I 

108TH CONGRESS 

1ST SESSION H. R. 724

To amend the Federal Food, Drug, and Cosmetic Act to require that manufacturers of dietary supplements register with the Food and Drug Administration, to require the submission to such Administration of reports 

on adverse experiences regarding such supplements, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 12, 2003

Mrs. DAVIS of California introduced the following bill; which was referred to 

the Committee on Energy and Commerce 

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to 

require that manufacturers of dietary supplements register with the Food and Drug Administration, to require 

the submission to such Administration of reports on adverse experiences regarding such supplements, 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 Information Act’’. 
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1 SEC. 2. REGISTRATION, REPORTING, AND POSTMARKET 

2 SURVEILLANCE REGARDING DIETARY SUP3 PLEMENTS. 

4 (a) IN GENERAL.—Chapter IV of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend6 ed by adding at the end the following section: 

7 ‘‘REGISTRATION, REPORTING, AND POSTMARKET

8 SURVEILLANCE REGARDING DIETARY SUPPLEMENTS

9 ‘‘SEC. 416. (a) REGISTRATION.—

10 ‘‘(1) ANNUAL REGISTRATION.—Each calendar 

11 year a person who in any State owns or operates an 

12 establishment engaged in the business of manufac13 turing, packing, or distributing a dietary supplement 

14 shall register with the Secretary the name of the 

15 person, places of business, and all such establish16 ments. 

17 ‘‘(2) INITIAL MANUFACTURING.—A person, 

18 upon first engaging in a business described in para19 graph (1) in an establishment that the person owns 

20 or operates in any State, shall immediately register 

21 with the Secretary the name of the person, place of 

22 business, and such establishment. 

23 ‘‘(3) ADDITIONAL ESTABLISHMENTS.—A person 

24 duly registered in accordance with paragraph (1) or 

25 (2), upon engaging in the business involved in any 

26 additional establishment that the person owns or op-
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1 erates in any State, shall immediately register with 

2 the Secretary the additional establishment. 

3 ‘‘(4) IMPORTS.—Any establishment within any 

4 foreign country engaged in the manufacture of a die5 tary supplement that is imported or offered for im6 port into the United States shall register with the 

7 Secretary the name and place of business of the es8 tablishment and the name of the United States 

9 agent for the establishment. 

10 ‘‘(5) PRODUCT INFORMATION.—

11 ‘‘(A) LABELING; OTHER INFORMATION.—

12 In addition to information that under any of 

13 paragraphs (1) through (4) is required to be 

14 provided in a registration, the registration shall 

15 provide the labeling of the dietary supplements 

16 involved (except to the extent that another reg17 istration under this subsection provides the la18 beling) and such other information describing 

19 the dietary supplements as the Secretary may 

20 by regulation require. 

21 ‘‘(B) CHANGES IN UNDERLYING FACTS.— 

22 With respect to information that pursuant to 

23 subparagraph (A) is submitted in a registra24 tion, if after submitting the registration to the 

25 Secretary any of the underlying facts change, 
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1 the person involved shall submit revised infor2 mation to the Secretary in accordance with 

3 such criteria and procedures as the Secretary 

4 may establish, which may include requiring the 

5 submission of a substitute registration. The re6 vised information shall be so submitted not 

7 later than 30 days after the date on which the 

8 factual changes occur. 

9 ‘‘(C) PREMARKET SUBMISSION OF LABEL10 ING FOR POSTENACTMENT PRODUCTS.—In the 

11 case of a dietary supplement that was not in 

12 commercial distribution as of the day before the 

13 date of the enactment of the Dietary Supple14 ment Information Act, the manufacturer of 

15 such supplement shall submit the labeling for 

16 the supplement to the Secretary in accordance 

17 with subparagraph (A) before introducing the 

18 supplement into interstate commerce or deliv19 ering the supplement for such introduction. 

20 ‘‘(6) FEES.—The Secretary may by regulation 

21 establish a requirement that a registration under 

22 this subsection is subject to a fee to be assessed and 

23 collected by the Secretary. Subject to the extent of 

24 amounts approved in advance by an appropriation 

25 Act for the fiscal year involved, amounts collected by 
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1 the Secretary under the preceding sentence are 

2 available to the Secretary for the purpose of car3 rying out the responsibilities of the Secretary under 

4 this subsection and subsection (b). The Secretary 

5 may waive the requirement that a person pay such 

6 a fee if the Secretary determines that the waiver is 

7 justified on the basis that the person is a small busi8 ness. 

9 ‘‘(b) REPORTING OF INFORMATION ON ADVERSE EX10 PERIENCES.—

11 ‘‘(1) SERIOUS EXPERIENCES.—Each person 

12 who is a manufacturer of a dietary supplement, or 

13 a packer or distributor of the supplement whose 

14 name appears on the labeling of the supplement, 

15 shall—

16 ‘‘(A) report to the Secretary in accordance 

17 with paragraph (2) any information received by 

18 such person on serious adverse experiences re19 garding the supplement; and

20 ‘‘(B) develop written procedures regarding 

21 the submission to the Secretary of such reports, 

22 including procedures for surveillance, receipt, 

23 and evaluation of information on such experi24 ences. 

25 ‘‘(2) REPORTING OF SERIOUS EXPERIENCES.—
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1 ‘‘(A) INITIAL REPORT.—With respect to 

2 the initial receipt of information on a serious 

3 adverse experience, a person with reporting re4 sponsibility under paragraph (1) shall submit 

5 the report to the Secretary as soon as is pos6 sible, but in no case later than 15 calendar days 

7 after the initial receipt of the information. Such 

8 report shall be accompanied by a copy of the 

9 current labeling for the dietary supplement in10 volved. 

11 ‘‘(B) INVESTIGATION AND FOLLOW-UP.—A 

12 person submitting an initial report under sub13 paragraph (A) on a serious adverse experience 

14 shall promptly investigate the experience, and if 

15 additional information is obtained, shall report 

16 the information to the Secretary not later than 

17 15 days after obtaining the information. If no 

18 additional information is obtained, records of 

19 the steps taken to seek additional information 

20 shall be maintained by the person. 

21 ‘‘(C) DUPLICATIVE REPORTING.—In order 

22 to avoid duplicative reporting under this para23 graph, the Secretary may provide for proce24 dures under which persons who are packers or 

25 distributors described in paragraph (1) submit 
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1 reports under this paragraph to the manufac2 turer involved rather than the Secretary, with 

3 the manufacturers then submitting the required 

4 reports to the Secretary, subject to the Sec5 retary establishing requirements to ensure that 

6 the Secretary receives reports within the appli7 cable period of time specified in subparagraph 

8 (A) or (B). 

9 ‘‘(3) CLINICAL EVALUATIONS BY SECRETARY.—

10 The Secretary shall conduct a clinical evaluation of 

11 each serious adverse experience reported to the Sec12 retary under paragraph (2) (except to the extent 

13 that the patient involved or the next of kin for the 

14 patient, as the case may be, elects not to cooperate 

15 with the Secretary). 

16 ‘‘(4) ADDITIONAL REQUIREMENTS FOR MANU17 FACTURERS.—

18 ‘‘(A) GENERAL REVIEW REGARDING AD19 VERSE EXPERIENCES.—A manufacturer of a di20 etary supplement shall promptly review all in21 formation on adverse experiences regarding the 

22 supplement obtained or otherwise received by 

23 the manufacturer. The preceding sentence ap24 plies to information without regard to the 

25 source of the information, foreign or domestic, 
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1 and includes information derived from sources 

2 such as commercial marketing experience, post3 marketing investigations, postmarketing surveil4 lance, studies, reports in the scientific lit5 erature, and unpublished scientific papers. 

6 ‘‘(B) PERIODIC REPORTS ON NONSERIOUS

7 EXPERIENCES.—With respect to the receipt of 

8 information on adverse experiences that are not 

9 serious, a manufacturer of the dietary supple10 ment involved shall submit reports to the Sec11 retary annually, or at such shorter intervals as 

12 the Secretary may require. Each such report 

13 shall meet such requirements as the Secretary 

14 may establish. 

15 ‘‘(5) AUTHORITY OF SECRETARY.—In addition 

16 to requirements established in this subsection, the 

17 Secretary may establish such requirements regarding 

18 the reporting of information on adverse experiences 

19 as the Secretary determines to be appropriate to 

20 protect the public health. The Secretary may estab21 lish waivers from requirements under this subsection 

22 regarding such information if the Secretary deter23 mines that compliance with the requirement involved 

24 is not necessary to protect the public health regard25 ing such supplements. 
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1 ‘‘(6) SYSTEM FOR COORDINATING REPORTS RE2 CEIVED BY SECRETARY.—With respect to reports of 

3 adverse health experiences submitted to the Sec4 retary (whether required under this subsection or 

5 otherwise), the Secretary shall establish a system to 

6 receive the reports, refer the reports to the appro7 priate officials within the Food and Drug Adminis8 tration, store and retrieve the reports, store and re9 trieve records of activities carried out in response to 

10 the reports, and carry out such other administrative 

11 functions regarding the reports as the Secretary de12 termines to be appropriate. 

13 ‘‘(7) DATA COLLECTION BY SECRETARY.—The 

14 Secretary shall carry out a program to collect data 

15 on serious adverse experiences, in addition to receiv16 ing reports required in this subsection. In carrying 

17 out such program, the Secretary shall seek the co18 operation of appropriate public and private entities, 

19 including entities that respond to medical emer20 gencies. 

21 ‘‘(8) DEFINITIONS.—For purposes of this sec22 tion: 

23 ‘‘(A) The term ‘adverse experience’ means 

24 an adverse experience regarding a dietary sup25 plement. 
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1 ‘‘(B) The term ‘adverse experience regard2 ing a dietary supplement’ means any adverse 

3 event associated with the use of such supple4 ment in humans, whether or not such event is 

5 considered to be related to the supplement by a 

6 person referred to in paragraph (1) who obtains 

7 the information. 

8 ‘‘(C) The term ‘serious’, with respect to an 

9 adverse experience, means an adverse experi10 ence to which any of clauses (i) through (iii) 

11 applies, as follows: 

12 ‘‘(i) The experience is associated with 

13 any of the following outcomes: Death; a 

14 life-threatening condition; inpatient hos15 pitalization or prolongation of existing hos16 pitalization; a persistent or significant dis17 ability or incapacity; or a congenital anom18 aly, birth defect, or other effect regarding 

19 pregnancy, including premature labor or 

20 low birth weight. 

21 ‘‘(ii) The experience requires medical 

22 or surgical intervention to prevent one of 

23 the outcomes specified in clause (i). 

24 ‘‘(iii) There is reason to believe that a 

25 factor associated with the experience is the 
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1 interaction of the dietary supplement in2 volved with a drug, without regard to 

3 whether clause (i) or (ii) applies to the ex4 perience. 

5 ‘‘(c) POSTMARKET SURVEILLANCE.—

6 ‘‘(1) AUTHORITY TO REQUIRE SURVEIL7 LANCE.—The Secretary may by order require a 

8 manufacturer of a dietary supplement to conduct 

9 postmarket surveillance for such supplement if the 

10 Secretary determines that there is a reasonable pos11 sibility that a use or expected use of the supplement 

12 by a significant number of consumers may have seri13 ous adverse health consequences. 

14 ‘‘(2) SURVEILLANCE PLAN.—

15 ‘‘(A) IN GENERAL.—Not later than 30 

16 days after receiving from the Secretary an 

17 order under paragraph (1) to conduct surveil18 lance for a dietary supplement, the manufac19 turer involved shall submit to the Secretary, for 

20 the approval of the Secretary, a plan for the re21 quired surveillance. 

22 ‘‘(B) QUALIFICATIONS REGARDING SUR23 VEILLANCE; DATA REGARDING ADVERSE EXPE24 RIENCES.—Not later than 60 days after a plan 

25 is submitted to the Secretary under subpara-
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1 graph (A), the Secretary shall determine wheth2 er—

3 ‘‘(i) the person designated to conduct 

4 the surveillance has appropriate qualifica5 tions and experience to conduct such sur6 veillance; and 

7 ‘‘(ii) the plan will result in the collec8 tion of useful data that can reveal adverse 

9 experiences or other information necessary 

10 to protect the public health. 

11 ‘‘(3) SURVEILLANCE PERIOD.—In consultation 

12 with a manufacturer of a dietary supplement that is 

13 required to conduct surveillance under paragraph 

14 (1), the Secretary may by order require a prospec15 tive surveillance period for the manufacturer of up 

16 to 36 months. Any determination by the Secretary 

17 that a longer period is necessary shall be made by 

18 mutual agreement between the Secretary and the 

19 manufacturer or, if no agreement can be reached, 

20 after the completion of a dispute resolution process 

21 that is established by the Secretary by regulation. 

22 ‘‘(d) REPORTING IN GENERAL.—In addition to re23 quirements otherwise established under this section, a 

24 manufacturer of a dietary supplement shall establish and 

25 maintain such records, make such reports, and provide 
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1 such information as the Secretary may by regulation rea2 sonably require to assure that such supplement is not 

3 adulterated or misbranded.’’. 

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

5 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend6 ed by adding at the end the following: 

7 ‘‘(hh) The failure of a person to register, submit re8 ports, or comply with any other requirement under section 

9 416.’’. 

10 SEC. 3. INSPECTION AUTHORITY REGARDING RECORDS ON 

11 DIETARY SUPPLEMENTS. 

12 Section 704 of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 374) is amended—

14 (1) in subsection (a)(1)—

15 (A) in the third sentence, by striking ‘‘or 

16 restricted devices’’ each place such term ap17 pears and inserting ‘‘restricted devices, or die18 tary supplements’’; and 

19 (B) in the fourth sentence—

20 (i) by striking ‘‘and devices’’ and in21 serting ‘‘devices, and dietary supplements’’; 

22 and 

23 (ii) by striking ‘‘section 505(i) or (k)’’ 

24 and inserting ‘‘section 416, section 505(i), 

25 section 505(k),’’; and 
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1 (2) in subsection (e), by striking ‘‘section 519’’ 

2 and inserting ‘‘section 416, 519,’’. 

3 SEC. 4. LABELING OF DIETARY SUPPLEMENTS. 

4 Section 403(e) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 343(e)) is amended—

6 (1) by striking ‘‘and (2)’’ and inserting the fol7 lowing: ‘‘(2) the toll-free telephone number, and the 

8 address of the Internet site, maintained by the Sec9 retary for purposes of the medical product reporting 

10 program (MedWatch or any successor program); and 

11 (3) ’’; and 

12 (2) by striking ‘‘clause (2)’’ and inserting 

13 ‘‘clause (3)’’. 

14 SEC. 5. PUBLICATION OF PROPOSED RULE ON CURRENT 

15 GOOD MANUFACTURING PRACTICES FOR DI16 ETARY SUPPLEMENTS. 

17 Not later than 30 days after the date of the enact18 ment of this Act, the Secretary of Health and Human 

19 Services shall publish in the Federal Register a proposed 

20 rule for carrying out section 402(g) of the Federal Food, 

21 Drug, and Cosmetic Act.

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