Babies Need More Formula Now Act of 2022
This bill addresses the regulation of infant formula, including by authorizing the Food and Drug Administration (FDA) to waive certain requirements related to importation.
The FDA may waive labeling requirements related to the importation (or distribution or sale) of infant formula from a country with requirements that provide a similar assurance of safety as U.S. requirements.
The FDA must, when appropriate, enter into arrangements to harmonize U.S. regulatory requirements pertaining to infant formula with the requirements of other nations.
The bill imposes time lines for the FDA to respond to submissions for market approval for new infant formula.
The FDA must also issue guidance as to what types of changes in the ingredients of infant formula, if any, may not require a new growth study to meet FDA requirements.
The bill also authorizes a person to import, without prior notice to the FDA, up to a three-month supply of infant formula for personal use from a country with formula safety standards similar to U.S. standards, such as Canada.
Before recommending or requiring a recall of infant formula due exclusively to a labeling deficiency, the FDA must ensure that the recall will not negatively affect the supply of formula in the United States.
The bill also requires the FDA to (1) notify Congress no later than 24 hours after initiating a formula recall, and (2) provide certain information to formula manufacturers about restarting production after an inspection of a manufacturing facility impacted by a recall.
To amend the Federal Food, Drug, and Cosmetic Act with respect to 
   improving the infant formula supply chain, 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 ``Babies Need More Formula Now Act of 
2022''.

SEC. 2. DEFINITION.

    In this Act, 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).

SEC. 3. IMPORTATION OF INFANT FORMULA.

    (a) Waiver of Labeling Requirements for Imports.--Section 412 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is amended by 
adding at the end the following:
    ``(j) Waiver of Labeling Requirements for Imports.--
            ``(1) In general.--The Secretary may waive any labeling 
        requirement under this Act applicable to--
                    ``(A) the importation of infant formula from any 
                country that is determined by the Secretary to be 
                implementing and enforcing requirements for infant 
                formula that provide a similar assurance of safety as 
                the regulatory requirements of this Act; or
                    ``(B) the distribution and sale of such imported 
                infant formula.
            ``(2) Rule of construction.--Nothing in paragraph (1) shall 
        be construed to limit the authority of the Secretary to require 
        a recall of, or otherwise impose restrictions and requirements 
        under this Act with respect to, infant formula that is subject 
        to a waiver under paragraph (1).''.
    (b) Harmonization.--The Secretary of Health and Human Services 
shall, when appropriate, enter into arrangements with other nations for 
the purpose of harmonizing the regulatory requirements of the United 
States for infant formula, including with respect to inspections, 
nutritional requirements, and common international labeling, with the 
corresponding regulatory requirements of such other nations.
    (c) Support for the Office of the United States Trade 
Representative.--Section 803(c)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 383(c)(2)) is amended by striking ``foods'' and 
inserting ``foods (including infant formula)''.
    (d) Study.--The Secretary of Health and Human Services shall enter 
into an arrangement with the National Academy of Medicine (or, if the 
National Academy declines to enter into such arrangement, another 
appropriate entity) under which the National Academy (or other 
appropriate entity) agrees to--
            (1) conduct a study comparing infant formula in the United 
        States and infant formula in the European Union, including with 
        respect to nutritional content and applicable labeling and 
        other regulatory requirements; and
            (2) not later than 1 year after the date of enactment of 
        this Act, complete such study and submit a report on the 
        results of such study to the Committee on Energy and Commerce 
        of the House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate.

SEC. 4. TRANSPARENCY TO SUPPORT INFANT FORMULA INNOVATION.

    (a) Annual Report to Congress.--Section 412 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by section 3(a) of 
this Act, is further amended by adding at the end the following:
    ``(k) Annual Report to Congress.--Not later than March 30 of each 
year, the Secretary shall submit a report to the Congress containing, 
with respect to the preceding calendar year, the following information:
            ``(1) The number of submissions received by the Secretary 
        under subsection (d).
            ``(2) For each such submission--
                    ``(A) the amount of time taken by the Secretary to 
                respond;
                    ``(B) the number of times the Secretary requested 
                additional information from the person making such 
                submission; and
                    ``(C) whether such submission included any new 
                ingredients that were not included in any infant 
                formula already on the market.
            ``(3) The number of inspections conducted by the Food and 
        Drug Administration or any agent thereof to evaluate compliance 
        with subsection (b)(2).
            ``(4) The time between any inspection referred to in 
        paragraph (3) and any necessary reinspection to evaluate 
        compliance with subsection (b)(2).''.
    (b) Marketing Submissions.--Section 412 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350a), as amended by subsection (a), is 
further amended by adding at the end the following:
    ``(l) Marketing Submissions.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall respond to a submission under subsection (d) for infant 
        formula not later than 90 days after receiving such 
        notification.
            ``(2) Expedited response.--The Secretary shall respond to a 
        submission under subsection (d) for infant formula not later 
        than 75 days after receiving such notification if it--
                    ``(A) is submitted by a manufacturer that is not 
                already marketing infant formula in the United States; 
                or
                    ``(B) is for infant formula containing one or more 
                ingredients that are not contained in infant formula 
                that is already being marketed in the United States.
            ``(3) Notification to congress.--Whenever the Secretary 
        fails to respond to a submission under subsection (d) by the 
        deadline applicable under paragraph (1) or (2), the Secretary 
        shall give notice of such failure to the Congress, including an 
        explanation of the reasons for failing to meet the deadline.''.
    (c) Technical Correction.--Section 412(c)(1)(B) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)(1)(B)) is amended by 
striking ``subsection (c)(1)'' and inserting ``subsection (d)(1)''.

SEC. 5. REDUCING BARRIERS TO INFANT FORMULA COMPETITION.

    Not later than 180 days after the date of enactment of this Act, 
the Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall issue guidance on which types of 
changes, if any, in the ingredients of infant formula may not require a 
new growth study to meet the requirements of section 412 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350a).

SEC. 6. COORDINATION OF EFFORTS TO MITIGATE SHORTAGES OF INFANT 
              FORMULA.

    The Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall require appropriate staff of the 
Office of Nutrition and Food Labeling, and the Office of Compliance, of 
the Center for Food Safety and Applied Nutrition, to meet at least 
biweekly to discuss, with respect to infant formula, pending 
inspections, the findings of pending and concluded inspections, and any 
need for additional inspections.

SEC. 7. IMPORTATION FOR PERSONAL USE.

    (a) In General.--During the period of 90 days following the date of 
enactment of this Act, a person may, without prior notice to the Food 
and Drug Administration, import up to a three-month supply of infant 
formula for personal use from Canada, the European Union, or any 
country that is determined by the Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, to have 
safety standards for infant formula similar to such standards 
applicable under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.).
    (b) Limitations.--Infant formula may be imported pursuant to 
subsection (a) only if the infant formula--
            (1) is exclusively for personal use and will not be 
        commercialized or promoted; and
            (2) does not present an unreasonable risk to human health.
    (c) Reporting of Adverse Events.--If a health care provider becomes 
aware of any adverse event which the health care provider reasonably 
suspects to be associated with infant formula imported pursuant to 
subsection (a), the health care provider shall report such adverse 
event to the Food and Drug Administration.
    (d) Public Notice.--The Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall post on the 
public website of the Food and Drug Administration notice that--
            (1) infant formula imported pursuant to subsection (a) may 
        not have been manufactured in a facility that has been 
        inspected by the Food and Drug Administration;
            (2) the labeling of such infant formula may not meet the 
        standards and other requirements applicable with respect to 
        infant formula under the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 301 et seq.); and
            (3) the nutritional content of the infant formula may vary 
        from that of infant formula meeting such standards and other 
        requirements.
    (e) Sense of Congress.--It is the sense of Congress that persons 
considering the personal importation of infant formula should consult 
with their pediatrician about such importation.

SEC. 8. CONSIDERATION OF SUPPLY EFFECTS PRIOR TO RECOMMENDING OR 
              REQUIRING A RECALL.

    (a) In General.--Section 412(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350a(f)(2)) is amended by adding at the end the 
following:
    ``(4) Before recommending or requiring any recall of infant formula 
due exclusively to labeling deficiencies, the Secretary shall ensure 
that the supply of infant formula in the United States will not be 
negatively affected by such recall.''.
    (b) Regulations.--Not later than 3 months after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall issue or 
update such regulations as may be necessary to implement paragraph (4) 
of section 412(f) of the Federal Food, Drug, and Cosmetic Act, as added 
by subsection (a).

SEC. 9. CONGRESSIONAL NOTIFICATION.

    (a) In General.--Not later than 24 hours after the initiation of a 
recall of infant formula, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall submit to the 
Congress a notification of such recall.
    (b) Contents.--A notification under subsection (a) shall include 
the following:
            (1) If the recall is required by the Food and Drug 
        Administration, a summary of the determination of a case of 
        adulterated or misbranded infant formula that presents a risk 
        to human health.
            (2) If the recall is voluntarily initiated by the 
        manufacturer, a summary of the information provided to the Food 
        and Drug Administration by the manufacturer regarding infant 
        formula that has left the control of the manufacturer that may 
        be adulterated or misbranded.
            (3) Specification of when the Food and Drug Administration 
        was first made aware of the instance or circumstances 
        surrounding the recall.
            (4) An initial estimate of the disruption in domestic 
        production that may result from the recall.

SEC. 10. REPORT TO CONGRESS.

    (a) In General.--Not later than 14 days after the initiation of a 
recall of infant formula, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall submit a 
report to the Congress regarding such recall.
    (b) Contents.--A report under subsection (a) shall include the 
following:
            (1) A plan (including an estimated timeline) of actions the 
        Food and Drug Administration and the manufacturer will take--
                    (A) to identify and address any cause of 
                adulteration or misbranding; and
                    (B) to restore operation of the impacted facilities 
                to meet production levels in place prior to the recall.
            (2) The current domestic supply of infant formula, 
        including--
                    (A) a breakdown of the specific types of formula 
                involved; and
                    (B) an estimate of how long current supplies will 
                last.
            (3) In the case that a recall and subsequent actions to 
        respond to the recall impact over 10 percent of the domestic 
        production of infant formula, a plan to backfill supplies if 
        the current domestic supply of infant formula has or is 
        expected to fall below the level demanded during the disruption 
        in domestic production, which plan shall include--
                    (A) actions to work with the impacted manufacturer 
                or other manufacturers to increase production; and
                    (B) specification of--
                            (i) any additional authorities needed 
                        regarding production or importation to fill a 
                        supply gap; and
                            (ii) any supplemental funding necessary to 
                        address the shortage.

SEC. 11. COORDINATION WITH MANUFACTURER ON RESTORING PRODUCTION.

    (a) In General.--Upon completing an inspection of an infant formula 
manufacturing facility impacted by a recall, the Secretary of Health 
and Human Services, acting through the Commissioner of Food and Drugs, 
shall provide the manufacturer involved a list of any actions 
necessary--
            (1) to address deficiencies contributing to the potential 
        adulteration or misbranding of product at the facility; and
            (2) to safely restart production at the facility.
    (b) Response to Manufacturer.--Not later than 7 days after 
receiving a written communication from a manufacturer of infant formula 
regarding safely restoring production following a recall of such 
product, the Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall provide a substantive response to 
such communication, including any necessary next steps.
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Babies Need More Formula Now Act of 2022
To amend the Federal Food, Drug, and Cosmetic Act with respect to improving the infant formula supply chain, and for other purposes.
Babies Need More Formula Now Act of 2022
Rep. Stefanik, Elise M.