Dietary Supplements Trigger FDA Crackdown: What's the Threat? (Product List)
(CBS/AP) Are supplement manufacturers trying to pull a fast one?
The FDA seems to think so. It's cracking down on makers of supplements sold for weight loss, body building and sexual enhancement, saying some contain potentially dangerous ingredients.
Some supplements are deceptively labeled to hide that they contain ingredients known to cause adverse health effects, the agency said on Wednesday. Others contain ingredients that should only be available only by prescription.
"These tainted products can cause serious adverse effects, including strokes, organ failure, and death," said FDA Commissioner Margaret Hamburg. "The manufacturers selling these tainted products are operating outside the law."
How did the supplements slip through the regulatory cracks? Unlike drugs, they don't need FDA approval before they are marketed. Manufacturers are responsible for making sure their products are safe.
Since 2007, the FDA has pressured companies to recall nearly 200 inappropriately formulated products, including 80 that were marketed as body building supplements, according to the agency. The recalled products were linked to reports of stroke, kidney failure, liver injury and death.
Executives from the supplement industry said they support the FDA crackdown and would share the letter with companies.
"The spiking of supplements with drugs is a crime, it endangers the public and undermines our members and other legitimate manufacturers and retailers of supplements," said John Gay, executive director of the Natural Products Association, on a media call with FDA leadership.
The FDA said it is targeting weight loss products containing sibutramine, which has been pulled from the market for boosting the risk of heart attack and stroke. The agency said it discovered "dozens of products" that contain sibutramine, including those marketed under the brand names Slimming Beauty, Solo Slim and Slim-30.
Body building products under scrutiny include those containing anabolic steroids or steroid analogs. The agency cited Tren Xtreme, ArimaDex, and Clomed as supplements that have been labeled to contain those products.
The agency also warned consumers to be wary of sexual enhancement products that contain ingredients similar to the prescription-only drugs Viagra, Cialis, and Levitra. It said products marketed under the names Vigor-25, Duro Extend Capsules for Men, and Magic Power Coffee are in violation of federal law.
"Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs," said Michael Levy, director of labeling compliance for the agency. "Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails."
