Companies Must Stop Fraudulently Promoting
as a Treatment to Quit Smoking.
Public Citizen Tells FDA
Companies Illegally Marketing Therapy
Despite Lack of Scientific Evidence and Lack of FDA Approval
Public Citizen News release
June 22, 2006
Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to stop five companies from illegally promoting low-power laser therapy as a means to quit smoking. The clinics, Freedom Laser Therapy Inc., the Anne Penman Laser Therapy clinics, New Beginnings Laser Therapy, Laser Concept and the Stop Smoking Laser Center, are marketing laser therapy as a safe and effective smoking cessation treatment despite the lack of FDA clearance or any evidence that it is effective.
Laser therapy, also known as laser acupuncture, aims a low-power laser beam rather than needles at various points of the body. It is approved by the FDA for marketing only for the temporary relief of pain. For all other uses, the therapy may be used only for investigational clinical trials or studies. “The laser device does not have marketing clearance for smoking cessation, and promotion of such use as well as claims of safety and/or efficacy for this use are illegal,” reads the seven-page Public Citizen petition.
Although all five companies are violating FDA laws and regulations, the petition focuses on Freedom Laser Therapy (FLT), which has garnered the most news coverage on multiple local and national television programs. FLT claims an 85% success rate for curing smoking addiction in just one 30-minute session. It also touts the support of “international clinical trials” to back up its claims. But inspection of the three “international clinical trials” offered on the company’s Web site reveals that none has been published and none is a proper trial that would offer scientific evidence that laser therapy is a valid treatment to stop smoking.
FLT’s therapy is $399 for the single 30-minute session, an expensive treatment for typical smokers who are trying to quit. According to the petition, this money would be better spent on treatments that have been proven to show some success: nicotine replacement therapy, physician advice, certain antidepressants and individual behavioral counseling.
Despite the lack of scientific evidence supporting its claims, the company has launched an aggressive marketing campaign to recruit a wide audience of vulnerable clients who are looking to stop smoking. It has created two promotional videos, orchestrated coverage on at least 20 local and national news programs and has run a demonstration booth backstage at the nationally televised American Music Awards to appeal to celebrities as potential spokespeople. In all of its advertising, FLT presents laser treatment as a much more credible option than has been shown in the medical literature.
“FLT claims it is conducting clinical trials authorized by the FDA, however the nature and extent of its advertising and promotional activities portray a company that is clearly marketing a self-proclaimed proven treatment,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “At this time, there is a lack of any scientific support for the use of laser therapy for smoking cessation, and to claim otherwise is illegal.”
A thorough review of the medical literature reveals only a single well-designed study that could answer the question about laser effectiveness for smoking cessation and this study revealed “no difference” between laser acupuncture and placebo.
Its violation of the law and misleading advertising to a susceptible audience make this industry a prime target for FDA action. According to FLT’s Web site, it plans to open franchises across the country and expand the treatment to include weight loss in addition to smoking cessation.
“Manipulative and aggressive marketing campaigns such as this must be met with equally aggressive FDA action in order to protect the health and interests of the public,” states the petition.
This article was posted on June 24, 2006.