Vale of Silence

In the federal courthouse at Brooklyn, a Queens native, cancer survivor, and New York City arm-wrestling champion, Jason Vale, is appearing this week to face off against the Food and Drug Administration over his promotion and sale of apricot seeds, so-called “vitamin B-17,” and a substance called laetrile as treatments for cancer. Mr. Vale, owner of the online retailer Christian Brothers Contracting Corp., says that a diet of apricot seeds helped him beat a rare form of cancer, but the science behind the products Mr. Vale is pushing falls somewhere between sketchy and non-existent.Still, the fight points up the trade-offs inherent in regulating the health claims that manufacturers can make regarding foods and dietary supplements. For some time, the FDA has leaned too far in the direction of caution, allowing only the most air-tight statements — imposing a black-and-white standard to a gray area of science, and thus restricting consumers’ access to quite a bit of information. It seems to us that consumers instead ought to have access to a wide variety of health products and be allowed to evaluate various claims for themselves. The FDA seems to be moving in such a direction and would do well to stay the course.The Vale case comes just as the FDA is beginning to implement a 1999 decision by the U.S. Court of Appeals for the District of Columbia, Pearson v. Shalala, that requires the agency, on First Amendment grounds, to allow a broader array of health claims to be included with dietary supplements. In March, the FDA allowed its first health claim under the Pearson decision for a substance called selenium, according to Food Chemical News. According to the publication, the label the FDA allowed reads in part: “Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”This seems like a reasonable compromise between the government’s desire to warn consumers and the market’s desire to promote new products.The FDA is on its way to allowing similar claims for traditional foods. Currently, only manufacturers that undertake rigorous clinical trials can include health claims on their products. Cheerios, for instance, can carry a label announcing the cereal’s desirable effects on cholesterol levels. But few companies have the resources of a General Mills. Thus did an FDA task force on health claims last week propose to create a graded system. Companies would submit proposed health claims to the FDA, and the agency would grade them “A” if there is significant scientific evidence, “B” if there is inconclusive evidence, “C” if there is limited and inconclusive evidence, and “D” if there is a small amount of evidence. The FDA will first be reviewing the cardiovascular health benefits of omega-3 fatty acids, typically contained in fish oils, and claims that lycopene in tomatoes can reduce the risk of heart disease. As the FDA’s commissioner, Mark McClellan, told the Washington Post: “This is aimed at making companies want to develop healthy products and to do the science that supports their health claims.”It may well be that Mr. Vale’s apricot seeds and related products would receive a D, or even an F, from the FDA as to the health claims he has been affixing to them. Yet, it is better that he have the chance to enter into a more liberal FDA labeling scheme than operate outside of the current one. As the general counsel of the Competitive Enterprise Institute, Samuel Kazman, told the Sun, “People still ought to have the right to take it, so long as they’ve been let to know it has no value.” More importantly, consumers would be well served if they were allowed to be active participants in decisions affecting their health, as opposed to being spoon-fed their information by the federal government. The benefits of living in a culture and a marketplace that allow for a freer exchange of information — and contain more incentives to research and innovate — would outweigh the consequences of a few bad seeds.

Vale of Silence

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