iQOS Hearings At FDA Cause A Stir
Updated February 6, 2017
The race to get the first official approval for tobacco products by the FDA may be in jeopardy as Phillip Morris International got slapped down by an FDA requested advisory panel called the Tobacco Product Scientific Advisory Committee. The goal of the hearing was to determine if the innovative iQOS “heat not burn” device truly does reduce harm from tobacco.
The panel was not convinced, which is a blow to one of the world’s largest tobacco companies, who spent $3 billion to develop a product that has been successful overseas. In Japan the iQOS has captured 14.6 percent of the market in less than two years.
The iQOS heats up a stick of tobacco but does not ignite. Their claim is that 90 to 95 percent of toxins are avoided.
Bear in mind that the TPSAC recommendations are non-binding and form just one part of the FDA’s decision on the application. The agency also considers their own scientific assessment, as well as public comments.
The need to get Pre-Market Tobacco Authorization, PMTA, is a significant one. After August 8, 2022, any “new” tobacco or vaping product launched after February 15, 2007, will be illegal. The advisory panel may have an influence, but the process for PMTA approval is still proceeding.
If a multi-billion-dollar conglomerate fails it may bode poorly for both industries. Vaping may not fare so well since virtually all vaping products are “new” and few companies have billion-dollar pockets.
The FDA must first decide if the product is less harmful, and then, if it can be marketed domestically. If they are successful it will be a resounding victory for them as well as the industry. The reputation of Phillip Morris, and all tobacco companies, is marred by their history of lying to the public about the dangers of cigarette smoking.
Though the committee did not find iQOS reduces risk, it did vote that it reduces exposure to the harmful compounds found in cigarette smoke; has a low likelihood of being adopted by never-smokers; and has a low likelihood of being adopted by former smokers.
The battle wages on and Phillip Morris is actively engaged in dialogues with the FDA.
Can the panel be convinced that heating without igniting is “less harmful?” The jury is out on that, and science must back up any decision before the FDA stamps their approval.
Do you have questions about mastering the vape industry? If so, send them on to norm@VapeMentors.com and we’ll address them in future columns.
Norm Bour is the founder of VapeMentors – a vape industry consulting company for vape shops, eCommerce sites and e-liquid brands. He’s also the host of Vape Radio, the largest vape business podcast in the world with more than 1.3 M downloads.
Contact him at norm@VapeMentors.com.