Laser acupuncture claims smoking cessation without FDA approval

“Laser acupuncture” promises a smooth transition to a smokefree life -- and a 90% success rate!

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Did you know there’s a smoking cessation treatment that claims a 90 percent success rate that the FDA allows on the market without approval?

Well, my friend, welcome to the magic that is low-level laser therapy — also known as “laser acupuncture.”

“Low level laser therapy uses acupuncture points to stimulate points on the ear, hand and legs. NO NEEDLES! We help you quit smoking, control weight, end addictions and ease internal mental and emotional stress. We are able to help with 100+ health issues, so please contact us to discuss your needs.”

That’s from the website of Dallas Laser Healthcare, which claims smoking cessation results more than 10 times greater than anything approved by the FDA. “Laser therapy to help you stop smoking with up to a 94% success rate*,” they brag.

Despite the asterisk leading to an “individual results may vary” disclaimer buried at the bottom of the page, they throw the 90 percent claim around liberally, especially on Twitter. That was where they caught the eyes of a lot of vapers last week, first by tweeting a link to a terrible clickbait headline about vaping and popcorn lung.

They deleted the popcorn lung tweet soon after I emailed the company asking several questions about their services. Employee Kim Wheeler explained to me, “I have spoken to our social media expert and asked to not spread or tweet anything that could hurt others who are trying to help smokers.”

That’s nice. But making extravagant claims about smoking cessation isn’t much better. How do they back up the 90 percent success claim? “To prove our statement of up to 90% success, we have a CID Program, which tracks all clients in all 60 locations,” wrote Wheeler. “Every month the results are pulled to be sure we are all getting the same results.”

She doesn’t seem concerned that advertising 90 percent cessation success will run afoul of the FDA’s strict standard for such boasts. The federal agency requires that products making therapeutic claims be proven effective for smoking cessation in clinical trials first. Then they must be approved by the FDA Center for Drug Evaluation and Research (CDER).

“Our website, paperwork and all literature have never claimed to be FDA approved for smoking but we do very successfully help smokers quit by easing the side effects of withdrawal,” Wheeler wrote. “I spoke to the FDA and our state myself and we are in no way violating any federal or state legislation. Our laser is in a class where it is not regulated by the FDA.”

A quick Google search shows that this therapy has been around for a while. A 2010 Reuters story details the efforts of a company called Laser Therapeutics to get FDA approval for its smoking cessation therapy.

However, seven years later, it appears that hasn’t happened yet. The company’s website only says that “Laser Therapeutics has been involved with a clinical research trial to document the effectiveness of low level laser for smoking cessation and weight control.”

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And according to a 2006 Associated Press story, the same company was warned as early as 2004 that it failed to properly monitor its clinical trials. At that time, Laser Therapeutics claimed it was just 90 days from submitting its application for approval to the FDA.

The Laser Therapeutics website walks a fine line, but doesn’t quite make the same kinds of specific claims of success that the Dallas company does. Nevertheless, both seem to be playing a dangerous game with a federal agency that‘s never shy about throwing its weight around.

Jim McDonald

I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.