The FDA has recently posted a new consumer advisory, warning that federal regulators have found dozens of products being touted as dietary supplements that actually contain hidden prescription drugs or compounds which have not been adequately studied in humans and can cause serious illness and even death.
“These products are not legal dietary supplements,” Michael Levy, director of the Food and Drug Administration’s (FDA’s) Division of New Drugs and Labeling Compliance, is quoted by the FDA as saying. “They are actually very powerful drugs masquerading as ‘all-natural’ or ‘herbal’ supplements, and they carry significant risks to unsuspecting consumers.”
“We have seen deaths associated with these weight-loss products,” added Levy. “Make no mistake—they can kill you.”
According to the FDA’s website, the FDA has found weight-loss products tainted with the prescription drug ingredient sibutramine. This was an ingredient in an FDA-approved drug called Meridia, which was removed from the market in October 2010 because it caused heart problems and strokes. The FDA has also found weight-loss products containing 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.,” said Levy.
Dietary supplements, in general, are not FDA-approved. By law, under the Dietary Supplement Health and Education Act of 1994, dietary supplement companies do not need FDA approval to market their products. The companies, however, do have a legal responsibility to make sure their products are safe and that their claims are true. But, the FDA does not have adequate resources to police and enforce this obligation. As a result, many fraudulent, illegal and dangerous weight-loss products are on the market.
Many of these tainted products are imported and sold over the Internet, but some are also found on store shelves. “Just because you see a supplement product on a store shelf does NOT mean it is safe or effective,” the FDA warns. The FDA has made it a priority to search for these dangerous products, stop them from being imported, and take legal action against firms that manufacture and distribute them.
The Agency has worked with industry to recall more than 40 products marketed for weight loss with potentially harmful ingredients, and has issued consumer alerts and warning letters about dozens more. It has also criminally prosecuted some people responsible for these illegal diet products.
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,” the FDA says. When safety issues are suspected, the FDA must investigate and, then take steps to have a fraudulent product removed from the market. This takes time and resources that the agency does not have. “FDA cannot test all products on the market to identify those that contain potentially harmful hidden ingredients,” the agency cautions.
In fact, the problem is so big that the FDA has said it needs help. The agency is asking the dietary supplement industry to help eliminate these products, and is also enlisting the help of consumers.
“We … need consumers to be aware of these dangerous products and to learn how to identify and avoid them,” says Levy (of the FDA’s Division of New Drugs and Labeling Compliance).
View this video posted by the FDA on how to recognize fraudulent weight-loss products and claims »
Following is a list of warning signs provided by the FDA, which should raise red flags of potentially tainted products:
- promises of quick action, such as “lose 10 pounds in one week”
- use of the words “guaranteed” or “scientific breakthrough”
- labeled or marketed in a foreign language
- marketed through mass e-mails
- marketed as an herbal alternative to an FDA-approved drug or as having effects similar to prescription drugs.
The FDA provides the following advice to 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.”
If you suspect a dietary supplement may be illegal, the FDA urges you to report that information to them online. You or your health care professional can also report an illness or injury that you believe to be related to the use of a dietary supplement by calling 1-800-FDA-1088 or visiting FDA online.
The FDA has also created an RSS feed on “Tainted Products That are Marketed as Dietary Supplements,” in an effort to alert consumers more rapidly when the agency finds a tainted product.
For further information on Weight Loss Fraud, see the FDA’s website at: FDA.gov/weightlossfraud.
The FDA’s Consumer Updates page provides the latest updates and consumer alerts on all FDA-regulated products.
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