WASHINGTON -- Smokers who pay hundreds of dollars to be zapped by lasers purported to help them quit are victims of fraud, a watchdog group alleged yesterday in seeking a federal crackdown.
Public Citizen petitioned the Food and Drug Administration to halt five companies from promoting low-power laser therapy for smoking cessation. The companies do not have FDA clearance to market the lasers for that purpose, nor is there any scientific evidence they are safe or effective, said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
``There is a prohibition on any kind of marketing or advertising for any unapproved uses of an FDA-regulated product," Wolfe said. ``It's just a massive fraud."
The FDA will evaluate the petition, spokeswoman Susan Cruzan said. The FDA has cleared the so-called biostimulation lasers or laser acupuncture devices to be marketed only to help provide temporary pain relief, according to its website .
Freedom Laser Therapy Inc. charges smokers as much as $349 for a 30-minute laser ``acupuncture" session and kit with vitamins, a booklet, and a video.
FDA regulations do allow the therapy to be used in investigational clinical trials or studies -- exactly what Freedom Laser Therapy said it is carrying out at its two locations, in Santa Monica, Calif. and Royal Oak, Mich., Craig Nabat, the company's president, said.
The companies claim laser therapy triggers the release of endorphins, or the body's natural painkillers, which can help smokers cope with withdrawal.