I 

108TH CONGRESS 

2D SESSION H. R. 4747

To ensure that the goals of the Dietary Supplement Health and Education 

Act of 1994 are met by authorizing appropriations to fully enforce 

and implement such Act and the amendments made by such Act, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 25, 2004

Mr. PALLONE introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL

To ensure that the goals of the Dietary Supplement Health 

and Education Act of 1994 are met by authorizing appropriations to fully enforce and implement such Act 

and the amendments made by such Act, 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 Regulatory Implementation Act of 2004’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 
2

•HR 4747 IH 

1 (1) Over 158,000,000 Americans regularly con2 sume dietary supplements to maintain and improve 

3 their health. 

4 (2) Consumer expenditures on dietary supple5 ments reached a reported $17,100,000,000 in 2000, 

6 double the amount spent in 1994. 

7 (3) According to a recent report issued by the 

8 Food and Drug Administration (‘‘FDA’’) the use of 

9 dietary supplements is likely to grow due to factors 

10 such as the aging of the baby boom generation, in11 creased interest in self-sufficiency, and advances in 

12 science that are uncovering new relationships be13 tween diet and disease. 

14 (4) In 1994, the Dietary Supplement Health 

15 and Education Act of 1994 (Public Law 103–417) 

16 (‘‘DSHEA’’) was enacted. That Act balanced contin17 ued consumer access to vitamins, minerals, and 

18 other dietary supplements, increased scientific re19 search on the benefits and risks of dietary supple20 ments, public education on dietary supplements, and 

21 needed consumer protections. 

22 (5) DSHEA requires that claims made on die23 tary supplement labels, packaging, and accom24 panying material be truthful, non-misleading, and 

25 substantiated. Manufacturers are prohibited from 
3

•HR 4747 IH 

1 making claims that products are intended to diag2 nose, treat, mitigate, cure, or prevent a disease. 

3 (6) DSHEA provides for good manufacturing 

4 practice standards setting requirements for potency, 

5 purity, sanitary conditions, and recordkeeping for di6 etary supplements. 

7 (7) DSHEA provides that dietary supplements 

8 are to be regulated like foods and not drugs or food 

9 additives. 

10 (8) DSHEA requires that manufacturers sub11 mit adequate information as to the safety of any 

12 new ingredients contained in dietary supplements be13 fore those products can be sold. 

14 (9) DSHEA provides the FDA with a number 

15 of powers to remove unsafe dietary supplements 

16 from the marketplace. 

17 (10) DSHEA created the Office of Dietary 

18 Supplements within the National Institutes of 

19 Health to expand research and consumer informa20 tion about the health effects of dietary supplements. 

21 (11) The FDA has not adequately used its au22 thority to enforce DSHEA. 

23 (12) The FDA needs adequate resources to ap24 propriately implement and enforce DSHEA. Con25 gress has appropriated additional funds over the last 
4

•HR 4747 IH 

1 several years beyond those requested in the Presi2 dent’s budget to implement and enforce DSHEA, 

3 reaching $9,700,000 in fiscal year 2003. 

4 (13) However, according to the FDA, full im5 plementation of DSHEA would require substantial 

6 additional resources. The FDA asserts that between 

7 $24,000,000 and $65,000,000 per year will be need8 ed to fully implement DSHEA. 

9 SEC. 3. AUTHORIZATION AND APPROPRIATION OF RE10 SOURCES. 

11 (a) AUTHORIZATION OF APPROPRIATIONS.—There 

12 are authorized to be appropriated to carry out the Dietary 

13 Supplement Health and Education Act of 1994 (Public 

14 Law 103–417), the amendments made by such Act, and 

15 all applicable regulatory requirements for dietary supple16 ments under the Federal Food, Drug, and Cosmetic Act 

17 (21 U.S.C. 301 et seq.)—

18 (1) $30,000,000 for fiscal year 2006; 

19 (2) $40,000,000 for fiscal year 2007; 

20 (3) $50,000,000 for fiscal year 2008; and 

21 (4) $65,000,000 for fiscal year 2009. 

22 (b) APPROPRIATION OF FUNDS FOR FISCAL YEAR

23 2005.—There is appropriated, out of any money in the 

24 Treasury not otherwise appropriated, to carry out the Die25 tary Supplement Health and Education Act of 1994 (Pub-
5

•HR 4747 IH 

1 lic Law 103–417), the amendments made by such Act, and 

2 all applicable regulatory requirements for dietary supple3 ments under the Federal Food, Drug, and Cosmetic Act 

4 (21 U.S.C. 301 et seq.), $20,000,000 for fiscal year 2005. 

5 (c) OFFICE OF DIETARY SUPPLEMENTS.—

6 (1) AUTHORIZATION OF APPROPRIATIONS.—

7 There are authorized to be appropriated for ex8 panded research and development of consumer infor9 mation, including information on safety and bene10 ficial effects, of dietary supplements by the Office of 

11 Dietary Supplements at the National Institutes of 

12 Health such sums as may be necessary for each of 

13 the fiscal years 2006 through 2009. 

14 (2) APPROPRIATION OF FUNDS FOR FISCAL

15 YEAR 2005.—There is appropriated, out of any 

16 money in the Treasury not otherwise appropriated, 

17 for expanded research and development of consumer 

18 information, including information on safety and 

19 beneficial effects, of dietary supplements by the Of20 fice of Dietary Supplements at the National Insti21 tutes of Health $30,000,000 for fiscal year 2005. 

22 (d) USE OF FUNDS.—The Secretary of Health and 

23 Human Services shall fully and appropriately use the 

24 funds appropriated in subsections (b) and (c) and pursu25 ant to subsection (a) to regulate dietary supplements. 
6

•HR 4747 IH 

1 SEC. 4. ANNUAL ACCOUNTABILITY REPORT ON THE REGU2 LATION OF DIETARY SUPPLEMENTS. 

3 (a) IN GENERAL.—Not later than January 31, 2006, 

4 and annually thereafter, the Secretary shall submit a re5 port to Congress on the implementation and enforcement 

6 of the Dietary Supplement Health and Education Act of 

7 1994 (Public Law 103–417). 

8 (b) CONTENTS.—The report under subsection (a) 

9 shall include the following: 

10 (1) The total funding and number of full-time 

11 equivalent personnel in the Food and Drug Adminis12 tration dedicated to dietary supplement regulation 

13 over the prior fiscal year. 

14 (2) The total funding and number of full-time 

15 equivalent personnel in the Food and Drug Adminis16 tration dedicated to administering adverse event re17 porting systems as they relate to dietary supplement 

18 regulation over the prior fiscal year. 

19 (3) The total funding and number of full-time 

20 equivalent personnel in the Food and Drug Adminis21 tration dedicated to enforcement of dietary supple22 ment labeling and claims requirements over the prior 

23 fiscal year and an explanation of their activities. 

24 (4) The total funding and number of full-time 

25 equivalent personnel in the Food and Drug Adminis26 tration dedicated to good manufacturing practices 
7

•HR 4747 IH 

1 inspections of dietary supplement manufacturers 

2 over the prior fiscal year and an explanation of their 

3 activities. 

4 (5) The number of good manufacturing prac5 tices inspections of dietary supplement manufactur6 ers by the Food and Drug Administration over the 

7 prior fiscal year and a summary of the results. 

8 (6) The number of new ingredient reviews and 

9 safety reviews related to dietary supplements and 

10 the results of those reviews. 

11 (7) An explanation of all enforcement actions 

12 taken by the Food and Drug Administration and the 

13 Department of Health and Human Services related 

14 to dietary supplements over the prior fiscal year, in15 cluding the number and type of actions. 

16 (8) The number of dietary supplement claims 

17 for which the Food and Drug Administration re18 quested substantiation from the manufacturer over 

19 the prior fiscal year, and the agency’s response. 

20 (9) The number of dietary supplement claims 

21 determined to be false, misleading, or unsubstan22 tiated by the Food and Drug Administration over 

23 the prior fiscal year. 
8

•HR 4747 IH 

1 (10) The research and consumer education ac2 tivities supported by the Office of Dietary Supple3 ments of the National Institutes of Health. 

4 (11) Any recommendations for administrative 

5 or legislative actions regarding the regulation of die6 tary supplements. 

7 (12) Any other information regarding the regu8 lation of dietary supplements determined appropriate 

9 by the Secretary. 

10 SEC. 5. DIETARY SUPPLEMENTS CONTAINING EPHEDRINE 

11 ALKALOIDS. 

12 (a) FINDINGS.—The Congress finds that—

13 (1) dietary supplements containing ephedrine 

14 alkaloids may present a significant or unreasonable 

15 risk of illness or injury; and 

16 (2) through section 402(f) of the Federal Food, 

17 Drug, and Cosmetic Act (established by the Dietary 

18 Supplement Health and Education Act of 1994), the 

19 Congress has granted the Secretary the authority to 

20 remove from the market dietary supplements that 

21 present such a risk. 

22 (b) SENSE OF CONGRESS REGARDING RISK OF ILL23 NESS OR INJURY.—It is the sense of the Congress that, 

24 in the event the Secretary determines under section 402(f) 

25 of the Federal Food, Drug, and Cosmetic Act that a die-
9

•HR 4747 IH 

1 tary supplement containing ephedrine alkaloids presents 

2 a significant or unreasonable risk of illness or injury—

3 (1) all dietary supplements containing such 

4 alkaloids should be declared to be adulterated in ac5 cordance with such section; and 

6 (2) the Secretary should take all necessary ac7 tions to remove all such supplements from the mar8 ket. 

9 (c) SENSE OF CONGRESS REGARDING BOTANICAL

10 SOURCES.—It is the sense of the Congress that the Sec11 retary should take steps to assure the continued avail12 ability of botanical sources of ephedrine alkaloids that—

13 (1) are in forms that have not been manipu14 lated or chemically altered to increase their ephed15 rine alkaloid concentration or content; 

16 (2) are marketed at dosages that are substan17 tiated to be at levels used in traditional herbal for18 mulas; and 

19 (3) are labeled only for traditional uses and not 

20 for weight loss or energy. 

21 SEC. 6. EDUCATION PROGRAMS REGARDING DIETARY SUP22 PLEMENTS. 

23 (a) HEALTH CARE PROFESSIONALS.—

24 (1) IN GENERAL.—The Secretary shall carry 

25 out a program to educate health professionals on the 
10

•HR 4747 IH 

1 safety and health benefits of dietary supplements, 

2 including the potential for dietary supplement/drug 

3 interactions. 

4 (2) AUTHORIZATION OF APPROPRIATIONS.—For 

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

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

7 year 2005, in addition to any other authorization of 

8 appropriations that is available with respect to such 

9 purpose. 

10 (b) CONSUMERS.—

11 (1) IN GENERAL.—The Secretary shall carry 

12 out a program to educate consumers of dietary sup13 plements on the safety and health benefits of the di14 etary supplements, including the potential for die15 tary supplement/drug interactions through public 

16 education forums, advertisements, and the Internet. 

17 (2) AUTHORIZATION OF APPROPRIATIONS.—For 

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

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

20 year 2005, in addition to any other authorization of 

21 appropriations that is available with respect to such 

22 purpose. 

23 SEC. 7. ADVERSE EVENT REPORTING SYSTEM. 

24 The Secretary shall establish a system for the re25 quirements for the reporting of serious adverse experi-
11

•HR 4747 IH 

1 ences associated with the use of a dietary supplement re2 ceived by the manufacturer, packer, or distributor whose 

3 name appears on the label of the product. 

4 SEC. 8. DEFINITION. 

5 For purposes of this Act, the term ‘‘Secretary’’ 

6 means the Secretary of Health and Human Services, act7 ing through the Commissioner of Food and Drugs.

Æ