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The Federal Trade Commission is cracking down on health products sold through infomercials, alleging that fraudulent claims are being made on everything from flabby ab solutions to pain relievers. The latest FTC target is QT Inc., the maker of the Q-Ray ionized bracelet, which was sued in federal court for allegedly misleading consumers into believing that its metal bracelet relieves pain. On Sept. 8, a federal judge in Chicago ordered QT to disgorge all of its profits from the sale of the bracelet, and refund all of the consumers who bought bracelets between 2000 and 2003. The judge’s ruling also provided injunctive relief, prohibiting QT Inc. from engaging in further deceptive conduct involving the bracelet or a similar product. FTC v. QT, Inc., No. 03-C-3578 (N.D. Ill.). FTC attorney Heather Hippsley said the ruling sends a strong message to the infomercial and health product industries. “You need to have science to back up your product claim,” she said. Hippsley said that the bracelet case is part of the government’s expanding effort to regulate the infomercial industry, noting that similar fraud suits have been filed in recent years involving a number of products, with several more in the pipeline. The placebo effect In the recent Q-Ray bracelet case, the FTC claimed that it wasn’t the bracelet that made people feel better, but a placebo effect, or a psychological effect. But that’s not false advertising, countered QT. If customers are feeling better after wearing their bracelets-even if it is a placebo effect-then that’s not false advertising. QT attorney Michael Ficaro of Chicago’s Ungaretti & Harris, was not available for comment after the verdict. Before the ruling, he said that QT is “selling something that four out of five people say works. And if it doesn’t, you get your money back . . . .How is that false advertising?” He also defended the validity of the placebo effect, saying it’s not just a “psychosomatic” effect, but a chemical and physiological change in the brain and body that causes a person to feel better. QT claimed that its bracelet, which costs between $50 and $250, is based on Oriental medicine and is designed to balance the negative and positive energy forces in one’s body. QT said that some people feel pain relief in a matter of minutes, for others it might take longer. But the FTC argued that it had evidence that the bracelets don’t work. In its complaint, the FTC cited a 2002 Mayo Clinic study that found that the bracelets did not actually relieve pain, but had a placebo effect on some wearers. That study was perfect ammunition for the FTC, noted attorney Saul Perloff, partner in the San Antonio office of Houston’s Fulbright & Jaworski who specializes in advertising-fraud litigation. “That’s where the FTC got ‘em,” Perloff said. “In order to show that a drug is effective, you have to show that it is superior to placebo, otherwise you can’t claim that it’s the drug that’s doing what you claim.” In the bracelet case, Perloff said, “It’s not that [QT] is saying if you wear a bracelet you’ll feel better, but that the bracelet is making you feel better. And that’s the link that they can’t show,” he said. Perloff correctly predicted that the FTC would prevail in the case, saying he doubted that “a judge or jury will buy” QT’s placebo defense. But if QT had prevailed, he noted, it would have set a dangerous precedent. “It will really open the floodgate for purveyors of just about anything to make unsubstantiated drug claims about their product,” Perloff said. Elaine Kolish in the Washington office of Sonnenschein Nath & Rosenthal, who advises clients on advertising and marketing, agreed. “If you allow a placebo effect to be a confident and reliable scientific evidence, you’re giving a license to steal,” she said. “I think it would suggest to advertisers that they don’t really need to have good clinical testing. They could just say, ‘We did a little test in our office and people said they felt better.’ “ Kolish also cited a 1994 case involving the placebo effect and a cure for baldness, in which the 9th U.S. Circuit Court of Appeals held that a placebo effect could not justify false advertising. FTC v Pantron Corp., 33F 3d 1088 (9th Cir. 1994). In that case, the court held that even though people had hair growth, and that it was related to a placebo, that does not change the fraud in the selling and promoting of the product.

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