Manufacturers who put tainted or undeclared ingredients into dietary supplements were warned Wednesday by the Food and Drug Administration that they can no longer market them as such. The FDA has received reports on well over 100 products over the last few years, a number of them detailed serious injuries, even deaths. In fact, since 2007 the agency has sent out consumer alerts about 300 adulterated products.
“These tainted products can cause serious adverse effects, including strokes, organ failure and death,” said FDA Commissioner Dr. Margaret Hamburg. “The manufacturers selling these tainted products are operating outside the law.”
Concern over the growing problem has led the agency to send a letter to five major trade associations – the Counil for Responsible Nutrition, Natural Products Assocation, United Natural Produdcts Alliance, Consumer Healthcare Products Association and American Herbal Products Association – whose member companies make dietary supplements, warning them of the problem and of “their legal obligations and their responsibility to prevent tainted products from reaching the US market.”
The FDA’s own laboratory tests revealed a variety of undeclared active ingredients in products sold as dietary supplements like anticoagulants, drugs that prevent blood from clotting and nonsteroidal anti-inflammatory drugs or NSAIDS, that prevent inflammation and pain. They also found supplements that contained active drugs that had been taken off the market as a safety precaution.
The agency is focusing on three categories where the bulk of these illegal products come from: weight loss, body building and sexual enhancement. The FDA found weight loss products that contained sibutramine, the active ingredient in the diet pill Merida, which was recently pulled off the market because it increased the risk of heart attack and stroke. Also body building products that contained anabolic steroids–a controlled substance, and sexual enhancement products like Vigor-25, Magic Power Coffee, Duro Extend Capsules for Men. These have the same active ingredient as approved drugs Viagra, Cialis and Levitra–which are available only by prescription.
The FDA has launched a new RSS Feed – a feed on their website that frequently updates information and other content like photographs. They are also establishing new ways to inform consumers about dangerous products and new ways for the industry to alert the agency to contaminated products–even anonymously.
Dr. Joshua Sharfstein, principal deputy commissioner, FDA says it’s buyer beware. “We want consumers to be aware that there are products masquerading as dietary supplements but pose significant dangers. Warning signs include products that claim to be alternatives to FDA approved drugs, products marketed primarily in a foreign language, .marketed though mass E-mails, or sexual enhancers that boast rapid affects.”
The dietary supplement industry is onboard.
“We fully support increased enforcement of those who put the health of consumers at risk by selling illegal spiked products and put the health of the legitimate dietary supplement industry at risk by injuring our reputation,” said Steve Mister, president and CEO, Council for Responsible Nutrition. “We applaud the agency’s resolve to get tough with the criminals and we will support these efforts in any way we can.”
“I am astonished at the growth of these intentionally spiked products,” said Loren Israelsen, executive director, United Natural Products Alliance. “We join with FDA and colleagues in the dietary supplement industry to drive these pirates out of the industry and protect public safety.”
Manufacturers of these tainted products could face product seizure and criminal prosecution the FDA says.