I 

112TH CONGRESS 

1ST SESSION H. R. 3380 

To amend the Federal Food, Drug, and Cosmetic Act concerning safe dietary 

ingredients in dietary supplements. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 4, 2011 

Mr. BURTON of Indiana 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 

concerning safe dietary ingredients in 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 Protection Act of 2011’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) Improving the health status of United 

9 States citizens ranks at the top of the national prior10 ities of the Federal Government. The importance of 


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1 nutrition and the benefits of dietary supplements to 

2 health promotion and disease prevention are well 

3 known and have been documented in scientific stud4 ies. 

5 (2) Since enactment of the Dietary Supplement 

6 Health and Education Act of 1994 (DSHEA), die7 tary supplements have had an exemplary public 

8 health safety record. Based on national surveys, in 

9 1994, 50 percent of the 260,000,000 Americans reg10 ularly consumed dietary supplements. In 2006, 

11 232,000,000 adults over the age of 18 alone con12 sumed dietary supplements, 53 percent of the 

13 United States adult population. 

14 (3) There were 4,000 dietary supplements in 

15 the marketplace in 1994, and in 2006 an estimated 

16 29,000 dietary supplements were being consumed 

17 daily by Americans. Since the enactment of 

18 DSHEA, there has been 17 years of additional his19 torical use-safety experience conducted by millions of 

20 Americans. Over 17 years, approximately 25,000 

21 new supplements with new dietary ingredients have 

22 been approved by the Food and Drug Administra23 tion (FDA) under DSHEA and have and are being 

24 safely consumed by Americans. 


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1 (4) Since January 2007, FDA regulations gov2 erning dietary supplement manufacturer good manu3 facturing practices, dietary supplement adverse 

4 event reporting, and private sector voluntary testing 

5 and auditing for supplement quality and purity have 

6 improved postmarketing consumer safety. Before 

7 DSHEA, these mechanisms did not exist. 

8 (5) There are DSHEA ‘‘grandfathered’’ supple9 ments, dietary ingredients, and classified products 

10 which were on the market before October 15, 1994, 

11 and ‘‘generally recognized as safe’’ for human con12 sumption. FDA regulatory policy, industry practices, 

13 and consumer marketplace paradigms have dras14 tically changed over 17 years, but this policy has 

15 not. 

16 (6) The definition of a new dietary ingredient 

17 in section 413 of the Federal Food, Drug and Cos18 metic Act (21 U.S.C. 350b) does not recognize the 

19 current safe market in supplements, nor how inten20 sively supplements have been regulated over the 17 

21 years since enactment of DSHEA to protect public 

22 health and safety, and should be updated to reflect 

23 this reality. 


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1 SEC. 3. NEW DIETARY INGREDIENT DEFINITION. 

2 Section 413(d) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 350b(d)) is amended by striking 

4 ‘‘October 15, 1994’’ each place it appears and inserting 

5 ‘‘January 1, 2007’’. 

Æ 


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