Tainted Products Marketed As Dietary Supplements Potentially Dangerous

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In a letter sent to dietary supplement manufacturers, the U.S. Food
and Drug Administration expressed concern about undeclared or
deceptively labeled ingredients in products marketed as dietary
supplements. These substances include the active ingredients in
FDA-approved drugs or their analogs (closely-related drugs), or other
compounds, such as novel synthetic steroids, that do not qualify as
dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted
products marketed as dietary supplements and received numerous
complaints of injury associated with these products.

The FDA's letter emphasizes that manufacturers and distributors are
responsible for ensuring that their products comply with the law. Five
major trade associations Council for Responsible Nutrition, Natural
Products Association, United Natural Products Alliance, Consumer
Healthcare Products Association and American Herbal Products
Association are joining FDA on a call for media and have agreed to
share the letter widely within the industry.

"These tainted products can cause serious adverse effects, including
strokes, organ failure, and death," said FDA Commissioner Margaret A.
Hamburg, M.D. "The manufacturers selling these tainted products are
operating outside the law."

The FDA is seeking input and collaboration from dietary supplement
trade associations to educate the industry about this problem and to
help develop new strategies to combat it, according to Hamburg.

The agency also announced a new RSS feed to warn consumers more
quickly about tainted products marketed as dietary supplements.

The FDA has noted the three most common categories of these illegal products:

-- Weight loss products containing active ingredients such as
sibutramine: Sibutramine is the active ingredient in the drug Merida,
which was recently withdrawn from the market due to increased risk of
heart attack and stroke. The FDA has discovered dozens of products,
such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain
sibutramine or closely related drugs (analogs).

-- Body-building products containing anabolic steroids or steroid
analogs: These products can cause acute liver injury and increase the
risk for heart attack, stroke and death. Products like Tren Xtreme,
ArimaDex, and Clomed have been labeled to contain either anabolic
steroids or aromatase inhibitors, which prevent anabolic steroids from
being converted to estrogen.

-- Sexual enhancement products that contain the same active ingredient
or an analog of the active ingredient in the approved drugs Viagra,
Cialis, and Levitra. The approved products are available only by
prescription, and they should not be used by people who have certain
medical conditions, such as cardiovascular disease. Products
determined to be in violation of federal law by the FDA include
Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and
others.

"The labeling of these tainted products may claim that they are
'alternatives' to FDA-approved drugs, or 'legal' alternatives to
anabolic steroids," said Michael Levy, director of the Division of New
Drugs and Labeling Compliance at the FDA's Center for Drug Evaluation
and Research. "Consumers should avoid products marketed as supplements
that claim to have effects similar to prescription drugs. Consumers
should also be wary of products with labeling only in a foreign
language or that are marketed through mass e-mails."

Companies that make or distribute tainted products may receive warning
letters and/or face enforcement actions such as product seizures,
injunctions, and criminal prosecution. Responsible individuals may
also face criminal prosecution.

Lawful dietary supplements contain minerals, vitamins or other dietary
ingredients and are intended to be an addition to a standard diet. The
FDA regulates these products under the Dietary Supplement Health and
Education Act, passed by Congress in 1994. Unlike drugs, dietary
supplements do not have to be approved by the FDA prior to marketing.
Dietary supplement manufacturers and distributors are responsible for
selling a safe product. FDA's Current Good Manufacturing Practices
require dietary supplement manufacturers to have proper manufacturing
and quality assurance controls in place to ensure the quality of their
products, including controls to prevent the inclusion of contaminants
that could adulterate their products.

Source: U.S. Food and Drug Administration