II 

109TH CONGRESS 

2D SESSION S. 3546 

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 SENATE OF THE UNITED STATES 

JUNE 21, 2006 

Mr. HATCH (for himself, Mr. DURBIN, Mr. HARKIN, Mr. ENZI, and Mr. KENNEDY) introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

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. 

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.—The manufac22 turer, packer, or distributor whose name (pursuant to sec23 tion 502(b)(1)) appears on the label of a nonprescription 

24 drug marketed in the United States (referred to in this 

25 section as the ‘responsible person’) shall submit to the 


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1 Secretary any report received of a serious adverse event 

2 associated with such drug when used in the United States, 

3 accompanied by a copy of the label on or within the retail 

4 package of such drug. 

5 ‘‘(c) SUBMISSION OF REPORTS.— 

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

7 person shall submit to the Secretary a serious ad8 verse event report no later than 15 business days 

9 after the report is received through the address or 

10 phone number described in section 502(x). 

11 ‘‘(2) NEW MEDICAL INFORMATION.—The re12 sponsible person shall submit to the Secretary any 

13 new medical information, related to a submitted seri14 ous adverse event report that is received by the re15 sponsible person within 1 year of the initial report, 

16 no later than 15 business days after the new infor17 mation is received by the responsible person. 

18 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec19 retary shall develop systems to ensure that duplicate 

20 reports of, and new medical information related to, 

21 a serious adverse event shall be consolidated into a 

22 single report. 

23 ‘‘(4) EXEMPTION.—The Secretary, after pro24 viding notice and an opportunity for comment from 

25 interested parties, may establish an exemption to the 


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

2 Secretary determines that such exemption would 

3 have no adverse effect on public health. 

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

5 event report under this section shall be submitted to the 

6 Secretary using the MedWatch form, which may be modi7 fied by the Secretary for nonprescription drugs, and may 

8 be accompanied by additional information. 

9 ‘‘(e) MAINTENANCE AND INSPECTION OF

10 RECORDS.— 

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

12 shall maintain records related to each report of an 

13 adverse event received by the responsible person for 

14 a period of 6 years. 

15 ‘‘(2) RECORDS INSPECTION.— 

16 ‘‘(A) IN GENERAL.—The responsible per17 son shall permit an authorized person to have 

18 access to records required to be maintained 

19 under this section, during an inspection pursu20 ant to section 704. 

21 ‘‘(B) AUTHORIZED PERSON.—For pur22 poses of this paragraph, the term ‘authorized 

23 person’ means an officer or employee of the De24 partment of Health and Human Services who 

25 has— 


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1 ‘‘(i) appropriate credentials, as deter2 mined by the Secretary; and 

3 ‘‘(ii) been duly designated by the Sec4 retary to have access to the records re5 quired under this section. 

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

7 event report submitted to the Secretary under this section, 

8 including any new medical information submitted under 

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

10 submitted to the Secretary shall be considered to be— 

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

12 be accompanied by a statement, which shall be a 

13 part of any report that is released for public disclo14 sure, that denies that the report or the records con15 stitute an admission that the product involved 

16 caused or contributed to the adverse event; and 

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

18 552a of title 5, United States Code (commonly re19 ferred to as the ‘Privacy Act of 1974’) and a med20 ical or similar file the disclosure of which would con21 stitute a violation of section 552 of such title 5 

22 (commonly referred to as the ‘Freedom of Informa23 tion Act’), and shall not be publicly disclosed unless 

24 all personally identifiable information is redacted. 


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

2 any adverse event report in compliance with this section 

3 shall not be construed as an admission that the non4 prescription drug involved caused or contributed to the ad5 verse event. 

6 ‘‘(h) PREEMPTION.— 

7 ‘‘(1) IN GENERAL.—No State or local govern8 ment shall establish or continue in effect any law, 

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

10 mandatory system for adverse event reports for non11 prescription drugs, that is different from, in addition 

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

13 ‘‘(2) EFFECT OF SECTION.— 

14 ‘‘(A) IN GENERAL.—Nothing in this sec15 tion shall affect the authority of the Secretary 

16 to provide adverse event reports and informa17 tion to any health, food, or drug officer or em18 ployee of any State, territory, or political sub19 division of a State or territory, under a memo20 randum of understanding between the Secretary 

21 and such State, territory, or political subdivi22 sion. 

23 ‘‘(B) PERSONALLY-IDENTIFIABLE INFOR24 MATION.—Notwithstanding any other provision 

25 of law, personally-identifiable information in adVerDate Aug 31 2005 22:35 Jun 22, 2006 Jkt 049196 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3546.IS S3546

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1 verse event reports provided by the Secretary to 

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

3 any State, territory, or political subdivision of a 

4 State or territory, shall not— 

5 ‘‘(i) be made publicly available pursu6 ant to any State or other law requiring dis7 closure of information or records; or 

8 ‘‘(ii) otherwise be disclosed or distrib9 uted to any party without the written con10 sent of the Secretary and the person sub11 mitting such information to the Secretary. 

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

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

14 political subdivision of a State or territory, to 

15 use any safety report received from the Sec16 retary in a manner inconsistent with subsection 

17 (g) or section 756. 

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

19 are authorized to be appropriated to carry out this section 

20 such sums as may be necessary.’’. 

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

22 Human Services may modify requirements under the 

23 amendments made by this section in accordance with sec24 tion 553 of title 5, United States Code, to maintain conVerDate Aug 31 2005 22:35 Jun 22, 2006 Jkt 049196 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3546.IS S3546

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1 sistency with international harmonization efforts over 

2 time. 

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

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

5 amended by— 

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

7 704(a), or 760;’’; and 

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

9 760’’. 

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

11 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend12 ed by adding at the end the following: 

13 ‘‘(x) If it is a nonprescription drug (as defined in sec14 tion 760) that is marketed in the United States, unless 

15 the label of such drug includes an address or phone num16 ber through which the responsible person (as described in 

17 section 760) may receive a report of a serious adverse 

18 event (as defined in section 760) with such drug.’’. 

19 (e) EFFECTIVE DATES.— 

20 (1) IN GENERAL.—Except as provided in para21 graph (2), the amendments made by this section 

22 shall take effect 1 year after the date of enactment 

23 of this Act. 

24 (2) MISBRANDING.—Section 502(x) of the Fed25 eral Food, Drug, and Cosmetic Act (as added by 


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1 this section) shall apply to any nonprescription drug 

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

3 after the date that is 1 year after the date of enact4 ment of this Act. 

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

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

7 Health and Human Services shall issue guidance on 

8 the minimum data elements that should be included 

9 in a serious adverse event report described under the 

10 amendments made by this Act. 

11 SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIE12 TARY SUPPLEMENTS. 

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

14 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend15 ed by adding at the end the following: 

16 ‘‘SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIE17 TARY SUPPLEMENTS. 

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

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

20 event’ means any health-related event associated 

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

22 ‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘se23 rious adverse event’ is an adverse event that— 

24 ‘‘(A) results in— 

25 ‘‘(i) death; 


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

2 ‘‘(iii) inpatient hospitalization; 

3 ‘‘(iv) a persistent or significant dis4 ability or incapacity; or 

5 ‘‘(v) a congenital anomaly or birth de6 fect; or 

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

8 judgment, a medical or surgical intervention to 

9 prevent an outcome described under subpara10 graph (A). 

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

12 term ‘serious adverse event report’ means a report 

13 that is required to be submitted to the Secretary 

14 under subsection (b). 

15 ‘‘(b) REPORTING REQUIREMENT.— 

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

17 or distributor of a dietary supplement whose name 

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

19 of a dietary supplement marketed in the United 

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

21 person’) shall submit to the Secretary any report re22 ceived of a serious adverse event associated with 

23 such dietary supplement when used in the United 

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


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1 within the retail packaging of such dietary supple2 ment. 

3 ‘‘(2) RETAILER.—A retailer whose name ap4 pears on the label described in paragraph (1) as a 

5 distributor may, by agreement, authorize the manu6 facturer or packer of the dietary supplement to sub7 mit the required reports for such dietary supple8 ments to the Secretary so long as the retailer directs 

9 to the manufacturer or packer all adverse events as10 sociated with such dietary supplement that are re11 ported to the retailer through the address or tele12 phone number described in section 403(y). 

13 ‘‘(c) SUBMISSION OF REPORTS.— 

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

15 person shall submit to the Secretary a serious ad16 verse event report no later than 15 business days 

17 after the report is received through the address or 

18 phone number described in section 403(y). 

19 ‘‘(2) NEW MEDICAL INFORMATION.—The re20 sponsible person shall submit to the Secretary any 

21 new medical information, related to a submitted seri22 ous adverse event report that is received by the re23 sponsible person within 1 year of the initial report, 

24 no later than 15 business days after the new infor25 mation is received by the responsible person. 


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1 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec2 retary shall develop systems to ensure that duplicate 

3 reports of, and new medical information related to, 

4 a serious adverse event shall be consolidated into a 

5 single report. 

6 ‘‘(4) EXEMPTION.—The Secretary, after pro7 viding notice and an opportunity for comment from 

8 interested parties, may establish an exemption to the 

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

10 Secretary determines that such exemption would 

11 have no adverse effect on public health. 

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

13 event report under this section shall be submitted to the 

14 Secretary using the MedWatch form, which may be modi15 fied by the Secretary for dietary supplements, and may 

16 be accompanied by additional information. 

17 ‘‘(e) MAINTENANCE AND INSPECTION OF

18 RECORDS.— 

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

20 shall maintain records related to each report of an 

21 adverse event received by the responsible person for 

22 a period of 6 years. 

23 ‘‘(2) RECORDS INSPECTION.— 

24 ‘‘(A) IN GENERAL.—The responsible per25 son shall permit an authorized person to have 


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1 access to records required to be maintained 

2 under this section during an inspection pursu3 ant to section 704. 

4 ‘‘(B) AUTHORIZED PERSON.—For pur5 poses of this paragraph, the term ‘authorized 

6 person’ means an officer or employee of the De7 partment of Health and Human Services, who 

8 has— 

9 ‘‘(i) appropriate credentials, as deter10 mined by the Secretary; and 

11 ‘‘(ii) been duly designated by the Sec12 retary to have access to the records re13 quired under this section. 

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

15 event report submitted to the Secretary under this section, 

16 including any new medical information submitted under 

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

18 submitted to the Secretary shall be considered to be— 

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

20 be accompanied by a statement, which shall be a 

21 part of any report that is released for public disclo22 sure, that denies that the report or the records con23 stitute an admission that the product involved 

24 caused or contributed to the adverse event; and 


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

2 552a of title 5, United States Code (commonly re3 ferred to as the ‘Privacy Act of 1974’) and a med4 ical or similar file the disclosure of which would con5 stitute a violation of section 552 of such title 5 

6 (commonly referred to as the ‘Freedom of Informa7 tion Act’), and shall not be publicly disclosed unless 

8 all personally identifiable information is redacted. 

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

10 any adverse event report in compliance with this section 

11 shall not be construed as an admission that the dietary 

12 supplement involved caused or contributed to the adverse 

13 event. 

14 ‘‘(h) PREEMPTION.— 

15 ‘‘(1) IN GENERAL.—No State or local govern16 ment shall establish or continue in effect any law, 

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

18 mandatory system for adverse event reports for die19 tary supplements, that is different from, in addition 

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

21 ‘‘(2) EFFECT OF SECTION.— 

22 ‘‘(A) IN GENERAL.—Nothing in this sec23 tion shall affect the authority of the Secretary 

24 to provide adverse event reports and informa25 tion to any health, food, or drug officer or emVerDate Aug 31 2005 22:35 Jun 22, 2006 Jkt 049196 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S3546.IS S3546

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1 ployee of any State, territory, or political sub2 division of a State or territory, under a memo3 randum of understanding between the Secretary 

4 and such State, territory, or political subdivi5 sion. 

6 ‘‘(B) PERSONALLY-IDENTIFIABLE INFOR7 MATION.—Notwithstanding any other provision 

8 of law, personally-identifiable information in ad9 verse event reports provided by the Secretary to 

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

11 any State, territory, or political subdivision of a 

12 State or territory, shall not— 

13 ‘‘(i) be made publicly available pursu14 ant to any State or other law requiring dis15 closure of information or records; or 

16 ‘‘(ii) otherwise be disclosed or distrib17 uted to any party without the written con18 sent of the Secretary and the person sub19 mitting such information to the Secretary. 

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

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

22 political subdivision of a State or territory, to 

23 use any safety report received from the Sec24 retary in a manner inconsistent with subsection 

25 (g) or section 756. 


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

2 are authorized to be appropriated to carry out this section 

3 such sums as may be necessary.’’. 

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

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

6 amended by— 

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

8 or 761;’’; and 

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

10 761’’. 

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

12 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend13 ed by adding at the end the following: 

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

15 in the United States, unless the label of such dietary sup16 plement includes an address or phone number through 

17 which the responsible person (as described in section 761) 

18 may receive a report of a serious adverse event with such 

19 dietary supplement.’’. 

20 (d) EFFECTIVE DATE.— 

21 (1) IN GENERAL.—Except as provided in para22 graph (2), the amendments made by this section 

23 shall take effect 1 year after the date of enactment 

24 of this Act. 


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1 (2) MISBRANDING.—Section 403(y) of the Fed2 eral Food, Drug, and Cosmetic Act (as added by 

3 this section) shall apply to any dietary supplement 

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

5 date of enactment of this Act. 

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

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

8 Health and Human Services shall issue guidance on 

9 the minimum data elements that should be included 

10 in a serious adverse event report as described under 

11 the amendments made by this Act. 

12 SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS. 

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

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

15 adding at the end the following: 

16 ‘‘(ii) The falsification of a report of a serious adverse 

17 event submitted to a responsible person (as defined under 

18 section 760 or 761) or the falsification of a serious adverse 

19 event report (as defined under section 760 or 761) sub20 mitted to the Secretary.’’. 

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

22 this section shall take effect 1 year after the date of enact23 ment of this Act. 

Æ 


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