Timothy A. Ulatowski, Director
Office of Compliance
Center for Devices and Radiologic Health
Food and Drug Administration
2098 Gaither Road
Rockville, MD 20850
Dear Mr. Ulatowski,
We are requesting that the FDA immediately stop the following companies from illegally promoting low-power laser therapy for smoking cessation: Freedom Laser Therapy Inc., the Anne Penman Laser Therapy clinics, New Beginnings Laser Therapy, Laser Concept, and the Stop Smoking Laser Center. These clinics are promoting and claiming that laser therapy, also known as laser acupuncture – which aims a low-power laser beam (rather than needles) at various points of the body – is a safe and effective way to quit smoking, despite the lack of FDA clearance to do so and the lack of any acceptable evidence that laser therapy is effective for this indication.
At this time, biostimulation lasers, also known as low-power laser therapy, are approved for marketing only for the temporary relief of pain. For other indications, such as smoking cessation, the lasers are considered to be “unapproved, nonsignificant risk Class III medical devices [which] may only be distributed in the U.S. to individual practitioners who have approval from an Institutional Review Board (IRB) for the investigational clinical use of the device, or to investigators participating in a study under an Investigational Device Exemption (IDE) approved by the Center for Devices and Radiologic Health (CDRH), as specified in the Code of Federal Regulations (CFR), 21CFR 812.”
In other words, 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 under 21 CFR 812.7 (a) and (d):
Prohibition of promotion and other practices:
A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:
(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.
Though there are several companies that are promoting laser therapy for smoking cessation, Freedom Laser Therapy has positioned itself most prominently before the public by way of multiple local and national television appearances and thus has likely had the greatest impact on the general public. For this reason, this petition will focus on the activities of Freedom Laser Therapy. However, the activities of the other companies similarly violate FDA regulations against “prohibition of promotion and other practices” as stated above.
Recruiting Research Subjects or Recruiting Buyers?
A promotional video on the Freedom Laser Therapy (FLT) website claims that “in May 2003, an Institutional Review Board…authorized investigational clinical trials using low- level laser therapy in compliance with FDA regulations.” In this same video, FLT claims to be the “first full-scale addiction-based clinic participating in this research study to test the efficiency of smoking cessation treatment.” However, upon investigating this company in further detail, the nature and extent of promotional activities portray a company that is marketing a product rather than collecting data for clinical trials.
The following is a partial list of the company’s aggressive promotional activities as well as a partial list of statements that represent the laser therapy as being safe and effective for smoking cessation:
Two promotional videos on the company website (www.freedomlasertherapy.com):
1) The video entitled Infomercial features the company’s president, Mr. Craig Nabat, stating his personal reasons for involvement with laser therapy, and also features client testimonials from satisfied customers. The video states that “Freedom Laser Therapy is opening up clinics across the U.S.,” (Quote can be heard at 2:20 of the 4:27 video) as well as offering “mobile treatment units” (2:25/4:27) for providing corporate and group treatment to customers who are not able to access the two clinics in Michigan and California. The video then ends with a bold printed message, “Dedicated to Freeing the World from Nicotine Addiction.”
2) The video entitled Promotional Video claims “decades of use in …other countries” that “has been proven successful in treating smokers…” (2:00/3:11) and ends with the phrase “Coming Soon to a Major City Near You.”
Promotional News Coverage
The company has been featured on at least 20 national and local television news programs, all across the country. (Media clips of all appearances are available on the company website at http://www.freeedomlasertherapy.com/video1.htm.) The news coverage exists primarily in two formats: 1) local viewers receive a free laser therapy session on-air, or 2) the news anchor makes a brief report on the laser treatment that is available by Freedom Laser Therapy. The transcripts from these media appearances contain very similar content and phrasing strongly suggesting that the company has orchestrated this coverage by providing the news stations with prepared materials.
In addition, at the current time, only two of the television appearances presented an opposing viewpoint, with advice for people to use therapies that have been scientifically proven and FDA-approved (Fox News national, and KTVK 3 Phoenix). Even these presentations, however, were still very favorable to laser therapy. For example, the on-air segment for KTVK Phoenix had a backdrop image that read “30 Minute Fix” which remained for nearly 20 seconds while the news anchor presented the introductory material for the segment on laser therapy.
Other news programs did appropriately comment that the therapy was undergoing investigational trials, but they also made inappropriate claims of safety and/or efficacy:
“The life-changing treatment which has been used in Canada and Europe for thirty years costs just under 400 bucks-experts say a small price to pay for a life-saving therapy.” (WNEM 5 Mid-Michigan, no date.)
“Preliminary studies show that it is about 85% effective.” (KCAL 9 Los Angeles, n.d.)
Dr. Mamoun Dabbagh states “the laser is painless and quick, and does not have any side effects and is also quite effective.”(WSMV NCB 4 Tennessee, n.d.)
“Success rates are as high as 85%.” This news clip also features a similar quote from Dr. Mamoun Dabbagh. (WPHL WB 17 Philadelphia, n.d.)
It is possible that Freedom Laser Therapy could claim that it is using these television appearances as advertisements to recruit research participants, but FDA guidance on the matter states that “no claims should be made, either explicitly or implicitly, that the device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other device.” Clearly, the television news appearances do not comply with these guidelines. In addition, phrases such as “life-saving therapy” and quotes from doctors stating that laser therapy is “quite effective” give false credibility to the product.
Promotional Events and Slogans
- Freedom Laser Therapy also had a demonstration booth backstage at the popular televised American Music Awards, thereby boosting exposure of this treatment to influential celebrities, as well as to the multiple media outlets that covered the event.
- Advertising slogans that emphasize the company’s name (Freedom Laser Therapy), such as the company’s phone number: 1-866-GOFREEDOM, and the company’s claim to promote “Freedom from Nicotine Addiction.”
Company Claims of Efficacy Do Not Match Scientific Evidence
The company’s promotional materials abound with unsubstantiated claims of safety and efficacy. The company often claims to be able to rid a client of tobacco addiction in “just one treatment,” and often touts a success rate of 85%. An article from AZfamily.com quotes the company president as saying, “We’ve coined the phrase ‘Quit smoking in 30 minutes’ because that’s all you need.” Moreover, the company website claims to have the backing of “over three decades [of use] in Europe and Canada,” as well as the support of “international clinical trials.”
Upon inspection of these three “international clinical trials” shown on the company’s website, none has actually been published, and none offers acceptable scientific evidence that laser therapy is a valid treatment for smoking cessation. The best-designed study of the three had two treatment groups and one placebo group, but suffered a significant lack of statistical power with only 31 participants finishing the study. Furthermore, there was a very short follow-up time of only 14 days. The findings of this study revealed the following results for complete cessation of smoking at the end of 14 days: placebo=0, treatment group with 24 Joules/cm² = 2 and treatment group with 48 Joules/cm²=1. In other words, only 3 of the 31 participants were smoke-free at the end of the 14 day period. Note that many elements of this unpublished study, including the details of randomization and methods for blinding, were not well-described.
A second study from the website was a hospital-based pilot study consisting of 70 hospital patients with cardiovascular, respiratory or diabetic disorders who were identified as being motivated to quit smoking (self-referred group with no randomization, no placebo-control). These patients all received the same two treatments with laser therapy. At a 6 month follow-up, it was found that 55% had successfully quit smoking. This study perhaps shows that the individuals most likely to be motivated to quit smoking (ill and in the hospital) are successful a little more than half of the time when using laser therapy. However, the study design has too many flaws to provide meaningful scientific evidence for or against the use of laser therapy in a more general population.
The third study from the website is similar in that it is not a randomized, controlled trial, but rather a compilation of data acquired from individuals seeking treatment at a laser therapy center in Scotland.
In Search of Published Scientific Evidence
We conducted a MEDLINE (National Library of Medicine) literature review using the following search terms in various combinations: laser therapy, laser acupuncture, smoking, and smoking cessation. Despite the company’s claims of decades of international use with proven success, we found relatively few studies on the matter. In fact, a recent Cochrane review (2006) of all published studies dealing with “acupuncture and related interventions for smoking cessation” found only one randomized, double-blind controlled trial investigating the use of lasers for smoking cessation.
This study, by Cai Yiming, et. al.,found “no difference” between laser therapy and sham laser (the control group in which the laser is not turned on). There was a 24.8% complete cessation rate in the treatment group at three months post-treatment vs. 26.2% complete cessation rate in the control group. What is also notable given these results is the high placebo response, given that 26.2% of individuals in the control (placebo) group quit smoking. Differentiating results from placebo vs. results from treatment is of course one of the reasons that randomized controlled-trials are needed to evaluate specific treatments.
The Cochrane review found only one other study involving lasers and it was excluded from the review for the following reasons: “not described as random; complete abstinence not reported.”
Clearly, at this time there is a lack of any scientific support for the use of laser therapy for smoking cessation. Priced at $399 for a single session, this is an expensive “experiment” for the typical smoker who is looking to end his/her addiction. Based on what is known now, 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.
Given that there are 44.5 million cigarette smokers in the U.S., and more than 70% have expressed a desire to quit smoking, the market for this type of product is very large. In addition, this is a population that is particularly susceptible to trying new (but unproven) treatments because so many of its members want so desperately to quit smoking. This situation-millions of people looking for a credible and cost-effective way to end their addiction-is exactly the foundation for the protective functions of the FDA.
In summary, Freedom Laser Therapy and the other four companies have been promoting a medical device that has not received marketing clearance for smoking cessation. The gravity of the situation is magnified by the vast media exposure that has brought this particular treatment before a wide audience of potential and susceptible clients and which portrays the treatment as being a much more credible option than has been portrayed in the medical literature.
In addition, the Freedom Laser Therapy company plans to open franchises across the country and expand the treatment indications to include weight loss as well as smoking cessation. This manipulative and aggressive marketing campaign must be met with equally aggressive FDA action in order to protect the health and interests of the public. We look forward to a prompt response to this request.
Michele Lynch, M.D., M.P.H.
Peter Lurie, M.D., M.P.H.
Sidney M. Wolfe, M.D.
Public Citizen’s Health Research Group
 CDRH. Laser Facts. CDRH Consumer Information. Updated May 17, 2002. http://www.fda.gov/cdrh/consumer/laserfacts.html#7. Viewed June 6, 2006.
 CDRH. Laser Facts. CDRH Consumer Information. Updated May 17, 2002. http://www.fda.gov/cdrh/consumer/laserfacts.html#7. Viewed June 6, 2006.
 Companies include, but are not limited to: Anne Penman Laser Therapy www.annepenmanlasertherpay.com 46 established clinics, including international locations Website documents 7 instances of press coverage by the news media New Beginnings Laser Therapy, www.stopsmokingnow.com, now available at: http://web.archive.org/web/20080615132136/http://stopsmokingnow.com/. Website documents media coverage by local television and print media. Laser Concept, www.laserconcept.com, now available at: http://web.archive.org/web/20080312143321/http://www.laserconcept.com/, 7 clinic locations Laser therapy for smoking cessation and weight control. Stop Smoking Laser Center, www.endsmoke.com, now available at: http://web.archive.org/web/20080625014007/http://www.endsmoke.com/, 1 clinic location Laser therapy for smoking cessation and weight control.
 “Promotional Video” http://www.freedomlasertherapy.com/video2.htm. Now available at: http://web.archive.org/web/20060618224156/http://www.freedomlasertherapy.com/video2.htm. Quote begins at 0:09/3:11 of the video.
 “Promotional Video” http://www.freedomlasertherapy.com/video2.htm. Now available at: http://web.archive.org/web/20060618224156/http://www.freedomlasertherapy.com/video2.htm. Quote begins at 0:57/3:11 of the video.
 Center for Devices and Radiologic Health. Guidance for Industry and FDA Staff: Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects. Issued March 19, 1999. www.fda.gov/cdrh/comp/2229.html.
 AZfamily.com, by Brandy Aguilar, 3TV Producer, posted November 17, 2005. http://www.azfamily.com/health/living/stories/KTVKHLiving20051117.6d23a55f.html. Now available at: http://web.archive.org/web/20070407004251/http://www.azfamily.com/health/living/stories/
KTVKHLiving20051117.6d23a55f.html. Viewed May 26, 2006.
 “1993 Double Blind Study on Smoking Cessation” as labeled on the Freedom Laser Therapy website. Title: “Double blind study to assess the effectiveness of the therapy as a treatment for stopping smoking.” Tony Harrison, Natural Health Clinic, Bristol. Unpublished. https://www.citizen.org/sites/default/files/lllt_study-harrison.pdf.
 Penman, A. Low Level Laser Therapy: Project Evaluation to assess the effectiveness of the therapy as a treatment for stopping smoking. Monklands Hospital, Scotland. Unpublished. 1995. www.freedomlasertherapy.com/docs/LLLT_Study-Monkland.pdf.
 Sheridan, A. Anna Sheridan Laser Therapy Centre Project Evaluation 1999-2000: Low level laser therapy?Project Evaluation to assess the effectiveness as a treatment for stopping smoking?The Clinical Experience. Unpublished. www.freedomlasertherapy.com/docs/LLLT_Study-Sheridan.pdf.
 White AR, Rampes H, Campbell JL. Acupuncture and related interventions for smoking cessation. The Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD000009. DOI: 10.1002/14651858.CD000009.pub2.
 Cai Yiming, Zhao Changxin, Wong Song Un, Zhang Lei, Lim Seuk Kean. Laser acupuncture for adolescent smokers-a randomized double-blind controlled trial. American Journal of Chinese Medicine 2000; 25 (3-4): 443-9. (Note: this article has been referenced as either Cai, et al, or Yiming, et al.)
 Tan CH. The use of laser on acupuncture points for smoking cessation. American Journal of Acupuncture 1987; 15(2):137-41, as cited in: White AR, Rampes H, Campbell JL. Acupuncture and related interventions for smoking cessation.The Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD000009. DOI: 10.1002/14651858.CD000009.pub2.
 Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. The Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD000146. DOI: 10.1002/14651858.CD000146.pub2. Abstract only.
 Lancaster T, Stead LF.Physician advice for smoking cessation. The Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD000165. DOI: 10.1002/14651858.CD000165.pub2. Abstract only.
 Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. The Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD000031. DOI: 10.1002/14651858.CD000031.pub2. Abstract only.
 Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation. The Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD001292. DOI: 10.1002/14651858.CD001292.pub2. Abstract only.
 CDC. Cigarette smoking among adults-United States, 2004. Morbidity and Mortality Weekly Report 2005; 54(44):1121-1124. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5444a2.htm.
 Fiore MC, Bailey WC, Cohen SJ, et.al. Treating Tobacco Use and Dependence. Quick Reference Guide for Clinicians. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. October 2000. http://www.surgeongeneral.gov/tobacco/tobaqrg.htm.