FDA warns against taking illegal dietary supplements
By Natasha Singer
New York Times
Posted: Sunday, Aug. 28, 2011
Popular products claim to enhance weight loss, bodybuilding and sex.
BOSTON Marketing drugs in the guise of supplements is illegal in the United States. Federal authorities are struggling to identify and intercept these black-market goods, which, they warn, pose grave health risks.
The makers of legal dietary supplements - the kind found at GNC, for example - acknowledge that they are reluctant to raise too many alarms. Even though there is little evidence that many dietary supplements provide real health benefits, legal supplements, from multivitamins to ginkgo biloba, are a big and growing business. Americans spent $28.1 billion on them last year, up from $21.3 billion five years ago, according to estimates from Nutrition Business Journal, a market research firm.
Many millions more are also being spent annually on black-market products, particularly those marketed for weight loss, bodybuilding and sexual enhancement. Officials say such products can cause heart attacks and strokes and can damage the kidneys and liver. A few people in the U.S., they say, have died after taking them.
Industry representatives say the vast majority of supplements are safe, and they fault regulators for failing to stop the influx of illegal products from places such as China.
The problem, says Michael Levy, acting director of the FDA's office of drug security, is that the FDA lacks the resources to stem the influx of illegal raw ingredients and finished products to the U.S. Moreover, he says, the agency cannot easily prevent adulterated products disguised as supplements from reaching the market.
U.S. supplement makers can introduce new products much more easily than pharmaceutical companies. Drug makers are required to prove that their products are safe and effective, and they must obtain federal approval before going to market. But dietary supplements, by definition, contain only dietary ingredients; the federal law on supplements does not require premarket approval.
Trying to get tainted products off the market is expensive and time-consuming. Before federal officials can take action, Levy says, they must first buy suspect items or catch them at the border and then test them in an agency lab.
Pills marketed as male sexual enhancement supplements often contain sildenafil citrate, the active ingredient in Viagra, or its analogues. But these adulterated pills sometimes contain up to seven times the recommended dose, Levy says. Another danger: Some of the analogues may have never been tested for safety in humans.
"These products may work," he says, but "if you take them, they could kill you."
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