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LE Magazine April 2003

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A New Day at FDA?
After years of battling in the courts,
the FDA may finally be forced to comply with the law... AGAIN

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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

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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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