SEC. 3. IMPORTATION OF INFANT FORMULA. 
(a) WAIVER OF LABELING REQUIREMENTS FOR IM-
PORTS.—Section 412 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350a) is amended by adding at the 
end the following: 
‘‘(j) WAIVER OF LABELING REQUIREMENTS FOR IM-
PORTS.— 
‘‘(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 re-
quirements for infant formula that provide a 
similar assurance of safety as the regulatory re-
quirements of this Act; or 
‘‘(B) the distribution and sale of such im-
ported infant formula. 
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in 
paragraph (1) shall be construed to limit the author-
ity of the Secretary to require a recall of, or other-
wise 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 ar-
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rangements with other nations for the purpose of harmo-
nizing the regulatory requirements of the United States 
for infant formula, including with respect to inspections, 
nutritional requirements, and common international label-
ing, 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 de-
clines to enter into such arrangement, another appropriate 
entity) under which the National Academy (or other ap-
propriate entity) agrees to— 
(1) conduct a study comparing infant formula 
in the United States and infant formula in the Eu-
ropean 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 en-
actment of this Act, complete such study and submit 
a report on the results of such study to the Com-
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mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate. 
SEC. 4. TRANSPARENCY TO SUPPORT INFANT FORMULA IN-
NOVATION. 
(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 Sec-
retary to respond; 
‘‘(B) the number of times the Secretary re-
quested 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. 
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‘‘(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 add-
ing 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 re-
ceiving 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 
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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 para-
graph (1) or (2), the Secretary shall give notice of 
such failure to the Congress, including an expla-
nation of the reasons for failing to meet the dead-
line.’’. 
(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 COM-
PETITION. 
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). 
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