VTA Meets with FDA Again on Synthetic Nicotine PMTAs

VTA Meets with FDA for Second Time in
30 Days on Synthetic Nicotine PMTAs

Washington, D.C. – May 3, 2022 –  As we reported on April 13, immediately after the new law governing synthetic nicotine was signed by President Biden, the Vapor Technology Association (VTA) knew that it had to engage with the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) on the issue of synthetic nicotine and we did so in early April.  During that meeting with dozens of CTP regulators from seven different offices inside CTP, we presented a thoughtful case for synthetic nicotine products that, to our knowledge, had not yet been made to any policy maker.  As we previously explained, we were encouraged by CTP’s level of engagement, but also knew that urgent follow up would be necessary given the arbitrarily short deadline imposed by Congress for the filing of synthetic nicotine pre-market tobacco applications (PMTAs).
To that end, yesterday, VTA’s Board of Directors and members conducted their second meeting in less than 30 days with CTP, this time with CTP’s Office of Science.  The meeting organized by our executive director ensured that the most relevant and accurate scientific picture of synthetic nicotine was presented through experts who have deep experience in tobacco and nicotine science and regulation, including Dr. Bill Jackson, PhD (Organic Chemistry), Dr. David Johnson, PhD (Physical Analytical Chemistry), Dr. Ray McCague, PhD (Organic Chemistry), and Dr. Willie McKinney, PhD (Inhalation Toxicology).  Importantly, Dr. Johnson and Dr. McKinney also have extensive experience with the FDA having, among other things, previously served on FDA’s Tobacco Products Scientific Advisory Council.
During the meeting, our experts were able to dig in on the science of synthetic nicotine explaining the processes by which synthetic nicotine is manufactured, the scientific purity of certain forms of synthetic nicotine, the similarities and differences between synthetic nicotine and tobacco-derived nicotine, the differences between synthetic nicotine products and cigarettes, and the numerous unique benefits that would be realized by the successful introduction of products containing synthetic nicotine into the marketplace.  Most importantly, we were able to discuss how science can and must be the driver of this PMTA process.
As with our first meeting, we are encouraged by the level of engagment by the Office of Science on this issue.  And, we greatly appreciate the participation of numerous FDA scientists from the various responsible divisions within the office with whom we were able to share our scientific knowledge and advanced thinking on the key issues.
But, our work is not done.  These meetings, and the additional meetings that we are working on, are just part of VTA’s multi-pronged strategy to ensure the proper and full assessment of synthetic nicotine PMTAs.  If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, you should strongly consider being engaged in our strategic efforts.
To learn more about what you can do, please reach out to us
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