FDA: We Need Help to Stop Adulteration

WASHINGTONFDA said it needs help from industry and consumers to purge the market of weight-loss products being touted as dietary supplements, but that actually contain hidden prescription drugs or compounds, according to an FDA consumer alert.

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." He added, We have seen deaths associated with these weight-loss products. Make no mistakethey can kill you."

The alert said FDA has found weight-loss products tainted with sibutramine, an ingredient found in the FDA-approved drug 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, including seizure medications, blood pressure medications and other illegal drugs.

FDA admitted that while it has made it a priority to eradicate these dangerous products, the problem is so big that FDA needs help." The agency said it is reaching out to the dietary supplement industry to help eliminate the availability and sale of these products, and FDA is asking consumers for help.

FDA recommended consumers avoid fraud by looking for potential warning signs of tainted products, such as promises of quick action, such as lose 10 pounds in one week;" use of the words guaranteed" or scientific breakthrough;" products marketed in a foreign language; products marketed through mass e-mails; and products marketed as an herbal alternative to an FDA-approved drug.

For all dietary supplements, FDA suggested consumers ask a health care professional before use, ask a health care professional to help distinguish between reliable and questionable information, question claims that sound too good to be true and avoid products with extreme claims.

FDA gave a brief description of DSHEA and noted that just because a shopper sees a supplement product on a store shelf, it does not mean it is safe or effective. 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," the alert said.

FDA applauded the industry, saying it has partnered with industry members to recall more than 40 products marketed for weight loss with potentially harmful ingredients.

 FDA urged consumers who suspect a dietary supplement sold online may be illegal to report that information online, and who have an illness or injury they believe to be related to the use of a dietary supplement to call 1-800-FDA-1088.