LOS ANGELES--Enforma Natural Products Inc., based here, is once again in the Federal Trade Commission's (FTC) crosshairs. In a release dated July 25, FTC filed a second civil contempt action against Enforma and its president, Andrew Grey, for continuing to violate the terms of a May 2000 final consent order prohibiting unsubstantiated claims for weight-loss products that included Fat Trapper Plus, Exercise in a Bottle, Acceleron and Chitozyme. The action also included charges against 24/7 LLC, an entity formed by Enforma and Grey, as well as Donna DiFerdinando, Enforma's vice president of research and development.
This time around, the company's Chitozyme and Acceleron are targeted for using false and unsubstantiated representations and not including the court-mandated disclosure that reducing caloric intake and/or increasing exercise is needed to lose weight. The two products are advertised through two infomercials and a Web site (www.enforma2000.com), which include statements such as Chitozyme is "a revolutionary fat trapping product that promotes weight-loss while letting you still eat your favorite food, guilt-free."
In its application for civil contempt, FTC alleges the defendants have not provided competent and reliable scientific evidence that Acceleron aids weight loss by increasing metabolism, or that Chitozyme "traps fat" and causes weight loss without diet or exercise. FTC also alleged that the defendants misrepresented results of studies in their advertising and packaging, as well as failed to include court-ordered disclosures in their infomercial.
FTC sought a preliminary injunction to prohibit dissemination of these and other unsubstantiated claims, a recall of all product packaging and labeling, and an order requiring Enforma, Grey, 24/7 and DiFerdinando to turn over all revenues received by them as a result of the alleged violations of this order. However, on July 23, the judge hearing the case denied FTC's requests and rescheduled another hearing for Sept. 16 to hear FTC's motion for a preliminary injunction.
According to DiFerdinando, every product is backed by double blind, placebo-controlled studies, which are reviewed by outside experts such as Harry G. Preuss, M.D., from Georgetown University. She does admit the company has changed quite a bit since FTC first approached Enforma in 2000. "If you look at how we were three years ago as a company and how we did business and how we do business now, it's remarkable in how we do our due diligence now," DiFerdinando said.
However, she feels FTC is giving Enforma the runaround. "FTC has always said it wants competent and reliable information," she said, adding that FTC does not define what kind of information it wants. "What kind of study? How many? They never define it. However, when we go to them with our studies, they say, `You have one? We want two. You have two? We want three. Have double blind? We want placebo-controlled.' We're just trying to reach a moving target."
In the meantime, as Enforma waits to go to trial yet again, DiFerdinando feels confident about the outcome. "The FTC has their experts, we have ours. They don't agree, so the court is assigning a third, independent expert to review the studies to make the call," she said. "I can't wait. I welcome it."