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Tag: Laura Leigh Oyler

  • 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.”

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”

  • ATNF Panel Examines State-Level Policy Challenges for Harm Reduction

    ATNF Panel Examines State-Level Policy Challenges for Harm Reduction

    At the American Tobacco and Nicotine Forum (ATNF), a panel moderated by Beth Oliva, a partner at Fox Rothschild, brought together industry, policy, and regulatory experts to examine how state and local policymaking is shaping harm reduction. Panelists Dr. Jeff Willett from the Progressive Policy Institute, Sarah McQuillan from JTI Liggett, Andrew Nunes from PwC, and Laura Leigh Oyler from Haypp Group, repeatedly emphasized a core issue: a widespread lack of understanding among state lawmakers about federal tobacco regulation and the FDA’s role. Several speakers noted that policymakers are often making decisions without a clear grasp of existing frameworks, definitions, or scientific standards, contributing to fragmented and sometimes contradictory regulations.

    A major theme was the disconnect between data and policymaking. Panelists pointed to declining cigarette use alongside growth in alternative products, yet said state responses are often driven more by headlines than evidence. Willett highlighted progress in reducing youth vaping since 2019 and stressed the importance of fact-based policy, while others noted that tax increases, flavor bans, and regulatory gaps can unintentionally push consumers toward illicit markets or cross-border purchases. Nunes and Oyler both underscored how inconsistent tax structures and regulatory approaches across states are distorting markets and complicating compliance for manufacturers and retailers.

    The panel also focused heavily on the growth of illicit markets, with speakers linking it to unmet consumer demand and regulatory gaps. Oyler argued that the lack of authorized products has created a “vacuum” filled by unregulated alternatives, while Willett pointed to evidence that high taxes and restrictions are driving illicit sales in markets like New York. Broader inconsistencies—such as stricter rules for nicotine compared to cannabis or alcohol—were cited as further complicating enforcement and public perception. Panelists warned that states are increasingly reliant on tobacco tax revenue, which can influence policy decisions, and called for more coordinated, evidence-based approaches rather than a patchwork of state-by-state rules.

    Finally, the discussion turned to communication and public health messaging. Speakers argued that the current narrative around nicotine lacks nuance, with limited recognition of the continuum of risk or the role of reduced-risk products. Several panelists called for the FDA to take a more active role in educating both lawmakers and the public, while also stressing the need for better data to be incorporated into legislative debates. Without improved communication and alignment between federal science and state policy, the panel suggested that regulatory fragmentation and market distortions are likely to persist.

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  • Examining the U.S. Regulatory Landscape

    Examining the U.S. Regulatory Landscape

    At the Global Tobacco and Nicotine Forum (GTNF) in Brussels, industry leaders examined the shifting regulatory climate in the United States, where overlapping state and federal actions continue to shape — and complicate — the tobacco and nicotine marketplace. The session was moderated by Paige Magness, Senior Vice President of Regulatory Affairs at Altria Client Services, with insights from Beth Oliva, a partner at Fox Rothschild, Laura Leigh Oyler, the Vice President of Regulatory at Haypp Group, Valerie Briggs Solomon, the Vice President of Scientific and Public Health Affairs at Reynolds American, and Dr. Jessica Zdinak, the founder and Chief Research Officer at Applied Research and Analysis Company (ARAC).

    Magness opened the panel, noting that “a change was inevitable” with the new U.S. administration, citing an encouraging shift toward addressing illicit markets. She commended the Tobacco Control Act’s intention but said, “It’s FDA’s implementation where things fall apart.”

    Oyler highlighted the fragmented nature of the U.S. system: “Sometimes it’s hard to remember the U.S. isn’t one big monolith — it’s 50 states that can directly conflict with the federal government.” She stressed that effective youth prevention starts with adult behavior, adding, “The biggest predictor of youth use is whether their parents use. Help the kids by helping their parents make better decisions.”

    Oliva described a growing disconnect between FDA oversight and state-level actions, noting California’s comprehensive flavor ban. “The FDA is the barrier to entry, the states are barriers to the shelf,” she said. “Today they are combining in ways never meant to happen.” Oliva argued that the FDA’s shifting authorization process and policy reversals have destabilized the marketplace, pushing consumers toward illicit products. “Unless we see a lot more authorizations for nicotine products, we’re going to see what happened with e-cigarettes all over again,” she warned. She urged the FDA to “partner with those tracking the data” and to “stop manipulating the industry and consumers in the process.”

    Zdinak focused on the disconnect between regulation, consumer understanding, and behavioral science. “Congress is making laws without understanding the people they govern,” she said, pointing to misinformation about relative risk. She argued that variety and flavor choice drive switching and, therefore, public health gains. “If CTP can’t communicate quickly, the market will move ahead without them,” she cautioned, predicting “another wild west” scenario similar to what happened with the e-cigarette category.

    Solomon criticized the FDA’s tendency to exaggerate youth-use trends while ignoring adult harm reduction. “FDA is calling things an epidemic that aren’t,” she said. “Scaring children away might be good, but scaring adults away from better options is counterproductive.” She underscored the importance of credible communication through trusted messengers: “[The nicotine industry is] not always trusted, so we have to equip those who are. Science will lead the way — if we let it.”

    Overall, the panel agreed that while the U.S. has one of the world’s most comprehensive regulatory systems, its complexity and inconsistency risk stifling innovation and harming public health goals. The consensus was that greater collaboration, transparency, and scientific grounding are urgently needed to make the regulatory system work for both consumers and harm reduction.

  • Haypp Strengthens U.S. Leadership with Legal and Regulatory Hires

    Haypp Strengthens U.S. Leadership with Legal and Regulatory Hires

    Haypp Group, the parent company of nicotine pouch retailers Nicokick.com and Northerner.com , publicized the appointments of Issa Abuaita as head of legal (U.S.), and Laura Leigh Oyler as vice president of regulatory affairs (U.S.). The move from earlier this year bolsters the company’s regulatory leadership as it expands in the U.S. market.

    Abuaita has more than a decade of legal experience, including FDA compliance and product authorization, while Oyler has more than 15 years of tobacco regulation experience from firms like PMI and Juul Labs.

    “We’re not just growing—we’re setting the bar on what a responsible and compliant nicotine pouch retailer looks like in 2025,” said Markus Lindblad, global head of legal and external affairs at Haypp Group. “Issa brings legal discipline, operational sharpness and peerless ability to decode the complex regulatory terrain, while Laura Leigh is a powerhouse in regulatory strategy, external engagement and unmatched credibility as a voice in harm reduction. Together, they enhance our ability to grow responsibly while championing adult access to modern oral nicotine alternatives. Their leadership empowers us to engage regulators, consumers, and the broader public with transparency and integrity.”