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The Problem With The FDA’s Retail Tobacco Enforcement

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The FDA Center for Tobacco Products (CTP) is being criticized for its enforcement efforts and with good reason. A new report of the Vapor Technology Association’s analysis of FDA’s enforcement data has revealed some striking findings that the FDA chooses not to synthesize for the public.

Since 2018, the FDA has spent presumably millions of dollars conducting more than 325,000 retail inspections resulting in a high compliance rate of 86% of inspections with “no violations” for the sale of tobacco products. Furthermore, 96% of FDA retail inspections used minors and the overwhelming majority of those inspections resulted in 85% with in “no violations”, again a high compliance rate.

FDA Tobacco Retail Inspection and Violation Rates since 2018 (1/1/2019 – 12/31/22)
Source: FDA Compliance Check Inspections of Tobacco Product Retailers database

The utility of CTP’s local enforcement efforts, aimed at youth sales and potential violations at retail stores, needs to be re-examined to determine whether they are worth the expenditure.

FDA Ignoring Combustible Tobacco Product Sales to Youth

The FDA has been rightly criticized by leading tobacco-control scientists for focusing its narrative, policies and efforts on youth vaping and e-cigarette products, but the data shows that warning letters for youth sales violations involving nicotine vaping products only account for 3.8% of all retail inspections conducted since 2018. In comparison, warning letters for youth sales violations for combustible products were twice as high. In 2022 alone, the rate of combustible violations was two and a half times that of nicotine vaping products.

FDA Rate of Combustible to Vape Youth Violations since 2018 (1/1/2019 – 12/31/22)
Source: FDA Compliance Check Inspections of Tobacco Product Retailers database

Moreover, FDA data reveals that penalties beyond warning letters for flagrant violations are imposed far more often for violations of combustible products than for vaping products.

The FDA’s continued refusal to publicly acknowledge that youth sales of combustible products are more than two times that of less harmful e-cigarette products raises serious questions about its purpose and intent.

FDA Ignoring the Fact that Vape Shops and Other Adult-Only Stores Have Best Compliance Rates

Our vaping association’s data has determined that FDA policies have, by design or effect, dramatically reduced the number of independent vape shops around the country since 2018 by 27%. This has occurred despite the fact that the FDA has known these stores have the best compliance rate.

However, VTA’s analysis of FDA data reveals that since 2018 adult-only retailers, such as vape shops, have been best at preventing unlawful sales to youth. While almost 78% of youth violations occurred at non-adult only stores, such as gas stations and convenience stores, only 21% of violations occurred in adult-only vape shops (5%) and tobacco shops (16%).

FDA Ignoring the Fact that Tobacco/Menthol E-Cigarettes Far Exceed Other Flavored Vape Sales Violations

FDA rarely makes any statement regarding vaping products without also warning about sales of flavored vaping products to youth. However, FDA’s data reveals that since 2018 youth sales violations of tobacco and menthol flavored vapes exceeded 55%, while sales violations involving other flavors lagged behind at 39%.

The FDA Center for Tobacco Products not only needs to question the resources it is spending to enforce against small businesses, but it needs to be truthful and transparent when it publicly characterizes the issues of youth vaping and retail sales.

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VTA Insider Jan 2023 – Smoking vs Vaping, Vaping Info and Regulations.

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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

Reagan-Udall Foundation Reports Serious Problems at FDA Tobacco

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

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

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

FDA's lack of strategic planning within the CTP

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

Wages & White Lion v. FDA

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

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.

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 December 2022 – FDA Tobacco Regulations

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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

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?

FDA Vapor Regulations

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…

E-Cigarette News

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

Happy Holidays

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!

VTA Responds to the Final Reagan-Udall Foundation Report

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Leading Vapor Trade Group Urges FDA to Adopt Reforms to Protect Sanctity of Scientific Process 

WASHINGTON, December 20, 2022 (Newswire.com) – Following the Reagan Udall Foundation release of their final report reviewing the operations of FDA’s tobacco program, the Vapor Technology Association, through its Executive Director Tony Abboud, released the following statement: 

“The Reagan-Udall Foundation’s independent review of FDA’s tobacco program has uncovered systemic problems inside the Center for Tobacco Products that allowed political decisions to override the science-based recommendations of FDA professional staff concerning the authorization of vaping products that would provide safer alternatives for adult smokers looking to quit combustible cigarettes.  

“The Reagan-Udall review was requested by FDA Commissioner Califf to address problems with the Center for Tobacco Products (CTP) programs for regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. Their observations included the following:

  • 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 must resolve how to weigh the public health benefits of adults who use ENDS that will completely quit smoking combustible tobacco products against the potential public health harms to youth who use ENDS.
  • CTP has not clearly articulated what is required to meet the appropriateness for the protection of public health 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.
  • CTP has not been transparent regarding its failure to clear the market of illegal products.
  • CTP’s current goals and priorities are unclear in communication and practice.

“The Vapor Technology Association has raised concerns for years about the opaque and questionable operations of the CTP. Reagan-Udall’s review highlights a shifting and arbitrary decision-making process, untethered from science due to political or external pressures, that has damaged the marketplace for safer vaping products, impaired the FDA’s credibility, undermined the FDA’s mission of harm reduction by denying millions of American smokers truthful information and authorized products. We are pleased to see many of the recommendations VTA provided to the Reagan-Udall Foundation reflected in the Foundation’s report.

“The fact that CTP has continued to issue major decisions despite deficiencies highlighted by Reagan-Udall is highly questionable. VTA agrees that ‘CTP must invest the time, now…to create and implement a Strategic Plan’ and that ‘the path to resolving many of the Center’s current challenges starts with establishing the scientific and policy framework to make clear and timely product decisions.’ For that reason, 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 Tony Abboud.

ABOUT VTA
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners. Source: Vapor Technology Association

VTA’s Recommendations to the Reagan-Udall Foundation

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VTA PMTA Recommendations

  1. FDA must implement safeguards at the Center for Tobacco Products (CTP) to ensure that the scientific review process is insulated from external pressures and that CTP scientists are allowed to unapologetically follow the science.
  2. Immediately rescind the July 9, 2021 and August 17, 2021 process memos which resulted in the en masse denial of flavored ENDS products, restore the holistic review process and the primacy of the appropriateness for the protection of public health balancing test.
  3. Build the off-ramp from smoking by accelerating the authorization of ENDS products and using the full scope of CTP’s post-marketing order authority to monitor and control for youth concerns.
  4. Clearly articulate CTP’s use of enforcement discretion to work companies through the PMTA process, particularly for non-tobacco nicotine (i.e., synthetic nicotine) applications.
  5. Communicate with companies to seek additional information or corrections and avoid rejections based on administrative or technical failings and the needless litigation that follows.
  6. Establish defined testing methods for END products which create transparency and certainty.
  7. Eliminate redundant and unnecessary testing to streamline the PMTA process.
  8. Develop and publish a PMTA proposed regulation with a finite checklist of required information that is required for PMTA review.
  9. Equally fund research for identifying how ENDS products can be solutions for smoking, rather than simply identifying problems with ENDS products and youth.

VTA Regulations and Guidance Recommendations

  1. CTP should implement a Comprehensive Plan on tobacco and nicotine that includes a clear acknowledgment of the FDA’s commitment to:
    1. the continuum of risk related to tobacco products and a recognition that ENDS and modern oral nicotine products sit at the lower end of the risk continuum,
    2. promoting innovation of those products at the lower end of the risk continuum, particularly ENDS and modern oral nicotine products,
    3. promoting innovation in nicotine, particularly synthetic nicotine,
    4. a pure scientific review process,
    5. funding science to evaluate the benefits of ENDS and modern oral nicotine products,
    6. working with companies to facilitate the application review process,
    7. aggressively educating adult smokers on the benefits of trying ENDS products if they are otherwise unwilling or unable to quit smoking using other methods,
    8. using its enforcement discretion to allow products under review to remain on the market pending authorization reviews, and
    9. a streamlined process which will ensure prompt review of product applications.
  2. CTP should engage industry and other stakeholders in the guidance and regulation processes by:
    1. Converting its listening sessions to engagement sessions so that CTP personnel are encouraged to communicate, ask questions and engage with stakeholders during meetings;
    2. Reinstituting its public stakeholder workshops which bring together all stakeholders to provide input on key regulatory policies and strategies; and
    3. Establishing an additional technical advisory committee dedicated to newly deemed alternative nicotine products to have a more focused strategy for less harmful nicotine products
  3. CTP should issue proposed regulation or guidance on product standards that:
    1. Explicitly allows widely accepted statistical design methods of research, aggregate testing, and extrapolation for ENDS product stability testing, and
    2. Permits manufacturers to market safety and/or quality enhancements with 60-Day notice to FDA.  

VTA Enforcement Recommendations

  1. CTP must use its full authority to ramp up interdiction of illicit products at the ports.
  2. CTP needs to streamline and reprioritize its enforcement efforts, rather than focusing so much on generally ineffective retail level enforcement.
  3. CTP should publish list of NTN products currently under PMTA review to facilitate industry and FDA enforcement efforts.
  4. CTP should restructure its enforcement efforts, through a guidance document, to achieve the following altered enforcement priorities:
    1. Stopping the flow all disposables into the U.S. market for which no PMTA has been filed by interdicting products at the ports;
    2. Enforcing against other ENDS products for which no PMTA has been filed, first prioritizing tobacco-derived products which make up the bulk of the market and then NTN products (since the latter are only a fraction of the market);
    3. Enforcing against counterfeit and illicit products which grossly violate marketing standards, trademark laws, or otherwise have marketing campaigns directed at youth; and
    4. Enforcing against products for which CTP has issued marketing denial orders (MDOs) after a full scientific review consistent with requirements of the Tobacco Control Act, except of course, those subject to an FDA administrative stay or a court-ordered stay of enforcement.

VTA Public Education & Communication Recommendations

  1. CTP must loudly and repeatedly correct the public record that nicotine does not cause cancer and that ENDS products, in the words of CTP Director King “have markedly less risk than a combustible cigarette”;
  2. CTP must commit equal resources to conducting an aggressive public education campaign, targeted to the adult consuming public, on the dangers of smoking and the lower risks of ENDS and modern oral nicotine products, explaining the continuum of risk, and encouraging adult smokers who have been unable or unwilling to quit to try e-cigarettes; and
  3. CTP must end the misleading youth education campaigns that are designed to scare youth (and adults) with false statements regarding the risks of e-cigarettes.
Read VTA’s Full Comments (PDF)

VTA Insider November 2022 – FDA Tobacco Laws and Regulations

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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?

FDA Commissioner Califf calls for an independent review

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

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…

E-Cigarette News

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

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.

The VTA Submits Supreme Court Amicus Brief on Vaping Flavor Ban

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WASHINGTON, November 15, 2022 (Newswire.com) – 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. On Nov. 9, 2022, R.J. Reynolds (RJR), filed a federal lawsuit challenging California’s ban as being unlawfully preempted by the Family Smoking Prevention and Tobacco Control Act of 2009, (TCA). Yesterday, the Vapor Technology Association (VTA) filed an amicus brief with the Supreme Court of the United States in support of a Petition for Writ of Certiorari in another RJR case asserting similar arguments against the earlier L.A. County ordinance banning all flavored tobacco products. Supreme Court review is critical for two reasons.

First, the “substantial effect on the Nation’s economy” created by the sale of tobacco products is of great significance. The passage of the TCA in 2009 led to the creation of a new, independent distribution chain of companies, including manufacturers, distributors, suppliers, and retailers, that has steadily grown outside of the traditional tobacco products industry, offering their customers non-combustible nicotine vapor products as alternatives to smoking cigarettes. According to a new economic impact report (prepared by John Dunham & Associates), the independent vapor industry comprises more than 10,000 companies across the United States and is responsible for generating more than 130,000 jobs and more than $22 billion in economic activity for the U.S. economy.

This industry would be devastated by unrestricted flavor bans, given its unique and substantial reliance on the sale of flavored vapor products to adult consumers. Importantly, the potential shutdown of close to 10,000 businesses, causing the loss of 99,158 full-time equivalent (FTE) jobs, the loss of $5,258,906,715 in wages and benefits, and the loss of $16,449,776,269 to the U.S. economy makes the issue before the Court incredibly important. In the state of California, where the majority of e-liquid manufacturers of the independent vapor products industry are based, losses would total approximately 6,925 FTE jobs, paying $445,565,776 in wages and benefits, and the economic output of the California economy would be diminished by $1,497,332,882 if flavored vapor products could not be sold. 

Second, since the passage of the L.A. County Ordinance – leading tobacco-control scientists have challenged the notion of banning flavored e-cigarette flavors and have warned that decreasing availability of flavored vaping products harms the ability of adult smokers to quit smoking cigarettes. Instead of blanket bans, these tobacco-control scientists endorse alternative time, place and manner restrictions for the sale of flavored vaping products.

Permitting local and state governments to implement unscientific bans that directly interfere with the fundamental purpose of the TCA and would overrule the FDA’s decision-making for products deemed appropriate for the protection of public health, is not only unlawful, but is dangerous from a public health perspective, in VTA’s view.

ABOUT VTA
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.

Here’s Why the FDA’s Vaping Policy Should Change

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Comments of the Vapor Technology Association

Presented by Tony Abboud, Executive Director

INTRODUCTION

Good morning.  The Reagan-Udall Foundation’s mission[1] of “modernization,… accelerating innovation and enhancing product safety” could not be better applied to any other product category within the FDA’s ambit of authority than less harmful nicotine products.

This review couldn’t have come at a more important time and Commissioner Califf should be applauded for calling for it and Director King should be applauded for embracing it. FDA’s new leaders have an historic opportunity to dramatically change public health in the U.S. by boldly correcting errors of the past, eliminating political interference in the scientific process, providing a clear roadmap for the approval of less harmful nicotine products, and accelerating innovation away from the deadliest product on the market – the combustible cigarette.

But, this will not happen, if at all, at a fast enough pace to save the lives of millions of Americans who still smoke cigarettes unless serious process changes are made.

What has the Agency done well?  

You have asked us to address three components and I will start with what the FDA has done well.

  1. In 2017, Commissioner Gottlieb announced a Comprehensive Plan for addressing tobacco and nicotine issues.  Foreseeing the challenges of PMTA compliance, Gottlieb extended the deadline for filing from 2018 to 2022 since the agency still needed to “issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers.” The comprehensive plan also expressly acknowledged the continuum frisk and that ENDS products fall at the lower end of the risk continuum when compared to cigarettes.
  2. CTP issued an ANPRM on the important issue of flavors to examine their impact on initiation and on smoking cessation.
  3. CTP has effectively administered its Substantial Equivalence application process for reviewing new tobacco products.  

What has the Agency not done well?

Unfortunately, these positive steps have not led to the successful execution of CTP’s mission.

Since January 2020, CTP’s efficient management of the SE process has bizarrely resulted in the authorization of 600 new combustible tobacco products, 250 of which are new cigarettes. In contrast, FDA’s management of the PMTA process has authorized only 6 less harmful ENDS devices, some of which are antiquated technologies and/or have virtually no market presence.  How did this happen?

First, the FDA abandoned its Comprehensive Plan and did everything but create the “efficient, predictable, and transparent” process Gottlieb said was necessary. 

CTP never finalized the “foundational rule” for PMTAs before applications were filed and it acquiesced to a 2-year acceleration of the filing deadline notwithstanding the unavailability of that final rule. This forced companies to rely on non-binding guidance, rush scientific research and data collection, submit redundant applications, and conduct unnecessary testing. 

Second, CTP failed to apply the continuum of risk in its comparative assessment of ENDS to cigarettes and also failed to distinguish between open and closed ENDS products.

Third, CTP abandoned its ANPRM on flavors in 2018, ignoring the enormous body of science presented by all stakeholders, including VTA’s substantive review of all flavor studies.

Fourth, CTP altered its review process and standards AFTER applications had been accepted for substantive review, using those changes to deny countless PMTAs all without conducting that substantive review, and failed to balance all the prongs of the APPH test, choosing instead to use single alleged deficiencies to deny applications.

These actions plunged the entire category into chaos and CTP’s decisions into protracted litigation.

This was all driven by an exclusive focus on youth and flavors which has been directly criticized by the 15 past presidents of SRNT, the most esteemed group of tobacco-control scientists, as threatening the chances of adult smokers to quit. I’ll briefly explain one example of how the Agency’s prior interim leadership allowed outside influences to subvert the PMTA scientific process on this issue alone.  

Flavor Example

In August 2020, CTP’s Office of Science documented its process for reviewing applications for flavored ENDS products and explained that it anticipated approving such products as APPH.  At a June 11, 2021 public meeting, the Office of Science transparently explained the process and priorities it was using to review PMTAs.

Two weeks later, when FDA’s Acting Commissioner Woodcock testified before a Congressional committee on June 23, committee members demanded that Woodcock deny JUUL’s PMTAs and deny any flavored e-liquid PMTAs claiming thatwas her responsibility regardless of the science.

Immediately after the hearing, I learned from those inside the FDA that Woodcock injected herself on the  flavor issue. Two weeks thereafter, CTP documented Woodcock’s interjection in a now infamous July 9 “fatal flaw” memorandum, explaining that the Office of Science was “tasked” by the Acting Commissioner to implement a “new plan” to “take final action” on as many flavored ENDS applications as possible – a complete reversal of both the process and priorities they announced less than one month earlier.

The memorandum articulated a review process which imposed a new testing prerequisite, 11 months after the applications were filed. CTP created a new “presumption” that all flavored products are attractive to youth to justify the new requirement for long-term product specific studies on cessation and a heightened standard for flavored ENDS.  CTP’s scientists were forced to alter their process to ensure the blanket rejection of virtually all flavored applications and did so without even reviewing the applications and science submitted.  The process change effectuated a de facto policy change and as it was unfolding in September 2021, I heard from people inside FDA who were stunned that the Agency had changed its position “without any scientific support.”

This leads me to recommendations.

RECOMMENDATIONS

  1. CTP must implement safeguards to ensure that the review process is free of external pressures. I have only highlighted one of many examples. Unless the process is insulated, CTP will never be allowed to execute its mission.
  2. Unapologetically follow the science and announce approvals.  The Office of Science must be allowed to complete its reviews and when it authorizes applications, those decisions should immediately and loudly be announced to the marketplace. 
  3. Immediately reverse the fatal flaw memo and actually review the science presented.  This means not imposing a non-product-specific presumption regarding initiation (i.e. that ALL flavored products are attractive to youth) while demanding “product specific” data regarding cessation.
  4. Restore the primacy of APPH balancing test. This means treating the cessation and population benefits prong equally to the initiation prong.  This means conducting a holistic review and not singling out one set of data on which it justifies denials.
  5. Use CTP’s enforcement discretion to work companies through the PMTA process.  Virtually all PMTAs have been submitted on grossly accelerated timeframe. Working with companies that can comply with the requirements and providing them the time necessary to complete the required science ensures a stronger process. This particularly applies to FDA’s recently acquired non-tobacco nicotine authority. This also applies to smaller manufacturers who don’t have large scientific staff or resources.
  6. Avoid rejections based on administrative or technical failings.  CTP has refused to accept certain otherwise robust applications because of technicalities. In these cases, reviewers should be authorized to pick up the phone and get those technicalities cured, rather than plunge the agency into protracted and wasteful litigation
  7. Establish defined testing methods.  This should be done for HPHC testing and while ensuring those methods are consistent with normal human use.
  8. Eliminate redundant and unnecessary testing.  For example, biomarker studies and inhalation studies are irrelevant when companies have presented data showing a dramatic reduction (or absence) of toxins.
  9. Use the full scope of its post-marketing order authority. In balancing the APPH, CTP should rely on post-market surveillance and post-market consumer studies to monitor its authorizations and suspend or withdraw a marketing order if it finds new evidence would so justify it.
  10. Equally fund research proposals.  FDA funded research is critical to the review process. To date, the agency has only funded research purporting to identify problems, i.e., youth initiation. CTP should equally fund research on smoking cessation.

CONCLUSION

In conclusion, today, CTP is stuck, trapped if you will, managing a monstrous rule of its own creation.  It needs direction from this Foundation to impose a transparent set of requirements and to ensure strict and fair adherence to science-based decisions.  As a final note, CTP needs to appreciate that the entire application approval process is being made virtually irrelevant due to the Agency’s inability to stop the flow of products into this country from companies ignoring the regulatory process. It is our hope that the Reagan-Udall Foundation’s review will ultimately create an “efficient, predictable, and transparent” process and, in so doing, make real the promise of less harmful nicotine products.

[1] Mission of R/U and mission of the FDA: “The Reagan-Udall Foundation for the Food and Drug Administration is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”

Vapor Association Challenges FDA’s Youth Vaping Analysis

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Vape Trade Group Warns That Latest FDA Action Risks Jeopardizing Agency Credibility and Harm Reduction Mission

WASHINGTON, October 7, 2022 (Newswire.com) – Following the Food and Drug Administration’s release of the National Youth Tobacco Survey, Vapor Technology Association Executive Director Tony Abboud released the following statement: 

“Yesterday, the FDA, in coordination with the CDC, released new data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth. 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. 

“The fact remains 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%, and the number of middle school students has plummeted by 70%. During that same time period, the number of high-school students who ‘frequently’ vape has dropped by 37% and the number of middle school students has dropped by 65%. 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. Simply removing products from the market is not the answer when those products are also proven to help adult smokers quit. 

“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 this. Since 2010, when e-cigarettes became widely available in the U.S., smoking rates have declined by more than half. 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. 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.”

ABOUT VTA
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.

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