emergency.
    ``(h) Risk Management Plans.--Each manufacturer of an essential 
source of nutrition shall develop, maintain, and, as appropriate, 
implement a redundancy risk management plan that identifies and 
evaluates risks to the supply of the food, as applicable, for each 
establishment in which such food is manufactured. A risk management 
plan under this subsection--
            ``(1) may identify and evaluate risks to the supply of more 
        than one food, or food category, manufactured at the same 
        establishment; and
            ``(2) shall be subject to inspection and copying by the 
        Secretary pursuant to section 704 or at the request of the 
        Secretary.
    ``(i) Definitions.--In this section:
            ``(1) Essential source of nutrition.--The term `essential 
        source of nutrition' means--
                    ``(A) an infant formula;
                    ``(B) a food that--
                            ``(i) meets the definition of `medical 
                        food' in section 5(b) of the Orphan Drug Act; 
                        and
                            ``(ii) is intended for use by individuals 
                        with--
                                    ``(I) certain inborn errors of 
                                metabolism; or
                                    ``(II) other conditions requiring a 
                                medical food, as determined by the 
                                Secretary in guidance issued under 
                                subsection (f); or
                    ``(C) a food so designated pursuant to subsection 
                (f).
            ``(2) Meaningful disruption.--The term `meaningful 
        disruption'--
                    ``(A) means a change in production that is 
                reasonably likely to lead to a reduction in the supply 
                of an essential source of nutrition by a manufacturer 
                that is more than negligible and affects the ability of 
                the manufacturer to fulfill contractual obligations or 
                meet expected demand for its product; and
                    ``(B) does not include interruptions in 
                manufacturing due to matters such as routine 
                maintenance or insignificant changes in manufacturing 
                so long as the manufacturer expects to resume 
                operations in a short period of time.''.
    (b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following new subsection:
    ``(fff) The failure to provide information as required under 
section 412A after receipt of a letter from the Secretary under 
subsection (e) of such section.''.

SEC. 3. REMOTE RECORDS ASSESSMENT FOR ESSENTIAL SOURCES OF NUTRITION.

    (a) Factory Inspection.--Section 704(a)(4)(A) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is amended in the first 
sentence by inserting ``or the manufacturing, processing, packing, or 
holding of an essential source of nutrition (as defined in section 
412A)'' after ``processing of a drug''.
    (b) Regulations.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services (referred to in 
this section as the ``Secretary'') shall promulgate regulations 
describing circumstances in which the Secretary may issue requests for 
records or other information in advance of, or in lieu of, an 
inspection pursuant to section 704(a)(4)(A) of the Federal Food, Drug, 
and Cosmetic Act, as amended by subsection (a), processes for 
responding to such requests electronically or in physical form, and 
factors the Secretary may consider in evaluating whether such records 
are provided within a reasonable timeframe, within reasonable limits, 
and in a reasonable manner, accounting for resource and other 
limitations that may exist, including for small businesses.
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