Dietary supplements, in general, are not FDA-approved. Under the law (Dietary Supplement Health and Education Act of 1994), dietary supplement firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure its products are safe and that any claims are true.

Just because you see a supplement product on a store shelf does NOT mean it is safe or effective. When safety issues are suspected, FDA must investigate and, when warranted, take steps to have the product removed from the market. However, it is much easier for a firm to get a product on the market than it is for FDA to take a product off the market.

FDA has worked with industry to recall more than 40 products marketed for weight loss with potentially harmful ingredients, and has issued consumer alerts about dozens more. The agency also has issued warning letters, seized products, and criminally prosecuted people responsible for these illegal diet products.

Some weight-loss supplements don’t live up to their claims. Even worse, they can cause serious harm, say federal regulators, who have found dozens of products being touted as dietary supplements but that actually contain hidden prescription drugs or compounds that have not been adequately studied in humans.

“These products are not legal dietary supplements,” says Michael Levy, director of the Food and Drug Administration’s (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.”

FDA has found weight-loss products tainted with the prescription drug ingredient sibutramine. This ingredient was in an FDA-approved drug called Meridia, which was removed from the market in October 2010 because it caused heart problems and strokes. FDA has also found other prescription drug ingredients that have been removed from the market or never approved at all.

“We’ve found other weight-loss products marketed as supplements that contain dangerous concoctions of hidden ingredients including seizure medications, blood pressure medications, and other drugs not approved in the U.S.,” says Levy.

Many of these tainted products are imported and sold through the Internet, but some can also be found on store shelves. FDA has made it a priority to seek out these dangerous products, stop them from being imported, and take legal action against firms that manufacture and distribute them.

But the problem is so big that FDA needs help. The agency is reaching out to the dietary supplement industry to help eliminate the availability and sale of these products. And FDA is enlisting the help of consumers.

Advice for Consumers

Generally, if you are using or considering using any product marketed as a dietary supplement, FDA suggests that you

  • check with your health care professional or a registered dietitian about any nutrients you may need in addition to your regular diet
  • ask your health care professional for help distinguishing between reliable and questionable information
  • ask yourself if it sounds too good to be true
    • Be cautious if the claims for the product seem exaggerated or unrealistic.
    • Watch out for extreme claims such as “quick and effective” or “totally safe.”
    • Be skeptical about anecdotal information from personal “testimonials” about incredible benefits or results obtained from using a product.