FDA Sued Over Qualified Health Claims
I’ll be curious to see how this one plays out…
The Food and Drug Administration is being sued. (Not for the first time.) This time, it’s by supplement companies who don’t like the way the agency denies or waters down the “qualified health claims” they can put on their wares.
…You can see why the companies don’t like the way the FDA alters the qualified claims they allow. One claim cited in the lawsuit started out as “Vitamin E may reduce the risk of bladder cancer. The scientific evidence supporting this claim is convincing, but not conclusive.”
It was changed to: “One small study suggests that vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, the FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.”
According to the press release issued by the law firm Emord & Associates…
FDA has reinstated a regime of censorship, demanding near conclusive proof before it allows any nutrition science to enter the market. That move violates four First Amendment cases that have repeatedly demanded that FDA favor disclosure of nutrition science over its suppression as the operative rule. Rather than permit public access to accurate representations of science, FDA refuses to allow any science to reach the market unless it thinks scientific proof established to a near conclusive degree, an extremely rare happenstance.
Emord & Associates has defeated FDA in five prior First Amendment cases, including the landmark Pearson v. Shalala, 172 F.3d 72 (D.C.Cir. 1999). The firm has also filed, and obtained approval, for most of the qualified health claims now permitted by the agency.
It’s an interesting case, as I can see both sides. To a point, the FDA’s versions ARE accurate representations of the science – more so than vague descriptions like “convincing, but not conclusive” (which is a damned confusing way to put it). On the flip side, I think the FDA is overreaching with language like “FDA concludes that there is little scientific evidence supporting this claim.” This goes beyond any reasonable definition of “qualified”… it’s more like “neutered”.
So let the games begin! My hunch is that the FDA will lose this one, but I guess we’ll just have to wait and see.