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LE Magazine April 2003
A New Day at
FDA?
After years of battling in the
courts,
the FDA may finally be forced to comply with the law...
AGAIN
DA responds to court losses
All of this repeated litigation finally
began to have an impact on the FDA's policy makers. On
December 18, 2002 FDA Commissioner Dr. Mark McClellan, in
conjunction with the White House, announced the agency's
"Better Health Information for Consumers." This initiative is
the FDA's attempt to comply with the requirements of both
Pearson I and Pearson II. According to a statement by the FDA,
it "anticipates that this policy will facilitate the provision
to consumers of additional, scientifically supported health
information" and that "the dissemination of current scientific
information concerning the health benefits of conventional
foods and dietary supplements should be encouraged to enable
consumers to make informed dietary choices yielding
potentially significant health benefits."
Before this announcement the FDA permitted
limited health claims only for certain dietary supplements but
not for conventional foods-even though there is much more
scientific data available to support the health benefits of
foods. Now average consumers will become aware of the specific
health benefits of, say, eating broccoli or salmon. According
to FDA documents, the consumer health information initiative
is focused on three main areas:
- Helping consumers obtain accurate, up-to-date and
scientifically-based information about conventional food and
dietary supplements.
- Allowing only those health claims for conventional foods
and dietary supplements that have been pre-approved by FDA
and meet the weight of scientific evidence.
- Enforcing against false or misleading claims about
dietary supplements.
The FDA now states "consumers are more
likely to respond to health messages in food labeling if the
messages are specific with respect to the health benefits
associated with particular substances in the food." The FDA
goes on to say that consumers' incorporating "beneficial foods
into their diets improves public health." Providing the public
with such enhanced nutritional information will hopefully
contribute to the decline of such current health epidemics as
diabetes, heart disease and cancer.
In "Better Health Information for
Consumers," the FDA makes it clear that it is finally
responding to the enormous growth of nutritional awareness by
the American consumer. A recently released FDA document, the
Dietary Supplement Enforcement Report, states that over
158-million consumers use dietary supplements for "ensuring
good health" and "preventing various illnesses." It certainly
appears the FDA has realized a vast number of Americans are
taking responsibility for enhancing their own health by
utilizing supplements with or without FDA approval.
Dr. McClellan sums up the initiative by
stating, "Our mission at the FDA is to improve health outcomes
for the nation, and some of the best opportunities for
improving health involve informed choices by consumers."
Hopefully, this statement signals the beginning of a new and
enlightened position for the FDA.
The impact of the court decisions and the FDA's new
initiative are likely to be profound and far-reaching:
- Americans will have access to much more information
regarding the therapeutic benefits of supplements and various
food products. This will enable them to make proactive
choices in managing their health. Ideally, a better-informed
public will become a healthier public focusing on prevention
rather than pharmaceutical cures.
- Manufacturers will now be encouraged to research and
develop targeted nutriceuticals aimed at specific conditions.
In the near future we might see manufacturers making the same
therapeutic claims for nutritional products as for standard
pharmaceuticals-but without the side effects. The FDA's
initiative will remove the barriers for innovation in the
expanding nutriceutical field.
- Doctors will be more likely to suggest nutritional
protocols along with traditional pharmaceuticals to their
patients.
Battle to protect free speech
continues
While these recent developments are
encouraging, much remains to be done and the battle against
the FDA and its restrictive policy toward nutrient claims
continues. A Federal Court recently denied manufacturers the
right to state on the label the benefits of saw palmetto in
reducing the symptoms of mild benign prostatic hypertrophy. As
it has repeatedly done in the past, the FDA refused to review
the claim, stating in this case that it was "a treatment claim
and, hence was not covered under the provisions for health
claims." This decision will be appealed. According to attorney
Jonathan Emord, he is "not finished with the FDA until it
allows health claims for foods and dietary supplements that
can be used to treat diseases, not just help prevent them."
The battle continues.
Don't believe the FDA's propaganda
The FDA was forced to launch its "Better Health Information
for Consumers" policy and pretends now that they are in favor
of allowing consumers to learn about the benefits of dietary
supplements.
The reality is that health activists, Congress and Federal
Judges forced the FDA to capitulate on this critical First
Amendment issue. It took decades of protests by American
consumers, passage of the Dietary Supplement Health and
Education Act (DSHEA) in 1994, and countless losses in the
Courts to compel the FDA to pull this public relations stunt
(the "Better Health Information for Consumers" initiative)
that makes it appear as if they are the good guys. The facts
are that Congress passed laws denying the FDA's power to
suppress truthful health information and Federal Courts have
mandated that the FDA adhere to the law.
When government agencies are proven wrong, they seldom
admit their errors. Remember in 1991 when Saddam Hussein lost
the Gulf War, he proclaimed to Iraqi citizens, "The soldiers
of faith have triumphed...and are now withdrawing from Kuwait
in accordance with peace." The reality was Iraqi troops were
fleeing Kuwait while being pummeled by relentless American air
strikes.
The FDA is in a similar embarrassing situation; they have
been cornered into a position that they cannot
constitutionally get out of, i.e. Congress has grown
increasingly hostile to new regulatory proposals and judges
are ruling against them on First Amendment issues. Instead of
admitting defeat, they created the "Better Health Information
For Consumers" as a charade to make it appear that the FDA
came up with the idea to uncensor health information and let
consumers learn some of the proven health benefits of certain
foods and supplements.
The sad fact is that tens of millions of Americans
needlessly died during most of the past century, as the FDA
prohibited manufacturers of dietary supplements from
disseminating information about peer-reviewed published
scientific studies. The FDA went further by actively
discouraging Americans from using dietary supplements and
conducting nationwide seizure actions against companies who
dared to make health claims.
Patriotic Americans who have participated in this
successful health-freedom battle should feel proud to have
helped defend the United States Constitution against one its
most abusive domestic enemies, the FDA.
References
Emord & Associates, FDA
Implements Pearson Decision; Expands to Foods;2002
Dec18.
Emord & Associates, Whitaker vs.
Thompson; 2002 Dec 26.
Emord, Jonathan, Interview, 2003, Jan
8.
Faloon, William, What's Wrong With the
FDA. Life Extension, 2001 May:26-29.
U.S. Food and Drug Administration, Dietary Supplement
Enforcement Report; 2002 Dec 18:1.
U.S. Food and Drug Administration, FDA
News, FDA Announces Initiative To Provide Better Health
Information for Consumers; 2002 Dec 18: 1.
U.S. Food and Drug Administration,
Guidance for Industry, Qualified Health Claims in the Labeling
of Conventional Foods and Dietary Supplements; 2002 Dec 18:
2.
Pearson, Durk; Shaw, Sandy, FDA
Folds; the First Amendment Wins After eight Years of Battle;
2002:7.
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To read recent court
transcripts of cases discussed in this article, log on
to attorney Jonathon Emord's website at www.emord.com.
For further information
about the FDA's initiative titled Consumer Health
Information for Better Nutrition mandate, log on to
www.fda.gov.
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