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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Dietary Supplement 
Protection Act of 2011’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) Improving the health status of United 
States citizens ranks at the top of the national prior-
ities of the Federal Government. The importance of 
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nutrition and the benefits of dietary supplements to 
health promotion and disease prevention are well 
known and have been documented in scientific stud-
ies. 
(2) Since enactment of the Dietary Supplement 
Health and Education Act of 1994 (DSHEA), die-
tary supplements have had an exemplary public 
health safety record. Based on national surveys, in 
1994, 50 percent of the 260,000,000 Americans reg-
ularly consumed dietary supplements. In 2006, 
232,000,000 adults over the age of 18 alone con-
sumed dietary supplements, 53 percent of the 
United States adult population. 
(3) There were 4,000 dietary supplements in 
the marketplace in 1994, and in 2006 an estimated 
29,000 dietary supplements were being consumed 
daily by Americans. Since the enactment of 
DSHEA, there has been 17 years of additional his-
torical use-safety experience conducted by millions of 
Americans. Over 17 years, approximately 25,000 
new supplements with new dietary ingredients have 
been approved by the Food and Drug Administra-
tion (FDA) under DSHEA and have and are being 
safely consumed by Americans. 
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(4) Since January 2007, FDA regulations gov-
erning dietary supplement manufacturer good manu-
facturing practices, dietary supplement adverse 
event reporting, and private sector voluntary testing 
and auditing for supplement quality and purity have 
improved postmarketing consumer safety. Before 
DSHEA, these mechanisms did not exist. 
(5) There are DSHEA ‘‘grandfathered’’ supple-
ments, dietary ingredients, and classified products 
which were on the market before October 15, 1994, 
and ‘‘generally recognized as safe’’ for human con-
sumption. FDA regulatory policy, industry practices, 
and consumer marketplace paradigms have dras-
tically changed over 17 years, but this policy has 
not. 
(6) The definition of a new dietary ingredient 
in section 413 of the Federal Food, Drug and Cos-
metic Act (21 U.S.C. 350b) does not recognize the 
current safe market in supplements, nor how inten-
sively supplements have been regulated over the 17 
years since enactment of DSHEA to protect public 
health and safety, and should be updated to reflect 
this reality. 
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SEC. 3. NEW DIETARY INGREDIENT DEFINITION. 
Section 413(d) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350b(d)) is amended by striking 
‘‘October 15, 1994’’ each place it appears and inserting 
‘‘January 1, 2007’’. 
Æ 
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