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Supplement 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 of speech."

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