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If the FDA is now going after health claims (see yesterday's post), will it also start going after dietary supplements? These, as I explained in my most recent column in the San Francisco Chronicle, excerpted below, get to make all kinds of unsubstantiated claims without the FDA being able to do much about them.
Congress passed the Dietary Supplement Health and Education Act of 1994 on the basis of two quite questionable assumptions: that supplements are basically harmless, and that supplement-makers are basically honest. The law does not require supplement manufacturers to demonstrate the safety or effectiveness of their products to the FDA before selling them. Instead, the FDA must prove a supplement harmful by providing documentation from clinical trials or multiple case reports in court--a tedious process.
Consider that it took the FDA 10 years to get ephedra (ma huang) off the market, despite at least 30 deaths and hundreds of reports of illness among young people who were taking it as an "upper" or to lose weight. The FDA could only institute a ban after ephedra appeared to be implicated in the 2003 death of Steve Bechler, a young pitcher for the Baltimore Orioles. That ban must be working; I cannot find ephedra in any of my local health food stores.
DSHEA did one other thing. Although it did not allow manufacturers to claim that a supplement could prevent or treat disease, it did allow "structure/function" claims that the product could support some structure or function of the body. Thus, labels cannot claim that a supplement prevents colds or AIDS, but they can say that it "supports a healthy immune system."
If this distinction is too subtle for anyone but a company lawyer or a FDA regulator to understand, that is the point. The purpose of DSHEA was to allow supplement-makers to market the health benefits of their products, with or without scientific proof.
More and more evidence is coming in suggesting that supplements can be harmful as well as ineffective. The latest example: antioxidant supplements are said to interfere with the beneficial effects of physical activity. Will such studies encourage the FDA to insist that manufacturers demonstrate safety and efficacy before they put supplements on the market? That would be a refreshing change, no?
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