The US FDA has moved the PMTA application deadline to Aug. 8 2022, giving the vapor industry 4 additional years to sell products that were on the market before Aug. 8 2016.

The FDA has 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.

The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts, according to its press release. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.e-cigarette

“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,” said FDA Commissioner Dr. Scott Gottlieb.

Among other aspects of the comprehensive approach, the FDA plans to:

  • Issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. This will help begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.
  • Extend timelines to submit tobacco product review applications for newly-regulated tobacco products that were on the market as of Aug. 8, 2016. This will allow the agency to further examine how existing regulatory science can encourage 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. Under the expected revised timeline, the application deadlines for newly-regulated products would be as follows:

– Combustible products, such as cigars and hookah tobacco: Aug. 8, 2021

– Non-combustible products, such as ENDS or e-cigarettes: Aug. 8, 2022

To learn more about FDA’s new comprehensive plan for tobacco and nicotine regulation, read the full press release


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