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Tag: Vapor Technology Association

  • Makary Resigns, Diamantas New Interim FDA Head 

    Makary Resigns, Diamantas New Interim FDA Head 

    Today (May 12), President Donald Trump confirmed earlier reports from White House officials that FDA Commissioner Dr. Marty Makary was stepping down after just over a year in the role, following a turbulent tenure that included growing friction over tobacco and nicotine policy. A White House official said the resignation was tied to “process at the FDA” rather than a single issue, though pressure had been building around the agency’s pace on key decisions, including flavored vape authorizations. Reports in recent weeks indicated frustration within the administration that the FDA had moved too slowly on advancing nicotine-related priorities, with one official bluntly stating: “What a mess Makary turned out to be.” He will be replaced on an interim basis by FDA food chief Kyle Diamantas.

    Makary’s leadership coincided with heightened scrutiny over the FDA’s handling of next-generation nicotine products, particularly flavored vapes, which have remained largely blocked pending extensive scientific review. The issue became a flashpoint within the administration, with critics arguing the agency had failed to align with broader policy goals aimed at expanding alternatives for adult smokers. At the same time, the FDA maintained its stance on requiring strong evidence of public health benefit, leaving the market tightly restricted and contributing to ongoing tension between regulators, industry stakeholders, and policymakers.

    His tenure was also shaped by broader political battles that indirectly impacted tobacco regulation, including disputes over drug approvals and internal agency direction, which critics said created uncertainty around regulatory timelines. For the tobacco and nicotine sector, Makary’s departure could signal a potential shift in FDA priorities, particularly as pressure mounts to accelerate decisions on reduced-risk products and flavored alternatives. The leadership change comes at a critical moment for the industry, with regulatory direction expected to play a central role in shaping market dynamics and product innovation in the years ahead.

    Since the news broke, interested observers have been responding in what is generally seen as a positive for the industry.

    “We have been disappointed by the pace of nicotine product reviews at the Center for Tobacco Products,” said Laura Leigh Oyler, VP of Regulatory Affairs at Nicokick.com. “If recent reporting is accurate, Commissioner Makary’s removal should be treated as an opportunity to refocus the FDA on timely, evidence-based decision-making. Adult consumers, responsible manufacturers, and retailers need a regulatory process that produces decisions, not indefinite uncertainty.

    “CTP already has the scientific expertise needed to evaluate nicotine product applications and make appropriate determinations under the law. The next FDA commissioner should remove unnecessary bottlenecks and make clear that pending reviews will be decided by FDA scientists, not politicians.”

    Vapor Technology Association Executive Director Tony Abboud said he met with Makary last week and felt the Commissioner realized the PMTA process needed to improve quickly.

    “The VTA now looks forward to continuing its constructive engagement with Acting FDA Commissioner Kyle Diamantas and whoever is ultimately selected to permanently lead the agency moving forward,” Abboud said. “For years, VTA has advocated for a regulatory framework that provides clear scientific requirements, transparent standards, and consistent enforcement against bad actors and illicit products.

    “We remain committed to working with FDA leadership, the Administration, and policymakers to modernize the PMTA process, strengthen responsible marketing standards, and ensure the United States leads with a balanced regulatory approach grounded in science, harm reduction, and common sense.”

    One of the bluntest responses came from Ross Marchand, Executive Director of the Taxpayers Protection Alliance, who said, “At long last, Makary is out. Since taking the helm of the agency last April, the Commissioner has made it far more difficult than it needs to be to bring new therapies to market. Millions of Americans have paid the price for this soap opera of suddenly spurned approvals, goalpost shifting, and even apparent violations of trade secret law.

    “The FDA needs a leader who will stand up for patients and allow access to new and innovative therapies. Makary’s successor must embrace market innovation and break with the prohibitionary policies of the past.”

  • ITC Rules ‘No Violation’ in RJR Complaint

    ITC Rules ‘No Violation’ in RJR Complaint

    The U.S. International Trade Commission issued a final determination in its investigation into certain disposable vaporizer devices, ruling that there was no violation of Section 337 in the case brought by R.J. Reynolds Tobacco Company, which targeted brands like Elf Bar and Geek Bar. This followed an earlier denial of a temporary exclusion order due to a lack of evidence regarding the likelihood of success on the merits.

    R.J. Reynolds began pivoting its legal strategy with a new investigation instituted by the USITC on March 3, which shifts focus to alleged violations of the PACT Act, state flavor bans, and tax laws by Chinese manufacturers and U.S. distributors. While the previous patent-based case is closed, the commission has begun its review of these new, broader regulatory and competition-based allegations.

    Following the ruling, the Vapor Technology Association’s executive director, Tony Abboud, issued a statement, saying, “The ITC’s decision represents a positive path forward for our industry. It proves that, unlike the misguided FDA, some federal agencies are still willing to stand up to corporate interests for the good of our free market and American public health. The ITC’s decision, rejecting all of the claims, is a decisive blow against those seeking to use government agencies to corner a market and a huge step for President Trump’s America First agenda. 

    “We appreciate the ITC referencing our submission in its final decision and take this inclusion as a sign that the ITC seriously listened to the concerns of the massive American independent vaping industry.” 

  • VTA ‘Disappointed’ by Lack of Progress from FDA Roundtable

    VTA ‘Disappointed’ by Lack of Progress from FDA Roundtable

    The Vapor Technology Association said it welcomed the chance to participate in a recent roundtable hosted by the U.S. Food and Drug Administration focused on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS), calling the meeting an opportunity for small businesses to engage directly with regulators. In a statement, VTA Executive Director Tony Abboud said industry representatives advocated for a more transparent, standards-based regulatory framework that would allow companies to invest in vapor technology and navigate product reviews with clearer scientific expectations.

    Abboud said VTA was encouraged by comments from FDA Commissioner Marty Makary acknowledging the need for predictability in regulatory standards but expressed frustration that some agency officials supported maintaining flexible or undefined scientific benchmarks.

    “Small businesses made it completely clear that they wanted and needed transparent and objective scientific standards governing how vape products should be made and how they should perform,” Abboud said. “Unfortunately, we were disappointed by so many FDA representatives throughout the meeting who either argued for continued scientific ambiguity or completely rejected standards. Their comments signaled a lack of alignment among FDA leadership on providing clear and predictable scientific standards or guidance for our industry – or even benchmarks that would ensure product and consumer safety. We received no guarantee of additional clarity on the broken and opaque PMTA rule and process, which has been used to prevent access to the products that Americans who smoke want and need to quit smoking deadly cigarettes.” 

    The association argued that clearer regulatory guidance would align with broader free-market principles supported by Donald Trump’s policy agenda.

  • VTA Celebrates Impact of U.S. Vaper Voters

    VTA Celebrates Impact of U.S. Vaper Voters

    The Vapor Technology Association (VTA) celebrated the political currency and success of vaper voters in critical 2024 battleground election states and districts during the recent U.S. elections. According to the trade group, vaper voters helped secure electoral victories for Conservative candidates up and down the ballot.

    VTA says its “I Vape I Vote” campaign activated over 360,000 low-propensity voters to support Conservative principles and candidates, including President-elect Donald Trump, in key battleground states and districts in Arizona, Michigan, Nevada, Ohio, Pennsylvania, Virginia and Wisconsin. 

    “Vaper voters showed up in droves to support Conservative candidates who will protect and preserve the rights of Americans to use flavored vaping products,” said VTA Executive Director Tony Abboud.

    “VTA’s I Vape I Vote campaign made clear that vaper voters had their voices heard at the ballot box and ensured that Conservative candidates would deliver full-throated endorsements of Americans’ right to use flavored vapes and, critically, use that support to establish a voter currency which propelled several Conservative candidates into office.

    “While we are proud to have engaged in the process with several of these Conservative candidates, we are now ready to see their campaign promises committed to action as they work with President-elect Trump and the relevant federal agencies to fix the broken regulatory process by implementing a streamlined regulatory process that ensures access to flavored vapes is protected and companies and distributors have transparent, rational and affordable rules of the road when it comes to this regulatory framework.”

  • Mixed Feelings at PMTA Anniversary

    Mixed Feelings at PMTA Anniversary

    Photo: stokkete

    Representatives of the U.S. vapor industry expressed mixed feelings at the four-year anniversary of the filing of the first premarket tobacco product applications (PMTAs).

    Since the Sept. 9, 2020, deadline, the Food and Drug Administration’s Center for Tobacco Products (CTP) has received applications for 26 million novel tobacco products, mostly electronic cigarettes or e-cigarettes.

    However, despite its acknowledgement that e-cigarettes overall are less harmful and less toxic than combustible cigarettes, the agency has rejected more than 99 percent of PMTAs for these products.

    At the same time, the FDA has authorized 6,670 new combustible tobacco products to be sold in the U.S., including 3,232 new cigars, 1,291 new pipe tobacco products,1,073 new hookah tobacco products and 973 new cigarettes.

    According to the Vapor Technology Association (VTA), current CTP Director Brian King has authorized only four vaping devices for as alternatives to cigarettes, compared with 1,270 combustible products.

    Director King has justified his refusal to authorize flavored e-cigarettes that are widely used by American adults with the need to protect youth. Yet the most recent National Youth Tobacco Survey revealed that the youth vaping rate—the share of users who say they’ve used an e-cigarettes at least once in the past 30 days—has declined to 5.9 percent, the lowest level in more than a decade.

    “Since Sep. 9, 2020, 1.93 million Americans have died from smoking cigarettes (480,000 each year), and approximately 64 million Americans suffered from smoking-related disease (16 million each year), according to the CDC, at a cost of hundreds of billions of dollars to the U.S. health care system and gross domestic product,” the VTA wrote in a statement.

    “In this time, the FDA has only allowed the purveyors of these deadly combustible products to strengthen their grip on the market. Meanwhile, more and more Americans die from smoking, making this anything but a happy anniversary.”

  • Vapor Industry Cheers Pot Reclassification

    Vapor Industry Cheers Pot Reclassification

    Photo: Africa Studio

    Representatives of the U.S. vapor industry have welcomed a decision by the Biden Administration to reclassify marijuana.

    “The decision clearly underscores this administration’s commitment to listening to constituents and demonstrates a willingness to recognize and accept real-world, category-wide scientific evidence, said Tony Abboud, executive director of the Vapor Technology Association (VTA) in an e-mailed statement.

    “In light of today’s decision, VTA is encouraging other agencies within the Biden Administration, specifically, the U.S. Food and Drug Administration, to follow the similarly overwhelming body of evidence on the use of vaping products as effective harm reduction and smoking cessation tools for adult smokers.

    “In just the past year, FDA’s selective pattern of prioritizing politics over science has led to the approval of more than 650 new cigarettes. VTA reiterates its call for the FDA to follow suit with other agencies in the Administration to stop turning a blind eye to the overwhelming body of science proving the benefits of flavored nicotine options to Americans looking to quit smoking.”

  • VTA Stands up for Lower-Risk Alternatives

    VTA Stands up for Lower-Risk Alternatives

    The Vapor Technology Association (VTA) today announced the launch of a cable news ad buy in the U.S. targeting Senator Chuck Schumer and his proposed ban on Zyn nicotine pouches. The ad runs this week on FOX News and FOX Business during key programming slots, including “FOX and Friends,” “Kudlow,” and “The Five.”

    The ad connects a proposed ban on e-cigarettes with a ban on all less harmful, tobacco-free nicotine products, such as Zyn nicotine pouches. The ad also calls out officials at the Food and Drug Administration’s Center for Tobacco Products (CTP) for repeatedly blocking access for millions of Americans to e-cigarettes as harm reduction tools.

    “Sen. Schumer and the FDA are simply wrong: wrong on e-cigarettes, wrong on Zyn, and wrong on the science,” said Tony Abboud, executive director of VTA, in a statement. “Rather than give adult smokers broader access to a greater number of lower-risk alternatives, the FDA and CTP have instead imposed a de facto ban on e-cigarettes—and Zyn is next.”

    The ad states that Schumer’s proposed Zyn ban mimics his attempts to eliminate e-cigarette use nationwide, amounting to an assault on Americans’ personal freedom to choose lower-risk, tobacco-free nicotine products that overwhelming scientific and medical data demonstrates are effective at helping adults quit smoking.

     “Why is the FDA denying access to a wide range of less harmful alternatives to combustible cigarettes that could otherwise be used by millions of adult smokers trying to quit?” asked Abboud.

    “Cigarettes kill. Rather than even acknowledging the settled science in support of e-cigarettes and other less harmful, tobacco-free nicotine products in recent years, the CTP has instead authorized nearly 900 new cigarettes for Americans’ use—but Sen. Schumer thinks it’s Zyn you need to be worried about.

    “The anti-nicotine FDA and congressional establishment has simply lost its bearings on the strategy of harm reduction, which it applies to every public health crisis, yet refuses to apply to the annual crisis of nearly half a million Americans dying from smoking every single year.”

     “VTA is running this ad buy because Americans deserve to know that less harmful nicotine products exist that can help adult smokers trying to quit. VTA supports Americans’ freedom to choose,” said Abboud.

  • Activists Protests ‘Misguided’ Zyn Probe

    Activists Protests ‘Misguided’ Zyn Probe

    Photo: Swedish Match

    U.S. Senate Majority Leader Chuck Schumer’s call on the U.S. Food and Drug Administration and Federal Trade Commission to investigate the marketing practices and health effects of Philip Morris International’s Zyn nicotine pouch brand provoked a backlash among advocates of tobacco harm reduction.

    “The American people have seen this movie before with less harmful e-cigarettes,” said Tony Abboud, executive director of the Vapor Technology Association (VTA).

    “Congressional leaders yell at unelected bureaucrats at the FDA who scurry to remove products from the market that offend their sensibilities—even though those products are less harmful than traditional cigarettes, and have been proven to help people quit smoking deadly cigarettes altogether.

    “These misguided actions deprive American adults of less harmful, non-combustible, and non-tobacco nicotine products that are a proven alternative to combustible cigarettes and that the largest clinical trial in the U.S. has found to cause them to quit smoking even if they have no intention to quit cigarettes.

    “There is already a de-facto ban on e-cigarettes. Sen. Schumer simply wants this ban extended to other products he and the Washington establishment deem undesirable.

    “As with e-cigarettes, Sen. Schumer falsely asserted that Zyn products are popular with younger users. Yet, the National Youth Tobacco Survey data demonstrates that only 1.5 percent of youth have even tried nicotine pouches. When will the federal government stop hiding behind an excuse that has been disproven by their own data? 

    “VTA stands with Zyn, and the makers of modern oral nicotine pouches, in the fight against arbitrary and capricious government action. Because cigarettes remain the No. 1 cause of preventable death and disease in the U.S., VTA insists on broad access to a wide variety of non-combustible products to preserve freedom of choice for adults who want to use nicotine – and to provide access to proven harm-reduction and smoking-cessation options essential for saving American lives.”

    Earlier, Schumer’s call for an investigation prompted PMI to publish a video clarifying its marketing practices.

  • VTA: MDOs Continue ‘De-Facto’ Flavor Ban

    VTA: MDOs Continue ‘De-Facto’ Flavor Ban

    Tony Abboud
    Tony Abboud, director of the Vapor Technology Association.

    When the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued marketing denial orders (MDOs) for Suorin and Blu PLUS+ e-cigarette products, Tony Abboud, executive director of the Vapor Technology Association (VTA), said the decision was just the latest installment of the FDA and CTP’s efforts to implement its de-facto ban on e-cigarettes in the U.S.

    “The constant refrain from CTP is that e-cigarette manufacturers are not providing ‘sufficient scientific evidence’ in their PMTAs, yet CTP refused to answer the Reagan-Udall Foundation’s most fundamental criticism of CTP’s entire regulatory process: that CTP has not clearly articulated what is required to prove what is appropriate for the protection of the public health (APPH) or how it is interpreting what is APPH,” Abboud stated in a release.

    He stated that the FDA has failed to objectively define the APPH standard while simultaneously using it to deny marketing authorization to critical smoking cessation and harm-reduction products, which is a “gross overreach” for any governmental institution whose mandate is to follow the science.

    “Courts have found that the process has become ‘arbitrary and capricious’ in practice, with CTP leadership choosing on a case-by-case basis how the standard ought to be defined,” he stated. “Meanwhile, companies are simply trying to do the right thing by complying with and adhering to the PMTA process set forth by the FDA.”

    Abboud stated that the actions of the FDA and CTP do nothing to protect public health or help Americans who smoke. “VTA once again calls on CTP to reverse course on its misguided actions and restore scientific integrity to its regulatory and decision-making process. Enough is enough,” he wrote.

  • New Global Vape Alliance Announced

    New Global Vape Alliance Announced

    Photo IEVA

    A new Global Vape Alliance has been announced at the InterTabac Trade Fair in Dortmund, Germany, alongside a declaration to foster collaboration, promote responsible practices and champion the cause of harm reduction in the vaping industry.

    The Global Vape Alliance brings together major international vaping bodies including the Electronic Cigarette Industry Committee of the China Electronics Chamber of Commerce (ECCC), the U.S. Vapor Technology Association (VTA), the U.K. Vaping Industry Association (UKVIA) and the Independent European Vape Alliance (IEVA).

    The declaration aims to underscore the power of unity within the vaping industry. By coming together under its umbrella, industry leaders will commit to effecting responsible and positive change on a global scale, thereby signifying a new era in the industry’s dedication to public health, environmental sustainability and the well-being of smokers seeking alternatives to traditional tobacco products.

    Key highlights of the Global Vape Alliance declaration include:

    • Regulatory Compliance: The alliance will facilitate the sharing of best practices to ensure member companies adhere to existing laws, regulations and industry standards, with a strong focus on responsible marketing and protecting youth.
    • Industry Promotion: The alliance aims to elevate the vaping industry’s professionalism, importance and sustainability by fostering communication among industry stakeholders and encouraging technological innovation.
    • Public Health: Emphasizing harm reduction, the alliance will actively promote the adoption of vaping products among conventional smokers to reduce harm, while openly providing information about their impact on physical health.
    • Environment Protection: In pursuit of a greener future, the alliance will advocate for eco-friendly strategies, promote recycling, low-carbon design and urge compliance with environmental laws.

    Our goal is clear—to make a significant impact on public health, support those looking to quit smoking and contribute to a sustainable, environmentally friendly future.

    Dustin Dahlmann, president, IEVA

    The Global Vape Alliance firmly believes that unity and cooperation within the vaping industry can lead to a world without smoking.

    “Our goal is clear—to make a significant impact on public health, support those looking to quit smoking and contribute to a sustainable, environmentally friendly future. With this declaration, we are combining the international forces of the industry to achieve important goals for the benefit of consumers,” said Dustin Dahlmann, president of the IEVA.

    “The signing of the declaration, as I believe, will guide the global vaping industry to the future of healthy development and prosperity. In this regard, ECCC will continue to deepen the cooperation with other partners,” said ECCC Secretary-General Will Ao.

    “The vaping sector is entering a critical chapter in its history with increased scrutiny from policy makers, regulators, public health officials, academics and campaigners,” said John Dunne, director general of the UKVIA. “It has to stand up and be counted, show strong leadership and the greatest levels of responsibility. The launch of the Global Vape Alliance and the declaration sets out to show the world that we are committed to best standards, practices and above all making smoking history.”

    “Despite the enormous body of science that has declared vaping nicotine dramatically safer than smoking, the vapor industry’s detractors around the globe push a dramatically misinformed narrative,” said Tony Abboud, executive director of the VTA. “Declaring a shared commitment to furthering sound science, truthful information, and a commitment to meaningful regulations, industry leaders around the world can better serve companies and, more importantly, millions of consumers using vaping products to reduce and/or quit smoking cigarettes.”

    For more information about the Global Vape Alliance declaration, please visit the Global Vaping Alliance website.