Under pressure of our court victory, the FDA is for the first time allowing reasonable “qualified health claims” for some supplements.
Despite numerous court decisions allowing supplement manufacturers and distributors to make qualified health claims about their products, the FDA has refused to allow them. The Agency has acted as if it were above the law. In June 2009, it denied multiple claims about the effectiveness of selenium and vitamins C and E in reducing cancer risk, and weakened and complicated other claims to the vanishing point.
In September 2009 we announced that famed attorney Jonathan Emord, representing ANH-USA, together with dietary supplement formulators Durk Pearson and Sandy Shaw and the Coalition to End FDA and FTC Censorship, filed three separate lawsuits against the FDA. The lawsuits sought to reverse the denial of qualified health claims for these supplements, and bring the Agency back into compliance with the law.
This past June, the US District Court of the District of Columbia ruled in our favor. The judge rendered a summary judgment—which means she felt the case was clear from the start: the FDA was indeed violating freedom of speech by saying that no cancer-related health claims about the selenium could be made unless the science was completely conclusive or unless ridiculous and misleading disclaimers were added to the message.
We are pleased to report that a settlement agreement with the FDA now allows selenium supplements to claim that “selenium may reduce the risk” of prostate, colon, bladder, or thyroid cancer. The statements must be followed with the disclaimer, “Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk” of these cancers.
This is the largest number of dietary supplement/cancer-risk-reduction claims ever approved by the FDA. And the disclaimer statements they’re requiring are the shortest and clearest ever approved. Nutrition science, like science generally, is almost never completely conclusive, so it is unremarkable that the health claims are qualified as being inconclusive. And the last sentence of the disclaimer—that the FDA does not agree—reflects not scientific fact but rather FDA’s opinion, which in turn reflects the agency’s well-known anti-supplement, pro-drug bias. This is a big step forward.