II 

Calendar No. 586 

109TH CONGRESS 

2D SESSION S. 3546 

[Report No. 109–324] 

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, Mr. KENNEDY, and Mr. CORNYN) introduced the following bill; which was read 

twice and referred to the Committee on Health, Education, Labor, and 

Pensions 

SEPTEMBER 5, 2006 

Reported by Mr. ENZI, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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, 


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1 SECTION 1. SHORT TITLE. 

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

3 and Nonprescription Drug Consumer Protection Act’’. 

4 SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NON5 PRESCRIPTION DRUGS. 

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

7 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend8 ed by adding at the end the following: 

9 ‘‘Subchapter H—Serious Adverse Event 

10 Reports 

11 ‘‘SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR NON12 PRESCRIPTION DRUGS. 

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

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

15 event’ means any health-related event associated 

16 with the use of a nonprescription drug that is ad17 verse, including— 

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

19 of the drug, whether accidental or intentional; 

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

21 drug; 

22 ‘‘(C) an event occurring from withdrawal 

23 from the drug; and 

24 ‘‘(D) any failure of expected pharma25 cological action of the drug. 


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

2 ‘nonprescription drug’ means a drug that is— 

3 ‘‘(A) not subject to section 503(b); and 

4 ‘‘(B) not subject to approval in an applica5 tion submitted under section 505. 

6 ‘‘(3) SERIOUS ADVERSE EVENT.—The term ‘se7 rious adverse event’ is an adverse event that— 

8 ‘‘(A) results in— 

9 ‘‘(i) death; 

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

11 ‘‘(iii) inpatient hospitalization; 

12 ‘‘(iv) a persistent or significant dis13 ability or incapacity; or 

14 ‘‘(v) a congenital anomaly or birth de15 fect; or 

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

17 judgment, a medical or surgical intervention to 

18 prevent an outcome described under subpara19 graph (A). 

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

21 term ‘serious adverse event report’ means a report 

22 that is required to be submitted to the Secretary 

23 under subsection (b). 

24 ‘‘(b) REPORTING REQUIREMENT.—The manufac25 turer, packer, or distributor whose name (pursuant to secVerDate Aug 31 2005 00:39 Sep 06, 2006 Jkt 049196 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S3546.RS S3546

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

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

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

4 Secretary any report received of a serious adverse event 

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

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

7 package of such drug. 

8 ‘‘(c) SUBMISSION OF REPORTS.— 

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

10 person shall submit to the Secretary a serious ad11 verse event report no later than 15 business days 

12 after the report is received through the address or 

13 phone number described in section 502(x). 

14 ‘‘(2) NEW MEDICAL INFORMATION.—The re15 sponsible person shall submit to the Secretary any 

16 new medical information, related to a submitted seri17 ous adverse event report that is received by the re18 sponsible person within 1 year of the initial report, 

19 no later than 15 business days after the new infor20 mation is received by the responsible person. 

21 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec22 retary shall develop systems to ensure that duplicate 

23 reports of, and new medical information related to, 

24 a serious adverse event shall be consolidated into a 

25 single report. 


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1 ‘‘(4) EXEMPTION.—The Secretary, after pro2 viding notice and an opportunity for comment from 

3 interested parties, may establish an exemption to the 

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

5 Secretary determines that such exemption would 

6 have no adverse effect on public health. 

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

8 event report under this section shall be submitted to the 

9 Secretary using the MedWatch form, which may be modi10 fied by the Secretary for nonprescription drugs, and may 

11 be accompanied by additional information. 

12 ‘‘(e) MAINTENANCE AND INSPECTION OF

13 RECORDS.— 

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

15 shall maintain records related to each report of an 

16 adverse event received by the responsible person for 

17 a period of 6 years. 

18 ‘‘(2) RECORDS INSPECTION.— 

19 ‘‘(A) IN GENERAL.—The responsible per20 son shall permit an authorized person to have 

21 access to records required to be maintained 

22 under this section, during an inspection pursu23 ant to section 704. 

24 ‘‘(B) AUTHORIZED PERSON.—For pur25 poses of this paragraph, the term ‘authorized 


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1 person’ means an officer or employee of the De2 partment of Health and Human Services who 

3 has— 

4 ‘‘(i) appropriate credentials, as deter5 mined by the Secretary; and 

6 ‘‘(ii) been duly designated by the Sec7 retary to have access to the records re8 quired under this section. 

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

10 event report submitted to the Secretary under this section, 

11 including any new medical information submitted under 

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

13 submitted to the Secretary shall be considered to be— 

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

15 be accompanied by a statement, which shall be a 

16 part of any report that is released for public disclo17 sure, that denies that the report or the records con18 stitute an admission that the product involved 

19 caused or contributed to the adverse event; and 

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

21 552a of title 5, United States Code (commonly re22 ferred to as the ‘Privacy Act of 1974’) and a med23 ical or similar file the disclosure of which would con24 stitute a violation of section 552 of such title 5 

25 (commonly referred to as the ‘Freedom of InformaVerDate Aug 31 2005 00:39 Sep 06, 2006 Jkt 049196 PO 00000 Frm 00006 Fmt 6652 Sfmt 6401 E:\BILLS\S3546.RS S3546

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1 tion Act’), and shall not be publicly disclosed unless 

2 all personally identifiable information is redacted. 

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

4 any adverse event report in compliance with this section 

5 shall not be construed as an admission that the non6 prescription drug involved caused or contributed to the ad7 verse event. 

8 ‘‘(h) PREEMPTION.— 

9 ‘‘(1) IN GENERAL.—No State or local govern10 ment shall establish or continue in effect any law, 

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

12 mandatory system for adverse event reports for non13 prescription drugs, that is different from, in addition 

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

15 ‘‘(2) EFFECT OF SECTION.— 

16 ‘‘(A) IN GENERAL.—Nothing in this sec17 tion shall affect the authority of the Secretary 

18 to provide adverse event reports and informa19 tion to any health, food, or drug officer or em20 ployee of any State, territory, or political sub21 division of a State or territory, under a memo22 randum of understanding between the Secretary 

23 and such State, territory, or political subdivi24 sion. 


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1 ‘‘(B) PERSONALLY-IDENTIFIABLE INFOR2 MATION.—Notwithstanding any other provision 

3 of law, personally-identifiable information in ad4 verse event reports provided by the Secretary to 

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

6 any State, territory, or political subdivision of a 

7 State or territory, shall not— 

8 ‘‘(i) be made publicly available pursu9 ant to any State or other law requiring dis10 closure of information or records; or 

11 ‘‘(ii) otherwise be disclosed or distrib12 uted to any party without the written con13 sent of the Secretary and the person sub14 mitting such information to the Secretary. 

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

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

17 political subdivision of a State or territory, to 

18 use any safety report received from the Sec19 retary in a manner inconsistent with subsection 

20 (g) or section 756. 

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

22 are authorized to be appropriated to carry out this section 

23 such sums as may be necessary.’’. 

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

25 Human Services may modify requirements under the 


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1 amendments made by this section in accordance with sec2 tion 553 of title 5, United States Code, to maintain con3 sistency with international harmonization efforts over 

4 time. 

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

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

7 amended by— 

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

9 704(a), or 760;’’; and 

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

11 760’’. 

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

13 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend14 ed by adding at the end the following: 

15 ‘‘(x) If it is a nonprescription drug (as defined in sec16 tion 760) that is marketed in the United States, unless 

17 the label of such drug includes an address or phone num18 ber through which the responsible person (as described in 

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

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

21 (e) EFFECTIVE DATES.— 

22 (1) IN GENERAL.—Except as provided in para23 graph (2), the amendments made by this section 

24 shall take effect 1 year after the date of enactment 

25 of this Act. 


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1 (2) MISBRANDING.—Section 502(x) of the Fed2 eral Food, Drug, and Cosmetic Act (as added by 

3 this section) shall apply to any nonprescription drug 

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

5 after the date that is 1 year after the date of enact6 ment of this Act. 

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

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

9 Health and Human Services shall issue guidance on 

10 the minimum data elements that should be included 

11 in a serious adverse event report described under the 

12 amendments made by this Act. 

13 SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIE14 TARY SUPPLEMENTS. 

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

16 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend17 ed by adding at the end the following: 

18 ‘‘SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIE19 TARY SUPPLEMENTS. 

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

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

22 event’ means any health-related event associated 

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

24 ‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘se25 rious adverse event’ is an adverse event that— 


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1 ‘‘(A) results in— 

2 ‘‘(i) death; 

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

4 ‘‘(iii) inpatient hospitalization; 

5 ‘‘(iv) a persistent or significant dis6 ability or incapacity; or 

7 ‘‘(v) a congenital anomaly or birth de8 fect; or 

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

10 judgment, a medical or surgical intervention to 

11 prevent an outcome described under subpara12 graph (A). 

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

14 term ‘serious adverse event report’ means a report 

15 that is required to be submitted to the Secretary 

16 under subsection (b). 

17 ‘‘(b) REPORTING REQUIREMENT.— 

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

19 or distributor of a dietary supplement whose name 

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

21 of a dietary supplement marketed in the United 

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

23 person’) shall submit to the Secretary any report re24 ceived of a serious adverse event associated with 

25 such dietary supplement when used in the United 


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

2 within the retail packaging of such dietary supple3 ment. 

4 ‘‘(2) RETAILER.—A retailer whose name ap5 pears on the label described in paragraph (1) as a 

6 distributor may, by agreement, authorize the manu7 facturer or packer of the dietary supplement to sub8 mit the required reports for such dietary supple9 ments to the Secretary so long as the retailer directs 

10 to the manufacturer or packer all adverse events as11 sociated with such dietary supplement that are re12 ported to the retailer through the address or tele13 phone number described in section 403(y). 

14 ‘‘(c) SUBMISSION OF REPORTS.— 

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

16 person shall submit to the Secretary a serious ad17 verse event report no later than 15 business days 

18 after the report is received through the address or 

19 phone number described in section 403(y). 

20 ‘‘(2) NEW MEDICAL INFORMATION.—The re21 sponsible person shall submit to the Secretary any 

22 new medical information, related to a submitted seri23 ous adverse event report that is received by the re24 sponsible person within 1 year of the initial report, 


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1 no later than 15 business days after the new infor2 mation is received by the responsible person. 

3 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec4 retary shall develop systems to ensure that duplicate 

5 reports of, and new medical information related to, 

6 a serious adverse event shall be consolidated into a 

7 single report. 

8 ‘‘(4) EXEMPTION.—The Secretary, after pro9 viding notice and an opportunity for comment from 

10 interested parties, may establish an exemption to the 

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

12 Secretary determines that such exemption would 

13 have no adverse effect on public health. 

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

15 event report under this section shall be submitted to the 

16 Secretary using the MedWatch form, which may be modi17 fied by the Secretary for dietary supplements, and may 

18 be accompanied by additional information. 

19 ‘‘(e) MAINTENANCE AND INSPECTION OF

20 RECORDS.— 

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

22 shall maintain records related to each report of an 

23 adverse event received by the responsible person for 

24 a period of 6 years. 

25 ‘‘(2) RECORDS INSPECTION.— 


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1 ‘‘(A) IN GENERAL.—The responsible per2 son shall permit an authorized person to have 

3 access to records required to be maintained 

4 under this section during an inspection pursu5 ant to section 704. 

6 ‘‘(B) AUTHORIZED PERSON.—For pur7 poses of this paragraph, the term ‘authorized 

8 person’ means an officer or employee of the De9 partment of Health and Human Services, who 

10 has— 

11 ‘‘(i) appropriate credentials, as deter12 mined by the Secretary; and 

13 ‘‘(ii) been duly designated by the Sec14 retary to have access to the records re15 quired under this section. 

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

17 event report submitted to the Secretary under this section, 

18 including any new medical information submitted under 

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

20 submitted to the Secretary shall be considered to be— 

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

22 be accompanied by a statement, which shall be a 

23 part of any report that is released for public disclo24 sure, that denies that the report or the records conVerDate Aug 31 2005 00:39 Sep 06, 2006 Jkt 049196 PO 00000 Frm 00014 Fmt 6652 Sfmt 6401 E:\BILLS\S3546.RS S3546

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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 dietary 

14 supplement involved caused or contributed to the adverse 

15 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 die21 tary supplements, 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 SecVerDate Aug 31 2005 00:39 Sep 06, 2006 Jkt 049196 PO 00000 Frm 00016 Fmt 6652 Sfmt 6401 E:\BILLS\S3546.RS S3546

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

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

8 amended by— 

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

10 or 761;’’; and 

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

12 761’’. 

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

14 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend15 ed by adding at the end the following: 

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

17 in the United States, unless the label of such dietary sup18 plement includes an address or phone number through 

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

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

21 dietary supplement.’’. 

22 (d) EFFECTIVE DATE.— 

23 (1) IN GENERAL.—Except as provided in para24 graph (2), the amendments made by this section 


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1 shall take effect 1 year after the date of enactment 

2 of this Act. 

3 (2) MISBRANDING.—Section 403(y) of the Fed4 eral Food, Drug, and Cosmetic Act (as added by 

5 this section) shall apply to any dietary supplement 

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

7 date of enactment of this Act. 

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

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

10 Health and Human Services shall issue guidance on 

11 the minimum data elements that should be included 

12 in a serious adverse event report as described under 

13 the amendments made by this Act. 

14 SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS. 

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

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

17 adding at the end the following: 

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

19 event submitted to a responsible person (as defined under 

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

21 event report (as defined under section 760 or 761) sub22 mitted to the Secretary.’’. 

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

24 this section shall take effect 1 year after the date of enact25 ment of this Act. 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Dietary Supplement and 

3 Nonprescription Drug Consumer Protection Act’’. 

4 SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NON5 PRESCRIPTION DRUGS. 

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

7 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended 

8 by adding at the end the following: 

9 ‘‘Subchapter H—Serious Adverse Event 

10 Reports 

11 ‘‘SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR NON12 PRESCRIPTION DRUGS. 

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

14 ‘‘(1) ADVERSE EVENT.—The term ‘adverse event’ 

15 means any health-related event associated with the 

16 use of a nonprescription drug that is adverse, includ17 ing— 

18 ‘‘(A) an event occurring from an overdose of 

19 the drug, whether accidental or intentional; 

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

21 drug; 

22 ‘‘(C) an event occurring from withdrawal 

23 from the drug; and 

24 ‘‘(D) any failure of expected pharma25 cological action of the drug. 


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1 ‘‘(2) NONPRESCRIPTION DRUG.—The term ‘non2 prescription drug’ means a drug that is— 

3 ‘‘(A) not subject to section 503(b); and 

4 ‘‘(B) not subject to approval in an applica5 tion submitted under section 505. 

6 ‘‘(3) SERIOUS ADVERSE EVENT.—The term ‘seri7 ous adverse event’ is an adverse event that— 

8 ‘‘(A) results in— 

9 ‘‘(i) death; 

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

11 ‘‘(iii) inpatient hospitalization; 

12 ‘‘(iv) a persistent or significant dis13 ability or incapacity; or 

14 ‘‘(v) a congenital anomaly or birth de15 fect; or 

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

17 judgment, a medical or surgical intervention to 

18 prevent an outcome described under subpara19 graph (A). 

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

21 term ‘serious adverse event report’ means a report 

22 that is required to be submitted to the Secretary 

23 under subsection (b). 

24 ‘‘(b) REPORTING REQUIREMENT.— 


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

2 or distributor whose name (pursuant to section 

3 502(b)(1)) appears on the label of a nonprescription 

4 drug marketed in the United States (referred to in 

5 this section as the ‘responsible person’) shall submit 

6 to the Secretary any report received of a serious ad7 verse event associated with such drug when used in 

8 the United States, accompanied by a copy of the label 

9 on or within the retail package of such drug. 

10 ‘‘(2) RETAILER.—A retailer whose name appears 

11 on the label described in paragraph (1) as a dis12 tributor may, by agreement, authorize the manufac13 turer or packer of the nonprescription drug to submit 

14 the required reports for such drugs to the Secretary so 

15 long as the retailer directs to the manufacturer or 

16 packer all adverse events associated with such drug 

17 that are reported to the retailer through the address 

18 or telephone number described in section 502(x). 

19 ‘‘(c) SUBMISSION OF REPORTS.— 

20 ‘‘(1) TIMING OF REPORTS.—The responsible per21 son shall submit to the Secretary a serious adverse 

22 event report no later than 15 business days after the 

23 report is received through the address or phone num24 ber described in section 502(x). 


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1 ‘‘(2) NEW MEDICAL INFORMATION.—The respon2 sible person shall submit to the Secretary any new 

3 medical information, related to a submitted serious 

4 adverse event report that is received by the responsible 

5 person within 1 year of the initial report, no later 

6 than 15 business days after the new information is 

7 received by the responsible person. 

8 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec9 retary shall develop systems to ensure that duplicate 

10 reports of, and new medical information related to, a 

11 serious adverse event shall be consolidated into a sin12 gle report. 

13 ‘‘(4) EXEMPTION.—The Secretary, after pro14 viding notice and an opportunity for comment from 

15 interested parties, may establish an exemption to the 

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

17 Secretary determines that such exemption would have 

18 no adverse effect on public health. 

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

20 event report under this section shall be submitted to the Sec21 retary using the MedWatch form, which may be modified 

22 by the Secretary for nonprescription drugs, and may be ac23 companied by additional information. 

24 ‘‘(e) MAINTENANCE AND INSPECTION OF RECORDS.— 


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

2 shall maintain records related to each report of an 

3 adverse event received by the responsible person for a 

4 period of 6 years. 

5 ‘‘(2) RECORDS INSPECTION.— 

6 ‘‘(A) IN GENERAL.—The responsible person 

7 shall permit an authorized person to have access 

8 to records required to be maintained under this 

9 section, during an inspection pursuant to section 

10 704. 

11 ‘‘(B) AUTHORIZED PERSON.—For purposes 

12 of this paragraph, the term ‘authorized person’ 

13 means an officer or employee of the Department 

14 of Health and Human Services who has— 

15 ‘‘(i) appropriate credentials, as deter16 mined by the Secretary; and 

17 ‘‘(ii) been duly designated by the Sec18 retary to have access to the records required 

19 under this section. 

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

21 event report submitted to the Secretary under this section, 

22 including any new medical information submitted under 

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

24 submitted to the Secretary shall be considered to be— 


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

2 be accompanied by a statement, which shall be a part 

3 of any report that is released for public disclosure, 

4 that denies that the report or the records constitute an 

5 admission that the product involved caused or con6 tributed to the adverse event; and 

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

8 552a of title 5, United States Code (commonly re9 ferred to as the ‘Privacy Act of 1974’) and a medical 

10 or similar file the disclosure of which would constitute 

11 a violation of section 552 of such title 5 (commonly 

12 referred to as the ‘Freedom of Information Act’), and 

13 shall not be publicly disclosed unless all personally 

14 identifiable information is redacted. 

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

16 any adverse event report in compliance with this section 

17 shall not be construed as an admission that the non18 prescription drug involved caused or contributed to the ad19 verse event. 

20 ‘‘(h) PREEMPTION.— 

21 ‘‘(1) IN GENERAL.—No State or local government 

22 shall establish or continue in effect any law, regula23 tion, order, or other requirement, related to a manda24 tory system for adverse event reports for nonprescripVerDate Aug 31 2005 00:39 Sep 06, 2006 Jkt 049196 PO 00000 Frm 00024 Fmt 6652 Sfmt 6203 E:\BILLS\S3546.RS S3546

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1 tion drugs, that is different from, in addition to, or 

2 otherwise not identical to, this section. 

3 ‘‘(2) EFFECT OF SECTION.— 

4 ‘‘(A) IN GENERAL.—Nothing in this section 

5 shall affect the authority of the Secretary to pro6 vide adverse event reports and information to 

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

8 any State, territory, or political subdivision of a 

9 State or territory, under a memorandum of un10 derstanding between the Secretary and such 

11 State, territory, or political subdivision. 

12 ‘‘(B) PERSONALLY-IDENTIFIABLE INFORMA13 TION.—Notwithstanding any other provision of 

14 law, personally-identifiable information in ad15 verse event reports provided by the Secretary to 

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

17 any State, territory, or political subdivision of a 

18 State or territory, shall not— 

19 ‘‘(i) be made publicly available pursu20 ant to any State or other law requiring dis21 closure of information or records; or 

22 ‘‘(ii) otherwise be disclosed or distrib23 uted to any party without the written con24 sent of the Secretary and the person submit25 ting such information to the Secretary. 


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

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

3 political subdivision of a State or territory, to 

4 use any safety report received from the Secretary 

5 in a manner inconsistent with subsection (g) or 

6 section 756. 

7 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There are 

8 authorized to be appropriated to carry out this section such 

9 sums as may be necessary.’’. 

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

11 Human Services may modify requirements under the 

12 amendments made by this section in accordance with sec13 tion 553 of title 5, United States Code, to maintain consist14 ency with international harmonization efforts over time. 

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

16 Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amend17 ed by— 

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

19 704(a), or 760;’’; and 

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

21 760’’. 

22 (d) MISBRANDING.—Section 502 of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 352) is amended by 

24 adding at the end the following: 


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1 ‘‘(x) If it is a nonprescription drug (as defined in sec2 tion 760) that is marketed in the United States, unless the 

3 label of such drug includes a domestic address or domestic 

4 phone number through which the responsible person (as de5 scribed in section 760) may receive a report of a serious 

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

7 (e) EFFECTIVE DATES.— 

8 (1) IN GENERAL.—Except as provided in para9 graph (2), the amendments made by this section shall 

10 take effect 1 year after the date of enactment of this 

11 Act. 

12 (2) MISBRANDING.—Section 502(x) of the Fed13 eral Food, Drug, and Cosmetic Act (as added by this 

14 section) shall apply to any nonprescription drug (as 

15 defined in such section 502(x)) labeled on or after the 

16 date that is 1 year after the date of enactment of this 

17 Act. 

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

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

20 Health and Human Services shall issue guidance on 

21 the minimum data elements that should be included 

22 in a serious adverse event report described under the 

23 amendments made by this Act. 


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1 SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIE2 TARY SUPPLEMENTS. 

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

4 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended 

5 by adding at the end the following: 

6 ‘‘SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIE7 TARY SUPPLEMENTS. 

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

9 ‘‘(1) ADVERSE EVENT.—The term ‘adverse event’ 

10 means any health-related event associated with the 

11 use of a dietary supplement that is adverse. 

12 ‘‘(2) SERIOUS ADVERSE EVENT.—The term ‘seri13 ous adverse event’ is an adverse event that— 

14 ‘‘(A) results in— 

15 ‘‘(i) death; 

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

17 ‘‘(iii) inpatient hospitalization; 

18 ‘‘(iv) a persistent or significant dis19 ability or incapacity; or 

20 ‘‘(v) a congenital anomaly or birth de21 fect; or 

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

23 judgment, a medical or surgical intervention to 

24 prevent an outcome described under subpara25 graph (A). 


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

2 term ‘serious adverse event report’ means a report 

3 that is required to be submitted to the Secretary 

4 under subsection (b). 

5 ‘‘(b) REPORTING REQUIREMENT.— 

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

7 or distributor of a dietary supplement whose name 

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

9 of a dietary supplement marketed in the United 

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

11 person’) shall submit to the Secretary any report re12 ceived of a serious adverse event associated with such 

13 dietary supplement when used in the United States, 

14 accompanied by a copy of the label on or within the 

15 retail packaging of such dietary supplement. 

16 ‘‘(2) RETAILER.—A retailer whose name appears 

17 on the label described in paragraph (1) as a dis18 tributor may, by agreement, authorize the manufac19 turer or packer of the dietary supplement to submit 

20 the required reports for such dietary supplements to 

21 the Secretary so long as the retailer directs to the 

22 manufacturer or packer all adverse events associated 

23 with such dietary supplement that are reported to the 

24 retailer through the address or telephone number de25 scribed in section 403(y). 


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1 ‘‘(c) SUBMISSION OF REPORTS.— 

2 ‘‘(1) TIMING OF REPORTS.—The responsible per3 son shall submit to the Secretary a serious adverse 

4 event report no later than 15 business days after the 

5 report is received through the address or phone num6 ber described in section 403(y). 

7 ‘‘(2) NEW MEDICAL INFORMATION.—The respon8 sible person shall submit to the Secretary any new 

9 medical information, related to a submitted serious 

10 adverse event report that is received by the responsible 

11 person within 1 year of the initial report, no later 

12 than 15 business days after the new information is 

13 received by the responsible person. 

14 ‘‘(3) CONSOLIDATION OF REPORTS.—The Sec15 retary shall develop systems to ensure that duplicate 

16 reports of, and new medical information related to, a 

17 serious adverse event shall be consolidated into a sin18 gle report. 

19 ‘‘(4) EXEMPTION.—The Secretary, after pro20 viding notice and an opportunity for comment from 

21 interested parties, may establish an exemption to the 

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

23 Secretary determines that such exemption would have 

24 no adverse effect on public health. 


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

2 event report under this section shall be submitted to the Sec3 retary using the MedWatch form, which may be modified 

4 by the Secretary for dietary supplements, and may be ac5 companied by additional information. 

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

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

8 shall maintain records related to each report of an 

9 adverse event received by the responsible person for a 

10 period of 6 years. 

11 ‘‘(2) RECORDS INSPECTION.— 

12 ‘‘(A) IN GENERAL.—The responsible person 

13 shall permit an authorized person to have access 

14 to records required to be maintained under this 

15 section during an inspection pursuant to section 

16 704. 

17 ‘‘(B) AUTHORIZED PERSON.—For purposes 

18 of this paragraph, the term ‘authorized person’ 

19 means an officer or employee of the Department 

20 of Health and Human Services, who has— 

21 ‘‘(i) appropriate credentials, as deter22 mined by the Secretary; and 

23 ‘‘(ii) been duly designated by the Sec24 retary to have access to the records required 

25 under this section. 


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

2 event report submitted to the Secretary under this section, 

3 including any new medical information submitted under 

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

5 submitted to the Secretary shall be considered to be— 

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

7 be accompanied by a statement, which shall be a part 

8 of any report that is released for public disclosure, 

9 that denies that the report or the records constitute an 

10 admission that the product involved caused or con11 tributed to the adverse event; and 

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

13 552a of title 5, United States Code (commonly re14 ferred to as the ‘Privacy Act of 1974’) and a medical 

15 or similar file the disclosure of which would constitute 

16 a violation of section 552 of such title 5 (commonly 

17 referred to as the ‘Freedom of Information Act’), and 

18 shall not be publicly disclosed unless all personally 

19 identifiable information is redacted. 

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

21 any adverse event report in compliance with this section 

22 shall not be construed as an admission that the dietary sup23 plement involved caused or contributed to the adverse event. 

24 ‘‘(h) PREEMPTION.— 


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1 ‘‘(1) IN GENERAL.—No State or local government 

2 shall establish or continue in effect any law, regula3 tion, order, or other requirement, related to a manda4 tory system for adverse event reports for dietary sup5 plements, that is different from, in addition to, or 

6 otherwise not identical to, this section. 

7 ‘‘(2) EFFECT OF SECTION.— 

8 ‘‘(A) IN GENERAL.—Nothing in this section 

9 shall affect the authority of the Secretary to pro10 vide adverse event reports and information to 

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

12 any State, territory, or political subdivision of a 

13 State or territory, under a memorandum of un14 derstanding between the Secretary and such 

15 State, territory, or political subdivision. 

16 ‘‘(B) PERSONALLY-IDENTIFIABLE INFORMA17 TION.—Notwithstanding any other provision of 

18 law, personally-identifiable information in ad19 verse event reports provided by the Secretary to 

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

21 any State, territory, or political subdivision of a 

22 State or territory, shall not— 

23 ‘‘(i) be made publicly available pursu24 ant to any State or other law requiring dis25 closure of information or records; or 


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1 ‘‘(ii) otherwise be disclosed or distrib2 uted to any party without the written con3 sent of the Secretary and the person submit4 ting such information to the Secretary. 

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

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

7 political subdivision of a State or territory, to 

8 use any safety report received from the Secretary 

9 in a manner inconsistent with subsection (g) or 

10 section 756. 

11 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There are 

12 authorized to be appropriated to carry out this section such 

13 sums as may be necessary.’’. 

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

15 Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amend16 ed by— 

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

18 761;’’; and 

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

20 761’’. 

21 (c) MISBRANDING.—Section 403 of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 343) is amended by 

23 adding at the end the following: 

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

25 the United States, unless the label of such dietary suppleVerDate Aug 31 2005 00:39 Sep 06, 2006 Jkt 049196 PO 00000 Frm 00034 Fmt 6652 Sfmt 6203 E:\BILLS\S3546.RS S3546

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1 ment includes a domestic address or domestic phone number 

2 through which the responsible person (as described in sec3 tion 761) may receive a report of a serious adverse event 

4 with such dietary supplement.’’. 

5 (d) EFFECTIVE DATE.— 

6 (1) IN GENERAL.—Except as provided in para7 graph (2), the amendments made by this section shall 

8 take effect 1 year after the date of enactment of this 

9 Act. 

10 (2) MISBRANDING.—Section 403(y) of the Fed11 eral Food, Drug, and Cosmetic Act (as added by this 

12 section) shall apply to any dietary supplement labeled 

13 on or after the date that is 1 year after the date of 

14 enactment 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 as described under 

20 the amendments made by this Act. 

21 SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS. 

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

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

24 adding at the end the following: 


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

2 event submitted to a responsible person (as defined under 

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

4 event report (as defined under section 760 or 761) submitted 

5 to the Secretary.’’. 

6 (b) EFFECTIVE DATE.—The amendment made by this 

7 section shall take effect 1 year after the date of enactment 

8 of this Act. 

9 SEC. 5. IMPORTATION OF CERTAIN NONPRESCRIPTION 

10 DRUGS AND DIETARY SUPPLEMENTS. 

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

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

13 (1) in subsection (a), by inserting after the third 

14 sentence the following: ‘‘If such article is subject to a 

15 requirement under section 760 or 761 and if the Sec16 retary has credible evidence or information indicating 

17 that the responsible person (as defined in such section 

18 760 or 761) has not complied with a requirement of 

19 such section 760 or 761 with respect to any such arti20 cle, or has not allowed access to records described in 

21 such section 760 or 761, then such article shall be re22 fused admission, except as provided in subsection (b) 

23 of this section.’’; and 

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


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1 (A) by inserting ‘‘(1)’’ before ‘‘an article in2 cluded’’; 

3 (B) by inserting before ‘‘final determina4 tion’’ the following: ‘‘or (2) with respect to an 

5 article included within the provision of the 

6 fourth sentence of subsection (a), the responsible 

7 person (as defined in section 760 or 761) can 

8 take action that would assure that the respon9 sible person is in compliance with section 760 or 

10 761, as the case may be,’’; and 

11 (C) by inserting ‘‘, or, with respect to clause 

12 (2), the responsible person,’’ before ‘‘to perform’’. 

13 (b) EFFECTIVE DATE.—The amendments made by this 

14 section shall take effect 1 year after the date of enactment 

15 of this Act. 


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Calendar No. 586 

109TH CONGRESS 

2D SESSION S. 3546 

[Report No. 109

–324] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

drugs, and for other purposes. ing for dietary supplements and nonprescription Act with respect to serious adverse event reportSEPTEMBER 5, 2006 

Reported with an amendment 


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