July 1, 2022: Michael Jordan once said that “obstacles don’t have to stop you. If you run into a wall, don’t turn around and give up. Figure out how to climb it, go through it, or work around it.”
This sentiment holds true for the vapor industry, especially for SFATA leadership that has spent an untold number of hours attempting to find a way “over the PMTA wall.”
Adding to the complexity of the situation the vapor industry is in is the fact that both the U.S. Food & Drug Administration (FDA) and the Center for Tobacco Products (CTP) agencies have had top-level leadership changes – circumstances we have stayed on top of and remained actively engaged in, engagement that ultimately led to the granting of a meeting with both agencies. And so, on Tuesday, June 21st, SFATA leadership met once more with officials from both agencies in a pre-mid-July-deadline attempt to work through the many obstacles threatening the vapor industry, focused on specific messaging.
Unlike our previous meetings that were more intimate in numbers, this listening session was packed with representatives from all areas of FDA and CTP, totaling sixty participants in all. The large turnout gave us hope that the Agencies were interested in what we had to say and actively tuned in to our proposed solutions.
You see, when a meeting is granted, an invitation to that meeting is sent to all relevant agency staff, including the materials for the meeting. It is then up to each agency staff member to decide if they wish to participate or not. This means that all of the persons present at our meeting had received a copy of our agenda and presentation and decided the content was of interest to them. The number of attendees at the June 21st meeting was nearly double the number of attendees of our previous meeting with the same Agencies, and a record turnout.
Presenting on behalf of SFATA was Board President, April Meyers, Board Secretary, Monica Schick, Board Member and Legislative Affairs Director, Schell Hammel, and Responsible Industry Network (RIN) Compliance Officer, Andrew O’Bright. Other SFATA Board Members listening in were Board Vice-President, Taylor Cage, and Directors Charles Archambeau and Victoria Walsh.
After making introductions, SFATA leadership dug into their presentation, challenging the FDA’s mass issuance of MDOs and very clearly pointing out the dangers presented when supply does not meet marketplace demands. We provided data and presented the looming threat of an entirely new “epidemic” as vapor sales shift from legitimate manufacturers attempting to comply with PMTA requirements to that of an unregulated illicit sales market.
SFATA cautioned FDA that in its endeavors to decrease youth use of vapor products, the agency has promulgated the belief that vapor products are as harmful, if not more harmful, than combustible tobacco and addressed the disservice this narrative has been to America’s adult vaping and smoking population. We honed in on the fact that should the FDA not be flexible in its authority, adults who have been utilizing lower nicotine concentrations will have no legally available options to them and be forced to choose between significantly increasing their nicotine intake, returning to combustible tobacco, or obtaining their products through illicit channels. Thanks to our friends at ECigIntelligence, we were able to provide data to back up our statements.
SFATA Leadership continued to press both agencies on the consequences of their failure to create a pathway for small businesses and questioned what their expectations were for the latter half of 2022, when only .0002% of products submitted for PMTA have received market authorization to satisfy a consumer base of nearly 15.5 million (according to a 2021 Gallup Poll). Leadership went on to point out that flavors have been legally available to these consumers for over a decade and that “flipping a regulatory switch” will only drive illicit sales, allowing adulterated products to litter the landscape while placing adult consumers and, more importantly teens, at risk.
As a solution to our common problem of youth use, we reiterated our previous request that FDA create a working group of industry stakeholders and Agency representatives to explore the true underlying cause of youth use and to create consensus between the Agencies and the industry on an actionable plan that keeps flavors in the hands of adult consumers. From here, SFATA went on to re-introduce its RIN Program, highlighting how a controlled distribution network would satisfy the “appropriate for the protection of public health” (APPH) requirement most companies were issued MDOs for.
As our dialogue continued, we remained consistent in our focus to ensure that both FDA and CTP were made fully aware of the imminent threat to public health being created by a vacuum of legally available vapor products – a vacuum created by the rigidity of those very agencies.
Upon conclusion of our meeting, and based on post-meeting conversations that took place during the Next Generation on Nicotine conference held in Miami last week, we strongly believe that urgent follow-up is required and are moving quickly forward.
SFATA firmly believes that flavors play a crucial role in helping adults quit combustible cigarettes and that vapor shops offer the education required to assist consumers with their transitions. SFATA will continue its work of advocating for a reasonably regulated marketplace. But, as we told the representatives of both agencies present during our meeting, “although you expected some consolidation of the industry, .0002% is by no definition a consolidation, but is more accurately defined as annihilation.”
If you agree, then we urge you to join SFATA in this fight and help us work toward the promised pathway for small businesses, keeping in mind these paraphrased words once spoken by wise scholar Fridtjof Nansen:
“The difficult is what takes a little time to accomplish; the impossible is going to take a while longer.”
With you, as always, in the trenches,
April L. Meyers, on behalf of SFATA Leadership
Smoke-Free Alternatives Trade Association – SFATA – Outlet – 2022-07-01.
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