Thursday, November 10, 2005

Qualified health claims quagmire

Twice in the past two weeks, the Food and Drug Administration has shown why it may have the second toughest and important job in America (after the job of parenting, of course). On November 2, FDA announced its ruling that "there is no credible evidence to support qualified health claims about calcium and breast cancer or calcium and prostate cancer. " Then this week, on November 9, the agency ruled that "there is very limited credible evidence for qualified health claims for tomatoes and/or tomato sauce, and prostate cancer." In short, FDA is denying qualified health claims, not describing them as its rules seemed to promise. Pity the FDA! On the one hand, the public expects approval of life-saving medicines double-quick and food labels that inform but don't mislead consumers. On the other, the courts have ruled against FDA's efforts to prevent food manufacturers from making certain claims about the healthfulness of their products -- "commercial free speech." FDA sought a way to navigate between the Scylla of unrestrained commercial hype and the Charybdis of suffocating hyper-regulation. After the courts invalidated as too restrictive its "health claims" rules for foods with nutrients where "significant scientific agreement" supports a relationship to a "disease or condition," FDA came up with a scheme of "qualified health claims" that manufacturers could make based on FDA's determination about the amount of evidence supporting the claim. So, worst case for a manufacturer, a food would have the right to claim a diet/disease relationship and also be required to carry an FDA warning that there is no evidence to support the claim. With these two decisions, however, FDA seems to have lost its nerve and reverted to denying claims. Rather than require ketchup manufacturers who want to say their product prevents prostate cancer to affix a warning that the scientific evidence for such a claim is very weak, or make sellers of dairy products warn consumers that medical scholars dispute their claims that their high-calcium product cuts the risk of breast cancer or prostate cancer, FDA is denying the claims entirely (or, in the case of tomato products, largely). Preserving the integrity of health claims is virtually a no-win situation. This blog is salt-related. How does this tie in? FDA has yet to consider or approve a health claim that low-salt foods reduce the risk of heart attacks and strokes, though lots of ink is spilled alleging that case. Such a claim about salt and heart attacks, according to my review of the evidence, would have to be judged entirely lacking in scientific support. What is clearly justified in science is the conclusion that "salt is an essential nutrient." Scientific, yes, but politically-incorrect.

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