The Vapor Technology Association (VTA) announced the launch of a cable news ad buy targeting Sen. Chuck Schumer and his proposed ban on Zyn nicotine pouches. The ad runs this week on FOX News and FOX Business during key programming slots, including “FOX and Friends,” “Kudlow,” and “The Five.”
Sen. Charles Schumer
The ad connects a proposed ban on e-cigarettes with a ban on all less harmful, tobacco-free nicotine products, such as Zyn nicotine pouches. The ad also calls out entrenched bureaucrats at the Food and Drug Administration’s Center for Tobacco Products (CTP), led by Brian King, for repeatedly blocking access for millions to e-cigarettes as harm reduction tools that the science has proven are the most effective product on the market to help people quit smoking cigarettes, according to an emailed press release.
“Sen. Schumer and the FDA are simply wrong: wrong on e-cigarettes, wrong on Zyn, and wrong on the science,” said Tony Abboud, executive director of VTA. “Rather than give adult smokers broader access to a greater number of lower-risk alternatives, the FDA and CTP have instead imposed a de facto ban on e-cigarettes – and Zyn is next.”
The ad states that Schumer’s proposed Zyn ban precisely mimics his attempts to eliminate e-cigarette use nationwide, amounting to an assault on Americans’ personal freedom to choose lower-risk, tobacco-free nicotine products that overwhelming scientific and medical data demonstrates are effective at helping adults quit smoking.
Tony Abboud, director of the Vapor Technology Association.
When the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued marketing denial orders (MDOs) for Suorin and Blu PLUS+ e-cigarette products, Tony Abboud, executive director of the Vapor Technology Association (VTA), said the decision was just the latest installment of the FDA and CTP’s efforts to implement its de-facto ban on e-cigarettes in the U.S.
“The constant refrain from CTP is that e-cigarette manufacturers are not providing ‘sufficient scientific evidence’ in their PMTAs, yet CTP refused to answer the Reagan-Udall Foundation’s most fundamental criticism of CTP’s entire regulatory process: that CTP has not clearly articulated what is required to prove what is appropriate for the protection of the public health (APPH) or how it is interpreting what is APPH,” Abboud stated in a release.
He stated that the FDA has failed to objectively define the APPH standard while simultaneously using it to deny marketing authorization to critical smoking cessation and harm-reduction products, which is a “gross overreach” for any governmental institution whose mandate is to follow the science.
“Courts have found that the process has become ‘arbitrary and capricious’ in practice, with CTP leadership choosing on a case-by-case basis how the standard ought to be defined,” he stated. “Meanwhile, companies are simply trying to do the right thing by complying with and adhering to the PMTA process set forth by the FDA.”
Abboud stated that the actions of the FDA and CTP do nothing to protect public health or help Americans who smoke. “VTA once again calls on CTP to reverse course on its misguided actions and restore scientific integrity to its regulatory and decision-making process. Enough is enough,” he wrote.
The Vapor Technology Association continues its mission to promote sensible regulation.
By Timothy S. Donahue
In many countries, such as the U.K., vaping is synonymous with harm reduction. These governments recognize the harm reduction benefits of vaping versus smoking combustible cigarettes. They actively engage their citizens in “swap to stop” efforts backed by sound policy and known science.
In the U.S., however, the Food and Drug Administration is actively pursuing policies that protect, if not elevate, combustible tobacco products’ status in the marketplace and limit consumer access to alternatives that are safer than cigarettes, according to Tony Abboud, the executive director of the Vapor Technology Association (VTA). Abboud and the VTA have been instrumental in advocating for rational science-based regulations for vaping products that will enable a diverse and robust industry to thrive in the U.S.
Vapor Voice sat down with Abboud to discuss the current state of vaping and the future of the VTA. He said that one needs only look at the fact that the FDA is authorizing combustible tobacco products over less harmful vaping products at a rate of 45:1. This is a huge problem for an evolving and innovative industry but with graver public health consequences.
Vapor Voice: What is the current state of the vaping industry in the U.S. in your opinion?
Tony Abboud, director of the Vapor Technology Association. To learn more about the Vapor Technology Association
Abboud: Today, the U.S. industry remains in unnecessary regulatory chaos due to the FDA’s lack of vision in executing its statutory obligations, loss of focus on its harm reduction mission and reactionary decisions made to ameliorate political pressure of special interest groups untethered from science.
[The] FDA’s obstinate inability or refusal to speak truthfully about the importance of less harmful nicotine alternatives, such as vaping and modern oral nicotine products, is imperiling its clearly articulated mission to end smoking. Specifically, [the] FDA’s actions to date have only driven up the public’s irrational fear of nicotine vaping, a fear that can only cement consumers’ bond with cigarettes.
[The] FDA’s unscientific and dramatic policy shifts (cloaked as case-by-case decision-making) have plunged the agency and the industry into costly and unnecessary litigation that will take years to resolve, and, thus, it will be years before a rational regulated marketplace will exist. The net result is that, rather than creating a clear and achievable pathway for innovative companies to introduce new technologies that are 2 [times] to 3 times more effective at helping people quit smoking than the few products, FDA’s actions will continue to drive a wedge between people who smoke cigarettes that kill and the myriad options that will give them dramatic relief.
It is essential that companies in the industry galvanize behind thoughtful efforts to reset the narrative, demand accountability and make common sense changes. It is equally essential that [the] FDA resets its narrative, unapologetically follows the science and uses its power not to rob Americans looking for alternatives to cigarettes but empower them with myriad attractive options that will entice them to switch.
Now that the Covid shutdown and Zoom calls have ended, what has changed for the VTA?
Organizationally, one of the biggest impacts of Covid was the recognition that we had to focus our efforts on the biggest challenges that needed to be addressed rather than taking on every fight. That refocusing has enabled us to architect a thoughtful and impactful strategy to engage with policymakers and decision-makers on the issues most critical to our industry and to public health.
From a practical perspective, the biggest change in the reopening of this country has been the reopening of congressional offices, which only fully occurred this year. That change has made it possible for our team to sit down across the table this year and have meaningful and essential conversations with congressional offices and to bring voices into the fold that have not been heard before. We are on pace this year to far outstrip our prior levels of congressional engagement with a clear and persuasive policy message not only based on science but also supported by leading tobacco control scientists.
What are the VTA’s goals for 2023?
There are 34 million Americans who still smoke. Every two years, a million of them will die from smoking-related diseases. This is an unconscionable and ongoing public health crisis. We can save tens of thousands of lives by not hiding the fact that vaping is far less risky than smoking.
In this year, our priorities are a set of common sense new marketing standards and smart science-based access restrictions for flavored vape products to ensure such flavored products remain available for adult smokers while less accessible to youth. At the same time, we will continue our constructive engagement with [the] FDA to provide insight on the key policy issues and specific regulatory strategies that are necessary to achieve a rationally regulated marketplace.
What will it take to accomplish these goals?
Despite the FDA’s parroting of its mantra that it “follows the science,” the examples of where it has failed to do so have become too numerous to ignore. And despite the FDA’s proclaimed concerns about misinformation, the examples of which it has engaged in are simply too extreme to believe that the agency can easily correct the course it has embarked upon to denigrate, dismiss and deny alternative nicotine products. Hence, public pressure, congressional oversight and accountability in the courts all are necessary to ensure that FDA adheres to the science, follows the law and corrects the record.
In addition, notwithstanding the dramatic decline in youth vaping (now at pre-“epidemic” levels) that has taken place even with the broad availability of flavored products, the industry must continue to demonstrate its commitment to reducing youth access and appeal by supporting long overdue and common sense marketing restrictions that will further reduce underage use. Additionally, just like with 21-plus legislation, for which the industry advocated, new 21-plus policies can further limit youth access to flavored vaping products.
Given the chaos in the marketplace created by [the] FDA’s past and present actions, and its apparent policy to bar every nontobacco-flavored vape product from the marketplace, congressional action can help calm the chaos by adopting leading tobacco control scientists’ recommendations that flavored vape products be sold in adult-only stores, making them less accessible to youth while preserving the availability of adults. All of our goals and strategies are based on both data and science as we continue to amplify the voice and role of science in the decision-making process.
Is there any hope for open systems and/or flavors?
Yes. Facts are stubborn things. There is no scientific or real-world evidence that youth are attracted to or use open systems in any material numbers. At the same time, data from the National Youth Tobacco Survey year after year proves that flavors are now one of the least cited reasons that youth may experiment with vaping.
And each day, more and more peer-reviewed science is published proving the important role that flavored vaping plays in the decision to switch away from deadly combustible cigarettes, particularly when compared to the FDA’s favorite ineffective solutions. There is also hope in the fact that the industry will continue to innovate.
There will be new technologies that capture the market in the future, and we should be open to that—and so should [the] FDA. Flavors are proven to be the preference for adults who are looking to quit, and adults are more likely to succeed when flavors are available to them. Consumers’ demand for flavored nicotine products should be no more paternalistically rejected than consumers’ demand for cannabis products.
Are nontobacco nicotine products going to gain broad acceptance, especially with regulators?
Well, that is entirely up to the FDA now that Congress was convinced by certain industry players that nontobacco nicotine was somehow a problem. True, it was a problem, but primarily for certain businesses which were dependent on tobacco-derived nicotine. But the reality is that nontobacco nicotine is the cleanest and purest form of nicotine available on the market, which is perfectly replicable and traceable to the batch level.
Nontobacco nicotine is precisely the type of innovation in a constantly changing landscape that should be encouraged as the industry advances toward a combustible-free future. Regulators have a huge opportunity to use their authority to regulate nontobacco (synthetic) nicotine products and to encourage their entry into the marketplace. But, given [the] FDA’s current trend toward eliminating virtually all nicotine alternatives from the market, one can only question whether [the] FDA could seize the opportunity to provide consumers access to products that would allow them to break free from the last vestige of tobacco.
Do you see congressional action as the only cure to the current FDA regulatory process?
Congressional action can help, but the challenges are significant. There are three ways that Congress can assist. The first is through its oversight committees, which have jurisdiction to question the FDA’s prior actions that have been inconsistent with the law and inconsistent with, according to CTP’s [Center for Tobacco Products] scientists, the science on vaping.
The second is through its appropriations committees, which must question exactly how FDA is using the hundreds of millions of dollars it receives, why it uses the majority of its resources to remove e-cigarettes from the market while ushering hundreds of new cigarettes to the market and what could possibly justify its request for another $100 million in fees that ultimately will be borne by the vaping consumer (giving them yet another disincentive to switch).
The third is through committees of jurisdiction that can end the absurd discussion of “ban, ban, ban” when it comes to flavors and instead focus on real solutions to real marketing issues of which vaping opponents have complained for years but have never truly sought to address.
Congressional action is not the only cure because [the] FDA currently has placed its thumb on the scale by creating a standard for companies seeking to comply and secure marketing approval without giving them the knowledge or opportunity to do so. For that reason, [the] FDA appears content with letting the courts sort out the mess that it has created.
After all, CTP appears to take delight in declaring that every vaping product on the market is “illegal” and “cannot be lawfully marketed” except for the small handful of tobacco-flavored products [the] FDA has authorized. So, while regulators often complain about industry lawyers, it should come as no surprise that the actions of prior agency leadership, which in a very short period of time demanded a complete reversal of CTP’s priorities, plans and policies as they related to flavored vaping products, would lead to legal challenges.
In the end, any branch of our federal government can have a major impact in fixing the mess created by a disregard for science and the law. The question now is which one(s) will do so.
With Republicans in control of the U.S. House, some experts expect the vape industry to thrive.
By Timothy S. Donahue
The next two years should be better than the past two years. That was the overall outlook from vapor industry experts speaking during the Vapor Technology Association’s (VTA) 2022 Post-Election Round-Up webinar in late November. Tony Abboud, executive director of the VTA, told attendees that his organization has been working diligently with two Washington, D.C.-based firms, West Front Strategies, a lobbying group, and FORA Partners, a public affairs agency, to promote the interests of the vaping industry as Republicans take over the U.S. House of Representatives in 2023. “We have a very specific agenda, some of which we’ve discussed (as an overview of what) we are pursuing,” he said. “We’ve done an enormous amount of groundwork.”
Shimmy Stein
Shimmy Stein, a partner with West Front Strategies, said the change in leadership at the House could have a positive impact on the vaping industry until at least the next election cycle. “Anytime you can take over the gavels, take over the control of the messaging, take over control of the chairmanships and the legislation, that is an important piece of governing,” he explained. “And so, while it was not to the extent or to the size which Republicans were hoping for in terms of the majority in the House of Representatives, it’s still pretty significant and will change the manner in which Washington will function.”
Over the next two years, the vaping industry should feel “a little more comfortable, a little more secure” going into a divided Congress (the U.S. Senate leadership did not change), according to Craig Kalkut, a partner with West Front Strategies. However, the vaping industry has always faced threats from both Democrats and Republicans due to their concerns over teen vaping. “We still need to work with both parties. We still could face issues and threats of overregulation and poorly conceived legislation. But the bottom line is that we will have a more comfortable environment with Republicans controlling one house of Congress,” said Kalkut.
Craig Kalkut
Reconciliation, a way for Congress to enact legislation on taxes, spending and the debt limit with only a majority vote, is no longer a threat to the vapor industry, according to Kalkut. He said that’s just not something that can happen in a divided Congress. “What that means, ultimately, is that anything that passes will need to have bipartisan support,” said Kalkut. “And because of that, [legislation] will likely be more limited, more moderate, and hopefully, if there’s any legislation passed in our area, that will be something that allows us to thrive, which addresses the concerns that linger over teen vaping but does not overregulate and drive people away from vaping.”
Kalkut also confirmed that gridlock is a concern in a divided Congress; however, gridlock could also provide incentives for both parties to compromise. “They’re both seen as in charge, so they both sometimes want to get something done. And that will bring people to the table and often over issues that are not central to either party’s ideology,” he said. “It’s hard to come to a compromise on taxes, or it’s hard to come to a compromise on healthcare … but something like vaping, perhaps there will be opportunity for common sense provisions to prevail in an area where Democrats and Republicans can come together.”
Max Hamel
Max Hamel, founding partner of FORA, said when Congress is split, the White House typically relies heavily on its executive privilege. There is no known administration agenda on vaping, so a vaping-related rule is unlikely. With Republicans in control of the House, they also head committees. The House oversight committee and its subcommittees could present opportunity for the vaping industry, according to Hamel.
“We do have new personalities on both the majority and the minority side, so they’ll probably have some growing pains,” he said. “The big question is, how does this new authority, especially in the House, get wielded[?] … whether it’s one seat or 40 seats, the authority with the majority is the same, and it is substantial from [an] investigation and oversight standpoint; [that’s] probably not necessarily true from a legislative standpoint … the oversight subcommittee, we do have the opportunity to surface some things, but it’s really an opportunity for us now to not be on defense and [to] put forth an agenda and some messaging that really focuses on the things that are advantageous to us.”
Additionally, with Juul losing its stranglehold on the vaping market, Hamel said the vaping landscape is changing. Juul became the focus to save youth from vaping, and today, Juul isn’t the focus. The market is made up of a more diverse group of companies with different technologies dedicated to harm reduction. Hamel said this is the message that should be projected. “I think our priority will be focusing on the messages that really emphasize the harm reduction aspects,” he said.
Kalkut then added that the vaping industry has an opportunity now to change the conversation, particularly with Democrats but also Republican critics and skeptics of vaping through the ever-expanding body of science that shows the relative safety and incredible potential for harm reduction that next-generation tobacco products have. “That has become more and more clear as time has gone on over the last couple of years,” he said. “I think once we show that, once we demonstrate our commitment as an association in the industry to addressing teen vaping, we have a real chance of changing the narrative.”
Ashley Davis
Ashley Davis, a founding partner at West Front Strategies, told attendees that, looking back on industry challenges, there has been success. However, her concerns going into the last Congress (2020–2022) were that she didn’t really know in what direction or how forcefully Biden would lean on the vapor industry. She says the industry “dodged a bullet.” The industry could have suffered more than it did those first two years in a Biden administration. She also said the issue of youth use will remain at the forefront of any discussion concerning electronic nicotine-delivery system products.
“We do have to still deal with the youth issue. And I think we all realize that any negative press that comes up is around the youth issue … Everyone loves a microphone. It’s a member of Congress. If there’s an issue to discuss, that’s what they’re going to discuss,” explained Davis. “[We are] trying to make sure that any bad legislation is not passed—it’s much more unlikely in this Congress than it was before.”
Taking a question from the audience, Abboud closed the session speculating on the impact of the Reagan-Udall Foundation’s external review of the U.S. Food and Drug Administration’s Center for Tobacco Products, the results of which are expected in mid-December.
Abboud said that numerous comments from staffers of the FDA for the Reagan-Udall assessment suggest the regulatory agency is in a state of disarray and is being influenced by outside forces not scientific research. He said he hopes the foundation will advise the FDA that premarket tobacco product application (PMTA) decisions should be free from any external pressures, especially political pressure.
“[The review should recommend to the FDA that PMTA] decisions must be made based upon the science that is submitted as well as making sure that the agency does, in fact, review all of the science that has been submitted as part of any applications as well as [reviewing] all of the applications that have [been] submitted,” said Abboud. “Because that was another big failing of the current process where applications have been rejected [without a full review].”
After the U.S. Food and Drug Administration released its latest National Youth Tobacco Survey, Vapor Technology Association (VTA) Executive Director Tony Abboud said the FDA’s reporting of the data is misleading.
“Yesterday, the FDA, in coordination with the [U.S. Centers for Disease Control and Prevention ], released new data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth,” Abboud stated. “The FDA represents the NYTS data to show that youth vaping ‘remains high,’ yet a deeper dive into the data show only a small uptick in experimental or infrequent use while regular use remains flat or is slightly down.
Abboud notes that since 2019, according to the CDC, the number of high school students who have tried vaping (1 time in the last 30 days) has dropped by 50 percent, and the number of middle school students has plummeted by 70 percent. During that same time period, the number of high-school students who ‘frequently’ vape dropped by 37 percent and the number of middle school students dropped by 65 percent.
” FDA’s near single-minded focus on youth who experiment with vaping versus those who are frequent users ignores what clearly is a consistent trend of youth away from vaping products. Rather than focusing on removing products from the market in an attempt to impact youth vaping, the FDA should instead support common-sense regulatory reforms that would better restrict access to products instead,” Abboud stated. “Simply removing products from the market is not the answer when those products are also proven to help adult smokers quit.”
Abboud explained that it is well documented that flavored vapor products help adult smokers to switch to less harmful vaping and “study after study after study” has confirmed the data. Since 2010, when e-cigarettes became widely available in the U.S., smoking rates have declined by more than half, he stated.
“Tobacco use is down. Youth vaping is down. These are both good things and are not in dispute. Unfortunately, there are still 40 million Americans addicted to cigarettes,” Abboud stated. “Every year, 500,000 die from smoking-related diseases and yet less than three percent of our kids are using vapes on a regular basis. The FDA’s failure to acknowledge this reality ignores the role vaping plays in harm reduction and smoking cessation, and puts more lives at risk.”
Under the new law governing synthetic nicotine products signed on March 15, 2022, Congress imposed a short 60-day deadline for companies to file premarket tobacco product applications (PMTAs) and declared that if such applications were not approved within 120 days (the Act) they would be “in violation of” the Federal Food Drug & Cosmetic Act’s (FDCA) PMTA requirement.
Since no authorizations have been granted as of today, the question is will FDA use its enforcement discretion to continue reviewing PMTAs, or will it precipitously declare that all synthetic nicotine products must be removed from the market after July 13, 2022?
There is no question that the FDA should use its enforcement discretion. In a series of direct engagements with FDA since the Act’s passage, the Vapor Technology Association (VTA) has provided a complete set of scientific and policy justifications for synthetic nicotine products, and specific recommendations on how FDA should use its enforcement discretion – just as it has in the past – to allow synthetic nicotine products to remain on the market during the PMTA review process.
However, some have suggested that Congress mandated all products be removed from the market this week if they are not approved by FDA. But a close review of the Act reveals that the opposite is true: Congress did not require synthetic nicotine products with pending PMTAs to be removed from the market after July 13.
In interpreting laws, a court will first look to the plain language of the Act and, only if there is an ambiguity, will it look to Congressional intent to resolve such a question. Here, both support the FDA’s continued use of enforcement discretion for pending PMTAs.
The Plain Language Supports Enforcement Discretion
There are four relevant sections of the Act. First, under Section (d)(2)(A), Congress expressly stated that “as a condition to market” all manufacturers wishing to continue selling their products must file a PMTA no later than May 14, 2022.
Tony Abboud
Second, under Section (d)(2)(B), Congress expressly stated that companies which filed PMTAs “may continue to market” their products during what the Act calls a “transition period.”
Third, under Section (d)(2)(C), Congress expressly required that if a company did not file a PMTA for its synthetic products by May 14, 2022, that company is “not eligible for continued marketing.” In each of these sections, Congress expressly uses some variation of the term “market” to articulate its direction on what may (not) be marketed and when.
However, in the operative Section (d)(3), which addresses what happens after July 13, 2022, Congress makes no statement regarding marketing at all. Instead, it states that products with pending PMTAs not yet approved would be “in violation of…section 910” of the FDCA (21 USC 387g).
When presented with this question, a court likely would rule that because Congress did not expressly state that pending applicants are “not eligible for continued marketing” or that they “may not market” after July 13, as it clearly said in the immediately preceding sections, Congress did not require the removal of products with pending PMTAs.
This places synthetic nicotine products with pending PMTAs in precisely the same position as all other products with pending PMTAs which, for years, FDA has made clear are “illegal” (i.e., in violation of section 910) but are allowed to remain on the market at FDA’s enforcement discretion.
Even if a court finds that Section (d)(3) is ambiguous, there is nothing in Congressional intent that would lead to the conclusion that Congress intended for products with pending PMTAs to be removed from the market.
First, Congress could have banned synthetic nicotine products, if that is what it intended, but it did not do so. To the contrary, Congress expressly authorized manufacturers to bring new products to market after the Act’s passage. Thus, it would be folly to suggest that Congress intended all synthetic nicotine products be removed from the market without PMTA review.
Second, Congressional intent is generally divined by on the record statements made in committee hearings and in floor debate (not from press releases or media statements). But there is little to nothing which a court could rely on [with] this question because the provision was quietly slipped into the Ukraine-omnibus spending bill with no relevant hearing or floor debate.
Third, Congress was fully aware that FDA could not review PMTAs within 180 days (as required under the FDCA). In fact, the FDA told a court it will not be finished reviewing tobacco derived PMTAs until June of 2023. Thus, no one could suggest that there ever was any reasonable expectation or intent that the FDA would rule on synthetic nicotine PMTAs in 60 days.
Hence, the only reasonable conclusion that can be drawn from the plain language and Congressional intent is that Congress did not require removal of products with pending PMTAs but, rather, expected the FDA to continue to use its discretion in enforcing its PMTA regulation after July 13.
Congress did, however, expressly state that products for which no PMTA was timely filed have no continuing ability to market, authorizing the FDA to take immediate action. VTA has repeatedly communicated to the FDA the need for it to aggressively remove all tobacco products from the market for which no PMTA has been filed and to publish a list of all products covered by a synthetic nicotine PMTA so that retailers know which products can be sold.
A Careful and Complete Evaluation of Synthetic Nicotine PMTAs is Required
We live in a world that remains captive to [combustible] cigarettes. Congress won’t ban them and Congress has prevented the FDA from doing so. While electronic nicotine-delivery system (ENDS) products offer a technological solution to delivering nicotine in a substantially less harmful way, synthetic nicotine now represents the first technological innovation in nicotine itself.
Synthetic nicotine uniquely offers consumers the cleanest and purest form of nicotine with numerous benefits, i.e., the absence of heavy metals, nitrosamines, and pesticides. Synthetic nicotine uniquely offers consumers the opportunity to break free from the last remaining vestige of the tobacco plant.
Synthetic nicotine uniquely offers the FDA unprecedented product constituent clarity, replicability, and traceability down to the batch level. Not only does synthetic nicotine offer companies the opportunity to change the dynamics regarding total reliance on tobacco-derived nicotine for all tobacco and pharmaceutical nicotine products, but it also provides companies the ability to address their ESG [sustainability] goals and take a significant step to ameliorate the adverse environmental impacts of tobacco.
Our message to the FDA has been constructive and clear: it is critical to the adult smoker that FDA takes aggressive steps to create an orderly and regulated marketplace with a diversity of desirable nicotine alternatives.
Given recent history with tobacco derived PMTAs, the best way for FDA to realize that objective now is to avoid the blanket denial mistakes of the past which have mired the agency in protracted litigation. Such litigation will only delay the time until we achieve an orderly and regulated marketplace.
Instead, we have asked the FDA to work companies which timely filed synthetic nicotine PMTAs – the good actors – through the PMTA scientific process and provide them the requisite time and guidance to fulfill FDA’s requirements.
At the same time, we have asked the FDA to aggressively enforce against the non-compliant companies that have refused participate in the PMTA process – the bad actors – by interdicting such products at the border and removing such products from the market Congress has clearly required.
In the end, it is incumbent on the new FDA leadership to use its power to create an orderly marketplace by embracing scientific innovations, stimulating additional financial investment, accelerating authorizations of pending tobacco-derived PMTAs, and ensuring that synthetic nicotine products which now contain the cleanest and purest form of nicotine that science has created are available to adult smokers.
Tony Abboud serves as president for Strategic Government Solutions, Inc., and executive director of the Vapor Technology Association (VTA).
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.
Credit: Opolja
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.”
