![]() ![]() However, the activities of the other companies similarly violate FDA regulations against “prohibition of promotion and other practices” as stated above. For this reason, this petition will focus on the activities of Freedom Laser Therapy. 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. ![]() (d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated. ![]() (a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution. Prohibition of promotion and other practices:Ī sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not: 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): 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.” For other indications, such as smoking cessation, the lasers are considered to be “unapproved, nonsignificant risk Class III medical devices may only be distributed in the U.S. 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.Īt this time, biostimulation lasers, also known as low-power laser therapy, are approved for marketing only for the temporary relief of pain. 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. ![]()
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