Dietary Supplement and Nonprescription Drug Consumer Protection Act
PL 109-462 (S.3546), enacted 12/22/2006

120 STAT. 3469
PUBLIC LAW 109–462—DEC. 22, 2006
Public Law 109–462
109th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to serious adverse
event reporting for dietary supplements and nonprescription drugs, 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 ‘‘Dietary Supplement and Non-
prescription Drug Consumer Protection Act’’.
SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIP-
TION DRUGS.
(a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at
the end the following:
‘‘Subchapter H—Serious Adverse Event Reports
‘‘SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIP-
TION DRUGS.
‘‘(a) DEFINITIONS.—In this section:
‘‘(1) ADVERSE EVENT.—The term ‘adverse event’ means any
health-related event associated with the use of a nonprescrip-
tion drug that is adverse, including—
‘‘(A) an event occurring from an overdose of the drug,
whether accidental or intentional;
‘‘(B) an event occurring from abuse of the drug;
‘‘(C) an event occurring from withdrawal from the drug;
and
‘‘(D) any failure of expected pharmacological action
of the drug.
‘‘(2) NONPRESCRIPTION DRUG.—The term ‘nonprescription
drug’ means a drug that is—
‘‘(A) not subject to section 503(b); and
‘‘(B) not subject to approval in an application submitted
under section 505.
‘‘(3) SERIOUS ADVERSE EVENT.—The term ‘serious adverse
event’ is an adverse event that—
‘‘(A) results in—
‘‘(i) death;
‘‘(ii) a life-threatening experience;
‘‘(iii) inpatient hospitalization;
‘‘(iv) a persistent or significant disability or inca-
pacity; or
21 USC 379aa.
21 USC 301 note.
Dietary
Supplement and
Nonprescription
Drug Consumer
Protection Act.
Dec. 22, 2006
[S. 3546]
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120 STAT. 3470
PUBLIC LAW 109–462—DEC. 22, 2006
‘‘(v) a congenital anomaly or birth defect; or
‘‘(B) requires, based on reasonable medical judgment,
a medical or surgical intervention to prevent an outcome
described under subparagraph (A).
‘‘(4) SERIOUS ADVERSE EVENT REPORT.—The term ‘serious
adverse event report’ means a report that is required to be
submitted to the Secretary under subsection (b).
‘‘(b) REPORTING REQUIREMENT.—
‘‘(1) IN GENERAL.—The manufacturer, packer, or distributor
whose name (pursuant to section 502(b)(1)) appears on the
label of a nonprescription drug marketed in the United States
(referred to in this section as the ‘responsible person’) shall
submit to the Secretary any report received of a serious adverse
event associated with such drug when used in the United
States, accompanied by a copy of the label on or within the
retail package of such drug.
‘‘(2) RETAILER.—A retailer whose name appears on the
label described in paragraph (1) as a distributor may, by agree-
ment, authorize the manufacturer or packer of the nonprescrip-
tion drug to submit the required reports for such drugs to
the Secretary so long as the retailer directs to the manufacturer
or packer all adverse events associated with such drug that
are reported to the retailer through the address or telephone
number described in section 502(x).
‘‘(c) SUBMISSION OF REPORTS.—
‘‘(1) TIMING
OF
REPORTS.—The responsible person shall
submit to the Secretary a serious adverse event report no
later than 15 business days after the report is received through
the address or phone number described in section 502(x).
‘‘(2) NEW MEDICAL INFORMATION.—The responsible person
shall submit to the Secretary any new medical information,
related to a submitted serious adverse event report that is
received by the responsible person within 1 year of the initial
report, no later than 15 business days after the new information
is received by the responsible person.
‘‘(3) CONSOLIDATION
OF
REPORTS.—The Secretary shall
develop systems to ensure that duplicate reports of, and new
medical information related to, a serious adverse event shall
be consolidated into a single report.
‘‘(4) EXEMPTION.—The Secretary, after providing notice and
an opportunity for comment from interested parties, may estab-
lish an exemption to the requirements under paragraphs (1)
and (2) if the Secretary determines that such exemption would
have no adverse effect on public health.
‘‘(d) CONTENTS OF REPORTS.—Each serious adverse event report
under this section shall be submitted to the Secretary using the
MedWatch form, which may be modified by the Secretary for non-
prescription drugs, and may be accompanied by additional informa-
tion.
‘‘(e) MAINTENANCE AND INSPECTION OF RECORDS.—
‘‘(1) MAINTENANCE.—The responsible person shall maintain
records related to each report of an adverse event received
by the responsible person for a period of 6 years.
‘‘(2) RECORDS INSPECTION.—
‘‘(A) IN GENERAL.—The responsible person shall permit
an authorized person to have access to records required
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120 STAT. 3471
PUBLIC LAW 109–462—DEC. 22, 2006
to be maintained under this section, during an inspection
pursuant to section 704.
‘‘(B) AUTHORIZED PERSON.—For purposes of this para-
graph, the term ‘authorized person’ means an officer or
employee of the Department of Health and Human Services
who has—
‘‘(i) appropriate credentials, as determined by the
Secretary; and
‘‘(ii) been duly designated by the Secretary to have
access to the records required under this section.
‘‘(f) PROTECTED INFORMATION.—A serious adverse event report
submitted to the Secretary under this section, including any new
medical information submitted under subsection (c)(2), or an
adverse event report voluntarily submitted to the Secretary shall
be considered to be—
‘‘(1) a safety report under section 756 and may be accom-
panied by a statement, which shall be a part of any report
that is released for public disclosure, that denies that the
report or the records constitute an admission that the product
involved caused or contributed to the adverse event; and
‘‘(2) a record about an individual under section 552a of
title 5, United States Code (commonly referred to as the ‘Privacy
Act of 1974’) and a medical or similar file the disclosure of
which would constitute a violation of section 552 of such title
5 (commonly referred to as the ‘Freedom of Information Act’),
and shall not be publicly disclosed unless all personally identifi-
able information is redacted.
‘‘(g) RULE OF CONSTRUCTION.—The submission of any adverse
event report in compliance with this section shall not be construed
as an admission that the nonprescription drug involved caused
or contributed to the adverse event.
‘‘(h) PREEMPTION.—
‘‘(1) IN GENERAL.—No State or local government shall estab-
lish or continue in effect any law, regulation, order, or other
requirement, related to a mandatory system for adverse event
reports for nonprescription drugs, that is different from, in
addition to, or otherwise not identical to, this section.
‘‘(2) EFFECT OF SECTION.—
‘‘(A) IN GENERAL.—Nothing in this section shall affect
the authority of the Secretary to provide adverse event
reports and information to any health, food, or drug officer
or employee of any State, territory, or political subdivision
of a State or territory, under a memorandum of under-
standing between the Secretary and such State, territory,
or political subdivision.
‘‘(B) 
PERSONALLY-IDENTIFIABLE
INFORMATION.—Not-
withstanding any other provision of law, personally-identifi-
able information in adverse event reports provided by the
Secretary to any health, food, or drug officer or employee
of any State, territory, or political subdivision of a State
or territory, shall not—
‘‘(i) be made publicly available pursuant to any
State or other law requiring disclosure of information
or records; or
‘‘(ii) otherwise be disclosed or distributed to any
party without the written consent of the Secretary
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120 STAT. 3472
PUBLIC LAW 109–462—DEC. 22, 2006
and the person submitting such information to the
Secretary.
‘‘(C) USE OF SAFETY REPORTS.—Nothing in this section
shall permit a State, territory, or political subdivision of
a State or territory, to use any safety report received from
the Secretary in a manner inconsistent with subsection
(g) or section 756.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section such sums as may
be necessary.’’.
(b) MODIFICATIONS.—The Secretary of Health and Human Serv-
ices may modify requirements under the amendments made by
this section in accordance with section 553 of title 5, United States
Code, to maintain consistency with international harmonization
efforts over time.
(c) PROHIBITED ACT.—Section 301(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331(e)) is amended by—
(1) striking ‘‘, or 704(a);’’ and inserting ‘‘, 704(a), or 760;’’;
and
(2) striking ‘‘, or 564’’ and inserting ‘‘, 564, or 760’’.
(d) MISBRANDING.—Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end
the following:
‘‘(x) If it is a nonprescription drug (as defined in section 760)
that is marketed in the United States, unless the label of such
drug includes a domestic address or domestic phone number through
which the responsible person (as described in section 760) may
receive a report of a serious adverse event (as defined in section
760) with such drug.’’.
(e) EFFECTIVE DATES.—
(1) IN GENERAL.—Except as provided in paragraph (2), the
amendments made by this section shall take effect 1 year
after the date of enactment of this Act.
(2) MISBRANDING.—Section 502(x) of the Federal Food,
Drug, and Cosmetic Act (as added by this section) shall apply
to any nonprescription drug (as defined in such section 502(x))
labeled on or after the date that is 1 year after the date
of enactment of this Act.
(3) GUIDANCE.—Not later than 270 days after the date
of enactment of this Act, the Secretary of Health and Human
Services shall issue guidance on the minimum data elements
that should be included in a serious adverse event report
described under the amendments made by this Act.
SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY SUPPLE-
MENTS.
(a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at
the end the following:
‘‘SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY
SUPPLEMENTS.
‘‘(a) DEFINITIONS.—In this section:
‘‘(1) ADVERSE EVENT.—The term ‘adverse event’ means any
health-related event associated with the use of a dietary supple-
ment that is adverse.
‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘serious adverse
event’ is an adverse event that—
21 USC 379aa–1.
21 USC 379aa
note.
21 USC 352 note.
21 USC 379aa
note.
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120 STAT. 3473
PUBLIC LAW 109–462—DEC. 22, 2006
‘‘(A) results in—
‘‘(i) death;
‘‘(ii) a life-threatening experience;
‘‘(iii) inpatient hospitalization;
‘‘(iv) a persistent or significant disability or inca-
pacity; or
‘‘(v) a congenital anomaly or birth defect; or
‘‘(B) requires, based on reasonable medical judgment,
a medical or surgical intervention to prevent an outcome
described under subparagraph (A).
‘‘(3) SERIOUS ADVERSE EVENT REPORT.—The term ‘serious
adverse event report’ means a report that is required to be
submitted to the Secretary under subsection (b).
‘‘(b) REPORTING REQUIREMENT.—
‘‘(1) IN GENERAL.—The manufacturer, packer, or distributor
of a dietary supplement whose name (pursuant to section
403(e)(1)) appears on the label of a dietary supplement mar-
keted in the United States (referred to in this section as the
‘responsible person’) shall submit to the Secretary any report
received of a serious adverse event associated with such dietary
supplement when used in the United States, accompanied by
a copy of the label on or within the retail packaging of such
dietary supplement.
‘‘(2) RETAILER.—A retailer whose name appears on the
label described in paragraph (1) as a distributor may, by agree-
ment, authorize the manufacturer or packer of the dietary
supplement to submit the required reports for such dietary
supplements to the Secretary so long as the retailer directs
to the manufacturer or packer all adverse events associated
with such dietary supplement that are reported to the retailer
through the address or telephone number described in section
403(y).
‘‘(c) SUBMISSION OF REPORTS.—
‘‘(1) TIMING
OF
REPORTS.—The responsible person shall
submit to the Secretary a serious adverse event report no
later than 15 business days after the report is received through
the address or phone number described in section 403(y).
‘‘(2) NEW MEDICAL INFORMATION.—The responsible person
shall submit to the Secretary any new medical information,
related to a submitted serious adverse event report that is
received by the responsible person within 1 year of the initial
report, no later than 15 business days after the new information
is received by the responsible person.
‘‘(3) CONSOLIDATION
OF
REPORTS.—The Secretary shall
develop systems to ensure that duplicate reports of, and new
medical information related to, a serious adverse event shall
be consolidated into a single report.
‘‘(4) EXEMPTION.—The Secretary, after providing notice and
an opportunity for comment from interested parties, may estab-
lish an exemption to the requirements under paragraphs (1)
and (2) if the Secretary determines that such exemption would
have no adverse effect on public health.
‘‘(d) CONTENTS OF REPORTS.—Each serious adverse event report
under this section shall be submitted to the Secretary using the
MedWatch form, which may be modified by the Secretary for dietary
supplements, and may be accompanied by additional information.
‘‘(e) MAINTENANCE AND INSPECTION OF RECORDS.—
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120 STAT. 3474
PUBLIC LAW 109–462—DEC. 22, 2006
‘‘(1) MAINTENANCE.—The responsible person shall maintain
records related to each report of an adverse event received
by the responsible person for a period of 6 years.
‘‘(2) RECORDS INSPECTION.—
‘‘(A) IN GENERAL.—The responsible person shall permit
an authorized person to have access to records required
to be maintained under this section during an inspection
pursuant to section 704.
‘‘(B) AUTHORIZED PERSON.—For purposes of this para-
graph, the term ‘authorized person’ means an officer or
employee of the Department of Health and Human Serv-
ices, who has—
‘‘(i) appropriate credentials, as determined by the
Secretary; and
‘‘(ii) been duly designated by the Secretary to have
access to the records required under this section.
‘‘(f) PROTECTED INFORMATION.—A serious adverse event report
submitted to the Secretary under this section, including any new
medical information submitted under subsection (c)(2), or an
adverse event report voluntarily submitted to the Secretary shall
be considered to be—
‘‘(1) a safety report under section 756 and may be accom-
panied by a statement, which shall be a part of any report
that is released for public disclosure, that denies that the
report or the records constitute an admission that the product
involved caused or contributed to the adverse event; and
‘‘(2) a record about an individual under section 552a of
title 5, United States Code (commonly referred to as the ‘Privacy
Act of 1974’) and a medical or similar file the disclosure of
which would constitute a violation of section 552 of such title
5 (commonly referred to as the ‘Freedom of Information Act’),
and shall not be publicly disclosed unless all personally identifi-
able information is redacted.
‘‘(g) RULE OF CONSTRUCTION.—The submission of any adverse
event report in compliance with this section shall not be construed
as an admission that the dietary supplement involved caused or
contributed to the adverse event.
‘‘(h) PREEMPTION.—
‘‘(1) IN GENERAL.—No State or local government shall estab-
lish or continue in effect any law, regulation, order, or other
requirement, related to a mandatory system for adverse event
reports for dietary supplements, that is different from, in addi-
tion to, or otherwise not identical to, this section.
‘‘(2) EFFECT OF SECTION.—
‘‘(A) IN GENERAL.—Nothing in this section shall affect
the authority of the Secretary to provide adverse event
reports and information to any health, food, or drug officer
or employee of any State, territory, or political subdivision
of a State or territory, under a memorandum of under-
standing between the Secretary and such State, territory,
or political subdivision.
‘‘(B) 
PERSONALLY-IDENTIFIABLE
INFORMATION.—Not-
withstanding any other provision of law, personally-identifi-
able information in adverse event reports provided by the
Secretary to any health, food, or drug officer or employee
of any State, territory, or political subdivision of a State
or territory, shall not—
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120 STAT. 3475
PUBLIC LAW 109–462—DEC. 22, 2006
‘‘(i) be made publicly available pursuant to any
State or other law requiring disclosure of information
or records; or
‘‘(ii) otherwise be disclosed or distributed to any
party without the written consent of the Secretary
and the person submitting such information to the
Secretary.
‘‘(C) USE OF SAFETY REPORTS.—Nothing in this section
shall permit a State, territory, or political subdivision of
a State or territory, to use any safety report received from
the Secretary in a manner inconsistent with subsection
(g) or section 756.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated to carry out this section such sums as may
be necessary.’’.
(b) PROHIBITED ACT.—Section 301(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331(e)) is amended by—
(1) striking ‘‘, or 760;’’ and inserting ‘‘, 760, or 761;’’; and
(2) striking ‘‘, or 760’’ and inserting ‘‘, 760, or 761’’.
(c) MISBRANDING.—Section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end
the following:
‘‘(y) If it is a dietary supplement that is marketed in the
United States, unless the label of such dietary supplement includes
a domestic address or domestic phone number through which the
responsible person (as described in section 761) may receive a
report of a serious adverse event with such dietary supplement.’’.
(d) EFFECTIVE DATE.—
(1) IN GENERAL.—Except as provided in paragraph (2), the
amendments made by this section shall take effect 1 year
after the date of enactment of this Act.
(2) MISBRANDING.—Section 403(y) of the Federal Food,
Drug, and Cosmetic Act (as added by this section) shall apply
to any dietary supplement labeled on or after the date that
is 1 year after the date of enactment of this Act.
(3) GUIDANCE.—Not later than 270 days after the date
of enactment of this Act, the Secretary of Health and Human
Services shall issue guidance on the minimum data elements
that should be included in a serious adverse event report as
described under the amendments made by this Act.
SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS.
(a) IN GENERAL.—Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end
the following:
‘‘(ii) The falsification of a report of a serious adverse event
submitted to a responsible person (as defined under section 760
or 761) or the falsification of a serious adverse event report (as
defined under section 760 or 761) submitted to the Secretary.’’.
(b) EFFECTIVE DATE.—The amendment made by this section
shall take effect 1 year after the date of enactment of this Act.
SEC. 5. IMPORTATION OF CERTAIN NONPRESCRIPTION DRUGS AND
DIETARY SUPPLEMENTS.
(a) IN GENERAL.—Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended—
(1) in subsection (a), by inserting after the third sentence
the following: ‘‘If such article is subject to a requirement under
21 USC 331 note.
21 USC 379aa
note.
21 USC 343 note.
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120 STAT. 3476
PUBLIC LAW 109–462—DEC. 22, 2006
LEGISLATIVE HISTORY—S. 3546:
SENATE REPORTS: No. 109–324 (Comm. on Health, Education, Labor, and Pen-
sions).
CONGRESSIONAL RECORD, Vol. 152 (2006):
Dec. 6, considered and passed Senate.
Dec. 8, considered and passed House.
section 760 or 761 and if the Secretary has credible evidence
or information indicating that the responsible person (as defined
in such section 760 or 761) has not complied with a requirement
of such section 760 or 761 with respect to any such article,
or has not allowed access to records described in such section
760 or 761, then such article shall be refused admission, except
as provided in subsection (b) of this section.’’; and
(2) in the second sentence of subsection (b)—
(A) by inserting ‘‘(1)’’ before ‘‘an article included’’;
(B) by inserting before ‘‘final determination’’ the fol-
lowing: ‘‘or (2) with respect to an article included within
the provision of the fourth sentence of subsection (a), the
responsible person (as defined in section 760 or 761) can
take action that would assure that the responsible person
is in compliance with section 760 or 761, as the case
may be,’’; and
(C) by inserting ‘‘, or, with respect to clause (2), the
responsible person,’’ before ‘‘to perform’’.
(b) EFFECTIVE DATE.—The amendments made by this section
shall take effect 1 year after the date of enactment of this Act.
Approved December 22, 2006.
21 USC 381 note.
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