The VTA Meets FDA on Vaping Innovation & Synthetic Nicotine PMTAs
Published on April 13, 2022
VTA Meets with FDA on New Federal Synthetic Nicotine Law
Washington, D.C. – April 13, 2022 – After passage of the new law governing synthetic nicotine last month, VTA had to adjust its prior strategy and immediately began working on a strategy to ensure a viable path for companies which are selling products containing synthetic nicotine and which are serious about regulatory compliance. A serious strategy for companies intending to file substantive applications would require at least two critical elements.
First, we knew that it would be critical to engage with FDA to give the Agency reasons to take seriously the PMTAs that will be filed. We knew that we had to present to FDA the scientific and public health benefits to the consumer and the Agency of encouraging the development and marketing of products containing synthetic nicotine. We knew that we had to counteract the narrative the synthetic nicotine products exist only to circumvent FDA regulation – a point that has been made by FDA and Members of Congress. We knew that we had to give FDA new reasons to use its enforcement discretion to engage in a full scientific analysis of synthetic nicotine PMTAs. And, we knew that we had to immediately act given the short time frames imposed by the new law.
To that end, last week, VTA’s Board of Directors and members met with the FDA Center for Tobacco Products (CTP) on the issue of synthetic nicotine. In attendance was a large group of FDA personnel (35+), including senior leaders, representing seven different offices inside CTP dedicated to addressing the issue of synthetic nicotine. Our team included presentations by three Ph.D’s in Organic Chemistry and Physical Analytical Chemistry, enabling us to frame critical scientific and public policy issues that we believe had not previously been presented to or considered by the FDA. We are encouraged by the meeting and are now working on the necessary follow-up.
Second, we knew that it would be critical to educate Members of Congress on synthetic nicotine who have been fed a negative and narrow narrative that synthetic nicotine products are merely an attempt at circumventing regulation. It is clear that Members of Congress know little to nothing about how and why synthetic nicotine was invented or what synthetic nicotine products offer by way of benefits to the public. To that end, VTA’s lobbying team – which has been working to defend the industry and promote a consistent message on harm reduction since 2015 – has developed a strategic plan for taking the same message we shared with FDA to Congress and for that we are going to need your help.
How You Can Help. As with every other major challenge, we know that a sound and strategic approach can reap benefits but only if approached in a thoughtful manner and if supported with adequate resources. VTA is the trade association that has had a continuous seven-year lobbying presence on Capitol Hill. We have been at the center of every major fight on vaping. While we have not won every fight, we played a pivotal role in every victory and, in so doing, dramatically extended the time our harm reduction industry had to grow. Here are a few examples:
- Getting the PMTA deadline extended from 2018 to 2022 (before it was snapped back to 2020).
- Stopping multiple federal and state flavor ban bills.
- Stopping Cuomo’s flavor ban executive order in court.
- Convincing President Trump to reverse the flavor ban he announced in 2019.
- Stopping the PACT Act bill three times before it finally passed.
- Defeating last year’s huge vape tax bill that would have imposed the first federal tax on vaping products which would have been 9 times higher than the cigarette tax.
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, we need your help and you need to be plugged into our campaign.
So, please join our team and support our efforts today. Your support has made everything we have done (and are doing) possible and will be critical to future success.
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