[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7830 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 7830
To amend the Federal Food, Drug, and Cosmetic Act with respect to
improving the infant formula supply chain, and for other purposes.
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IN THE HOUSE OF REPRESENTATIVES
May 18, 2022
Ms. Stefanik (for herself, Mrs. Rodgers of Washington, Mrs. Hinson, and
Mrs. Bice of Oklahoma) introduced the following bill; which was
referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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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