By Justin Wiesehan is VP of Regulatory Affairs for Mistic E-Cigs, a leading manufacturer of vapor products, including mods, personal vaporizers, e-liquids and cig-alikes.
Two weeks ago, FDA Commissioner Dr. Scott Gottlieb announced major changes to the agency’s compliance policy for newly deemed products.
The most welcomed modification was the extension of PMTAs (Premarket Tobacco Applications) to August 8, 2022. While our company is fully complying with current FDA e cig regulations, challenging as it may be, the new deadline is fair and gives all manufacturers much needed time to complete their product submissions. It also allows the vapor industry to continue to work on legislative fixes to change the February 15, 2007 “grandfather date” to August 8, 2016, the day the new FDA regulations went into effect.
One of the most profound shifts at the FDA is its acknowledgment of a continuum of risk, with combustible cigarettes being the most harmful form of nicotine delivery, stating that switching to lower risk products can benefit public health.
The commissioner’s remarks were part of a broader initiative to create a multi-year roadmap focused on building greater public awareness that nicotine is not the cause of death and disease, and to begin a public dialogue on the impact of reducing nicotine in cigarettes to non-addictive levels.
Other developments at the FDA include:
- Issuing product standards for vapor products, including batteries "to protect against known public health risks."
- Setting new "foundational rules" to modify the product review process, improving transparency and creating a clearly defined PMTA.
- Studying the effects of flavors, both on young people and adult smokers who are looking for a less harmful alternative than combustible cigarettes.
The good news is that more and more research continues to emerge on the health risks of smoking, compared to vapor products. One such report from the Royal College of Physicians affirms that e-cigarette use likely poses no more than 5 percent of the risks of smoking
The question remains whether the requirements for completing a PMTA will change, and we eagerly await additional guidance from the FDA. Dr. Gottlieb also indicated that the FDA would be revising the sunset policy so that existing products under review remain on the market.
We are very optimistic of these recent developments, and applaud the FDA’s shift toward a more scientific-based approach on harm reduction compared to its previous tobacco-free abstinence stance, which is what we’ve been advocating all along.
Many factors played a significant role in this historic policy shift, including the vapor industry’s collective advocacy work educating policymakers, and, we believe, our own in-person meetings and correspondence with the FDA. The good news is that more and more research continues to emerge on the health risks of smoking, compared to vapor products. One such report from the Royal College of Physicians affirms that e-cigarette use likely poses no more than 5 percent of the risks of smoking.
There is still more work ahead of us, however. We will continue to push for legislation that gives vapor products grandfather protection, just as cigarettes and smokeless tobacco products did when they were subjected to the 2009 Family Smoking Prevention and Tobacco Control Act.
We also will remain outspoken proponents of the importance of flavors among adult vapers. Our research points to adult consumers wanting more choices with their vaping experiences, including a mix of flavor profiles in their efforts to switch to e-cigs.
All in all, this is great news for our industry. We look forward to working with the FDA to ensure that vapor products stay on the market to provide the 37 million U.S. adults still smoking a significant alternative to combustible cigarettes.
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