FDA's Loss is Our Gain

Momentous First Amendment Victory
Durk Pearson & Sandy Shaw® Beat FDA in Lawsuit

he FDA's stranglehold on the expression of Constitutionally-protected free speech is coming to an end. The FDA's attempts to severely regulate truthful speech has been ruled unconstitutional.

On January 15, 1999, in a decision that is rocking the regulatory world, scientists Durk Pearson & Sandy Shaw, joined by the American Preventative Medical Association and Citizens for Health, pummeled the Food and Drug Administration to the ground in their FDA lawsuit (Pearson vs FDA1). Ruling unanimously in their favor ( a 3-0 decision), the U.S. Court of Appeals for the District of Columbia Circuit decided against the FDA on all issues raised by Durk & Sandy's lawsuit. The issues included the FDA's health claim approval process now declared unconstitutional.

In an article published in The Laissez Faire City Times,2 Durk Pearson & Sandy Shaw vent their indignation that "commercial speech" has been considered less deserving of constitutional protection under the First Amendment than non-commercial speech. This doctrine, they complain, "makes those of us involved in commercial transactions - either as buyers or sellers - into second class citizens." Into this judicial vacuum, the FDA has deeded itself "unprecedented control over the communication of truthful scientific information when it accompanied a product."

By prohibiting the scientific truth to be told about dietary supplements, the FDA's policies have had a disastrous effect on the public's awareness of dietary supplements as well as over-the-counter drugs. Low-dose aspirin is one such example, but only one. As Pearson & Shaw reported in their 1993 book, Freedom of Informed Choice: FDA vs. Nutritional Supplements,a 1989 study established that for previously-healthy men over 50, an aspirin every other day reduced the risk of a first heart attack by about 44 percent.3 Yet ten years later, the FDA still unconstitutionally prohibits aspirin companies from communicating this information to the general public. During this period, hundreds of thousands of people may have died of heart attacks prematurely because they did not know about the value of low-dose aspirin.

Guiding Pearson & Shaw's case against the FDA from its initial filing in 1994 has been lawyer Jonathan Emord, whose skillful work has been instrumental in achieving this long-awaited victory.4 While the FDA may appeal, Durk & Sandy do not expect the FDA will be able to reverse this decision. This lawsuit has been expensive and aside from a lot of their own money, major financial assistance came from Julian Whitaker, M.D. and the American Preventive Medical Association. Additional financial help came from the National Health Federation, Life Enhancement Products, Life Extension Foundation, and Greg and Michelle Pryor of Life Priority, Inc.

Out of their ardent study of the Constitution and "commercial speech," Durk & Sandy grew the idea that a lawsuit "might push the envelope to help restore freedom of speech and help remove constitutional restraints in the area of what is called 'commercial speech.'" And indeed they have achieved this!

In its decision, the Appeals Court logically developed its conclusions from prior U.S. Supreme Court decisions  concerning First Amendment limitations on government censorship, especially with regard to the communication of scientific information as it pertains to "commercial speech."  The beauty of the decision is that it curtails federal governmental regulatory power as "off limits" when it crosses the Constitutional boundaries of freedom of speech as recognized by the Courts.

It is now incumbent on the FDA to define "significant scientific agreement," a phrase not previously defined by the FDA, making it easy for them to disqualify health statements by nutrient companies. The Court also stated that even if a nutrient company's health claim doesn't meet the FDA's criteria, it may be still be  possible to legally make their health claims if proper disclaimers are used.

At one point the FDA argued that any health claims could mislead the public, to which the Court replied that the position was "almost frivolous." Additional winners, those filing amicus (friendly) briefs in support, are Direct AIDS Alternative Information Resources, People Against Cancer, and the Foundation for Advancement of Innovative Medicine. Other losers, those filing an amicus brief supporting FDA restrictions, are the American Cancer Society, the American Heart Association, the Center for Science in the Public Interest, Public Citizen, and the Consumer Federation of America.

Pearson & Shaw conjecture that the FDA will, at first, attempt to propose the same old unconstitutional rules dressed up in new verbiage. "You can be sure we will be filing Public Comments!," retort Durk & Sandy. Feeling happy about the Court's decision, they believe that it is possible to strengthen and "put teeth into the Constitution's limits on federal actions" with enough conviction and care given to choice of issues, court and attorney. It helps to have lots of time and money too. Perhaps some of those making money as a direct result of being allowed to provide truthful information about their product will decide to pitch in. We all have a lot to gain - health freedom is in the opposition's interest too!

Medical researchers Durk Pearson & Sandy Shaw are the authors of Life Extension: A Practical Scientific Approach as well as other books on health and freedom. They are also formulators of products manufactured and marketed by Life Enhancement Products, Inc.

References

  1. See http://www.ll.georgetown.edu/Fed-Ct/Circuit/dc/opinions/98-5043a.html.
  2. Pearson D Shaw S. FDA Loses Landmark First Amendment Case. The Laissez Faire City Times,Vol 3, No 4, Jan. 25, 1999 (http://www.zolatimes.com/v3.4/FDA.htm).
  3. Final report on the aspirin component of the ongoing Physicians' Health Study. Steering Committee of the Physicians' Health Study Research Group. N Engl J Med 1989 Jul 20;321(3):129-35.
  4. Jonathan Emord may be contacted through his law firm's website at http://www.emord.com/

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