“This much needed move will save the vapour industry from decimation in 2018”- from the press release from the American Vape Association.
The FDA’s press release stated “The U.S. Food and Drug Administration announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi year roadmap to better protect kids and significantly reduce tobacco related disease and death ”
Greg Conley, the President of the AVA (American Vaping Association) summarised the FDA’s key points.
- Delay of PMTA deadline – In a major change in policy, manufacturers of non-combustible products like vapour products now have until August 8 2022 to submit their premarket tobacco applications (PMTA)
- Product Standards – FDA plans to issue product standards for vapour products to “protect against knowing public health risks”
- Process clarity – FDA will issue new “foundational rules” to modify the product review process.
- Flavours – FDA will study the effects of flavours, both on young people and adult smokers looking for a less harmful alternative
- Reduced-nicotine cigarettes – FDA will begin a public dialouge on the impact of reducing nicotine in cigarettes to non addictive levels.
Through all the noise, there remains a point of concern for vapers “to possibly regulate kid appealing flavours in products like electronic nicotine delivery systems.”
Dr. Scott Gottlieb, Commissioner of the FDA commented in his announcement speech that the marketplace has witnessed a huge shift as a result of non tobacco products, “As a physician who cared for hospitalized cancer patients, and as a cancer survivor myself, i saw first hand the impact of tobacco. and i know all too well that its cigarettes that are the primary cause of tobacco related disease and death. whats now clear is that the FDA is at a unique moment in history, with profound new tools to address this devastating impact.
Conley concluded “The FDA’s deeming rule still bans any innovation in the market and, without major changes to the agency’s premarket review process, could still result in that vast majority of the market being banned in 2022 if Dr.gottlieb turly wants to reduce the death and disease in the long term, today’s announcement must be the first step of many in reforming the FDA regulatory process.
Greg Conley, President, American Vape Association.