I 
109TH CONGRESS 
2D SESSION 
H. R. 6168 
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. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 25, 2006 
Mr. CANNON 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 serious adverse event reporting for dietary 
supplements and nonprescription drugs, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Dietary Supplement 
and Nonprescription Drug Consumer Protection Act’’. 
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SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NON-
PRESCRIPTION DRUGS. 
(a) IN GENERAL.—Chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend-
ed by adding at the end the following: 
‘‘Subchapter H—Serious Adverse Event 
Reports 
‘‘SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR NON-
PRESCRIPTION DRUGS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ADVERSE
EVENT.—The term ‘adverse 
event’ means any health-related event associated 
with the use of a nonprescription drug that is ad-
verse, 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 pharma-
cological action of the drug. 
‘‘(2) 
NONPRESCRIPTION
DRUG.—The 
term 
‘nonprescription drug’ means a drug that is— 
‘‘(A) not subject to section 503(b); and 
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‘‘(B) not subject to approval in an applica-
tion submitted under section 505. 
‘‘(3) SERIOUS ADVERSE EVENT.—The term ‘se-
rious 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 dis-
ability or incapacity; or 
‘‘(v) a congenital anomaly or birth de-
fect; or 
‘‘(B) requires, based on reasonable medical 
judgment, a medical or surgical intervention to 
prevent an outcome described under subpara-
graph (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 
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this section as the ‘responsible person’) shall submit 
to the Secretary any report received of a serious ad-
verse 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 ap-
pears on the label described in paragraph (1) as a 
distributor may, by agreement, authorize the manu-
facturer or packer of the nonprescription drug to 
submit the required reports for such drugs to the 
Secretary so long as the retailer directs to the manu-
facturer 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 ad-
verse 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 re-
sponsible person shall submit to the Secretary any 
new medical information, related to a submitted seri-
ous adverse event report that is received by the re-
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sponsible person within 1 year of the initial report, 
no later than 15 business days after the new infor-
mation is received by the responsible person. 
‘‘(3) CONSOLIDATION OF REPORTS.—The Sec-
retary 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 pro-
viding notice and an opportunity for comment from 
interested parties, may establish 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 modi-
fied by the Secretary for nonprescription drugs, and may 
be accompanied by additional information. 
‘‘(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. 
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‘‘(2) RECORDS INSPECTION.— 
‘‘(A) IN GENERAL.—The responsible per-
son shall permit an authorized person to have 
access to records required to be maintained 
under this section, during an inspection pursu-
ant to section 704. 
‘‘(B) AUTHORIZED
PERSON.—For pur-
poses of this paragraph, the term ‘authorized 
person’ means an officer or employee of the De-
partment of Health and Human Services who 
has— 
‘‘(i) appropriate credentials, as deter-
mined by the Secretary; and 
‘‘(ii) been duly designated by the Sec-
retary to have access to the records re-
quired 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 accompanied by a statement, which shall be a 
part of any report that is released for public disclo-
sure, that denies that the report or the records con-
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stitute 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 re-
ferred to as the ‘Privacy Act of 1974’) and a med-
ical or similar file the disclosure of which would con-
stitute a violation of section 552 of such title 5 
(commonly referred to as the ‘Freedom of Informa-
tion Act’), and shall not be publicly disclosed unless 
all personally identifiable 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 non-
prescription drug involved caused or contributed to the ad-
verse event. 
‘‘(h) PREEMPTION.— 
‘‘(1) IN GENERAL.—No State or local govern-
ment shall establish or continue in effect any law, 
regulation, order, or other requirement, related to a 
mandatory system for adverse event reports for non-
prescription 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 sec-
tion shall affect the authority of the Secretary 
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to provide adverse event reports and informa-
tion to any health, food, or drug officer or em-
ployee of any State, territory, or political sub-
division of a State or territory, under a memo-
randum of understanding between the Secretary 
and such State, territory, or political subdivi-
sion. 
‘‘(B) PERSONALLY-IDENTIFIABLE
INFOR-
MATION.—Notwithstanding any other provision 
of law, personally-identifiable information in ad-
verse 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 pursu-
ant to any State or other law requiring dis-
closure of information or records; or 
‘‘(ii) otherwise be disclosed or distrib-
uted to any party without the written con-
sent of the Secretary and the person sub-
mitting 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 Sec-
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retary 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 Services may modify requirements under the 
amendments made by this section in accordance with sec-
tion 553 of title 5, United States Code, to maintain con-
sistency 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 amend-
ed by adding at the end the following: 
‘‘(x) If it is a nonprescription drug (as defined in sec-
tion 760) that is marketed in the United States, unless 
the label of such drug includes a domestic address or do-
mestic phone number through which the responsible per-
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son (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 para-
graph (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 Fed-
eral 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 enact-
ment 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 DIE-
TARY SUPPLEMENTS. 
(a) IN GENERAL.—Chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend-
ed by adding at the end the following: 
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‘‘SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIE-
TARY 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 supplement that is adverse. 
‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘se-
rious 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 dis-
ability or incapacity; or 
‘‘(v) a congenital anomaly or birth de-
fect; or 
‘‘(B) requires, based on reasonable medical 
judgment, a medical or surgical intervention to 
prevent an outcome described under subpara-
graph (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.— 
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‘‘(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 marketed in the United 
States (referred to in this section as the ‘responsible 
person’) shall submit to the Secretary any report re-
ceived 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 supple-
ment. 
‘‘(2) RETAILER.—A retailer whose name ap-
pears on the label described in paragraph (1) as a 
distributor may, by agreement, authorize the manu-
facturer or packer of the dietary supplement to sub-
mit the required reports for such dietary supple-
ments to the Secretary so long as the retailer directs 
to the manufacturer or packer all adverse events as-
sociated with such dietary supplement that are re-
ported to the retailer through the address or tele-
phone number described in section 403(y). 
‘‘(c) SUBMISSION OF REPORTS.— 
‘‘(1) TIMING
OF
REPORTS.—The responsible 
person shall submit to the Secretary a serious ad-
verse event report no later than 15 business days 
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after the report is received through the address or 
phone number described in section 403(y). 
‘‘(2) NEW
MEDICAL
INFORMATION.—The re-
sponsible person shall submit to the Secretary any 
new medical information, related to a submitted seri-
ous adverse event report that is received by the re-
sponsible person within 1 year of the initial report, 
no later than 15 business days after the new infor-
mation is received by the responsible person. 
‘‘(3) CONSOLIDATION OF REPORTS.—The Sec-
retary 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 pro-
viding notice and an opportunity for comment from 
interested parties, may establish 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 modi-
fied by the Secretary for dietary supplements, and may 
be accompanied by additional information. 
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‘‘(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 per-
son shall permit an authorized person to have 
access to records required to be maintained 
under this section during an inspection pursu-
ant to section 704. 
‘‘(B) AUTHORIZED
PERSON.—For pur-
poses of this paragraph, the term ‘authorized 
person’ means an officer or employee of the De-
partment of Health and Human Services, who 
has— 
‘‘(i) appropriate credentials, as deter-
mined by the Secretary; and 
‘‘(ii) been duly designated by the Sec-
retary to have access to the records re-
quired 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 
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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 accompanied by a statement, which shall be a 
part of any report that is released for public disclo-
sure, that denies that the report or the records con-
stitute 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 re-
ferred to as the ‘Privacy Act of 1974’) and a med-
ical or similar file the disclosure of which would con-
stitute a violation of section 552 of such title 5 
(commonly referred to as the ‘Freedom of Informa-
tion Act’), and shall not be publicly disclosed unless 
all personally identifiable 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 govern-
ment shall establish or continue in effect any law, 
regulation, order, or other requirement, related to a 
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mandatory system for adverse event reports for die-
tary supplements, that is different from, in addition 
to, or otherwise not identical to, this section. 
‘‘(2) EFFECT OF SECTION.— 
‘‘(A) IN GENERAL.—Nothing in this sec-
tion shall affect the authority of the Secretary 
to provide adverse event reports and informa-
tion to any health, food, or drug officer or em-
ployee of any State, territory, or political sub-
division of a State or territory, under a memo-
randum of understanding between the Secretary 
and such State, territory, or political subdivi-
sion. 
‘‘(B) PERSONALLY-IDENTIFIABLE
INFOR-
MATION.—Notwithstanding any other provision 
of law, personally-identifiable information in ad-
verse 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 pursu-
ant to any State or other law requiring dis-
closure of information or records; or 
‘‘(ii) otherwise be disclosed or distrib-
uted to any party without the written con-
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sent of the Secretary and the person sub-
mitting 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 Sec-
retary 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 amend-
ed 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 sup-
plement includes a domestic address or domestic phone 
number through which the responsible person (as de-
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scribed 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 para-
graph (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 Fed-
eral 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 
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event report (as defined under section 760 or 761) sub-
mitted to the Secretary.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall take effect 1 year after the date of enact-
ment 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 sub-
ject to a requirement under 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 re-
quirement 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 determina-
tion’’ the following: ‘‘or (2) with respect to an 
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article included within the provision of the 
fourth sentence of subsection (a), the respon-
sible person (as defined in section 760 or 761) 
can take action that would assure that the re-
sponsible 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 enact-
ment of this Act. 
Æ 
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