Study Calls for Stricter FDA Enforcement on Supplements

While the FDA is busy building felony cases against bad drug companies, those very companies often continue to sell their tainted drug to the public. The most recent study, published in JAMA, the Journal of the American Medical Association, found that out of more than two dozen supplements found to contain anabolic steroids or powerful prescription drugs that were pulled from shelves, almost two-thirds were back on the market a year later, with the same illicit ingredients.

Most frightening is that the majority of the supplements were marketed for weight loss, exercise, and sexual enhancement. They were sold across the country at easily accessible convenience stores, in health food shops and over the Internet. The accessible supplements were found to contain steroids and prescription drugs like Viagra and Prozac. Alarmingly, several of the weight-loss products contained Sibutramine, an amphetamine-like drug that was supposedly completely removed from the market in the United States, Asia, and Europe, after a clinical trial showed it increased the risk of heart attacks and strokes.

The research paper by JAMA calls for more aggressive enforcement by the U.S. Food and Drug Administration, and asks for an increase in the agency’s powers to prevent alleged all-natural dietary supplements spiked with prohibited pharmaceuticals from being marketed to consumers. The research is the latest to raise questions about the adequacy of FDA oversight of the $33 billion supplement industry.

Tougher FDA enforcement is needed, as even industry officials recognize the gap between citing a company and enforcing the ban in stores and online. However, Steve Mister, president of the Council for Responsible Nutrition, said the new journal article “grossly misrepresents the extent of the situation and understates the success of FDA’s efforts.” Mister and Daniel Fabricant, executive director of the Natural Products Association, say the researchers in the most recent study were able to buy only 27 of the recalled supplements, and the tests didn’t find pharmaceuticals in nine of them, indicating that some had been reformulate and remarketed.

“Do I think stronger enforcement is needed? Oh, yes,” said Fabricant, who was the FDA’s top supplement regulator until this year. In a statement, the FDA said it “faces the challenge of providing effective deterrents to prevent unscrupulous firms from fraudulently marketing and importing these products.” The supplement industry is “extremely fragmented” and often involves products made overseas and packaged and sold by many small distributors, some of them difficult to identify and locate, according to the FDA.