SEC. 6. COORDINATION OF EFFORTS TO MITIGATE SHORT-
AGES OF INFANT FORMULA. 
The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall re-
quire 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 bi-
weekly to discuss, with respect to infant formula, pending 
inspections, the findings of pending and concluded inspec-
tions, and any need for additional inspections. 
SEC. 7. IMPORTATION FOR PERSONAL USE. 
(a) IN GENERAL.—During the period of 90 days fol-
lowing 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 for-
mula similar to such standards applicable under the Fed-
eral 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 
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(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 associ-
ated 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 sub-
section (a) may not have been manufactured in a fa-
cility 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 applica-
ble 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. 
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(e) SENSE OF CONGRESS.—It is the sense of Con-
gress 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 Commis-
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sioner 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 determina-
tion 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 pro-
vided to the Food and Drug Administration by the 
manufacturer regarding infant formula that has left 
the control of the manufacturer that may be adulter-
ated 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 do-
mestic 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 Commis-
sioner of Food and Drugs, shall submit a report to the 
Congress regarding such recall. 
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(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 for-
mula, including— 
(A) a breakdown of the specific types of 
formula involved; and 
(B) an estimate of how long current sup-
plies will last. 
(3) In the case that a recall and subsequent ac-
tions 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— 
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