To sell their vitamin C and vitamin E dietary supplements, Durk Pearson and Sandy Shaw said the products “may reduce” the risk of lung, colon and gastric cancer. And to improve their chances of getting regulatory approval, they proposed a disclaimer for the packaging that said, “The scientific evidence supporting this claim is convincing, but not conclusive.”
But in a blow to the supplement industry, a Washington, D.C., judge has ruled that the Food and Drug Administration could block Pearson and Shaw from making even that toned-down, or “qualified,” type of claim. The FDA, U.S. District Judge Beryl A. Howell said in her decision last week, properly determined there was no “credible evidence” to support their claims.
The case goes back to April, 2008, when manufacturers Pearson and Shaw asked the FDA to approve 17 qualified health claims linking vitamins C and E with a reduction in the risk of certain types of cancer. The agency denied 13 of the proposed claims entirely and allowed four others to be made as qualified claims with modified language. Pearson and Shaw then challenged the FDA’s outright bans on four claims involving lung, colon and gastric cancer.
Unlike pharmaceutical products, supplements do not have to be submitted to the FDA for approval before they are put on the market. But they may carry a health claim only if the FDA determines that “significant scientific agreement” supports it.
Pearson and Shaw argued, unsuccessfully, that “the scientific evidence for the claims is not outweighed by scientific evidence against them, and the claims are not inherently misleading.”
As part of their case, the plaintiffs submitted two studies indicating vitamin C might have a beneficial effect on lung cancer. But Howell said the FDA acted reasonably in deciding that such studies “do not provide credible scientific evidence of the disease risk effects of single nutrient supplements.”
At the same time, she sent two bladder and gastric cancer claims back to the FDA so the disclaimers could be worded more precisely.
