I 
109TH CONGRESS 
1ST SESSION H. R. 2510 
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. 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 ‘‘Dietary Supplement 
Regulatory Implementation Act of 2005’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows:
(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 $20,500,000,000 in 2004, 
more than double the amount spent in 1994. 
(3) According to a recent report issued by the 
Food and Drug Administration (‘‘FDA’’) the use of 
dietary supplements is likely to grow due to factors 
such as the aging of the baby boom generation, in-
creased interest in self-sufficiency, and advances in 
science that are uncovering new relationships be-
tween diet and disease. 
(4) In 1994, the Dietary Supplement Health 
and Education Act of 1994 (Public Law 103–417) 
(‘‘DSHEA’’) was enacted. That Act balanced contin-
ued consumer access to vitamins, minerals, and 
other dietary supplements, increased scientific re-
search on the benefits and risks of dietary supple-
ments, 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 provides that dietary supplements 
are to be regulated like foods and not drugs or food 
additives. 
(8) 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. 
(9) DSHEA provides the FDA with a number 
of powers 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 $10,800,000 in fiscal year 2005. 
(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) $30,000,000 for fiscal year 2007; 
(2) $40,000,000 for fiscal year 2008; 
(3) $50,000,000 for fiscal year 2009; and 
(4) $65,000,000 for fiscal year 2010. 
(b) APPROPRIATION OF FUNDS FOR FISCAL YEAR 
2006.—There is 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.— 
(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated for ex-
panded research and development of consumer infor-
mation, including information on safety and bene-
ficial effects, of dietary supplements by the Office of 
Dietary Supplements at the National Institutes of 
Health such sums as may be necessary for each of 
the fiscal years 2007 through 2010. 
(2) APPROPRIATION
OF
FUNDS
FOR
FISCAL 
YEAR
2006.—There is appropriated, out of any 
money in the Treasury not otherwise appropriated, 
for expanded research and development of consumer 
information, including information on safety and 
beneficial effects, of dietary supplements by the Of-
fice of Dietary Supplements at the National Insti-
tutes of Health $30,000,000 for fiscal year 2006. 
(d) USE OF FUNDS.—The Secretary of Health and 
Human Services shall fully and appropriately use the 
funds appropriated in subsections (b) and (c) and pursu-
ant to subsection (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, 2007, 
and annually thereafter, the Secretary shall submit a re-
port to Congress on the implementation and enforcement 
of the Dietary Supplement 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. 
(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 unsubstan-
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. 
(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. 
SEC. 5. DIETARY SUPPLEMENTS CONTAINING EPHEDRINE 
ALKALOIDS. 
(a) FINDINGS.—The Congress finds that— 
(1) dietary supplements containing ephedrine 
alkaloids may present a significant or unreasonable 
risk of illness or injury; and 
(2) through section 402(f) of the Federal Food, 
Drug, and Cosmetic Act (established by the Dietary 
Supplement Health and Education Act of 1994), the 
Congress has granted the Secretary the authority to 
remove from the market dietary supplements that 
present such a risk. 
(b) SENSE OF CONGRESS REGARDING RISK OF ILL-
NESS OR INJURY.—It is the sense of the Congress that, 
in the event the Secretary determines under section 402(f) 
of the Federal Food, Drug, and Cosmetic Act that a die-
tary supplement containing ephedrine alkaloids presents 
a significant or unreasonable risk of illness or injury— 
(1) all dietary supplements containing such 
alkaloids should be declared to be adulterated in ac-
cordance with such section; and 
(2) the Secretary should take all necessary ac-
tions to remove all such supplements from the mar-
ket. 
(c) SENSE OF CONGRESS REGARDING BOTANICAL 
SOURCES.—It is the sense of the Congress that the Sec-
retary should take steps to assure the continued avail-
ability of botanical sources of ephedrine alkaloids that— 
(1) are in forms that have not been manipu-
lated or chemically altered to increase their ephed-
rine alkaloid concentration or content; 
(2) are marketed at dosages that are substan-
tiated to be at levels used in traditional herbal for-
mulas; and 
(3) are labeled only for traditional uses and not 
for weight loss or energy. 
SEC. 6. EDUCATION PROGRAMS REGARDING DIETARY SUP-
PLEMENTS. 
(a) HEALTH CARE PROFESSIONALS.— 
(1) IN
GENERAL.—The Secretary shall carry 
out a program to educate health professionals on the
safety and health benefits of dietary supplements, 
including the potential for dietary supplement/drug 
interactions. 
(2) AUTHORIZATION OF APPROPRIATIONS.—For 
the purpose of carrying out paragraph (1), there is 
authorized to be appropriated $5,000,000 for fiscal 
year 2006, in addition to any other authorization of 
appropriations that is available with respect to such 
purpose. 
(b) CONSUMERS.— 
(1) IN
GENERAL.—The Secretary shall carry 
out a program to educate consumers of dietary sup-
plements on the safety and health benefits of dietary 
supplements, including the potential for dietary sup-
plement/drug interactions through public education 
forums, advertisements, and the Internet. 
(2) AUTHORIZATION OF APPROPRIATIONS.—For 
the purpose of carrying out paragraph (1), there is 
authorized to be appropriated $5,000,000 for fiscal 
year 2006, in addition to any other authorization of 
appropriations that is available with respect to such 
purpose. 
SEC. 7. ADVERSE EVENT REPORTING SYSTEM. 
The Secretary shall establish a system for the re-
quirements for the reporting of serious adverse experi-
ences associated with the use of a dietary supplement re-
ceived by the manufacturer, packer, or distributor whose 
name appears on the label of the product. 
SEC. 8. DEFINITION. 
For purposes of this Act, the term ‘‘Secretary’’ 
means the Secretary of Health and Human Services, act-
ing through the Commissioner of Food and Drugs. 
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