"All-Natural Herbal" Supplement May Illegally Harbor Prescription Drug

Update, 9/20/07: FDA Posts News of Axcil Recall. TWC Global, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Axcil samples found the product contains potentially harmful, undeclared ingredients.

Update, 9/10/07: FDA Posts News of Zencore Recall. Bodee LLC is conducting this recall after being informed by the FDA that its lab analysis of Zencore Tabs samples found the product contains potentially harmful, undeclared ingredients.

WASHINGTON— A dietary supplement marketed as a sexual stimulant for men is adulterated with a prescription erectile-dysfunction drug and poses "serious health risks" for consumers, according to Health Canada, that country's food and drug regulatory agency.Zencore Tabs, advertised by Bodee, LLC, of Los Angeles as an “all-natural” herbal supplement “without side effects,” is laced with an undeclared drug similar to Cialis, says the Canadian agency. Health Canada has warned Canadians, especially those with heart conditions, not to buy the product. A previous version of Zencore Tabs called Encore Tabs was also adulterated with the drug, according to Health Canada.

In a letter to the Food and Drug Administration (FDA) and Federal Trade Commission, the Center for Science in the Public Interest (CSPI) asked the agencies to immediately analyze Zencore Tabs for the presence of drugs and to halt its sales and advertising until the company can prove it is free from adulteration. CSPI also asked the FDA to investigate an apparently identical product, Axcil, made by Vitogen, Inc., of Palo Alto, California.

“It’s unfortunate that Americans have to rely on Health Canada to learn about a dishonestly labeled, potentially dangerous American-made dietary supplement like Zencore Tabs,” said David Schardt, senior nutritionist at CSPI. “The Canadian government has twice found this U.S. company’s supplements to be adulterated with a prescription drug, yet the supplements continue to be sold here and advertised in the Washington Post, USA Today, and other media.”

CSPI says that Zencore is only one of many cases of deceptive marketing of dietary supplements. An article in the September issue of CSPI’s Nutrition Action Healthletter describes a number of other questionable products making dubious claims.

An ad for Promensil, a red clover supplement for women, claims that “22 clinical studies can’t be wrong” in showing that it relieves hot flashes and mood swings “while promoting breast health, heart health and emotional well-being.” Natrol of Chatsworth, California, the marketer of Promensil, grossly misrepresented the results of that research, according to CSPI. Six of the “can’t be wrong” studies, including the largest and the longest studies of Promensil in women with menopausal symptoms, actually found Promensil useless; two didn’t look for or find any benefits; and a few indicated possible minor benefits. And to top it off, there were only 19 different studies, not 22, on Natrol’s list because the company counted one study three times and another study twice.

Nutrition Action also warns consumers to be wary of supplements touted as “doctor recommended.” The president and formulator of one supplement company called “Doctor’s Best” isn’t a doctor. The six-member advisory board of a company called “Doctor’s Trust Vitamins” is doctor-free.

Other common marketing ploys include describing supplements as the “world’s most powerful,” “patented” (patenting doesn’t require any proof of efficacy), or “now available without a prescription”—when it never needed one to begin with.