103d CONGRESS
2d Session
S. 784
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 16, 1994
Referred to the Committee on Energy and Commerce
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to establish
standards with respect to dietary supplements, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Dietary Supplement Health and
Education Act of 1994''.
SEC. 2. FINDINGS AND PURPOSE.
(a) Findings.--Congress finds that--
(1) improving the health status of United States citizens
ranks at the top of the national priorities of the Federal
Government;
(2) the importance of nutrition and the benefits of dietary
supplements to health promotion and disease prevention have
been documented increasingly in scientific studies;
(3)(A) there is a definitive link between the ingestion of
certain nutrients or dietary supplements and the prevention of
chronic diseases such as cancer, heart disease, and
osteoporosis; and
(B) clinical research has shown that several chronic
diseases can be prevented simply with a healthful diet, such as
a diet that is low in fat, saturated fat, cholesterol, and
sodium, with a high proportion of plant-based foods;
(4) healthful diets may mitigate the need for expensive
medical procedures, such as coronary bypass surgery or
angioplasty;
(5) preventive health measures, including education, good
nutrition, and appropriate use of safe nutritional supplements
will limit the incidence of chronic diseases, and reduce long-
term health care expenditures;
(6)(A) promotion of good health and healthy lifestyles
improves and extends lives while reducing health care
expenditures; and
(B) reduction in health care expenditures is of paramount
importance to the future of the country and the economic well-
being of the country;
(7) there is a growing need for emphasis on the
dissemination of information linking nutrition and long-term
good health;
(8) consumers should be empowered to make choices about
preventive health care programs based on data from scientific
studies of health benefits related to particular dietary
supplements;
(9)(A) national surveys have revealed that almost 50
percent of the 260,000,000 Americans regularly consume dietary
supplements of vitamins, minerals, or herbs as a means of
improving their nutrition; and
(B) nearly all consumers indicate that dietary supplements
should not be regulated as drugs;
(10) studies indicate that consumers are placing increased
reliance on the use of nontraditional health care providers to
avoid the excessive costs of traditional medical services and
to obtain more holistic consideration of their needs;
(11) the United States will spend over $1,000,000,000,000
on health care in 1994, which is about 12 percent of the Gross
National Product of the United States, and this amount and
percentage will continue to increase unless significant efforts
are undertaken to reverse the increase;
(12)(A) the nutritional supplement industry is an integral
part of the economy of the United States;
(B) the industry consistently projects a positive trade
balance; and
(C) the estimated 600 dietary supplement manufacturers in
the United States produce approximately 4,000 products, with
total annual sales of such products alone reaching at least
$4,000,000,000;
(13) although the Federal Government should take swift
action against products that are unsafe or adulterated, the
Federal Government should not take any actions to impose
regulatory barriers limiting or slowing the flow of safe
products and needed information to consumers;
(14) dietary supplements are safe within a broad range of
intake, and safety problems with the supplements are relatively
rare; and
(15)(A) legislative action that protects the right of
access of consumers to safe dietary supplements is necessary in
order to promote wellness; and
(B) a rational Federal framework must be established to
supersede the current ad hoc, patchwork regulatory policy on
dietary supplements.
(b) Purpose.--It is the purpose of this Act to--
(1) improve the health status of the people of the United
States and help constrain runaway health care spending by
ensuring that the Federal Government erects no regulatory
barriers that impede the ability of consumers to improve their
nutrition through the free choice of safe dietary supplements;
(2) clarify that--
(A) dietary supplements are not drugs or food
additives;
(B) dietary supplements should not be regulated as
drugs;
(C) regulations relating to food additives are not
applicable to dietary supplements and their ingredients
used for food additive purposes, including stabilizers,
processing agents, or preservatives; and
(D) the burden of proof is on the Food and Drug
Administration to prove that a product is unsafe before
it can be removed from the marketplace;
(3) establish a new definition of a dietary supplement that
differentiates dietary supplements from conventional foods,
while recognizing the broad range of food ingredients used to
supplement the diet;
(4) strengthen the current enforcement authority of the
Food and Drug Administration by providing to the Administration
additional mechanisms to take enforcement action against unsafe
or fraudulent products;
(5) establish a series of labeling requirements that will
provide consumers with greater information and assurance about
the quality and content of dietary supplements, while at the
same time assuring the consumers the freedom to use the
supplements of their choice;
(6) provide new administrative and judicial review
procedures to affected parties if the Food and Drug
Administration takes certain actions to enforce dietary
supplement requirements; and
(7) establish a Commission on Dietary Supplement Labels
within the executive branch to develop recommendations on a
procedure to evaluate health claims for dietary supplements and
provide recommendations to the President and the Congress.
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