In an astonishing development, Scott Gottlieb, the newly appointed Commissioner of the Food and Drug Administration, has announced that the submission deadline for the PMTAs has been pushed back to 2022, via an FDA press release. The change also includes new plans to reduce the amount of nicotine in tobacco cigarettes in hopes it will help smokers quit or push them towards alternative forms of nicotine like vaping, patches or gum.
This action will give the FDA time to do their research to ensure that they have a solid foundation to properly implement the Family Smoking Prevention and Tobacco Control Act. The FDA is also working towards finding a balance between regulation and encouraging development of less harmful and innovative nicotine products like vaping devices and e-liquids.
Great News for the Vapor Industry
This move has led the FDA to provide an incredible change for the vaping industry and a little relief on the Deeming Regulations timeline originally set in the May 2016 final rule with the following changes:
- Applications for non-combustible products like ENDS or vapor products would be submitted by August 8, 2022
The FDA expects that manufacturers would continue to market products while they review future product applications. Additionally the new policy only affects newly regulated products like electronic cigarettes and cigars and will not affect current policies on cigarettes and smokeless tobacco. It also does not apply to provisions on the final rule that have already passed such as mandatory age and photo-ID checks to prevent sales to minors.
“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigaretes—the only legal consumer product that, when used as intended, will kill half of all long-term users,” stated FDA Commisioner Scott Gottlieb. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it’s vital that we pursue this common ground.”
Read the full FDA press release here.
