marketers win First Amendment rights in FDA court battle
by Rob McCaleb
In a major victory for supplement makers, in February a federal
court in the District of Columbia ruled against the FDA and in
favor of free speech rights for companies selling folic acid supplements.
This is considered an important case because it shows that the
courts won't allow the FDA to prevent companies from presenting
truthful information about supplements to the public. The impact
of the ruling will likely extend far beyond folic acid supplements.
In this case, the FDA's position was that supplement companies
should not be allowed to say that folic acid supplements containing
0.8 mg folic acid are more effective in preventing birth defects
than foods high in this nutrient. In a previous ruling, the court
of appeals ruled that there was credible evidence that the claim
was true, that FDA had been "arbitrary and capricious"
in denying the claim, and that their standard of evidence is undefined.
The Appellate Court directed the FDA to "explain what it
means by significant scientific agreement or, at minimum, what
it does not mean."
FDA responded by denying the claim again without reviewing any
new evidence, saying it was "inherently misleading"
The court disagreed, and in a sharp rebuke US District Court Judge
Gladys Kessler wrote that the FDA "simply failed to comply
with the constitutional guidelines," and "at best misunderstood
and at worst deliberately ignored highly relevant portions"
of the court decision against them. Kessler directed the FDA to
draft disclaimers if they believe that the claim is potentially
misleading, because disclaimers are constitutionally preferable
to outright suppression. Judge Kessler then dismantled the FDA's
arguments, pointing out that while the courts usually do not rule
on scientific evidence, in this case even a cursory reading of
the evidence goes against the FDA. She wrote that there is evidence
that .8 mg is better than .4 mg, that there is no evidence to
the contrary, that numerous authorities including the Centers
for Disease Control agree that folic acid in supplements is better
absorbed than that in food, and that cooking and canning destroys
folic acid, further supporting the superiority of supplements.
It was a bad day for the FDA. The court ruled, "The FDA's
actions in violation of the First Amendment thus constitute irreparable
harm, agreeing with legal precedent that opportunities for speech
if repressed are irretrievably lost." Finally, the court
noted that even if the claim proves to be misleading, there is
no health risk to the public and the only "injury" to
the public might be buying a product they didn't need. The judge
concluded: "This type of injury, while not insignificant,
cannot compare to the harm resulting from the unlawful suppression