S. 3546

One Hundred Ninth Congress

of the

United States of America

AT THE SECOND SESSION

Begun and held at the City of Washington on Tuesday,

the third day of January, two thousand and six

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 Nonprescription Drug Consumer Protection Act’’.

SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIPTION 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 NONPRESCRIPTION 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 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 incapacity; or
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‘‘(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 agreement, authorize the manufacturer 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 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 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 modified 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.

‘‘(2) RECORDS INSPECTION.—

‘‘(A) IN GENERAL.—The responsible person shall permit

an authorized person to have access to records required
S. 3546—3

to be maintained under this section, during an inspection

pursuant to section 704.

‘‘(B) AUTHORIZED PERSON.—For purposes of this paragraph, 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 accompanied 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 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 nonprescription drug involved caused

or contributed to the adverse event.

‘‘(h) PREEMPTION.—

‘‘(1) IN GENERAL.—No State or local government shall establish 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 understanding between the Secretary and such State, territory,

or political subdivision.

‘‘(B) PERSONALLY-IDENTIFIABLE INFORMATION.—Notwithstanding any other provision of law, personally-identifiable 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
S. 3546—4

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 Services 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 SUPPLEMENTS.

(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 supplement that is adverse. ‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘serious adverse

event’ is an adverse event that—
S. 3546—5

‘‘(A) results in— ‘‘(i) death;

‘‘(ii) a life-threatening experience;

‘‘(iii) inpatient hospitalization;

‘‘(iv) a persistent or significant disability or incapacity; 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 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 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 agreement, 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 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 modified by the Secretary for dietary

supplements, and may be accompanied by additional information.

‘‘(e) MAINTENANCE AND INSPECTION OF RECORDS.—
S. 3546—6

‘‘(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 paragraph, 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 accompanied 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 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 government shall establish 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 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 understanding between the Secretary and such State, territory,

or political subdivision.

‘‘(B) PERSONALLY-IDENTIFIABLE INFORMATION.—Notwithstanding any other provision of law, personally-identifiable 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—
S. 3546—7

‘‘(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
S. 3546—8

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 following: ‘‘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.

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.