The FDA ignoring a court ordered ruling on real science
"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 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 make qualified health claims (QHCs) on their labels 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.
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, 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.”
We won’t let the FDA just ignore this legal ruling. We will insist that they live up to it and continue to take them to court as necessary. Even if progress is slow, we will make progress.
Why are we doing all this? Because we believe that American consumers have a right to know about scientific evidence that exists regarding the foods they eat or supplements they take. We believe that denying the right to free speech, simply because it falls under two government agencies’ jurisdictions, is both an attack on consumers and consumers’ health and is also unconstitutional.
These agencies keep demanding double-blind RCTs, but that is not an appropriate standard for foods or supplements. RCTs are impossibly expensive. Because natural supplements cannot be patented, the manufacturer could never charge enough to recoup their costs. This is why the Free Speech about Science Act (FSAS) is so terribly important.
If you have not done so already, please contact your congressional representative today and ask for his or her support on FSAS! "