TobaccoReporter logo

Tag: Taxpayers Protection Alliance

  • 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.”

  • COP11, Good Gop 2.0 Both Open in Geneva

    COP11, Good Gop 2.0 Both Open in Geneva

    The 11th Conference of the Parties (COP11) to the WHO Framework Convention on Tobacco Control (FCTC) began today (November 17) in Geneva, bringing together global health leaders and over 1,400 delegates from 183 countries for the week-long event. The conference “aims to strengthen international cooperation to combat tobacco use, rising nicotine addiction, and environmental harm caused by cigarette products.” Discussions are expected to revolve around familiar topics such as youth smoking, flavorings, and cigarette butt pollution. Delegates are also expected to address “aggressive marketing” of tobacco and nicotine products, youth vaping, and strategies to combat the illicit tobacco trade.

    Running parallel, and just steps away from COP11, is Good Cop 2.0, an event hosted by the Taxpayers Protection Alliance, designed to be a rapid-response and fact-checking forum to counter discussions from the WHO. “The event aims to unite taxpayer-, free-market-, and harm-reduction organizations to challenge misinformation and present alternative, evidence-based perspectives. It is intended to be an open forum for consumers, independent scientists, and journalists who are often excluded from WHO’s closed-door sessions.”

    Speaking on one of the Good Cop panels today, Clive Bates, a public health consultant and director of Counterfactual Consulting, summed up WHO critics’ frustration that stems from having decisions that will influence global tobacco control and public health policies for years to come being made in secrecy, behind closed doors, with virtually no input from consumers or industry.

    “There’s no harm and having discussions about the frontier ideas of tobacco control,” said Bates. “[But COP11 is] a really graphic illustration of the weakness of expert groups. The experts that have been chosen to come up with these figures are [basically] fringe fanatics in the tobacco control world. In any normal conversation with users or consumers, a lot of these ideas would seem mad.

    “That’s the danger of getting away from the working groups. The working groups of parties have to think about the politics of actually delivering this to the actual public, whereas the expert groups are fanatics pushing forward an agenda to the extremes of what they think they can get away with.”

  • “Good COP” to Parallel WHO’s COP11

    “Good COP” to Parallel WHO’s COP11

    The Taxpayers Protection Alliance (TPA) announced the launch of “Conference of the People (Good COP)” to be held November 19 in Geneva, parallel to the World Health Organization’s COP11. Good COP will be a “rapid-response and fact-checking forum” to counter discussions from the WHO’s Framework Convention on Tobacco Control.

    The event aims to unite taxpayer-, free-market-, and harm-reduction organizations to challenge misinformation and present alternative, evidence-based perspectives. It is intended to be an open forum for consumers, independent scientists, and journalists who are often excluded from WHO’s closed-door sessions.

    “Currently, there is no cohesive, organized message to balance the misinformation stemming from the WHO and institutions under the auspices of the FCTC,” the TPA said in a press release. “Each day of the conference, experts and consumers will gather to respond in real-time to COP proceedings and hear from sponsoring organizations who will set the agenda for their respective day.”

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) also announced today (October 27) that it will hold “Asia Day – The Good Cop 2.0,” in conjunction with the TPA event. “Asia Pacific cannot afford another decade of ‘quit or die’ policies,” said Clarisse Virgino, CAPHRA’s Philippines representative. “We’ve seen harm reduction save lives in HIV, alcohol, and drug policy — denying it for tobacco is both unscientific and unethical.”

    “Asia Day will not be about slogans or ideology — it’s about dialogue, data, and human rights,” said Nancy Loucas, CAPHRA’s Executive Coordinator.

  • FCTC Deserves Criticism, Not Celebration, Says TPA

    FCTC Deserves Criticism, Not Celebration, Says TPA

    As the World Health Organization (WHO) marks the 20th anniversary of its Framework Convention on Tobacco Control (FCTC), a panel hosted by the Taxpayers Protection Alliance (TPA) used the occasion to reflect on what they called decades of stagnation, missed opportunities, and dangerous resistance to innovation in the field of tobacco harm reduction.

    “The FCTC should have marked a turning point in global tobacco control,” said Clive Bates, former director of Action on Smoking and Health (UK). “Instead, the WHO remains entrenched in outdated, prohibition-style thinking. They actively oppose safer alternatives like vaping, heated tobacco products, and nicotine pouches—tools that are demonstrably helping people quit smoking.”

    Panelists argued that the WHO’s refusal to embrace harm-reduction approaches is not just short-sighted but scientifically indefensible. Many urged countries participating in the treaty to reconsider their blind alignment with WHO policy and instead focus on pragmatic, evidence-based strategies that prioritize public health outcomes.

    “Whether it’s COVID-19 or tobacco policy, the WHO has failed repeatedly,” Roger Bate, a global health policy expert at the International Center for Law and Economics said. “We need fundamental reform. If the organization cannot evolve to incorporate modern science and real-world solutions, then it risks becoming obsolete.”

    David Williams, president of TPA, echoed this sentiment, calling the WHO’s current approach “dangerous and irresponsible.” He cited the organization’s refusal to recognize smoke-free alternatives, even as mounting research shows their effectiveness in reducing harm. “E-cigarettes and nicotine pouches are saving lives,” Williams said. “These are tools funded by taxpayers, yet the WHO continues to reject them without sound justification. That’s not just bad policy—it’s negligence.”

    Williams also promoted TPA’s global campaign, Good COP/Bad COP, which launched during the 2024 FCTC COP10 meeting in Panama. A follow-up event is planned for 2025 in Geneva, aimed at holding the WHO accountable. “We’re building a coalition of doctors, consumers, and advocates who want the WHO to work for the people, not against them,” he said.

    Martin Cullip, international fellow at TPA’s Consumer Center, summed up the panel’s frustration. “The FCTC was a good idea that has gone terribly wrong. We’ve lost 20 years of potential progress because of rigid ideology.”

    The panel urged WHO leaders to abandon a dogmatic stance and embrace harm reduction as a key component of tobacco control moving forward. As Clive Bates concluded, “The WHO has become unethical, unaccountable, and ineffective. If they truly care about saving lives, they must stop ignoring the science. Harm reduction has to be part of the solution.”

  • Taxpayer Group Files Amicus Brief

    Taxpayer Group Files Amicus Brief

    Image: hafakot

    The Taxpayers Protection Alliance (TPA) submitted an amicus curiae brief to the U.S. Supreme Court in support of the Wages and White Lion Investments case, challenging the Food and Drug Administration’s regulation of e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA). The TPA argues that the FDA’s actions have been arbitrary, capricious and detrimental to public health.

    The brief contends that the TCA’s standard for determining what is “appropriate for the protection of the public health” is unconstitutionally vague, providing insufficient guidance to regulated entities and delegating excessive authority to the FDA. This vagueness has led to unpredictable enforcement, adversely affecting both taxpayers and adults who smoke and are seeking safer alternatives to conventional cigarettes.

    Furthermore, the TPA criticizes the FDA for failing to recognize the significant benefits of e-cigarettes as a smoking cessation tool, as acknowledged by leading health organizations such as Public Health England. According to the TPA, the TCA is clear on the need for the FDA to consider the impact of e-cigarettes on smoking cessation, yet the agency has abjectly failed to undertake this analysis. The TPA highlights the FDA’s stringent regulatory approach and high denial rates for new e-cigarette products, which the group says stifle market diversity and limit consumer choice, particularly harming adults who smoke and who might benefit from less harmful alternatives.

    The TPA also notes the FDA’s disregard for market realities and consumer preferences, particularly the benefits of open-system e-cigarettes that allow for customization and have been shown to be more effective for quitting smoking.

    The TPA urges the Supreme Court to uphold the 5th Circuit’s decision, affirming that the FDA’s regulatory approach under the TCA is arbitrary and capricious and violates due process. The TPA calls for a regulatory framework that adequately considers the benefits of e-cigarettes and gives regulated parties fair notice of how their products will be evaluated.

  • Taxpayers Group Holds ‘Counter COP’

    Taxpayers Group Holds ‘Counter COP’

    Photo: TPA

    Concurrent with the 10the Conference of the Parties (COP10) to the World Health Organization Framework Convention on Tobacco Control (FCTC), which takes place in Panama City this week, the Taxpayers Protection Alliance (TPA) is hosting an event at the Central Hotel Panama under the name “Good Cop/Bad Cop.” The event will be livestreamed on TPA’s YouTube channel.

    Good COP will feature nearly two dozen tobacco harm reduction experts, representing 14 different countries and highlighting some of the leading experts on consumer issues, national and global policies, and the science surrounding harm reduction.

    Throughout the event, TPA and the Good COP participants will be monitoring the WHO’s meeting and providing running commentary via livestreams, media interviews, blogs, and social media.

    “The taxpayer-funded WHO ignores science and puts billions of smokers at risk of not having access to life-saving technology to quit smoking,” said TPA’s President, David William in a statement.

    “The participants of Good COP will hold the WHO accountable for denying life-saving access to tobacco harm reduction products and denying access to the public and media to these meetings. “In real time, harm reduction experts from around the globe will be fact-checking and providing commentary on the WHO’s anti-science agenda at COP10.”