FDA targets weight-loss products

March 29, 2011

Weight-loss products that promise consumers quick and easy ways to shed pounds don't live up to their claims and, even worse, can cause serious harm, FDA has announced.

Weight-loss products that promise consumers quick and easy ways to shed pounds don't live up to their claims and, even worse, can cause serious harm, FDA has announced.

Federal regulators found that 69 products claiming to be dietary supplements contained hidden prescription drugs or compounds that have not been adequately studied in humans.

"These products are not legal dietary supplements," said Michael Levy, director of FDA's Division of New Drugs and Labeling Compliance. They are actually very powerful drugs masquerading as 'all-natural' or 'herbal' supplements, and they carry significant risks to unsuspecting consumers. We have even seen deaths associated with these weight-loss products. Make no mistake - they can kill you."

Many consumers are purchasing these tainted products from foreign sources through the internet; however, some are found on store shelves. Among the undeclared active ingredients FDA discovered in products marketed as dietary supplements are the following:

  • Erectile dysfunction drugs (e.g., sildenafil, tadalafil, vardenafil)

  • Anabolic steroids (e.g., madol, androstenedione, turinabol)

  • Weight-loss drugs that have never been approved or have been removed from the market for safety reasons (e.g., sibutramine, cetilistat, rimonabant, fenfluramine)

  • Cancer-causing agents (e.g., phenolphthalein)

  • Anticonvulsants (e.g., phenytoin)

  • Cholesterol drugs (e.g., lovastatin)

  • Blood-pressure drugs (e.g., propranolol)

  • Controlled substances (e.g., sibutramine and anabolic steroids)

Potential warning signs
The FDA advises consumers to look for potential warning signs of tainted products. These include:

  • Promises of quick action, such as “Lose 10 pounds in one week"

  • Use of the words "guaranteed" or "scientific breakthrough"

  • Labels or marketing materials in a foreign language

  • Mass e-mails used to market product

  • Designation as an herbal alternative to an FDA-approved drug or claim for effects similar to prescription drugs

Dietary supplements, in general, are not FDA-approved, nor do firms need to obtain such approval before marketing their products. Consumers should be aware that dietary supplements sold in stores may not be safe or effective.

FDA widget for pharmacy websites
To keep consumers informed about weight-loss products, FDA is offering pharmacy websites a "Tainted Products Marketed as Supplements” widget. A widget is a portable application that displays featured content directly on a web page. There is no technical maintenance involved and FDA automatically provides content updates to the widget.

For more information on FDA's widget visithttp://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm242603.htm