FDA: Next Steps

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 6 No. 1 • February 2003

It is the purpose of the First Amendment to preserve an uninhibited marketplace of ideas in which truth will ultimately prevail.

— Byron White, U.S. Supreme Court Justice, 1917–2002

The illegal we do immediately. The unconstitutional takes a bit longer.

— Henry Kissinger

Nothing could so completely divest us of . . . liberty as the establishment of the opinion that the state has a perpetual right to the services of all its members.

— Thomas Jefferson

FDA: Next Steps

New victory

On December 23, 2002, the U.S. District Court for the District of Columbia ruled that the FDA’s suppression of a health claim that “antioxidant vitamins may reduce the risk of certain kinds of cancer” is unconstitutional. [This is the second time we have won this decision in the courts. Remember, the court of appeals (Jan. 19, 1999) had already ruled that the suppression of this health claim, as well as three others, was unconstitutional.] The judge for the district court ordered the FDA to draft one or more “short, succinct, and accurate” disclaimers from which we might choose, to accompany our antioxidant vitamin claim. The FDA provided three choices. The one that the two of us chose was, “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, the FDA has determined that this evidence is limited and not conclusive.” The great virtue of this disclaimer is that it clearly distinguishes between the statement of scientific fact and the opinion of the FDA.

The defeat

On January 3, 2003, the U.S. District Court for the District of Columbia upheld the FDA’s refusal to process a health claim for saw palmetto [“Consumption of 320 mg daily of saw palmetto extract may improve urine flow, reduce nocturia, and reduce voiding urgency associated with mild benign prostatic hyperplasia (BPH).”] The FDA deems this claim to be a “treatment” claim, not a health claim, and therefore the FDA need not review the claim under the Food Drug and Cosmetic Act’s (FDCA) dietary supplement health claim provision. In order to use this “treatment” claim for saw palmetto, we would have to get the FDA’s drug approval—at a cost of at least $50,000,000 for an unpatentable product. The saw palmetto “treatment” speech is virtually prohibited under these conditions.

We disagree. The FDCA’s dietary supplement health provisions refer to a health claim as one that “characterizes the relationship of any nutrient . . . to a disease or a health-related condition.” This language clearly allows for the saw palmetto claim and other similar “treatment” claims. The district court ruled that the court had to give the FDA “deference” in its decision to exclude claims of an effect of a supplement on an existing disease under the health claims definition. This is incorrect. The U.S. Supreme Court has ruled that an agency cannot be given deference when a constitutional issue is at stake: “Where an administrative interpretation of a statute would raise serious constitutional problems, the court will construe the statute to avoid such problems unless the construction is plainly contrary to Congress’ intent.” Solid Waste Agency of Northern Cook County v. United States Army Corps of Engineers et al., No. 99-1178, decided January 9, 2001.

The district court refused to evaluate the FDA’s suppression of the FDA’s decision under the applicable First Amendment commercial speech standard (the four-pronged Central Hudson test) because, the court held, the claim proposed by the plaintiffs was “illegal” and therefore, since only truthful speech concerning legal products is protected speech under the First Amendment, need not be evaluated under the First Amendment standard. This is an immense legal error. Under this sort of reasoning, all commercial applications of the First Amendment could be eliminated by simply declaring that the speech itself was “illegal.” Moreover, we had entered into evidence a letter from the FDA stating unequivocally that saw palmetto is a legal dietary supplement, so long as no health claims are made. Hence, this is a pure First Amendment issue. You can get a copy of the district court’s decision by contacting Katie Bond at 202-466- 6937.

The appeal

In order to expand the universe of health claims to include “treatment” claims (e.g., where a supplement affects an existing disease), we have filed a notice of appeal concerning this decision to the U.S. Court of Appeals for the District of Columbia. Keep in mind that being able to offer dietary supplements for the treatment of existing diseases is a very serious disruption to the FDA’s current drug monopoly approval process, in which “treatment” speech is reserved only for the use of companies producing certain products (drugs), which requires the payment of immense sums to go through the FDA’s drug approval process and pay the FDA’s “user fees,” which will total about $200,000,000 in 2004. However, under the First Amendment, the government is explicitly denied any authority to “reserve” the communication of certain truthful information only to certain government-preferred people. The prevention of just that sort of government-granted speech privilege was one of the main purposes of the First Amendment.

There can be no doubt that if we win this appeal, the FDA will appeal to the U.S. Supreme Court. They have no choice if they wish to retain their current monopoly-granting power over speech concerning medical therapies. If we lose the appeal, we will appeal to the U.S. Supreme Court. Hence, the next three or four years, until this case is finally decided, will cost us and our coplaintiffs about $500,000. Yet somebody has to do it, and, if not us, who? We’ve got very strong arguments and a brilliant attorney. What else do we need? More money. If there are those of you out there with ideas on how to raise money for this important cause, please contact us c/o this magazine or Web site. If anyone wants to help, you can do so by sending any size donation (small donations add up, you know) to: The Pearson & Shaw FDA Litigation Fund, c/o Emord & Associates, 5282 Lyngate Court, Burke, VA 22015.

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