109TH CONGRESS

2D SESSION S. 3546

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Dietary Supplement

5 and Nonprescription Drug Consumer Protection Act’’.
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1 SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NON2 PRESCRIPTION DRUGS.

3 (a) IN GENERAL.—Chapter VII of the Federal Food,

4 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend5 ed by adding at the end the following:

6 ‘‘Subchapter H—Serious Adverse Event

7 Reports

8 ‘‘SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR NON9 PRESCRIPTION DRUGS.

10 ‘‘(a) DEFINITIONS.—In this section:

11 ‘‘(1) ADVERSE EVENT.—The term ‘adverse

12 event’ means any health-related event associated

13 with the use of a nonprescription drug that is ad14 verse, including—

15 ‘‘(A) an event occurring from an overdose

16 of the drug, whether accidental or intentional;

17 ‘‘(B) an event occurring from abuse of the

18 drug;

19 ‘‘(C) an event occurring from withdrawal

20 from the drug; and

21 ‘‘(D) any failure of expected pharma22 cological action of the drug.

23 ‘‘(2) NONPRESCRIPTION DRUG.—The term

24 ‘nonprescription drug’ means a drug that is—

25 ‘‘(A) not subject to section 503(b); and
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1 ‘‘(B) not subject to approval in an applica2 tion submitted under section 505.

3 ‘‘(3) SERIOUS ADVERSE EVENT.—The term ‘se4 rious adverse event’ is an adverse event that—

5 ‘‘(A) results in—

6 ‘‘(i) death;

7 ‘‘(ii) a life-threatening experience;

8 ‘‘(iii) inpatient hospitalization;

9 ‘‘(iv) a persistent or significant dis10 ability or incapacity; or

11 ‘‘(v) a congenital anomaly or birth de12 fect; or

13 ‘‘(B) requires, based on reasonable medical

14 judgment, a medical or surgical intervention to

15 prevent an outcome described under subpara16 graph (A).

17 ‘‘(4) SERIOUS ADVERSE EVENT REPORT.—The

18 term ‘serious adverse event report’ means a report

19 that is required to be submitted to the Secretary

20 under subsection (b).

21 ‘‘(b) REPORTING REQUIREMENT.—

22 ‘‘(1) IN GENERAL.—The manufacturer, packer,

23 or distributor whose name (pursuant to section

24 502(b)(1)) appears on the label of a nonprescription

25 drug marketed in the United States (referred to in
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1 this section as the ‘responsible person’) shall submit

2 to the Secretary any report received of a serious ad3 verse event associated with such drug when used in

4 the United States, accompanied by a copy of the

5 label on or within the retail package of such drug.

6 ‘‘(2) RETAILER.—A retailer whose name ap7 pears on the label described in paragraph (1) as a

8 distributor may, by agreement, authorize the manu9 facturer or packer of the nonprescription drug to

10 submit the required reports for such drugs to the

11 Secretary so long as the retailer directs to the manu12 facturer or packer all adverse events associated with

13 such drug that are reported to the retailer through

14 the address or telephone number described in section

15 502(x).

16 ‘‘(c) SUBMISSION OF REPORTS.—

17 ‘‘(1) TIMING OF REPORTS.—The responsible

18 person shall submit to the Secretary a serious ad19 verse event report no later than 15 business days

20 after the report is received through the address or

21 phone number described in section 502(x).

22 ‘‘(2) NEW MEDICAL INFORMATION.—The re23 sponsible person shall submit to the Secretary any

24 new medical information, related to a submitted seri25 ous adverse event report that is received by the re-
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1 sponsible person within 1 year of the initial report,

2 no later than 15 business days after the new infor3 mation is received by the responsible person.

4 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec5 retary shall develop systems to ensure that duplicate

6 reports of, and new medical information related to,

7 a serious adverse event shall be consolidated into a

8 single report.

9 ‘‘(4) EXEMPTION.—The Secretary, after pro10 viding notice and an opportunity for comment from

11 interested parties, may establish an exemption to the

12 requirements under paragraphs (1) and (2) if the

13 Secretary determines that such exemption would

14 have no adverse effect on public health.

15 ‘‘(d) CONTENTS OF REPORTS.—Each serious adverse

16 event report under this section shall be submitted to the

17 Secretary using the MedWatch form, which may be modi18 fied by the Secretary for nonprescription drugs, and may

19 be accompanied by additional information.

20 ‘‘(e) MAINTENANCE AND INSPECTION OF

21 RECORDS.—

22 ‘‘(1) MAINTENANCE.—The responsible person

23 shall maintain records related to each report of an

24 adverse event received by the responsible person for

25 a period of 6 years.
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1 ‘‘(2) RECORDS INSPECTION.—

2 ‘‘(A) IN GENERAL.—The responsible per3 son shall permit an authorized person to have

4 access to records required to be maintained

5 under this section, during an inspection pursu6 ant to section 704.

7 ‘‘(B) AUTHORIZED PERSON.—For pur8 poses of this paragraph, the term ‘authorized

9 person’ means an officer or employee of the De10 partment of Health and Human Services who

11 has—

12 ‘‘(i) appropriate credentials, as deter13 mined by the Secretary; and

14 ‘‘(ii) been duly designated by the Sec15 retary to have access to the records re16 quired under this section.

17 ‘‘(f) PROTECTED INFORMATION.—A serious adverse

18 event report submitted to the Secretary under this section,

19 including any new medical information submitted under

20 subsection (c)(2), or an adverse event report voluntarily

21 submitted to the Secretary shall be considered to be—

22 ‘‘(1) a safety report under section 756 and may

23 be accompanied by a statement, which shall be a

24 part of any report that is released for public disclo25 sure, that denies that the report or the records con-
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1 stitute an admission that the product involved

2 caused or contributed to the adverse event; and

3 ‘‘(2) a record about an individual under section

4 552a of title 5, United States Code (commonly re5 ferred to as the ‘Privacy Act of 1974’) and a med6 ical or similar file the disclosure of which would con7 stitute a violation of section 552 of such title 5

8 (commonly referred to as the ‘Freedom of Informa9 tion Act’), and shall not be publicly disclosed unless

10 all personally identifiable information is redacted.

11 ‘‘(g) RULE OF CONSTRUCTION.—The submission of

12 any adverse event report in compliance with this section

13 shall not be construed as an admission that the non14 prescription drug involved caused or contributed to the ad15 verse event.

16 ‘‘(h) PREEMPTION.—

17 ‘‘(1) IN GENERAL.—No State or local govern18 ment shall establish or continue in effect any law,

19 regulation, order, or other requirement, related to a

20 mandatory system for adverse event reports for non21 prescription drugs, that is different from, in addition

22 to, or otherwise not identical to, this section.

23 ‘‘(2) EFFECT OF SECTION.—

24 ‘‘(A) IN GENERAL.—Nothing in this sec25 tion shall affect the authority of the Secretary
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1 to provide adverse event reports and informa2 tion to any health, food, or drug officer or em3 ployee of any State, territory, or political sub4 division of a State or territory, under a memo5 randum of understanding between the Secretary

6 and such State, territory, or political subdivi7 sion.

8 ‘‘(B) PERSONALLY-IDENTIFIABLE INFOR9 MATION.—Notwithstanding any other provision

10 of law, personally-identifiable information in ad11 verse event reports provided by the Secretary to

12 any health, food, or drug officer or employee of

13 any State, territory, or political subdivision of a

14 State or territory, shall not—

15 ‘‘(i) be made publicly available pursu16 ant to any State or other law requiring dis17 closure of information or records; or

18 ‘‘(ii) otherwise be disclosed or distrib19 uted to any party without the written con20 sent of the Secretary and the person sub21 mitting such information to the Secretary.

22 ‘‘(C) USE OF SAFETY REPORTS.—Nothing

23 in this section shall permit a State, territory, or

24 political subdivision of a State or territory, to

25 use any safety report received from the Sec-
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1 retary in a manner inconsistent with subsection

2 (g) or section 756.

3 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There

4 are authorized to be appropriated to carry out this section

5 such sums as may be necessary.’’.

6 (b) MODIFICATIONS.—The Secretary of Health and

7 Human Services may modify requirements under the

8 amendments made by this section in accordance with sec9 tion 553 of title 5, United States Code, to maintain con10 sistency with international harmonization efforts over

11 time.

12 (c) PROHIBITED ACT.—Section 301(e) of the Federal

13 Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) is

14 amended by—

15 (1) striking ‘‘, or 704(a);’’ and inserting ‘‘,

16 704(a), or 760;’’; and

17 (2) striking ‘‘, or 564’’ and inserting ‘‘, 564, or

18 760’’.

19 (d) MISBRANDING.—Section 502 of the Federal

20 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend21 ed by adding at the end the following:

22 ‘‘(x) If it is a nonprescription drug (as defined in sec

23 tion 760) that is marketed in the United States, unless

24 the label of such drug includes a domestic address or do25 mestic phone number through which the responsible per-
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1 son (as described in section 760) may receive a report of

2 a serious adverse event (as defined in section 760) with

3 such drug.’’.

4 (e) EFFECTIVE DATES.—

5 (1) IN GENERAL.—Except as provided in para6 graph (2), the amendments made by this section

7 shall take effect 1 year after the date of enactment

8 of this Act.

9 (2) MISBRANDING.—Section 502(x) of the Fed10 eral Food, Drug, and Cosmetic Act (as added by

11 this section) shall apply to any nonprescription drug

12 (as defined in such section 502(x)) labeled on or

13 after the date that is 1 year after the date of enact14 ment of this Act.

15 (3) GUIDANCE.—Not later than 270 days after

16 the date of enactment of this Act, the Secretary of

17 Health and Human Services shall issue guidance on

18 the minimum data elements that should be included

19 in a serious adverse event report described under the

20 amendments made by this Act.

21 SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIE22 TARY SUPPLEMENTS.

23 (a) IN GENERAL.—Chapter VII of the Federal Food,

24 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend25 ed by adding at the end the following:
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1 ‘‘SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIE2 TARY SUPPLEMENTS.

3 ‘‘(a) DEFINITIONS.—In this section:

4 ‘‘(1) ADVERSE EVENT.—The term ‘adverse

5 event’ means any health-related event associated

6 with the use of a dietary supplement that is adverse.

7 ‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘se8 rious adverse event’ is an adverse event that—

9 ‘‘(A) results in—

10 ‘‘(i) death;

11 ‘‘(ii) a life-threatening experience;

12 ‘‘(iii) inpatient hospitalization;

13 ‘‘(iv) a persistent or significant dis14 ability or incapacity; or

15 ‘‘(v) a congenital anomaly or birth de16 fect; or

17 ‘‘(B) requires, based on reasonable medical

18 judgment, a medical or surgical intervention to

19 prevent an outcome described under subpara20 graph (A).

21 ‘‘(3) SERIOUS ADVERSE EVENT REPORT.—The

22 term ‘serious adverse event report’ means a report

23 that is required to be submitted to the Secretary

24 under subsection (b).

25 ‘‘(b) REPORTING REQUIREMENT.—
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1 ‘‘(1) IN GENERAL.—The manufacturer, packer,

2 or distributor of a dietary supplement whose name

3 (pursuant to section 403(e)(1)) appears on the label

4 of a dietary supplement marketed in the United

5 States (referred to in this section as the ‘responsible

6 person’) shall submit to the Secretary any report re7 ceived of a serious adverse event associated with

8 such dietary supplement when used in the United

9 States, accompanied by a copy of the label on or

10 within the retail packaging of such dietary supple11 ment.

12 ‘‘(2) RETAILER.—A retailer whose name ap13 pears on the label described in paragraph (1) as a

14 distributor may, by agreement, authorize the manu15 facturer or packer of the dietary supplement to sub16 mit the required reports for such dietary supple17 ments to the Secretary so long as the retailer directs

18 to the manufacturer or packer all adverse events as19 sociated with such dietary supplement that are re20 ported to the retailer through the address or tele21 phone number described in section 403(y).

22 ‘‘(c) SUBMISSION OF REPORTS.—

23 ‘‘(1) TIMING OF REPORTS.—The responsible

24 person shall submit to the Secretary a serious ad25 verse event report no later than 15 business days
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1 after the report is received through the address or

2 phone number described in section 403(y).

3 ‘‘(2) NEW MEDICAL INFORMATION.—The re4 sponsible person shall submit to the Secretary any

5 new medical information, related to a submitted seri6 ous adverse event report that is received by the re7 sponsible person within 1 year of the initial report,

8 no later than 15 business days after the new infor9 mation is received by the responsible person.

10 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec11 retary shall develop systems to ensure that duplicate

12 reports of, and new medical information related to,

13 a serious adverse event shall be consolidated into a

14 single report.

15 ‘‘(4) EXEMPTION.—The Secretary, after pro16 viding notice and an opportunity for comment from

17 interested parties, may establish an exemption to the

18 requirements under paragraphs (1) and (2) if the

19 Secretary determines that such exemption would

20 have no adverse effect on public health.

21 ‘‘(d) CONTENTS OF REPORTS.—Each serious adverse

22 event report under this section shall be submitted to the

23 Secretary using the MedWatch form, which may be modi24 fied by the Secretary for dietary supplements, and may

25 be accompanied by additional information.
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1 ‘‘(e) MAINTENANCE AND INSPECTION OF

2 RECORDS.—

3 ‘‘(1) MAINTENANCE.—The responsible person

4 shall maintain records related to each report of an

5 adverse event received by the responsible person for

6 a period of 6 years.

7 ‘‘(2) RECORDS INSPECTION.—

8 ‘‘(A) IN GENERAL.—The responsible per9 son shall permit an authorized person to have

10 access to records required to be maintained

11 under this section during an inspection pursu12 ant to section 704.

13 ‘‘(B) AUTHORIZED PERSON.—For pur14 poses of this paragraph, the term ‘authorized

15 person’ means an officer or employee of the De16 partment of Health and Human Services, who

17 has—

18 ‘‘(i) appropriate credentials, as deter19 mined by the Secretary; and

20 ‘‘(ii) been duly designated by the Sec21 retary to have access to the records re22 quired under this section.

23 ‘‘(f) PROTECTED INFORMATION.—A serious adverse

24 event report submitted to the Secretary under this section,

25 including any new medical information submitted under
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1 subsection (c)(2), or an adverse event report voluntarily

2 submitted to the Secretary shall be considered to be—

3 ‘‘(1) a safety report under section 756 and may

4 be accompanied by a statement, which shall be a

5 part of any report that is released for public disclo6 sure, that denies that the report or the records con7 stitute an admission that the product involved

8 caused or contributed to the adverse event; and

9 ‘‘(2) a record about an individual under section

10 552a of title 5, United States Code (commonly re11 ferred to as the ‘Privacy Act of 1974’) and a med12 ical or similar file the disclosure of which would con13 stitute a violation of section 552 of such title 5

14 (commonly referred to as the ‘Freedom of Informa15 tion Act’), and shall not be publicly disclosed unless

16 all personally identifiable information is redacted.

17 ‘‘(g) RULE OF CONSTRUCTION.—The submission of

18 any adverse event report in compliance with this section

19 shall not be construed as an admission that the dietary

20 supplement involved caused or contributed to the adverse

21 event.

22 ‘‘(h) PREEMPTION.—

23 ‘‘(1) IN GENERAL.—No State or local govern24 ment shall establish or continue in effect any law,

25 regulation, order, or other requirement, related to a
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1 mandatory system for adverse event reports for die2 tary supplements, that is different from, in addition

3 to, or otherwise not identical to, this section.

4 ‘‘(2) EFFECT OF SECTION.—

5 ‘‘(A) IN GENERAL.—Nothing in this sec6 tion shall affect the authority of the Secretary

7 to provide adverse event reports and informa8 tion to any health, food, or drug officer or em9 ployee of any State, territory, or political sub10 division of a State or territory, under a memo11 randum of understanding between the Secretary

12 and such State, territory, or political subdivi13 sion.

14 ‘‘(B) PERSONALLY-IDENTIFIABLE INFOR15 MATION.—Notwithstanding any other provision

16 of law, personally-identifiable information in ad17 verse event reports provided by the Secretary to

18 any health, food, or drug officer or employee of

19 any State, territory, or political subdivision of a

20 State or territory, shall not—

21 ‘‘(i) be made publicly available pursu22 ant to any State or other law requiring dis23 closure of information or records; or

24 ‘‘(ii) otherwise be disclosed or distrib25 uted to any party without the written con-
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1 sent of the Secretary and the person sub2 mitting such information to the Secretary.

3 ‘‘(C) USE OF SAFETY REPORTS.—Nothing

4 in this section shall permit a State, territory, or

5 political subdivision of a State or territory, to

6 use any safety report received from the Sec7 retary in a manner inconsistent with subsection

8 (g) or section 756.

9 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There

10 are authorized to be appropriated to carry out this section

11 such sums as may be necessary.’’.

12 (b) PROHIBITED ACT.—Section 301(e) of the Federal

13 Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) is

14 amended by—

15 (1) striking ‘‘, or 760;’’ and inserting ‘‘, 760,

16 or 761;’’; and

17 (2) striking ‘‘, or 760’’ and inserting ‘‘, 760, or

18 761’’.

19 (c) MISBRANDING.—Section 403 of the Federal

20 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend21 ed by adding at the end the following:

22 ‘‘(y) If it is a dietary supplement that is marketed

23 in the United States, unless the label of such dietary sup

24 plement includes a domestic address or domestic phone

25 number through which the responsible person (as de-
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1 scribed in section 761) may receive a report of a serious

2 adverse event with such dietary supplement.’’.

3 (d) EFFECTIVE DATE.—

4 (1) IN GENERAL.—Except as provided in para5 graph (2), the amendments made by this section

6 shall take effect 1 year after the date of enactment

7 of this Act.

8 (2) MISBRANDING.—Section 403(y) of the Fed9 eral Food, Drug, and Cosmetic Act (as added by

10 this section) shall apply to any dietary supplement

11 labeled on or after the date that is 1 year after the

12 date of enactment of this Act.

13 (3) GUIDANCE.—Not later than 270 days after

14 the date of enactment of this Act, the Secretary of

15 Health and Human Services shall issue guidance on

16 the minimum data elements that should be included

17 in a serious adverse event report as described under

18 the amendments made by this Act.

19 SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS.

20 (a) IN GENERAL.—Section 301 of the Federal Food,

21 Drug, and Cosmetic Act (21 U.S.C. 331) is amended by

22 adding at the end the following:

23 ‘‘(ii) The falsification of a report of a serious adver

24 event submitted to a responsible person (as defined under

25 section 760 or 761) or the falsification of a serious adver
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1 event report (as defined under section 760 or 761) sub2 mitted to the Secretary.’’.

3 (b) EFFECTIVE DATE.—The amendment made by

4 this section shall take effect 1 year after the date of ena

5 ment of this Act.

6 SEC. 5. IMPORTATION OF CERTAIN NONPRESCRIPTION

7 DRUGS AND DIETARY SUPPLEMENTS.

8 (a) IN GENERAL.—Section 801 of the Federal Food,

9 Drug, and Cosmetic Act (21 U.S.C. 381) is amended—

10 (1) in subsection (a), by inserting after the

11 third sentence the following: ‘‘If such article is sub

12 ject to a requirement under section 760 or 761 and

13 if the Secretary has credible evidence or information

14 indicating that the responsible person (as defined in

15 such section 760 or 761) has not complied with a re16 quirement of such section 760 or 761 with respect

17 to any such article, or has not allowed access to

18 records described in such section 760 or 761, then

19 such article shall be refused admission, except as

20 provided in subsection (b) of this section.’’; and

21 (2) in the second sentence of subsection (b)—

22 (A) by inserting ‘‘(1)’’ before ‘‘an article

23 included’’;

24 (B) by inserting before ‘‘final determina25 tion’’ the following: ‘‘or (2) with respect to an
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1 article included within the provision of the

2 fourth sentence of subsection (a), the respon3 sible person (as defined in section 760 or 761)

4 can take action that would assure that the re5 sponsible person is in compliance with section

6 760 or 761, as the case may be,’’; and

7 (C) by inserting ‘‘, or, with respect to

8 clause (2), the responsible person,’’ before ‘‘to

9 perform’’.

10 (b) EFFECTIVE DATE.—The amendments made by

11 this section shall take effect 1 year after the date of ena

12 ment of this Act.

Passed the Senate December 6, 2006.

Attest:

Secretary.
109TH CONGRESS

2D SESSION S. 3546

AN ACT

To amend the Federal Food, Drug, and Cosmetic

drugs, and for other purposes.ing for dietary supplements and nonprescriptionAct with respect to serious adverse event report-