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
— 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
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.
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
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.