II 

111TH CONGRESS 

2D SESSION S. 3414 

To ensure that the Dietary Supplement Health and Education Act of 1994 

and other requirements for dietary supplements under the jurisdiction 

of the Food and Drug Administration are fully implemented and enforced, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 25, 2010 

Mr. HARKIN (for himself and Mr. HATCH) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To ensure that the Dietary Supplement Health and Education Act of 1994 and other requirements for dietary 

supplements under the jurisdiction of the Food and Drug 

Administration are fully implemented and enforced, 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 Full Implementation and Enforcement Act of 2010’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


smartinez on DSKB9S0YB1PROD with BILLS
2 

•S 3414 IS

1 (1) Each year, more than 150,000,000 Ameri2 cans regularly consume dietary supplements to 

3 maintain and improve their health. 

4 (2) Consumer expenditures on dietary supple5 ments exceeded $25,000,000,000 in 2008. 

6 (3) Given the growing awareness of the impor7 tance of prevention and wellness in the health care 

8 system of the United States, it is vital that laws gov9 erning the safety of, and education about, dietary 

10 supplements be fully implemented and enforced. 

11 (4) In 1994, Congress approved, and the Presi12 dent signed into law, the Dietary Supplement Health 

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

14 (referred to in this Act as ‘‘DSHEA’’). DSHEA bal15 anced the importance of continuing consumer access 

16 to vitamins, minerals, and other dietary supple17 ments, promoting scientific research on the benefits 

18 and risks of dietary supplements, and fostering pub19 lic education on the benefits and risks of supplement 

20 use with the need for regulatory safeguards to pro21 tect consumer health, including a new standard for 

22 safety, penalties for mislabeled or adulterated die23 tary supplements, rules to ensure scientific substan24 tiation of the claims made regarding dietary supple25 ments, and a notification requirement to the Food 


smartinez on DSKB9S0YB1PROD with BILLS
3 

•S 3414 IS

1 and Drug Administration before dietary supplements 

2 that contain certain new dietary ingredients may be 

3 marketed. 

4 (5) DSHEA requires that claims made on die5 tary supplement labels, packaging, and accom6 panying material be truthful, non-misleading, and 

7 substantiated. Manufacturers are prohibited from 

8 making claims that products are intended to diag9 nose, treat, mitigate, cure, or prevent a disease. 

10 (6) DSHEA requires that dietary supplements 

11 comply with good manufacturing practice (referred 

12 to in this section as ‘‘GMP’’) requirements, and au13 thorizes the Food and Drug Administration to estab14 lish such requirements. 

15 (7) In 2007, after many years of delay, the 

16 Food and Drug Administration published regula17 tions detailing the GMP requirements for dietary 

18 supplements, including requirements for identity, pu19 rity, strength, sanitary conditions, and record20 keeping. The Food and Drug Administration began 

21 to enforce those requirements in 2008. 

22 (8) DSHEA requires that, before marketing a 

23 dietary supplement containing certain new dietary 

24 ingredients, the manufacturer or distributor must 

25 submit notice to the Food and Drug Administration 


smartinez on DSKB9S0YB1PROD with BILLS
4 

•S 3414 IS

1 that includes information showing that the dietary 

2 supplement will reasonably be expected to be safe. 

3 According to the Food and Drug Administration, the 

4 Food and Drug Administration has raised objections 

5 to more than 70 percent of all new dietary ingre6 dient notifications submitted to the agency. 

7 (9) The Food and Drug Administration has 

8 successfully used the adulteration provisions of 

9 DSHEA to remove from the marketplace dietary 

10 supplements that present an unreasonable risk of in11 jury or illness. 

12 (10) In 2002, Congress passed the Public 

13 Health Security and Bioterrorism Preparedness and 

14 Response Act (Public Law 107–188). This law re15 quires any facility engaged in manufacturing, proc16 essing, packing, or holding food for consumption in 

17 the United States, including dietary supplements, to 

18 be registered with the Food and Drug Administra19 tion. 

20 (11) In 2006, Congress supplemented DSHEA 

21 by approving the Dietary Supplement and Non22 prescription Drug Consumer Protection Act (Public 

23 Law 109–462). This law requires dietary supple24 ment manufacturers, packers, and distributors to re25 port promptly to the Food and Drug Administration 


smartinez on DSKB9S0YB1PROD with BILLS
5 

•S 3414 IS

1 any reports the manufacturer or other responsible 

2 person receives of serious adverse events associated 

3 with the use of the products of such manufacturer 

4 or other responsible person. Information the Food 

5 and Drug Administration receives under this report6 ing requirement may help the agency detect possible 

7 safety problems related to dietary supplement prod8 ucts or ingredients. 

9 (12) DSHEA created the Office of Dietary 

10 Supplements within the National Institutes of 

11 Health to expand research and consumer informa12 tion about the health effects of dietary supplements. 

13 The Office of Dietary Supplements has greatly ex14 panded the number of scientific studies of dietary 

15 supplements and the availability of reliable informa16 tion to consumers. 

17 (13) While the Food and Drug Administration 

18 has taken some important steps to implement and 

19 enforce DSHEA and the other laws governing the 

20 regulation of dietary supplements, the agency has 

21 not fully implemented and enforced DSHEA and the 

22 other laws governing the regulation of dietary sup23 plements. 

24 (14) Both the public and regulated industry 

25 would benefit from more guidance from the Food 


smartinez on DSKB9S0YB1PROD with BILLS
6 

•S 3414 IS

1 and Drug Administration on the procedures and 

2 definitions concerning the regulation of new dietary 

3 ingredients under section 413 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 350b). 

5 (15) If the Food and Drug Administration de6 termines that a product labeled as a dietary supple7 ment includes an anabolic steroid or an analogue of 

8 an anabolic steroid, the Food and Drug Administra9 tion does not systematically notify the Drug En10 forcement Administration of that determination. 

11 (16) The Food and Drug Administration needs 

12 adequate resources to implement and enforce 

13 DSHEA and other laws governing the regulation of 

14 dietary supplements appropriately. Congress has ap15 propriated additional funds over the last several 

16 years to implement and enforce DSHEA, reaching 

17 more than $14,000,000 for fiscal year 2009. 

18 (17) According to the Food and Drug Adminis19 tration, full implementation of DSHEA and the 

20 other laws governing the regulation of dietary sup21 plements would require substantial additional re22 sources. In 2002, the Food and Drug Administra23 tion reported to Congress in writing that the agency 

24 would need between $24,000,000 and $65,000,000 

25 per year to fully implement DSHEA. 


smartinez on DSKB9S0YB1PROD with BILLS
7 

•S 3414 IS

1 SEC. 3. SENSE OF CONGRESS. 

2 It is the sense of Congress that: 

3 (1) The Food and Drug Administration should 

4 increase efforts to implement DSHEA more fully 

5 and effectively, by— 

6 (A) providing Congress with a professional 

7 judgment estimate of the annual costs during 

8 the 5-year period beginning on the date of en9 actment of this Act to fully implement and en10 force DSHEA and other dietary supplement 

11 laws and regulations under the jurisdiction of 

12 the Food and Drug Administration; 

13 (B) conducting inspections, using appro14 priately trained inspection personnel, of all fa15 cilities in which a dietary supplement is manu16 factured, processed, packed, or held to ensure 

17 compliance with the new dietary supplement 

18 good manufacturing practices regulations; 

19 (C) using the authority under DSHEA to 

20 protect the public from unsafe dietary supple21 ment products and ingredients and to ensure 

22 that claims made are truthful, non-misleading, 

23 and substantiated, with highest regulatory pri24 ority given to cases of clear violations of the law 

25 (including the intentional adulteration and spik26 ing of products); 


smartinez on DSKB9S0YB1PROD with BILLS
8 

•S 3414 IS

1 (D) implementing the recommendations 

2 contained in the January 2009 report of the 

3 Government Accountability Office, entitled, 

4 ‘‘Dietary Supplements: FDA Should Take Fur5 ther Actions To Improve Oversight and Con6 sumer Understanding’’, (GAO 09–250) that the 

7 Food and Drug Administration— 

8 (i) require all dietary supplement 

9 manufacturers, packers, and distributors 

10 to identify themselves specifically as such 

11 under existing registration requirements 

12 and to update such information annually; 

13 (ii) promptly issue guidance to clarify 

14 when a dietary supplement ingredient is a 

15 new dietary ingredient, the evidence needed 

16 to document the safety of new dietary in17 gredients, and appropriate methods for es18 tablishing the identity of a new dietary in19 gredient; and 

20 (iii) coordinate with stakeholder 

21 groups involved in consumer outreach to 

22 identify, implement, and evaluate the effec23 tiveness of additional mechanisms for edu24 cating consumers about the safety, effiVerDate Mar 15 2010 03:02 May 26, 2010 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3414.IS S3414

smartinez on DSKB9S0YB1PROD with BILLS
9 

•S 3414 IS

1 cacy, and labeling of dietary supplements; 

2 and 

3 (E) notifying the Drug Enforcement Ad4 ministration if the Food and Drug Administra5 tion determines that the information in a new 

6 dietary ingredient notification submitted under 

7 section 413 of the Federal Food, Drug, and 

8 Cosmetic Act (21 U.S.C. 350b) is inadequate to 

9 establish that the new dietary ingredient will 

10 reasonably be expected to be safe, because the 

11 dietary supplement may contain an anabolic 

12 steroid or an analogue of an anabolic steroid. 

13 (2) The manufacturers, packers, retailers, and 

14 distributors of dietary supplements and dietary sup15 plement ingredients should increase efforts to— 

16 (A) comply fully with all requirements of 

17 DSHEA and the Dietary Supplement and Non18 prescription Drug Consumer Protection Act; 

19 (B) cooperate fully and appropriately with 

20 the Food and Drug Administration in imple21 mentation and enforcement of Federal laws and 

22 regulations; and 

23 (C) provide the Food and Drug Adminis24 tration with appropriate input on known and 


smartinez on DSKB9S0YB1PROD with BILLS
10 

•S 3414 IS

1 suspected violations of such laws and regula2 tions. 

3 SEC. 4. AUTHORIZATION OF APPROPRIATIONS AND ALLO4 CATION OF RESOURCES. 

5 (a) AUTHORIZATION OF APPROPRIATIONS.—There 

6 are authorized to be appropriated to carry out the Dietary 

7 Supplement Health and Education Act of 1994, the 

8 amendments made by such Act, and other provisions 

9 under the Federal Food, Drug, and Cosmetic Act (21 

10 U.S.C. 301 et seq.) that apply to dietary supplements, 

11 $30,000,000 for fiscal year 2011 and such sums as may 

12 be necessary for each of fiscal years 2012 through 2014. 

13 (b) ALLOCATION OF FUNDS FOR FISCAL YEAR

14 2010.—From funds appropriated to the Food and Drug 

15 Administration for fiscal year 2010 for the purpose of en16 hancing food safety, not less than $20,000,000 shall be 

17 expended to effectively and fully implement and enforce 

18 the Dietary Supplement Health and Education Act of 

19 1994, the amendments made by such Act, and other provi20 sions under the Federal Food, Drug, and Cosmetic Act 

21 (21 U.S.C. 301 et seq.) that apply to dietary supplements. 

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

23 authorized to be appropriated for expanded research and 

24 development of consumer information on dietary suppleVerDate Mar 15 2010 03:02 May 26, 2010 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3414.IS S3414

smartinez on DSKB9S0YB1PROD with BILLS
11 

•S 3414 IS

1 ments by the Office of Dietary Supplements at the Na2 tional Institutes of Health— 

3 (1) $40,000,000 for fiscal year 2010; and 

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

5 the fiscal years 2011 through 2014. 

6 SEC. 5. ANNUAL ACCOUNTABILITY REPORT ON THE REGU7 LATION OF DIETARY SUPPLEMENTS. 

8 (a) IN GENERAL.—Not later than January 31, 2011, 

9 and annually thereafter, the Secretary of Health and 

10 Human Services shall submit a report to Congress on the 

11 implementation and enforcement of the Dietary Supple12 ment Health and Education Act of 1994 and the amend13 ments made by such Act. 

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

15 shall include the following: 

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

17 equivalent personnel in the Food and Drug Adminis18 tration dedicated to dietary supplement regulation 

19 during the prior fiscal year. 

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

21 equivalent personnel in the Food and Drug Adminis22 tration dedicated to administering adverse event re23 porting systems, as such systems relate to dietary 

24 supplement regulation, during the prior fiscal year. 


smartinez on DSKB9S0YB1PROD with BILLS
12 

•S 3414 IS

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

2 equivalent personnel in the Food and Drug Adminis3 tration dedicated to enforcement of dietary supple4 ment labeling and claims requirements during the 

5 prior fiscal year and a brief explanation of the activi6 ties of such personnel. 

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

8 equivalent personnel in the Food and Drug Adminis9 tration dedicated to the review and enforcement of 

10 good manufacturing practice requirements with re11 spect to dietary supplements during the prior fiscal 

12 year. 

13 (5) The number of inspections at which the 

14 Food and Drug Administration evaluated or re15 viewed the compliance of a manufacturer with good 

16 manufacturing practices for dietary supplements 

17 during the prior fiscal year, and the number of times 

18 the Food and Drug Administration issued a warning 

19 letter because it determined that such manufacturer 

20 was not in compliance with some aspect of such re21 quirements. 

22 (6) The number of new dietary ingredient noti23 fication reviews that the Food and Drug Administra24 tion performed during the prior fiscal year and the 

25 number of times the Food and Drug Administration 


smartinez on DSKB9S0YB1PROD with BILLS
13 

•S 3414 IS

1 objected to the marketing of the dietary supplement 

2 described in such notification reviews. 

3 (7) The number of times the Food and Drug 

4 Administration issued a warning letter or initiated 

5 an enforcement action against a manufacturer or 

6 distributor for failure to file a new dietary ingredient 

7 notification as required under section 413 of the 

8 Federal Food, Drug, and Cosmetic Act. 

9 (8) A brief summary and explanation of all en10 forcement actions taken by the Food and Drug Ad11 ministration and the Department of Health and 

12 Human Services related to dietary supplements dur13 ing the prior fiscal year, including the number and 

14 type of actions. 

15 (9) The number of times the Food and Drug 

16 Administration requested substantiation of dietary 

17 supplement claims from a manufacturer during the 

18 prior fiscal year, the number of times a manufac19 turer refused to provide such information, and the 

20 response of the agency in such situations. 

21 (10) The number of dietary supplement claims 

22 determined by the Food and Drug Administration 

23 during the prior fiscal year to be false, misleading, 

24 or not substantiated, and a description of the follow25 up action taken by the agency in such instances. 


smartinez on DSKB9S0YB1PROD with BILLS
14 

•S 3414 IS

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

4 the prior fiscal year. 

5 (12) Any recommendations for administrative 

6 or legislative actions to improve the regulation of di7 etary supplements. 

8 (13) Any other information regarding the regu9 lation of dietary supplements determined appropriate 

10 by the Secretary of Health and Human Services or 

11 the Commissioner of Food and Drugs. 

12 SEC. 6. NEW DIETARY INGREDIENTS. 

13 (a) GUIDELINES FOR INTRODUCING NEW DIETARY

14 INGREDIENTS.—Section 413 of the Federal Food, Drug, 

15 and Cosmetic Act (21 U.S.C. 350b) is amended— 

16 (1) by redesignating subsection (c) as sub17 section (e); and 

18 (2) by inserting after subsection (b) the fol19 lowing: 

20 ‘‘(c) GUIDELINES.—Not later than 180 days after the 

21 date of enactment of the Dietary Supplement Full Imple22 mentation and Enforcement Act of 2010, the Secretary 

23 shall publish guidance that clarifies when a dietary supple24 ment ingredient is a new dietary ingredient, when the 

25 manufacturer or distributor of a dietary ingredient or dieVerDate Mar 15 2010 03:02 May 26, 2010 Jkt 089200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S3414.IS S3414

smartinez on DSKB9S0YB1PROD with BILLS
15 

•S 3414 IS

1 tary supplement should provide the Secretary with infor2 mation as described in subsection (a)(2), the evidence 

3 needed to document the safety of new dietary ingredients, 

4 and appropriate methods for establishing the identity of 

5 a new dietary ingredient. 

6 ‘‘(d) NOTIFICATION TO DEA.— 

7 ‘‘(1) IN GENERAL.—If the Secretary determines 

8 that the information in a new dietary ingredient no9 tification submitted under this section for an article 

10 purported to be a new dietary ingredient is inad11 equate to establish that a dietary supplement con12 taining such article will reasonably be expected to be 

13 safe because the article may be, or may contain, an 

14 anabolic steroid or an analogue of an anabolic ster15 oid, the Secretary shall notify the Drug Enforcement 

16 Administration of such determination. Such notifica17 tion by the Secretary shall include, at a minimum, 

18 the name of the product or article, the name of the 

19 person or persons who marketed the product or 

20 made the submission of information regarding the 

21 article to the Secretary under this section, and any 

22 contact information for such person or persons that 

23 the Secretary has. 

24 ‘‘(2) DEFINITIONS.—For purposes of this sub25 section— 


smartinez on DSKB9S0YB1PROD with BILLS
16 

•S 3414 IS

1 ‘‘(A) the term ‘anabolic steroid’ has the 

2 meaning given such term in section 102(41) of 

3 the Controlled Substances Act; and 

4 ‘‘(B) the term ‘analogue of an anabolic 

5 steroid’ means a substance whose chemical 

6 structure is substantially similar to the chem7 ical structure of an anabolic steroid.’’. 

Æ 


smartinez on DSKB9S0YB1PROD with BILLS