I 

109TH CONGRESS 

1ST SESSION H. R. 3156

To amend the Federal Food, Drug, and Cosmetic Act with respect to dietary 

supplements. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 30, 2005

Mrs. DAVIS of California (for herself, Mr. WAXMAN, and Mr. DINGELL) 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 with 

respect to dietary supplements.

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 Access and Awareness Act’’. 
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1 SEC. 2. DIETARY SUPPLEMENTS; PRODUCT LISTING; RE2 PORTING, POSTMARKET SURVEILLANCE, AND 

3 OTHER PROVISIONS REGARDING SAFETY. 

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 ‘‘SEC. 416. DIETARY SUPPLEMENTS; PRODUCT LISTING; RE8 PORTING, POSTMARKET SURVEILLANCE, AND 

9 OTHER PROVISIONS REGARDING SAFETY. 

10 ‘‘(a) LIMITATION ON APPLICABILITY.—Notwith11 standing the other subsections of this section, this section 

12 does not apply to any dietary supplement that meets the 

13 conditions described in paragraphs (1) and (2), as follows: 

14 ‘‘(1) The supplement bears or contains one or 

15 more of the following dietary ingredients: 

16 ‘‘(A) A vitamin. 

17 ‘‘(B) A mineral. 

18 ‘‘(C) A concentrate, metabolite, con19 stituent, extract, or combination of any vitamin 

20 or mineral. 

21 ‘‘(2) The supplement does not bear or con22 tain—

23 ‘‘(A) an herb or other botanical, an amino 

24 acid, or a dietary substance for use by man to 

25 supplement the diet by increasing the total die26 tary intake; or 
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1 ‘‘(B) a concentrate, metabolite, con2 stituent, extract, or combination of any ingre3 dient specified in subparagraph (A). 

4 ‘‘(b) PRODUCT LISTING.—Every person who is re5 quired under section 415 to register with the Secretary 

6 with respect to manufacturing or processing a dietary sup7 plement shall, in the form and manner prescribed by the 

8 Secretary, report to the Secretary twice each year, once 

9 during the month of June and once during the month of 

10 December, the following information: 

11 ‘‘(1) A list of each dietary supplement manufac12 tured or processed by the person for commercial dis13 tribution in the United States, other than dietary 

14 supplements previously included on a list reported 

15 under this subsection by the person. 

16 ‘‘(2) The labeling for each of the dietary supple17 ments on the list. 

18 ‘‘(3) A listing of the major ingredients of each 

19 dietary supplement on the list (including active in20 gredients, as applicable), except that the Secretary 

21 may require the submission of a quantitative listing 

22 of all ingredients in such a supplement if the Sec23 retary finds that such submission is necessary to 

24 carry out the purposes of this Act. 
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1 ‘‘(4) If, since the date the person last made a 

2 report under this subsection (or if the person has 

3 not previously made such a report, since the effective 

4 date of this section), the person has discontinued the 

5 manufacture or processing of a dietary supplement 

6 included on a list reported under this subsection by 

7 the person—

8 ‘‘(A) notice of such discontinuance; 

9 ‘‘(B) the date of such discontinuance; and 

10 ‘‘(C) the identity of such supplement. 

11 ‘‘(5) Such other information describing the die12 tary supplements as the Secretary may by regulation 

13 require. 

14 ‘‘(c) REPORTING OF INFORMATION ON ADVERSE EX15 PERIENCES.—

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

17 who is a manufacturer or distributor of a dietary 

18 supplement shall report to the Secretary any infor19 mation received by such person on serious adverse 

20 experiences regarding the supplement. Such a report 

21 shall be submitted to the Secretary not later than 15 

22 days after the date on which the person receives 

23 such information. 

24 ‘‘(2) INVESTIGATION AND FOLLOW-UP.—A per25 son submitting a report under paragraph (1) on a 
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1 serious adverse experience shall promptly investigate 

2 the experience, and if additional information is ob3 tained, shall report the information to the Secretary 

4 not later than 15 days after obtaining the informa5 tion. If no additional information is obtained, 

6 records of the steps taken to seek additional infor7 mation shall be maintained by the person. 

8 ‘‘(3) AUTHORITY OF SECRETARY.—In addition 

9 to requirements established in this subsection, the 

10 Secretary may establish such requirements regarding 

11 the reporting of information on adverse experiences 

12 as the Secretary determines to be appropriate to 

13 protect the public health. The Secretary may estab14 lish waivers from requirements under this subsection 

15 regarding such information if the Secretary deter16 mines that compliance with the requirement involved 

17 is not necessary to protect the public health regard18 ing such supplements. 

19 ‘‘(4) DEFINITIONS.—For purposes of this sub20 section: 

21 ‘‘(A) The term ‘adverse experience regard22 ing a dietary supplement’ means any adverse 

23 event associated with the use of such supple24 ment in humans, whether or not such event is 

25 considered to be related to the supplement by a 
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1 person referred to in paragraph (1) who obtains 

2 the information. 

3 ‘‘(B) The term ‘serious’, with respect to an 

4 adverse experience regarding a dietary supple5 ment, means an adverse experience that—

6 ‘‘(i) results in death; a life-threatening 

7 condition; inpatient hospitalization or pro8 longation of hospitalization; a persistent or 

9 significant disability or incapacity; or a 

10 congenital anomaly, birth defect, or other 

11 effect regarding pregnancy, including pre12 mature labor or low birth weight; or 

13 ‘‘(ii) requires medical or surgical 

14 intervention to prevent one of the outcomes 

15 described in clause (i). 

16 ‘‘(d) POSTMARKET SURVEILLANCE.—The Secretary 

17 may by order require a manufacturer of a dietary supple18 ment to conduct postmarket surveillance for the supple19 ment if the Secretary determines that there is a reasonable 

20 possibility that a use or expected use of the supplement 

21 may have serious adverse health consequences. 

22 ‘‘(e) AUTHORITY TO ORDER DEMONSTRATION OF

23 SAFETY.—

24 ‘‘(1) IN GENERAL.—If the Secretary has rea25 sonable grounds for believing that a dietary supple-
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1 ment may be adulterated under section 402(f)(1), 

2 the Secretary may by order require the manufac3 turer to demonstrate to the Secretary that the sup4 plement is not so adulterated. 

5 ‘‘(2) DISTRIBUTION OF PRODUCT PENDING

6 COMPLETION OF PROCESS.—

7 ‘‘(A) IN GENERAL.—Subject to subpara8 graph (B), a dietary supplement may not be 

9 considered adulterated under section 402(f)(1) 

10 during the pendency of a demonstration under 

11 paragraph (1) by the manufacturer of the sup12 plement and during the pendency of the review 

13 under paragraph (4) by the Secretary with re14 spect to the demonstration. 

15 ‘‘(B) IMMINENT HAZARD TO PUBLIC

16 HEALTH OR SAFETY.—This subsection does not 

17 affect the authority of the Secretary under sec18 tion 402(f)(1)(C). 

19 ‘‘(3) TIMEFRAME FOR DEMONSTRATION.—

20 ‘‘(A) IN GENERAL.—An order under para21 graph (1) shall provide that the demonstration 

22 under such paragraph by a manufacturer is re23 quired to be completed not later than the expi24 ration of 180 days after the date on which the 

25 order is issued, except that the Secretary may 
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1 extend such period if the Secretary determines 

2 that an extension is appropriate. Any informa3 tion submitted for such purpose by the manu4 facturer after the expiration of the applicable 

5 period under the preceding sentence may not be 

6 considered by the Secretary, except to the ex7 tent that the Secretary requests the manufac8 turer to provide additional information after 

9 such period. 

10 ‘‘(B) COMPLETION DATE OF DEMONSTRA11 TION.—A demonstration under paragraph (1) 

12 shall be considered complete on the expiration 

13 of the applicable period under subparagraph 

14 (A), or on such earlier date as the manufac15 turer informs the Secretary that the manufac16 turer has completed the demonstration, or on 

17 such earlier date as the Secretary reasonably 

18 concludes that the manufacturer has no further 

19 information to provide to the Secretary as part 

20 of the demonstration or that the manufacturer 

21 is not in substantial compliance with the order 

22 under paragraph (1). 

23 ‘‘(4) REVIEW BY SECRETARY.—Once a dem24 onstration under paragraph (1) by a manufacturer is 

25 completed, the Secretary shall review all relevant in-
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1 formation received by the Secretary pursuant to the 

2 demonstration or otherwise available to the Sec3 retary and make a determination of whether the 

4 Secretary considers the dietary supplement involved 

5 to be adulterated under section 402(f)(1). Such de6 termination shall be made not later than 180 days 

7 after the completion of the demonstration. 

8 ‘‘(5) REQUIREMENTS REGARDING DEMONSTRA9 TIONS.—The Secretary may, by order or by regula10 tion, establish requirements for demonstrations 

11 under paragraph (1). 

12 ‘‘(6) RELATION TO OTHER PROCEDURES.—In 

13 the case of a dietary supplement with respect to 

14 which the Secretary has not issued an order under 

15 paragraph (1), this subsection may not be construed 

16 as preventing the Secretary from acting pursuant to 

17 section 402(f)(1) to the same extent and in the same 

18 manner as would apply in the absence of this sub19 section. In the case of a dietary supplement with re20 spect to which the Secretary has issued an order 

21 under paragraph (1), a determination under para22 graph (4) that the supplement is not adulterated 

23 under section 402(f)(1) does not prevent the Sec24 retary from making a determination, on the basis of 
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1 additional information obtained by the Secretary, 

2 that the supplement is so adulterated. 

3 ‘‘(f) SALES TO MINORS; SIGNIFICANT RISK.—

4 ‘‘(1) CRITERIA.—Not later than the expiration 

5 of the two-year period beginning on the date of the 

6 enactment of the Dietary Supplement Access and 

7 Awareness Act, the Secretary shall by regulation es8 tablish criteria for making a determination that a di9 etary supplement may pose a significant risk to indi10 viduals who are under the age of 18 (referred to in 

11 this section individually as a ‘minor’). 

12 ‘‘(2) PRODUCT DETERMINATION; PROHIBITED

13 ACT.—The Secretary may, by order or by regulation, 

14 make a determination described in paragraph (1) 

15 with respect to a dietary supplement. Effective upon 

16 the expiration of a period designated by the Sec17 retary in publishing such determination in the Fed18 eral Register, the act of selling the dietary supple19 ment to a minor shall be deemed to be an act which 

20 results in such supplement being misbranded while 

21 held for sale. During the two-year period referred to 

22 in paragraph (1), an order making such a deter23 mination may be issued notwithstanding that criteria 

24 have not yet been established in accordance with 

25 such paragraph. 
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1 ‘‘(g) RECORDKEEPING ON SAFETY ISSUES.—

2 ‘‘(1) IN GENERAL.—The Secretary shall by reg3 ulation require manufacturers of dietary supple4 ments to maintain records regarding reports of seri5 ous adverse experiences under subsection (c) and 

6 records regarding compliance with section 402. 

7 ‘‘(2) RETENTION PERIOD.—Regulations under 

8 paragraph (1) shall specify the number of years for 

9 which records required in such paragraph are re10 quired to be retained, except that, if under section 

11 402(g)(1) the Secretary makes a determination that 

12 expiration date labeling is necessary for dietary sup13 plements, records regarding dietary supplements in 

14 a lot shall be retained for not less than one year 

15 after the expiration date of supplements in the lot.’’. 

16 (b) PROHIBITED ACTS.—

17 (1) IN GENERAL.—Section 301 of the Federal 

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

19 amended by adding at the end the following: 

20 ‘‘(hh) The failure of a person to comply with any re21 quirement under section 416, other than an order under 

22 subsection (e)(1) of such section.’’. 

23 (2) ADULTERATED DIETARY SUPPLEMENTS.—

24 (A) ORDER REGARDING DEMONSTRATION

25 OF SAFETY.—Section 402 of the Federal Food, 
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1 Drug, and Cosmetic Act (21 U.S.C. 342) is 

2 amended by adding at the end the following: 

3 ‘‘(i) If it is a dietary supplement and the manufac4 turer of the supplement fails to comply with an order of 

5 the Secretary under section 416(e)(1) that is issued with 

6 respect to the supplement.’’. 

7 (B) CERTAIN COURT PROCEDURES; DE8 TERMINATION OF UNREASONABLE RISK.—Sec9 tion 402(f) of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 342(f)) is amended—

11 (i) in subparagraph (1), by striking 

12 the matter after and below clause (D) of 

13 such subparagraph; and 

14 (ii) by adding at the end the following 

15 subparagraph: 

16 ‘‘(3)(A) For purposes of clause (A) or (B) of subpara17 graph (1), the Secretary shall consider a dietary supple18 ment or dietary ingredient as presenting an unreasonable 

19 risk of illness or injury if the Secretary determines that 

20 the risks of such product outweighs its benefits, as indi21 cated by a relative weighing of the known and reasonably 

22 likely risks of the product against its known and reason23 ably likely benefits. In the absence of a sufficient benefit, 

24 the presence of even a relatively small risk of a serious 
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1 adverse health effect to a user may be considered by the 

2 Secretary as unreasonable. 

3 ‘‘(B) A determination by the Secretary under clause 

4 (A) with respect to the risk of a product may be made 

5 on the basis of any science-based evidence of risk, without 

6 the need to prove that the substance has actually caused 

7 harm in particular cases. The Secretary shall consider any 

8 relevant evidence including but not limited to scientific 

9 data about the toxicological properties of a dietary ingre10 dient or its mechanism of action; known effects of pharma11 cologically related compounds, including those regulated 

12 as drugs; the results of clinical studies, including observa13 tional studies; and adverse event reports. 

14 ‘‘(C) A determination that a product presents an un15 reasonable risk may be made under clause (A) by the Sec16 retary even though there are uncertainties as to the levels 

17 of a dietary ingredient that may present a risk.’’. 

18 (3) TRADE SECRETS.—Section 301(j) of the 

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

20 331(j)) is amended by inserting ‘‘416,’’ after 

21 ‘‘414,’’. 

22 (c) INSPECTION AUTHORITY.—Section 704(a) of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) 

24 is amended—
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1 (1) in paragraph (1), by inserting after the sec2 ond sentence the following: ‘‘In the case of any per3 son who manufactures, processes, packs, transports, 

4 distributes, holds, or imports a dietary supplement 

5 with respect to which an order under section 

6 416(e)(1) has been issued, the inspection shall ex7 tend to all records, files, papers, processes, controls, 

8 and facilities bearing on whether the dietary supple9 ment is adulterated under section 402(f)(1).’’; and 

10 (2) in paragraph (2), in the matter preceding 

11 subparagraph (A), by striking ‘‘third sentence’’ and 

12 inserting ‘‘fourth sentence’’. 

13 SEC. 3. EDUCATION PROGRAMS REGARDING DIETARY SUP14 PLEMENTS. 

15 (a) HEALTH CARE PROFESSIONALS.—

16 (1) IN GENERAL.—The Secretary of Health and 

17 Human Services (referred to in this section as the 

18 ‘‘Secretary’’), acting through the Commissioner of 

19 Food and Drugs, shall carry out a program to edu20 cate health professionals on the importance of re21 porting to the Food and Drug Administration ad22 verse health experiences that are associated with die23 tary supplements. 

24 (2) AUTHORIZATION OF APPROPRIATIONS.—For 

25 the purpose of carrying out paragraph (1), there is 
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1 authorized to be appropriated $5,000,000 for fiscal 

2 year 2006, in addition to any other authorization of 

3 appropriations that is available with respect to such 

4 purpose. 

5 (b) CONSUMERS.—

6 (1) IN GENERAL.—The Secretary, acting 

7 through the Commissioner of Food and Drugs, shall 

8 carry out a program to educate consumers of dietary 

9 supplements on the importance of informing their 

10 health professionals of the dietary supplements and 

11 drugs the consumers are taking. 

12 (2) AUTHORIZATION OF APPROPRIATIONS.—For 

13 the purpose of carrying out paragraph (1), there is 

14 authorized to be appropriated $5,000,000 for fiscal 

15 year 2006, in addition to any other authorization of 

16 appropriations that is available with respect to such 

17 purpose.

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