I 
109TH CONGRESS 
1ST SESSION H. R. 2485 
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 
MAY 19, 2005 
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 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 2005’’. 
SEC. 2. FINDINGS. 
Congress finds the following:
(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
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 authoritites 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
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 2006; 
(2) $30,000,000 for fiscal year 2007; 
(3) $40,000,000 for fiscal year 2008; 
(4) $50,000,000 for fiscal year 2009; and 
(5) $65,000,000 for fiscal year 2010. 
(b) APPROPRIATION OF FUNDS FOR FISCAL YEAR 
2006.—There are appropriated, out of any money in the 
Treasury not otherwise appropriated, to carry out the Die-
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 2006. 
(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 2006; and 
(2) such sums as may be necessary for each of 
the fiscal years 2007 through 2010. 
(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, 2006, 
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-