I 
111TH CONGRESS 
1ST SESSION H. R. 3262 
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 20, 2009 
Mr. BURTON of Indiana 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 ap-
propriations to fully enforce and implement such Act 
and the amendments made by such Act, and for other 
purposes. 
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 ‘‘DSHEA Full Imple-
mentation and Enforcement Act of 2009’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
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(1) Over 158,000,000 Americans regularly con-
sume dietary supplements to maintain and improve 
their health. 
(2) Consumer expenditures on dietary supple-
ments reached a reported $17,100,000,000 in 2000, 
double the amount spent in 1994. 
(3) According to a recent report issued by the 
Food and Drug Administration (in this Act referred 
to as the ‘‘FDA’’) the use of dietary supplements is 
likely to grow due to factors such as the aging of the 
baby boom generation, increased interest in self-suf-
ficiency, and advances in science that are uncovering 
new relationships between diet and disease. 
(4) In 1994, the Dietary Supplement Health 
and Education Act of 1994 (Public Law 103–417) 
(in this Act referred to as ‘‘DSHEA’’) was enacted. 
This Act balanced continued consumer access to vi-
tamins, minerals, and other dietary supplements, in-
creased scientific research on the benefits and risks 
of dietary supplements, public education on dietary 
supplements, and needed consumer protections. 
(5) DSHEA requires that claims made on die-
tary supplement labels, packaging, and accom-
panying material be truthful, non-misleading, and 
substantiated. Manufacturers are prohibited from 
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making claims that products are intended to diag-
nose, treat, mitigate, cure, or prevent a disease. 
(6) DSHEA provides for good manufacturing 
practice standards setting requirements for potency, 
purity, sanitary conditions, and recordkeeping for di-
etary supplements. 
(7) DSHEA requires that manufacturers sub-
mit adequate information as to the safety of any 
new ingredients contained in dietary supplements be-
fore those products can be sold. 
(8) The FDA has updated and expanded its 
system for the reporting, collection, and analysis of 
dietary supplement adverse events reports. 
(9) DSHEA provides the FDA with a number 
of authorities to remove unsafe dietary supplements 
from the marketplace. 
(10) DSHEA created the Office of Dietary 
Supplements within the National Institutes of 
Health to expand research and consumer informa-
tion about the health effects of dietary supplements. 
(11) The FDA has not adequately used its au-
thority to enforce DSHEA. 
(12) The FDA needs adequate resources to ap-
propriately implement and enforce DSHEA. Con-
gress has appropriated additional funds over the last 
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several years beyond those requested in the Presi-
dent’s budget to implement and enforce DSHEA, 
reaching $9,700,000 in fiscal year 2003. 
(13) However, according to the FDA, full im-
plementation of DSHEA would require substantial 
additional resources. The FDA asserts that between 
$24,000,000 and $65,000,000 per year will be need-
ed to fully implement DSHEA. 
SEC. 3. AUTHORIZATION AND APPROPRIATION OF RE-
SOURCES. 
(a) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out the Dietary 
Supplement Health and Education Act of 1994 (Public 
Law 103–417), the amendments made by such Act, and 
all applicable regulatory requirements for dietary supple-
ments under the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.)— 
(1) $20,000,000 for fiscal year 2010; 
(2) $30,000,000 for fiscal year 2011; 
(3) $40,000,000 for fiscal year 2012; 
(4) $50,000,000 for fiscal year 2013; and 
(5) $65,000,000 for fiscal year 2014. 
(b) APPROPRIATION OF FUNDS FOR FISCAL YEAR 
2010.—There are appropriated, out of any money in the 
Treasury not otherwise appropriated, to carry out the Die-
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tary Supplement Health and Education Act of 1994 (Pub-
lic Law 103–417), the amendments made by such Act, and 
all applicable regulatory requirements for dietary supple-
ments under the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.), $20,000,000 for fiscal year 2010. 
(c) OFFICE OF DIETARY SUPPLEMENTS.—There are 
authorized to be appropriated and there are appropriated, 
out of any money in the Treasury not otherwise appro-
priated, for expanded research and development of con-
sumer information on dietary supplements by the Office 
of Dietary Supplements at the National Institutes of 
Health— 
(1) $30,000,000 for fiscal year 2010; and 
(2) such sums as may be necessary for each of 
the fiscal years 2011 through 2014. 
(d) USE OF FUNDS.—The Food and Drug Adminis-
tration shall fully and appropriately use the funds appro-
priated in subsections (b) and (c) and pursuant to sub-
section (a) to regulate dietary supplements. 
SEC. 4. ANNUAL ACCOUNTABILITY REPORT ON THE REGU-
LATION OF DIETARY SUPPLEMENTS. 
(a) IN GENERAL.—Not later than January 31, 2010, 
and annually thereafter, the Secretary of Health and 
Human Services shall submit a report to Congress on the 
implementation and enforcement of the Dietary Supple-
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ment Health and Education Act of 1994 (Public Law 
103–417). 
(b) CONTENTS.—The report under subsection (a) 
shall include the following: 
(1) The total funding and number of full-time 
equivalent personnel in the Food and Drug Adminis-
tration dedicated to dietary supplement regulation 
over the prior fiscal year. 
(2) The total funding and number of full-time 
equivalent personnel in the Food and Drug Adminis-
tration dedicated to administering adverse event re-
porting systems as they relate to dietary supplement 
regulation over the prior fiscal year. 
(3) The total funding and number of full-time 
equivalent personnel in the Food and Drug Adminis-
tration dedicated to enforcement of dietary supple-
ment labeling and claims requirements over the prior 
fiscal year and an explanation of their activities. 
(4) The total funding and number of full-time 
equivalent personnel in the Food and Drug Adminis-
tration dedicated to good manufacturing practices 
inspections of dietary supplement manufacturers 
over the prior fiscal year and an explanation of their 
activities. 
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(5) The number of good manufacturing prac-
tices inspections of dietary supplement manufactur-
ers by the Food and Drug Administration over the 
prior fiscal year and a summary of the results. 
(6) The number of new ingredient reviews and 
safety reviews related to dietary supplements and 
the results of those reviews. 
(7) An explanation of all enforcement actions 
taken by the Food and Drug Administration and the 
Department of Health and Human Services related 
to dietary supplements over the prior fiscal year, in-
cluding the number and type of actions. 
(8) The number of dietary supplement claims 
for which the Food and Drug Administration re-
quested substantiation from the manufacturer over 
the prior fiscal year, and the agency’s response. 
(9) The number of dietary supplement claims 
determined to be false, misleading, or nonsubstan-
tiated by the Food and Drug Administration over 
the prior fiscal year. 
(10) The research and consumer education ac-
tivities supported by the Office of Dietary Supple-
ments of the National Institutes of Health. 
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(11) Any recommendations for administrative 
or legislative actions regarding the regulation of die-
tary supplements. 
(12) Any other information regarding the regu-
lation of dietary supplements determined appropriate 
by the Secretary of Health and Human Services or 
the Commissioner of Food and Drugs. 
Æ 
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