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.

In a letter to the supplement industry, the agency said manufacturers who
distribute tainted products could face criminal prosecution.

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 the agency is targeting weight loss products containing
sibutramine, which has been withdrawn from the market for causing increased risk
of heart attack and stroke. The agency said it has discovered “dozens of
products” that contain the ingredient, 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 include similar ingredients to the approved drugs Viagra, Cialis, and
Levitra. Those ingredients should only be available by prescription. The FDA
said products marketed under the names Vigor-25, Duro Extend Capsules for Men,
and Magic Power Coffee have been determined to be 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.”