Subject: NHA 10/9/94: Congress passes S-784 (Dietary Supp. H&E Act)

From: [email-masked]
Date: Mon, 10 Oct 1994 17:31:26 GMT

NUTRITIONAL HEALTH ALLIANCE UPDATE
10/9/94

Dietary Supplement Health and Education Act passes the 103rd
Congress!

	At approximately 12:30 AM EDT on Saturday, Oct. 7th, the U.S.
Senate passed the House version of S. 784 by unanimous consent.
The measure now goes to the President. The passage of this
legislation marks the second time in eighteen years that the
U.S. Congress stepped in to enact legislation to halt the
regulatory abuse of the Food and Drug Administration with
respect to dietary supplements.

	"Senator Orrin Hatch (R-UT),  Rep. Bill Richardson (D-NM), and
Sen. Tom Harkin (D-IA) are to be congratulated by the American
people for their hard work and leadership in moving this
critical legislation forward," stated NHA's Executive Director,
Jerry Kessler.  "We could not have come this far without their
steadfast commitment and gallant courage in standing up to the
opponents of the public's health freedom.  We owe a debt of
gratitude to these great leaders and to their dedicated
congressional staff; Patricia Knight,  John Lewis,  Peter
Reinecke, and Kay Holcombe for the hundreds of hours they
tirelessly devoted to this legislation.  We would also like to
thank and acknowledge Health Subcommittee Ranking Member Tom
Bliley (R-VA),  Republican Whip Newt Gingrich (R-GA), and Rep.
Elton Gallegly (R-CA) for their leadership in bringing this
issue to the attention of the entire House of Representatives. 
These legislators and their staffs have diligently fought to
protect the rights of the American public to maintain access to
dietary supplements and truthful nonmisleading information as to
their use."

	We especially wish to thank the health food stores and  the
grassroots who were the driving force that assured the passage
of this legislation.

Key Issues Resolved by the Dietary Supplement Health and
Education Act of 1994

1) Dietary supplements will have a unique statutory definition
within the umbrella of food in the Federal Food, Drug, and
Cosmetics Act.

2) Dietary supplements can no longer be classified as food
additives.

3) The FDA maintains the burden of proof to establish that a
dietary supplement is unsafe.

4) Dietary supplements can make truthful, nonmisleading
statements as to how dietary ingredients affect human body
functions and structures.  Such statements must be accompanied
by a disclaimer that the FDA has not "evaluated"  the statement
and the product is not intended for the prevention, treatment,
cure, or mitigation of disease.

5) Third party literature such as peer reviewed scientific
articles can be used in connection with the sale of dietary
supplements provided the information is not false or misleading
so as to present a balanced view of the available scientific
information on a dietary supplement.

6) New dietary supplement labels will have to comply with the
Act by December 31, 1996. 

Unresolved Issues

	Health claims--the right to make statements on product labels
as to how dietary ingredients can prevent disease has been
postponed for four years.  A presidential commission will study
the issue for two years. Congress will have two additional years
to take action on their findings.

	The legislation created many new areas of  law which must be
tested by the courts.  "We must continue to be on guard and
vigilant.  We will carefully watch the FDA's implementation of
this legislation and keep the Congress informed and empowered to
act on behalf of the American people," stated NHA's Jerry
Kessler.  "The Act that passed the 103rd Congress does not give
the broad protection to consumers' rights demanded by millions
of Americans in their letter writing campaign to Congress.  In
view of the FDA's historic bias against dietary supplements,
there are major concerns as to how the FDA will interpret this
legislation."

The Fight For Health Freedom Continues

Consumers, the dietary supplement industry, and the food
industry, must work together in the 104th Congress to ensure
that the right to make health claims is achieved.  The NHA will
maintain its vigilance to clarify unresolved regulatory and
statutory issues created by the enactment of the Dietary
Supplement Health and Education Act.

The fight for health freedom has united consumers and the
industry.

Congratulations for a job well done!