The Vapor Technology Association (VTA) has again met with the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) to help clarify any questions the regulatory agency may have surrounding synthetic nicotine.
VTA representatives met with dozens of CTP regulators from seven different offices inside CTP to confront any concerns about premarket tobacco product applications (PMTAs) for synthetic products that are due on May 14, according to a VTA email.
During the meeting, several speakers joined the VTA in shedding light on how synthetic nicotine is manufactured, its purity, and its similarities and differences compared to tobacco-derived nicotine. 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), all have experience in synthetic products and shared that expertise with the regulatory agency.
Johnson and McKinney also have extensive experience with the FDA having previously served on FDA’s Tobacco Products Scientific Advisory Council, according to the VTA.
“As with our first meeting, we are encouraged by the level of engagement by the CTP’s Office of Science on this issue,” the VTA stated in a release. “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.”
The VTA is hoping to continue to engage the FDA to help the agency better understand the nature of synthetic nicotine, according to Tony Abboud, executive director of the VTA.
“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,” said Abboud. “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.”