The FDA move comes after several reports of injury and even death from the use of illegal dietary supplements that are contain undeclared ingredients or are deceptively labeled. These include dietary supplements that contain the same active ingredients as drugs already approved by the U.S. FDA, analogs (close copies) of those drugs or novel synthetic steroids that don't qualify as dietary ingredients.
"Some [dietary supplements] contain prescription drugs or analogs never tested in humans and the results can be tragic," said Dr. Joshua Sharfstein, principal deputy commissioner at the FDA, at a news conference. "We have received reports of serious adverse events and injuries associated with consumer use of these tainted products, including stroke, liver damage, kidney damage, pulmonary failure and death."
Dietary Supplements not Regulated by the FDA
Legitimate dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994. Supplements do not have to be approved by the FDA before reaching consumers, but manufacturers are expected to ensure standards.
FDA Issued Alerts on Tainted Dietary Supplements Common
Since 2007, Sharfstein, added, the FDA has issued alerts on 300 tainted dietary supplements.
"FDA is calling attention to an important public health problem," Sharfstein said. "Serious injuries have resulted from supplement products masquerading as dietary supplements. . . They're [dietary supplements] usually poorly labeled so consumers don't know what they're buying."
Most of the illegal supplements are marketed in three categories: to promote weight loss, to enhance sexual prowess and as body-building products, the FDA noted.
The weight-loss products identified with problems include Slimming Beauty, Slim-30 and Solo Slim, which contain sibutramine (or analogs), the active ingredient in the FDA-approved drug Merida, recently withdrawn from pharmacy shelves due to a heightened risk of heart attack and stroke.
The body-building products include Tren Xtreme, ArimaDex and Clomed, which contain anabolic steroids or aromatase inhibitors, a class of cancer-fighting drugs that interfere with estrogen production. Consumers should also be aware of "products that provide warnings about testing positive in performance drug tests," Sharfstein said.
The sexual-enhancement products tend to include the active ingredient or an analog of the popular approved erectile-dysfunction (ED) drugs Viagra, Cialis and Levitra. Illegal products include Duro Extend Capsules for Men, Magic Power Coffee and Vigor-25. In particular, sexual enhancement products promising rapid effects in minutes to hours or long-lasting effects of 24 to 72 hours, should be viewed with caution, the FDA warned.
Consumers should also be skeptical of products that claim to be alternatives to or similar to FDA-approved drugs; those that say they are a legal alternative to anabolic steroids; and those marketed primarily in foreign languages and through mass e-mails, FDA officials cautioned.
FDA Resources to Educate Consumers Regarding Tainted Supplement Products
FDA is launching a new RSS feed, which is a Web-based service, so consumers can keep abreast of rapidly changing developments regarding tainted supplements and other products.
The agency is also introducing a new way for the supplement industry to refer suspects, including referring them anonymously, Sharfstein said.
Dietary Supplement Industry Supports FDA Actions
Representatives from five trade associations representing the dietary supplement industry -- the Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association -- also spoke at the news conference pledging their support, including help putting out the word within the industry.
"We want to drive these pirates out of our [dietary supplement] industry to protect the public health and safety of millions of consumers who do rely on these products for daily health needs," said Loren Israelsen, executive director of the United Natural Products Alliance.
"We have been astonished at the unfortunate growth of this particular class of products, which are intentionally spiked," Israelsen added. "These are illegal products marketed by people who work in the shadows. They are difficult to find but we are committed to working with FDA to find them and drive them out of our industry and out of the U.S."
- Dec. 15, 2010 teleconference with Joshua Sharfstein, M.D., principal deputy commissioner, U.S. Food and Drug Administration a
- Dec. 15, 2010 teleconference with Loren Israelsen, executive director, United Natural Products Alliance