FDA, Under Court Order, Nevertheless Refuses to Allow Truthful Claims Based on Good Science
May 23, 2012 You would think the FDA would obey a judge’s ruling on qualified health claims. Think again.
The FTC case described elsewhere in this issue [1] was especially important because the FDA was hoping to use the FTC to evade some recent court rulings that it cannot willfully and unreasonably censor all science about food and supplements. Meanwhile the FDA continues to dig in its heels on the same subject.
As you know, we have for some time been fighting for freedom of speech with the FDA. Supplement and food companies are allowed by law to makequalified health claims (QHCs) on their labels [2] if they are approved by the FDA. However, QHCs are rarely approved by FDA, and when they are, the FDA-approved language usually undermines the meaning. Because of their denial of two health claims (that vitamin C reduces the risk of gastric cancer, and the vitamin E reduces the risk of bladder cancer), we took FDA to court—and won [3].
FDA was then ordered by the court to revise those QHCs. They did, and we have just received the revised versions—and they are as bad and intentionally misleading as before! The new QHCs all have the qualifier that “FDA has concluded there is very little scientific evidence for this claim.” Example: “Vitamin C may reduce the risk of gastric cancer although the FDA has concluded that there is very little scientific evidence for this claim.”
Frankly, we find this outrageous. It is clear that the FDA, in crafting these revised QHCs, has chosen to ignore the recent precedent set in the green tea case [2], where the judge stated that the FDA-approved QHC “effectively negates the substance–disease relationship claim altogether….There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.”
Read More: