The FDA finally gets it. The organization announced Thursday that it was launching a comprehensive plan that targets traditional cigarettes and eases proposed restrictions on “innovative tobacco products that may be less dangerous than cigarettes.” This is good news for e-cigarette users and an industry that seeks to help smokers find viable alternatives to cigarettes. It buys vape shops time too. The PMTA submission date has also been pushed back to August 8, 2022.
The most striking part of the initiative is a drastic departure from the FDA’s former blanket attack on nicotine products in general. FDA officials acknowledge the addictive properties of nicotine, but admit that cigarette-related deaths are caused by the makeup of combustible cigarettes and not the nicotine. “A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.”FDA Commissioner Scott Gottlieb, MD, added that “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users.” This acknowledgment opens the door for vape products to be used as a method harm reduction and it’s something the FDA is willing to admit and even support. The FDA plan’s main goal is lowering nicotine levels in cigarettes and “encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes.” Vaping is much less villainized in this new approach, in which the FDA will focus more on battery safety, illegal sales to minors, and ingredients listings. Since a big complaint about e-cigs has focused on flavors that “appeal to kids,” the FDA will invite public comment to gain more information about flavors to gain a greater understanding of their significance to vapers. The FDA admits that the issue is complex and must be better understood with the help of more open public discourse and scientific research. As far as pre-market tobacco analysis for e-cigarettes, the FDA is also planning a more open and comprehensive approach. “Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS.” It’s hard to believe that we may have finally reached a point at which the FDA has broken free of the grasp of big tobacco. Altria’s stocks plummeted after the announcement, which seems to be just what vapers —and smokers— need.