VTA Insider keeps you informed of critical issues impacting the nicotine products industry both in Washington, DC and in the states. We will cover regulatory developments, legislation, news of note and other industry insights. VTA will also share our analysis of what we as an industry need to do to grow and prosper.

Let’s Dive In.

---

Beware of the Fentanyl False Flag

What’s New: Recently, VTA’s Executive Director Tony Abboud presented a stark warning to the industry at the Next Generation Nicotine Delivery Conference in Miami, Florida. The newest and greatest threat to the availability of less harmful nicotine vaping products in the U.S. is an ongoing orchestrated public affairs campaign to the unsubstantiated claims that illicit Chinese supplied vaping products are being laced with products such as fentanyl. 

Why it matters: This will have ramifications for the entire industry and the millions of consumers because it jeopardizes all vaping products. 

The facts: If, as asserted, millions of “illegal flavored disposables” are being imported into the U.S. with fentanyl, where’s the outbreak? The made up fentanyl narrative has all the markings of EVALI:

• Hospitalizations and illnesses involving young people using THC vapes.
• Products clearly adulterated by unscrupulous drug dealers.
• Headlines are hyped and conflate all vaping products.
• Direct calls for eliminating flavored nicotine vaping.
• Regulators and legislators are feeding the misleading narrative.

What it means: The fentanyl narrative threatens all nicotine vaping because nearly every vaping product is manufactured in China. If we allow this fiction to take root – it will scare consumers away from vaping and back to smoking and create an opening for FDA to deny all PMTAs.

The damage will NOT be limited to disposables. The campaign is as anti-flavor as it is anti-disposable.The geopolitical narrative is so hyped it will taint all vape devices since they ALL are made in China.

Bottom line: the vaping industry will not get three strikes. The industry must coalesce around a response on the level of the actions we took to stop the ill-conceived flavor ban response to the EVALI crisis. A copy of VTA’s presentation is available here.

---

FDA’s Poisonous Pantomime

The big picture: At the end of June, the FDA staged yet another “retail blitz” to manufacture a vaping crisis that does not exist. If this sounds vaguely familiar it’s because it’s the same playbook that FDA has used time and again. 

• What’s different this time: FDA paired their blitz announcement with two CDC reports that traffic in dangerous misinformation and blatantly misrepresent the real trends in youth vaping. 
• The first study FDA presents includes aggregated retail data (not youth usage) that show vapes sales are up and by implication – youth usage. This is not the case. CDC’s own National Youth Tobacco Survey has shown the dramatic reduction in youth e-cigarette use. As smokers use ENDS products to quit cigarettes – we should expect to see replacement trends at the retail level. 
• The second study FDA presents attempts to portray an increase in calls to poison control centers related to vaping as sign that a crisis as at our doorstep. To do that, FDA presents this data out of context.
• Go deeper: If we told you that there were 6,074 cases for children under the age of five related to vaping you might be concerned. But what if you also knew that:
  • There were 96,000 cases involving cosmetics
  • There were 94,000 cases involving household cleaners
  • There were 72,000 cases involving prescription drugs
  • There were 6,180 cases involving THC (cannabis)

The bottom line: 34 million adults are addicted to cigarettes – the only product which when used as intended will kill you. By selectively targeting vaping under the false pretense of a youth cris, FDA is working overtime to eliminate effective harm reduction options for adults and ensuring the only option for many will be to continue smoking.

---

VTA Files SCOTUS Brief Supporting Avail Vapor’s 4th Circuit Appeal

The big picture: On June 14, 2023, the Vapor Technology Association (VTA) filed an amicus curiae brief  with the Supreme Court of the United States in the case Avail Vapor, LLC, et al. v. US Food & Drug Administration. VTA’s petition seeks Supreme Court review of the Marketing Denial Orders issued to petitioners in connection with their open-system flavored vaping products.

Go deeper: World’s leading tobacco and nicotine researchers have undermined the scientific underpinnings of the FDA’s decision-making rationale. Review by the Court is important not to re-examine the science (which courts will not do), but to evaluate the propriety of the highly questionable process. 

By the numbers: The independent vapor industry comprises more than 10,000 companies across the U.S. The industry is responsible for generating more than 130,000 jobs. FDA’s removal of all flavored vaping products from the market would lead to the shutdown of close to 10,000 businesses, causing the loss of 99,158 full-time equivalent jobs.

Why it matters: One week after the Fourth Circuit’s decision upholding the MDOs, an Independent Tobacco Expert Panel released its report on FDA’s Center for Tobacco Products which revealed serious regulatory failings of the agency, including those specifically raised by Petitioners in the Supreme Court Petition.

---

Worth your time

• A recent study in the American Journal of Medicine finds that among individuals attempting to quit smoking, nicotine e-cigarettes are more efficacious than conventional nicotine replacement or behavioral smoking cessation therapies, and may prove beneficial in reducing smoking-related health risks.
• Reason Magazine recently published a piece highlighting that since the Food and Drug Administration began regulating ENDS as “tobacco products,” public understanding of the relative risks of various tobacco products has declined.

---

Stay tuned in with us for lots of new developments and make sure your friends and colleagues are signed up to receive our news and information.

Got questions? If you have any questions about the issues we have covered, have suggestions for content, or how you can support our efforts, please feel free to contact us at press@vaportechnology.org.

VTA Insider keeps you informed of critical issues impacting the nicotine products industry both in Washington, DC and in the states. We will cover regulatory developments, legislation, news of note and other industry insights. VTA will also share our analysis of what we as an industry need to do to grow and prosper.

Let’s Dive In.

---

A heavy lift in DC

The big picture: The E-Cig Summit and the Food and Drug Law Institute convened in Washington, D.C. There is too much to detail in this newsletter but a few key big-picture takeaways:

Science is clear: Scientists from around the world convened to discuss the continuing growing body of the science behind the importance of vaping and nicotine alternatives to smoking cigarettes. In study after study presented, the scientists presented unflinching perspectives on everything from data to policy. 

The Consensus: FDA is broken and is failing in delivering an effective harm reduction message. Vaping can be a huge benefit to public health and there is ample evidence supporting the potential of vaping to reduce smoking’s toll. Making it harder for adults to access vapor products makes it harder for them quit and ensures that they engage in the riskiest behavior, (smoking) longer.

Why it matters: Litigation is now effectively driving health policy. FDA had a plan to review the large number of PMTAs received and to streamline its reviews in a scientifically defensible matter for flavored ENDS. FDA had announced its plans, priorities and processes in June 2021. 

• Then, all that changed with the direct interference from a former Acting Commissioner who forced the creation of the “fatal flaw” memorandum which was used to en masse deny all flavored vaping products.
• This and other interference with scientific decisions was called out by scientists inside & outside FDA’s Center for Tobacco Products.
• Given FDA’s actions, companies had no option but to litigate.

FDA enforcement needs to be focused on the bad actors, i.e., those companies which have completely ignored FDA’s regulations. While Director Brian King proudly spoke about the pace of PMTA denials (99% of all vaping products) he acknowledged the difficulty with enforcement. No surprise here since bans cannot be enforced. But, as was highlighted in the Reagan-Udall report, FDA has taken little action against companies that chose never to even apply through the PMTA process.

---

Misinformation for the masses

At the E-Cig summit last week, our friend Clive Bates of Counterfactual gave an excellent presentation focused on how the U.S. should be rethinking tobacco and nicotine regulation. The entire presentation is worth a read but the chart above is a perfect encapsulation of the problem. 

The public is being fed misinformation concerning the relative health risks of smoking vs. vaping and the problem is getting worse. People are now more likely to believe that vaping is as dangerous as smoking than they were ten years ago. 

FDA officials acknowledged the problem of misinformation during the Q&A segment at the E-Cig Summit and committed to developing a public affairs campaign targeted at adults. These type of campaigns take months to develop so don’t expect anything dramatic anytime soon. 

Doubling Down on Youth.  In the same talk, however, CTP Director Brian King, who again acknowledged the dramatic decline in youth vaping, doubled down on youth experiementation. He said there is no acceptable level of youth vaping usage, foretelling what will continue to dictate FDA’s continued vaping product denials. 

The bottom line: Quitting smoking is hard. Only 10% of adults who try to quit will ultimately succeed. FDA needs to expand the understanding of the dramatically less risky alternatives to smoking for tens of millions of adults who are addicted. Of course vaping is not free from risk and there are trade-offs but those tradeoffs should be made explicit so that we can reduce death and disease by giving people the information to de-risk their behavior.

• But, Director King went on to say that there was a difference between enforcement discretion and enforcement prioritization.
• King promised promised a formal letter soon from CTP in response to VTA’s questions to clarify CTP’s position.

---

Advancing harm reduction equity

The big picture: CTP Director Brian King has made the concept of “health equity” as it relates to tobacco product regulation a centerpiece of his plan. King characterized FDA’s focus on health equity in the following way:

• “We have a tremendous opportunity to prioritize health equity and create meaningful change for populations that have been disproportionately affected by tobacco use.”
• Director King also created the first “health equity” leadership position inside CTP.

By the numbers: Smoking remains the number one health risk to adults in the United States. Approximately 34 million adults are still addicted to cigarettes – the only product which when used as intended will kill you. In the LBGTQ communities – the problem is worse. LGBTQ people out-smoke the general population by 68%. This high rate of LGBTQ smoking is a current and ongoing health crisis. In fact, according to the NIH, smoking related deaths are on track to surpass HIV/AIDS as a cause of death among gay men.

Why it matters: CTP is promoting health inequity and would be better served to focus on vaping as a tool to promote “harm reduction equity” which would have more immediate benefits and potentially immeasurable benefits for historically marginalized communities. 

The bottom line: The FDA and its Center for Tobacco Products (CTP) is charged with protecting all Americans from tobacco-related disease and death. 

• This means the FDA must do everything to help people move off combustible tobacco and toward lower risk alternatives. FDA’s backward approach to harm reduction means that it is easier to get a new deadly cigarette product approved than an e-cigarette alternative.
• And the fact that the FDA has declared more than 99% of vaping products “illegal” means that the only choice left remaining will be deadly cigarettes.

Harm Reduction Equity: Conversely, a focus on harm reduction equity means telling the communities that are disproportionately impacted by smoking related death and disease the truth – that vaping while not risk free is less risky than smoking. Given the unequal burden the LGBTQ community and other populations disproportionately affected by smoking (such as the African-American community, those of lower incomes, those afflicted with mental health issues) bear for cancer and other health risks associated with smoking, limiting adult choices and access to lower risk products will only serve to expand health inequities in our society.

---

The real story on combustibles

FDA has a responsibility to create a marketplace that allows the most innovative and safe products to emerge so that adults have access to them. With all the news about the product denials for flavored vaping products, you might be surprised to learn that the FDA has approved for sale more than 1,200 combustible products including nearly 900 new cigarettes!

FDA Approvals of Combustible Tobacco Products 2018 –2022

FDA Commissioner Robert Califf recently said in a March 6, 2023 Wall Street Journal interview, “There aren’t many people who argue in favor of combustible tobacco … Well, I mean, we always start from the presumption that combustible tobacco is the most dangerous part of this. And we need to get rid of that as much as we possibly can. It’s written into the mission of the FDA.”

There aren’t many people who would argue with that. So why is the FDA under his leadership approving so many of combustible products? You can check out the full VTA analysis of FDA product approval data here. 

FDA’s continued refusal to accept known scientific truths about vaping and modern oral nicotine will only ensure that cigarettes remain dominant in the U.S. 

---

Worth your time

Leading Tobacco-Control Experts call on FDA to change – and fast.

• some of the world’s leading tobacco-control scientists and public health experts wrote to FDA Commissioner Califf calling on him and the FDA to rethink its current posture.
• The group focused on the hyper-critical findings of the Reagan-Udall Foundation’s review of CTP and made specific recommendations for changing the way CTP handles tobacco and vaping regulations.

Juul Whitepaper:  Juul Labs Inc. has published  “The Real-World Impact of ENDS for Adult Smokers: Tobacco Harm Reduction Through Real-World Data and Evidence.” We encourage you to read it here. 

Two main requirements of effective harm reduction: (1) that the products are much less harmful than cigarettes, and (2) that these products displace smoking at the population level. 

No doubt the whitepaper it will be panned because of the source but “risk-proportionate regulation” is related to FDA’s “continuum of risk” concept. We have to keep pushing to embed this harm reduction priority as our public health strategy.

---

Stay tuned in with us for lots of new developments and make sure your friends and colleagues are signed up to receive our news and information.

Got questions? If you have any questions about the issues we have covered, have suggestions for content, or how you can support our efforts, please feel free to contact us at press@vaportechnology.org.

VTA Insider keeps you informed of critical issues impacting the nicotine products industry both in Washington, DC and in the states. We will cover regulatory developments, legislation, news of note and other industry insights. VTA will also share our analysis of what we as an industry need to do to grow and prosper.

Let’s Dive In.

---

1 big thing: VTA meets with King…again

The big picture: Kicking off the New Year, on January 10, 2023, VTA leadership and select board members met with CTP Director Brian King and other leadership at the Center for Tobacco Products (CTP) to discuss top agenda items for the year. This was the second meeting that VTA has had with King in the last four months.

Top takeaway: Director King acknowledged the fact that youth e-cigarette use continues to decline but was ambiguous on the reshaping of CTP policy regarding adults, noting they are considering how to address the Reagan-Udall recommendations and looking to engage more with stakeholders.

Remember, Reagan-Udall told CTP to: “resolve how to weigh the public health benefits of adults who use ENDS that will quit smoking combustible tobacco products against the potential public health harms to youth who use e-cigarettes.”

The rest of the agenda: VTA focused on the most pressing issues impacting our members and the industry including:

• Implementing Reagan-Udall Recommendations
• Enforcement Discretion for Non-Tobacco Nicotine
• Need for an Objective APPH Test
• Industry Stakeholder Engagement

---

VTA presses CTP on clarifying enforcement discretion policy

The “million dollar” question: CTP has historically allowed all tobacco products with pending PMTAs to remain on the market, subject to FDA’s enforcement discretion, but in the past few months has been making confusing statements particularly with respect to non-tobacco nicotine products. Following up on VTA correspondence from early November 2022, we asked Director King: “Has CTP had changed its well-established enforcement discretion policy for non-tobacco nicotine products only?”

What we said: It’s extremely important that we get clarity on this question so all market participants understand CTP’s position and so that companies are not able to misrepresent CTP’s position for their own benefit.

• For years, CTP has used enforcement discretion to allow all tobacco products with pending PMTAs to remain on the market and that policy should be consistently applied to tobacco and non-tobacco nicotine products alike.
• Some companies have been attempting to confuse retailers and dissuade them from carrying synthetic nicotine products by claiming that CTP uses enforcement discretion only for tobacco-dervied nicotine products and not for synthetic nicotine products.
• Nothing in the new law limited CTP’s enforcement discretion – in fact, CTP has been exercising that discretion – and CTP would never unilaterally limit its own discretion.

What they’re saying: During the meeting Director King indicated that had been no policy change with respect to CTP’s use of enforcement discretion.

• But, Director King went on to say that there was a difference between enforcement discretion and enforcement prioritization.
• King promised promised a formal letter soon from CTP in response to VTA’s questions to clarify CTP’s position.

---

King to VTA: FDA has no enforcement discretion policy for TDN or NTN products

The big picture: CTP has exercised enforcement discretion for years. CTP has asked courts not to limit its enforcement discretion. CTP has explained its actions or inactions based on enforcement discretion.

Why it matters: CTP has consistently used its enforcement discretion to allow products under PMTA review to remain on the market pending a final PMTA determination. Manufacturers, distributors and retailers have relied on CTP’s statements to continue selling less harmful vaping products. Heck, CTP has been criticized by anti-harm reduction forces for using enforcment discretion.

About Face: On February 2, 2023, VTA received the formal response letter promised by Director King in which he clarified that:

• TDN products are not being treated differently than NTN products.
• CTP has not been using enforcement discretion for tobacco-derived nicotine products or synthetic nicotine products.
• In fact, CTP does not even have a policy on enforcement discretion.
• All products, regardless of whether they include tobacco-derived nicotine or synthetic nicotine, are illegal and cannot be sold until their PMTAs have been authorized.

Go deeper: While CTP acknowledged that FDA originally said it would use enforcement discretion, that changed. Here is how Director King recasts what CTP has been doing:

“Accordingly, your letter’s assertion that FDA is “us[ing] its enforcement discretion to allow . . .products to remain on the market” while they undergo review is not correct. On the contrary, as the guidance reiterates, all illegally marketed TDN e-cigarette products are subject to FDA enforcement. The same principle applies to NTN products; specifically, all illegally marketed NTN products are subject to enforcement.”

“FDA cannot affirmatively allow or permit the unlawful marketing of tobacco products, including TDN and NTN e-cigarette products; as the above statements reflect, all illegally marketed products are subject to FDA enforcement, such a seizure, civil money penalty, or injunction. Moreover, FDA has not adopted a broad policy of enforcement discretion with respect to TDN or NTN e-cigarette products that lack the required premarket authorization.”

Why Now?

• Sure, VTA has been presssing CTP on clarifying the question of enforcement discretion for months.
• But, we can’t help noting that CTP’s 2-page letter (three months in the making) was received just one day after Sen. Richard Durbin (D-IL) and other Senators issued another press release and sent a letter to HHS Secretary Xavier Becerra blasting CTP for its, yes, “exercise [of] enforcement discretion,” and demanding “This enforcement discretion should have ended years ago. It must end today.”
• At least now we know that FDA is not using enforement discretion for any nicotine-containing product.

---

VTA to FDA on Reagan-Udall: Need to Pull It Together, Together

One big thing: The Reagan-Udall report raised a number of critical issues regarding CTP’s handling of tobacco regulation that demand immediate attention and immediate industry engagement. VTA learned that CTP will formally respond to the Reagan-Udall report in mid – February. With that in mind, in our January conversation with Director King, VTA highlighted the Reagan-Udall recommendations that mirrored VTA’s own recommendations:

• CTP needs a strategy: Reagan-Udall said that CTP has no strategic plan and “must create [a strategic plan] that identifies the CTP’s strategic objectives and plots an operational roadmap of the steps CTP will take over the next five years to achieve those objectives.” VTA strongly supports this recommendation and noted its agreement with Reagan-Udall that the path to resolving many of the CTP’s self inflicted problems starts with establishing the scientific and policy framework for tobacco harm reduction.
• CTP needs to establish what is APPH: Reagan-Udall made clear that CTP must “explain how FDA is interpreting the [appropriate for the protection of public health] APPH standard” and how it is weighing “the public health benefits of the percentage of adults who use ENDS that will completely quit smoking … against the potential public health harms [to] youth.” VTA noted that APPH evaluations were being subjectively decided in conflict with the science. VTA offered to work with CTP on an objective process for ensuring that APPH decisions are made without political or outside interference.
• CTP must advocate clearly for harm reduction: Reagan-Udall noted that “CTP lacks consistent implementation of its own policies, particularly with respect to harm reduction” which undercuts CTP’s mission. CTP has acknowledged the continuum of risk but has no clear policy or strategy on harm reduction. VTA emphasized the need for a clear APPH standard and clear messaging from FDA on harm reduction.
• CTP must be transparent: VTA has consistently raised concerns regarding the opaque operations of the CTP. Reagan-Udall’s review highlights a shifting decision-making process, lack of clarity on responsibilities, and impact of extreme external pressures. Transparency in decision making is as imporatnt as transparency and engagement in the policy process. We urged CTP to create opportunities for communication outside of the rule making process and recognize that companies which are spending millions of dollars are acting in good faith and need to be engaged early.

What’s next: Based on Director King’s statements and promises, we should expect a much higher degree of stakeholder engagement, including VTA and other industry engagement, with CTP on the critical issues raised by Reagan-Udall. However, it is unclear how FDA/CTP will choose to address Reagan-Udall’s serious criticisms. It is equally unclear whether CTP will tackle the problems with enough force to change CTP’s trajectory away from propping up cigarettes and toward replacing them with less harmful vaping and modern oral products.

---

Progress in The Courts

The big picture: FDA CTP is embroiled in litigation throughtout the country which is testing whether FDA’s “fatal flaw” approach to PMTAs and its implementation of post-application testing prerequisites violate the law. Those cases, pending in various federal appellate courts, could end up in conflict thus paving the way for SCOTUS review.

One important case: Wages & White Lion v. FDA, is pending in the 5th Circuit. There, the petitionr originally secured the “suprise switcheroo” opinion which heavily criticized the FDA for changing the application requirements after the fact and imposed a preliminary injunction barring the FDA from enforcing its MDO against Wages & White Lion. However, in a split-decision (2-1), the final panel agreed with the FDA and denied the appeal.

5th Circuit Rehearing: Wages & White Lion asked all 9 judges of the 5th Circuit to review the case and that request was granted so the full 5th Circuit panel will now make the court’s final decision. VTA filed an amicus brief in support of the request for a rehearing en banc, provinding the court with the findings of its experts’ analysis of the severe economic ramifications of the FDA’s flavor ban.

---

FDA’s Illogical VUSE on Menthol

The big picture: Last month, FDA issued market denial orders for two VUSE menthol PMTAs filed by R.J. Reynolds. You can read FDA’s statement here. This after FDA denied LOGIC’s menthol vape PMTAs, filed by JTI, last year. The tobacco giant quickly obtained an injunction from a federal court to bar enforcement of the FDA’s decisions.

Why it matters: It is safe to say that we have entered the unfortunate reality where FDA is intent on treating menthol products in the same dismissive manner in which it has treated all other flavored vaping products to date. It appears that no amount of science will be sufficient for FDA leadership and that in the absence of menthol vapes, former smokers will become smokers again.

---

Stay tuned in with us for lots of new developments and make sure your friends and colleagues are signed up to receive our news and information.

Got questions? If you have any questions about the issues we have covered, have suggestions for content, or how you can support our efforts, please feel free to contact us at press@vaportechnology.org.

Welcome to the December edition of the VTA Insider, your industry focused briefing from the Vapor Technology Association.

VTA Insider keeps you informed of critical issues impacting the nicotine products industry both in Washington, DC and in the states. We will cover regulatory developments, legislation, news of note and other industry insights. VTA will also share our analysis of what we as an industry need to do to grow and prosper.

Let’s Dive In.

---

Reagan-Udall Issues Critical Report on FDA Tobacco

The big picture: Last July, FDA Commissioner Robert Califf called for an indpendent review of the FDA’s heavily criticized Center for Tobacco Products (CTP) by the Reagan-Udall Foundation (RUF). The RUF report, released last week, painted a troubled picture of a CTP’s culture, inconsistent and opaque rules and standards, and political interference with what should be scientific decisions.

What the experts found: RUF’s independent panel of tobacco experts found:

• CTP has no strategic plan and must create one that identifies the Center’s strategic objectives and plots an operational roadmap to achieve them.
• CTP has not clearly articulated what is required to meet the appropriateness for the protection of public health (APPH) standard or how it is applying the APPH standard.
• CTP struggles to function as a regulator due to some of its own policy choices.
• CTP faces significant challenges in clearing policies through the career and political infrastructure.
• CTP lacks consistent implementation of its own policies, particularly with respect to harm reduction.

RUF Recommendations: Some of the most important recommendations of the independent tobacco expert panel:

• “The Panel strongly recommends that the center invests the time – now – in … thinking strategically about where it is deficient, where it needs to be in the future, and how best to get to that future.”
• “The path to resolving many of the Center’s current challengesstarts with establishing the scientific and policy framework to make clear and timely product decisions.”
• “The plan must … explain how FDA is interpreting the APPH standard.”
• “CTP has a responsibility to clearly identify application requirements.”
• “CTP must resolve how to weigh the public health benefits of adults who use ENDS that will quit smoking combustible tobacco products against the potential public health harms to youth who use e-cigarettes.”

Why it matters: Using the addled prcess described by RUF, CTP hasrejected the overwhelming majority of applications for millions of less-harmful vaping products and has done so without being able to articulate how it is balancing the public health standard.

Keeping score: 600 – 8 – 0 – 0 – 0 – 0

• 600 = the # of combustible tobacco products, including 250 new cigarettes, authorized for sale.
• 8 = the # of less harmful tobacco-flavored e-cigarettes authorized.
• 0 = the # of less harmful menthol-flavored e-cigarettes authorized.
• 0 = the # of less harmful other-flavored e-cigarettes authorized.
• 0 = the # of less harmful open-system devices authorized.
• 0 = the # of less harmful nicotine pouch products authorized.

Our thought bubble: “The FDA Commissioner should instruct CTP to stand down on issuing any further denials of less harmful nicotine alternative product applications until CTP has been able to review and implement the safeguards and recommendations made by the Reagan-Udall Foundation, and VTA stands ready to assist FDA and CTP by providing the necessary stakeholder input that the Foundation also said was necessary,” said VTA’s Executive Director.

Read VTA’s full statement on the RUF Report, VTA’s oral testimony to RUF, the summary of VTA’s recommendations and its full written submission to RUF.

Watch VTA’s Executive Director discuss the RUF report on Regulator Watch.

---

Where’s the logic?

The big picture: On October 26, 2022, FDA denied Logic Technology Development, LLC’s (LOGIC) menthol-ENDS PMTA applications claiming that LOGIC failed to prove that its menthol products were appropriate for the protection of public health (APPH). But, in documents made public recently, LOGIC revealed that CTP’s Office of Science changed its standards for reviewing menthol-ENDS PMTAs aftereffectively being told to do so by the CTP Center Director’s office.

• In a memo written by the head of the Office of Science, it was disclsoed that the scientists initially decided to authorizeLOGIC’s menthol-ENDS products back “in the latter half of 2021” after taking into account all factors including potential attraction to youth.
• But, after the Center Director’s office “shared [its] views,” the Office of Science changed its approach and recommendation to deny LOGIC’s menthol PMTAs.

Why it matters: It appears that CTP is applying the same flawed youth-oriented decision making process for evaluating menthol-flavored vaping products as it did other-flavored vaping products. In other words, anypotential youth use outweighs LOGIC’s studies demonstrating little to no youth uptake and significant adult smoking cessation.

What we’re saying: CTP’s decision was made during using a process which the Reagan-Udall Foundation was highly critical of due to CTP’s lack of transparency on the balancing test and what appear to be scientific decisions getting overriden by policymakers at the agency. VTAshared copies of the internal FDA memos with the Reagan-Udall Foundation before it issued its report. 

What’s next: LOGIC, having already filed suit, has its case on what appears to be a fast track so we hope to see a court decision soon.

---

Worth your time…

Must-see webinar on age-gating. Missed the recent webinar Protecting your Brand, Products, & Consumers: Age-Gating and Supply Chain Security? Watch this free 60-minute webinar moderated by Dr. Jessica Zdinak, with Dave DeJean and Eric Hawk. Use the passcode: =rk0V3k0

Attorney General Tom Miller and leading tobacco-control scientists published a must-read editorial in Addiction entitled United States Public Health Officials Need to Correct E-cigarette Health Misinformation

“Health misinformation is harmful as it can cause confusion and sow mistrust regarding the adoption of public health recommendations and policies. We provide examples of e-cigarette misinformation promoted by the United States public health officials, which have persisted despite new data challenging the validity of the original assertions.”

VTA Executive Director Tony Abboud speaks to Regulator Watchabout a number of regulatory updates. Abboud discusses litigation, flavored ENDS appeals, and Supreme Court flavor cases and much more.

---

Happy Holidays To All

We at VTA are wishing everyone a safe (warm!) and happy holidays as we look forward to a new year filled with change and prosperity!

Stay tuned in with us for lots of new developments in the coming year and make sure your friends and colleagues are signed up to receive our news and information..

Welcome to the inaugural edition of the VTA Insider, your industry focused briefing from the Vapor Technology Association.

The VTA Insider will keep you informed of critical issues impacting the nicotine products industry both in Washington, DC and in the states. We will cover regulatory developments, legislation, news of note and other industry insights. VTA will also share our analysis of what we as an industry need to do to grow and prosper.

Let’s Dive In.

1 big thing: GOP takes the House

The big picture: Although vote counting continues in some races, Republicans have officially picked up enough seats to take majority control in the House. But, with Republican control of the House floor, committees and the policy agenda, split party rule returns to Washington D.C. While this is often a recipe for legislative gridlock – split control can help focus leaders of both parties on solving problems that they were not motivated to address before. 

Why it matters: The vast oversight and investigation authority the new House majority will have will put a number of federal agencies and programs under the microscope. GOP leaders already have articulated a large number of issues on which they plan to conduct oversight and investigations: everything from the Afghanistan withdrawal, to COVID, to possible impeachment.

What’s next: VTA’s lobbying and public affairs teams will share their insights on what happened in the recent election and what we can expect to change in Congres in 2023 during VTA’s 2022 Post-Election Round Up webinar on November 30, 2022. Register for the webinar today.

Our thought bubble: VTA has spent the past year working on a bi-partisan strategy that would take serious strides in addressing both youth and adult access to flavored vaping products and the closely divided Congress will necessitate a bi-partisan approach. Also, VTA will be working with the new Congress to ensure they it understands the problems that FDA’s Center for Tobacco Products has had historically.

---

FDA under the microscope?

The big picture: This summer, FDA Commissioner Califf called for an independent review, by the Reagan – Udall Foundation (RUF), of FDA’s Center for Tobacco Products (CTP) and its handling of tobacco products. RUF was created by Congress “to advance the mission of the FDA…” and it is now taking a deep dive into the operations of the CTP.

Why it matters: The issues at CTP which VTA has been working to resolve for a number of years, particularly how CTP has handled e-cigarette PMTAs, are beginning to receive long overdue attention. All parties were able to submit comments to RUF and, suprisingly, some of the most troubling feedback has come from FDA staff. 

What they’re saying: Some CTP staff have been highly critical of how CTP has handled e-cigarettes and they lay bare some of the worst fears about what has been going on inside CTP. Here’s a sample of some of the more concerning comments from CTP staff:

• “Politics are being permitted to drive the science and even limit or alter science-based decisions.”
• “In cases where reviews are finished and scientific decisions are made they are also overruled by political agendas and pushed to change decisions.”
• “…leadership pushes a “gotta get em” mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”
• “FDA needs to use its authority … to refuse import of all disposable tobacco ENDS products that lack pre-market authorization. This would virtually eliminate youth access to disposables and address unauthorized, unsafe, and in many cases counterfeit disposable products.”

Go deeper: VTA was invited to present comments on needed changes to RUF’s independent tobacco expert panel in October and offered a number of specific recommendations, most notably stating the need for CTP to insulate itself from politics and external pressures in reviewing PMTAs and to “unapologetically” follow the science.

What’s next: RUF will complete its review and will publish a report with recommendations in December of this year.

---

Defending flavored vapes

The big picture: On Nov. 8, 2022, voters in California passed a ballot initiative (Proposition 31) upholding a 2020 law banning the sale of most flavored tobacco products. The next day, R.J. Reynolds (RJR), filed a federal lawsuit challenging California’s ban. On November 14, VTA filed an amicus brief with SCOTUS in support of a similar RJR case arguing that federal law preempts local and state flavor bans. These cases could have a big impact on local/state flavor bans across the country.

VTA argued that Supreme Court review is critical for economic and public health reasons:

By the numbers: The independent vapor industry comprises more than 10,000 companies across the U.S. VTA’s economists found that the independent vapor industry is responsible for generating more than 130,000 jobs. In new economic impact report VTA commissioned, experts found that a flavor ban would cause the loss of more than:

• 99,000 jobs;
• $5 billion in wages and benefits; and
• $16 billion in lost economic output for the U.S.

What experts are saying: VTA also argued that leading tobacco-control scientists have challenged banning flavored e-cigarettes and have warned that decreasing availability of flavored vaping products harms the ability of adult smokers to quit smoking. Instead of blanket bans, these tobacco-control scientists endorse alternative time, place and manner restrictions for the sale of flavored vaping products.

The bottom line to SCOTUS: Permitting local and state governments to implement unscientific sales bans which directly interfere with the fundamental purpose of the TCA and which would overrule FDA’s decisions that a product is appropriate for the protection of public health, is not only unlawful, but is dangerous from a public health perspective.

What’s next: VTA will keep you updated as the litigation proceeds. 

---

Worth your time…

What we’re saying

VTA’s Executive Director at the ENDS US 2022 conference speaking on “PMTA: Lessons Learned.” Watch the video below.

In an excellent piece by Marc Gunter in Filter Mag entitled Can the Tobacco Control Debate Find Common Ground?:

“Some industry leaders are willing to accept regulation. Tony Abboud, the Executive Director of the Vapor Technology Association, which represents vape shops, says his group would accept reasonable restrictions on where e-cigarettes can be sold and how they can be marketed. Abboud also said: ‘We’ll sit down with anybody.’”

Worth the read

• California’s Vaping Flavor Ban Could Be Lethal
• New Study Shows that Vaping Helps Adult Smoker Quit
• FDA and CDC Are Misleading the Public About Youth Vaping Data