The FDA said Wednesday that some manufacturers are deceptively labeling products to hide that they contain ingredients known to cause adverse health effects. Other supplements contain ingredients that should only be available 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."
Dietary supplements can slip through the regulatory cracks because, unlike drugs, they do not have to be approved by the FDA before they are marketed. Manufacturers are responsible for making sure their products are safe.
The FDA has pressured companies to recall nearly 200 inappropriately-formulated products since 2007, 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.
Government regulators do not have the power to force companies to recall products, and instead the FDA usually issues warning letters to draw attention to illegal products.