I 

108TH CONGRESS 

2D SESSION H. R. 4760 

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 

JULY 6, 2004 

Mr. BURTON of Indiana (for himself and 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 ‘‘DSHEA Full Imple5 mentation and Enforcement Act of 2004’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 
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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 (in this Act referred 

9 to as the ‘‘FDA’’) the use of dietary supplements is 

10 likely to grow due to factors such as the aging of the 

11 baby boom generation, increased interest in self-suf12 ficiency, and advances in science that are uncovering 

13 new relationships between diet and disease. 

14 (4) In 1994, the Dietary Supplement Health 

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

16 (in this Act referred to as ‘‘DSHEA’’) was enacted. 

17 This Act balanced continued consumer access to vi18 tamins, minerals, and other dietary supplements, in19 creased scientific research on the benefits and risks 

20 of dietary supplements, public education on dietary 

21 supplements, and 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 
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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 requires that manufacturers sub8 mit adequate information as to the safety of any 

9 new ingredients contained in dietary supplements be10 fore those products can be sold. 

11 (8) The FDA has updated and expanded its 

12 system for the reporting, collection, and analysis of 

13 dietary supplement adverse events reports. 

14 (9) DSHEA provides the FDA with a number 

15 of authoritites 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 
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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) $20,000,000 for fiscal year 2005; 

19 (2) $30,000,000 for fiscal year 2006; 

20 (3) $40,000,000 for fiscal year 2007; 

21 (4) $50,000,000 for fiscal year 2008; and 

22 (5) $65,000,000 for fiscal year 2009. 

23 (b) APPROPRIATION OF FUNDS FOR FISCAL YEAR

24 2005.—There are appropriated, out of any money in the 

25 Treasury not otherwise appropriated, to carry out the Die-
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1 tary Supplement Health and Education Act of 1994 (Pub2 lic Law 103–417), the amendments made by such Act, and 

3 all applicable regulatory requirements for dietary supple4 ments under the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 301 et seq.), $20,000,000 for fiscal year 2005. 

6 (c) OFFICE OF DIETARY SUPPLEMENTS.—There are 

7 authorized to be appropriated and there are appropriated, 

8 out of any money in the Treasury not otherwise appro9 priated, for expanded research and development of con10 sumer information on dietary supplements by the Office 

11 of Dietary Supplements at the National Institutes of 

12 Health— 

13 (1) $30,000,000 for fiscal year 2005; and 

14 (2) such sums as may be necessary for each of 

15 the fiscal years 2006 through 2009. 

16 (d) USE OF FUNDS.—The Food and Drug Adminis17 tration shall fully and appropriately use the funds appro18 priated in subsections (b) and (c) and pursuant to sub19 section (a) to regulate dietary supplements. 

20 SEC. 4. ANNUAL ACCOUNTABILITY REPORT ON THE REGU21 LATION OF DIETARY SUPPLEMENTS. 

22 (a) IN GENERAL.—Not later than January 31, 2005, 

23 and annually thereafter, the Secretary of Health and 

24 Human Services shall submit a report to Congress on the 

25 implementation and enforcement of the Dietary Supple-
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1 ment Health and Education Act of 1994 (Public Law 

2 103–417). 

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

4 shall include the following: 

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

6 equivalent personnel in the Food and Drug Adminis7 tration dedicated to dietary supplement regulation 

8 over the prior fiscal year. 

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

10 equivalent personnel in the Food and Drug Adminis11 tration dedicated to administering adverse event re12 porting systems as they relate to dietary supplement 

13 regulation over the prior fiscal year. 

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

15 equivalent personnel in the Food and Drug Adminis16 tration dedicated to enforcement of dietary supple17 ment labeling and claims requirements over the prior 

18 fiscal year and an explanation of their activities. 

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

20 equivalent personnel in the Food and Drug Adminis21 tration dedicated to good manufacturing practices 

22 inspections of dietary supplement manufacturers 

23 over the prior fiscal year and an explanation of their 

24 activities. 
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1 (5) The number of good manufacturing prac2 tices inspections of dietary supplement manufactur3 ers by the Food and Drug Administration over the 

4 prior fiscal year and a summary of the results. 

5 (6) The number of new ingredient reviews and 

6 safety reviews related to dietary supplements and 

7 the results of those reviews. 

8 (7) An explanation of all enforcement actions 

9 taken by the Food and Drug Administration and the 

10 Department of Health and Human Services related 

11 to dietary supplements over the prior fiscal year, in12 cluding the number and type of actions. 

13 (8) The number of dietary supplement claims 

14 for which the Food and Drug Administration re15 quested substantiation from the manufacturer over 

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

17 (9) The number of dietary supplement claims 

18 determined to be false, misleading, or nonsubstan19 tiated by the Food and Drug Administration over 

20 the prior fiscal year. 

21 (10) The research and consumer education ac22 tivities supported by the Office of Dietary Supple23 ments of the National Institutes of Health. 
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1 (11) Any recommendations for administrative 

2 or legislative actions regarding the regulation of die3 tary supplements. 

4 (12) Any other information regarding the regu5 lation of dietary supplements determined appropriate 

6 by the Secretary of Health and Human Services or 

7 the Commissioner of Food and Drugs. 

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