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  • Don’t Gamble Your PMTA: Bet on Your Quality System

    Don’t Gamble Your PMTA: Bet on Your Quality System

    By: Gabriel Muñiz

    The recent leadership changes and staffing reductions at the FDA’s Center for Tobacco Products (CTP) have created a moment of uncertainty, but also opportunity, for the tobacco and nicotine industry. With shifting priorities and new leadership on the horizon, some manufacturers see a chance to reset the regulatory conversation. While some companies are using this moment to tighten up operations and reinforce compliance in order to have a better chance at a favorable premarket tobacco product application (PMTA) outcome, others are taking a gamble, scaling back on quality systems and asking themselves, “Do we really have to keep doing all of this?”

    The question often centers around the expectations outlined in 21 CFR Part 1114 and the commitments companies made in their PMTAs. In a push to save costs, some manufacturers are reportedly reducing quality oversight, cutting corners in documentation, and stepping away from key controls they originally described in their PMTAs. The rationale? If enforcement is slowing down, maybe the FDA won’t notice or maybe it won’t matter.

    That’s a risky assumption.

    A PMTA is more than a regulatory formality. It’s a company’s game plan. A commitment to how the product will be manufactured, tested, controlled, and distributed. If your application included a robust quality management system (QMS), specific product testing protocols, or detailed supplier qualification processes, you’re expected to follow through. Along with the science, those commitments were the basis on which the FDA evaluated whether your product was “appropriate for the protection of public health.”

    Under Section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has the authority to withdraw or suspend a marketing granted order (MGO) if it determines that a tobacco product is no longer “appropriate for the protection of public health,” the standard upon which PMTAs are evaluated and approved. If an inspection or oversight activity reveals that a company has significantly deviated from the manufacturing methods, testing protocols, or quality systems described in its PMTA, the FDA may conclude that the product no longer meets the criteria for market authorization. While there hasn’t yet been a public case of an MGO being rescinded solely for failure to follow internal PMTA commitments, the legal basis for such action is clear. An MGO is conditional—it depends on a company continuing to manufacture its product as promised. Deviating from that blueprint introduces real regulatory risk.

    While some in the industry viewed the Fifth Circuit’s ruling in Bidi Vapor v. FDA as a signal that the tide was turning in manufacturers’ favor, the outcome in FDA v. Wages and White Lion Investments LLC made it clear: Companies are still expected to meet regulatory requirements and support their products with quality data and compliance. The courts may question FDA procedures, but they won’t eliminate the work required to maintain market authorization.

    Even in a more industry-friendly political environment, the responsibility to protect public health isn’t going away. The current administration may support regulatory efficiency and streamlined processes, but not at the expense of consumer safety. Companies that ignore or scale back their quality systems risk finding themselves unprepared when FDA inspections or compliance reviews resume in full force.

    Now is the time for manufacturers to take stock of their internal systems and ensure alignment with their PMTAs. This includes verifying that quality controls, personnel training, document management, complaint handling, and supplier oversight are functioning as described. A comprehensive, well-maintained QMS doesn’t just satisfy regulatory requirements; it builds trust and stability, especially in a time of change.

    This transition at CTP represents a golden opportunity, but only if companies take the right approach. Cutting corners today to save money may end up costing you far more if it puts your MGO at risk. Regulatory clarity, product stability, and long-term market access depend on more than a favorable headline—they depend on daily operational integrity.

    The FDA may be shifting, but its core mandate remains. This is the moment for responsible manufacturers to lead by example, double down on quality, and show that this industry can thrive without sacrificing quality or consumer trust. For those willing to roll the dice, just remember, being the first company to lose an MGO over PMTA noncompliance isn’t the kind of milestone you want your brand remembered for.

    Gabriel Muñiz, an independent consultant with EAS Consulting Group, is a regulatory compliance expert with extensive experience in the tobacco industry. Muñiz’s tenure at the FDA, particularly as a director within the Office of Regulatory Affairs (ORA), involved leading compliance and enforcement activities for the agency’s tobacco program. His work in building the tobacco operations program and shaping tobacco regulatory policy was instrumental in the development of key compliance strategies and regulatory frameworks, including the proposed tobacco product manufacturing practices. After his FDA career, Muñiz further honed his skills at Juul Labs, where he played a key role in developing premarket tobacco product applications and ensuring alignment with evolving federal regulations. His deep expertise in tobacco regulation will be invaluable to EAS’ clients seeking strategic compliance advice and navigating tobacco-related regulatory challenges.

    About EAS Consulting Group

    EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by the FDA, USDA, and other federal and state agencies. As part of Certified Group, EAS Consulting Group delivers expert regulatory solutions our customers can feel confident in—so the world can trust in what it consumes. Our network of over 200 independent consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.

  • FDA Completes AI-Assisted Review Pilot, Ready for Agency-Wide Rollout

    FDA Completes AI-Assisted Review Pilot, Ready for Agency-Wide Rollout

    FDA Commissioner Dr. Martin A. Makary today (May 8) announced an aggressive timeline to scale the use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.

    “I was blown away by the success of our first AI-assisted scientific review pilot,” Makary said. “We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”

    The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.

    “This is a game-changer technology that has enabled me to perform scientific review tasks in minutes that used to take three days,” said Jinzhong (Jin) Liu, Deputy Director, Office of Drug Evaluation Sciences, Office of New Drugs in FDA’s Center for Drug Evaluation and Research (CDER).

    To reflect the urgency of this effort, Makary directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality, and adapt to the evolving needs of each center after June 30. By that date, all centers will be operating on a common, secure generative AI system integrated with FDA’s internal data platforms.

    “There have been years of talk about AI capabilities in frameworks, conferences, and panels, but we cannot afford to keep talking,” Makary said. “It is time to take action. The opportunity to reduce tasks that once took days to just minutes is too important to delay.”

    Looking ahead, the FDA plans to expand generative AI capabilities across all centers using a secure, unified platform. Future enhancements will focus on improving usability, expanding document integration, and tailoring outputs to center-specific needs, while maintaining strict information security and compliance with FDA policy.

    The agency-wide rollout is being coordinated by Jeremy Walsh, the FDA’s newly appointed Chief AI Officer and Sridhar Mantha. Walsh previously led enterprise-scale technology deployments across federal health and intelligence agencies and Mantha recently led the Office of Business Informatics in CDER.

    The agency will continue to assess performance, gather user feedback, and refine features to support the evolving needs of FDA staff and advance its public health mission. Additional details and updates on the initiative will be shared publicly in June.

  • Brian King Joins Campaign for Tobacco-Free Kids

    Brian King Joins Campaign for Tobacco-Free Kids

    Yesterday (May 1), the Campaign for Tobacco-Free Kids today named Brian King as Executive Vice President for U.S. Programs to lead the organization’s work at the federal, state and local levels. Last month King was forced out of his role as the director of the U.S. Food & Drug Administration’s (FDA) Center for Tobacco Products (CTP).

    “Brian King is extraordinarily qualified to lead our U.S. programs at this critical time.,” said Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids. “Brian has dedicated his career to advancing science-based policies and programs that reduce tobacco use and its devastating consequences. His leadership, passion and breadth of knowledge and experience will guide us in the next phase of our work to protect children and end the death and disease caused by tobacco.”

    Under King’s leadership, the CTP was besieged by criticism from all sides, including politicians, anti-smoking advocates, and tobacco and vaping companies, as the FDA rejected applications for millions of flavored e-cigarettes, citing insufficient data that the products would help adult smokers while not becoming popular with underage kids. Those rejections resulted in multiple lawsuits against the FDA from vape makers.

    Prior to joining FDA, King served as the Deputy Director for Research Translation in CDC’s Office on Smoking and Health and as Executive Editor of CDC’s Morbidity & Mortality Weekly Report. He holds a doctorate and M.P.H. in Epidemiology from the State University of New York at Buffalo.

  • Opinion: Hopes for Transforming the FDA

    Opinion: Hopes for Transforming the FDA

    Writing for the Tax Foundation, Adam Hoffer published “Opportunities to Reform the Food and Drug Administration’s Center for Tobacco Products,” where he discussed the lingering challenges plaguing the CTP and suggested a pathway forward.

    “The CTP has come under heavy criticism in recent years, which we have covered extensively due to the surge in illicit market activity and the resulting challenges of implementing tax policy on alternative tobacco products (ATPs),” Hoffer wrote. “In 2022, the FDA requested the Reagan Udall Foundation conduct an independent investigation of the CTP. The resulting report highlighted several shortcomings, including a lack of a clear regulatory and product approval framework, an inefficient and slow product review process, a lack of transparency and communication, and broad struggles with the vaping market. We have identified four broad categories for CTP reform with direct policy actions to achieve each goal.”

    The suggestions were:

    1. Enhance Transparency and Accountability

    • CTP Should Publish a Rubric that Includes Requirements for Product Approval

    2. Streamline the Premarket Tobacco Product Application (PMTA) Process

    • CTP Should Create a Fast-Track PMTA Approval Pathway for Reduced-Risk Products
    • Default Marketing Authorization Approval Should Occur After 180 Days

    3. Fix the US Vaping Market

    • CTP Should Authorize More Legal Vaping Products
    • CTP Should Strengthen Enforcement Against Illegal Products

    4. Address Blind Spots – The Teen Vaping Crisis That Isn’t

    Dr. Adam Hoffer is the director of excise tax policy at the Tax Foundation. He earned his doctorate in economics from West Virginia University and his undergraduate degree from Washington & Jefferson College.

  • FDA Whistleblower Dishes on Agency’s Shortfalls

    FDA Whistleblower Dishes on Agency’s Shortfalls

    David Oliveira, who recently left the FDA after six years as a senior staffer, is speaking out about problems at the agency under the Biden administration, including tobacco control, diversity, equity and inclusion, and failures to combat China flooding the U.S. market with illicit vapes after the FDA’s top tobacco official was removed from his position. 

    “Many of us had been anticipating it for quite some time. We knew that change was drastically needed at FDA when it came to Tobacco Control,” Oliveira said in an interview with Fox News Digital. “Because Tobacco Control had really gotten out of control, there were many, many failures in core missions for the center that needed dramatic change and new leadership.

    “Many of us, whether it be from public health, consumers, small business owners, industry, and including even Senator Dick Durbin, who last year at a hearing said to Brian King, ‘It looks to me that you have fallen down on the job.’ So really, it runs the spectrum of people who are unhappy with what’s gone on recently with FDA in terms of tobacco regulation.

    “I frequently would attend shows and visit vape shops, and I was somewhat a canary in a coalmine, and would report back as to what I was seeing, and I would warn them that what I was seeing on the ground was out of control. We had a lot of people in the building who would go online and try to do some surveillance, but when you get out into the real world and you see the number of vape shops that are flooded with these illicit products, and I started to warn them about the amount of nicotine that was in these devices. We went from a Juul device, which had around 200 puffs, which was the equivalent of one pack of cigarettes, then I started seeing 5,000 puffs. I brought that warning back to the center, and then the following year would see 10,000 puffs. Now on the market, you can see 40,000 and 50,000 puffs. This is what the Chinese have done. They have not sought to get products authorized. They will introduce the latest and greatest technology. I saw a Santa one that was red and white. They’ll introduce flavors like Gummy Bear, Blow Pop, and Fruit Rollups, and these things that are absolutely youth-appealing because they do not care.” 

    View the 15-minute interview here.

  • USN&WR Runs Down Last Week’s Federal Cuts

    USN&WR Runs Down Last Week’s Federal Cuts

    Today, U.S. News and World Report is running down the major anti-smoking efforts that have been shut down or paused by the U.S. government, most notably the CDC’s popular “Tips From Former Smokers” ad campaign. The program, which began in 2012, features real people who suffered health damage from smoking.

    “We estimate the Tips campaign generated nearly 2.1 million additional calls to 1-800-QUIT-NOW during 2012-2023,” researchers wrote. The CDC’s Office on Smoking and Health, which led work on smoking cessation and research into youth tobacco use, was also cut. Now, with the CDC’s tobacco office staff cut, the campaign may go off the air, a former employee said.

    Former CDC Director Dr. Tom Frieden, now president of the global health organization Resolve to Save Lives, called the decision a “gift to Big Tobacco.” He told NBC News that, “the only winner here is the tobacco industry and cancer cells.”

    Last week, the Department of Health and Human Services (HHS) made major cuts to tobacco control offices at the U.S. Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA). Dozens of workers were let go, including Brian King, the FDA’s top tobacco regulator.

    In 2023, the CDC gave more than $84 million to state health departments to run quitlines and help smokers quit. Thirteen states may lose at least 30% of their funding, and five states — Connecticut, New Jersey, Tennessee, Virginia and West Virginia — rely on the CDC for at least 75% of their quitline support, NBC News said.

    Other losses include research projects on tobacco use and the National Youth Tobacco Survey, which tracks smoking and vaping trends among teens. This survey first identified a spike in youth vaping in 2018.

    Kevin Caron, another fired CDC employee, helped trace the deadly 2019 vaping outbreak to vitamin E acetate in fake THC vapes. He said at least five major research projects may end “unless people just independently decide in their free time that they’re going to try to work on them.”

    Despite the cuts, HHS spokesperson Andrew Nixon said tobacco efforts would continue and that the move was part of a larger plan to “streamline operations, enhance responsiveness to the American people, and ultimately improve the nation’s health as part of the Make America Healthy Again initiative.”

  • Bidi Opens Latest Appeal Against FDA

    Bidi Opens Latest Appeal Against FDA

    Yesterday (April 2), Bidi Vapor LLC urged the Eleventh Circuit to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully. In oral arguments in Miami, attorney Eric Gotting told an appellate panel that the FDA’s decision was “arbitrary and capricious and unlawful,” and that the agency admitted adult smokers would likely switch to Bidi’s safer product—a disposable e-cigarette prefilled with tobacco-flavored e-liquid—but still denied the application.

    In January 2024, the FDA issued a marketing denial order (MDO) for the tobacco-flavored Bidi Stick-Classic disposable vape. The decision came while the agency was continuing a court-ordered second review of marketing applications for flavored Bidi Vapor products. The FDA said Bidi’s premarket tobacco application “did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.”

    Bidi believes the FDA violated the Administrative Procedure Act and hopes to build on its record of successfully contesting adverse FDA decisions. In August 2022, the 11th Circuit set aside the original MDOs issued for its 10 non-tobacco-flavored products. That ruling put the 10 PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products.

  • Supreme Court Favors FDA in Flavor Battle

    Supreme Court Favors FDA in Flavor Battle

    Today (April 2), the Supreme Court unanimously overturned a lower court’s decision that the U.S. Food and Drug Administration incorrectly blocked flavored nicotine e-liquids, rejecting e-cigarette makers that were challenging regulatory hurdles on tobacco products.

    E-liquid companies Triton Distribution and Vapetasia LLC claimed the FDA unlawfully denied the marketing authorization for flavored vape products and disputed that the products appealed to children, arguing that the government was harming nicotine-addicted adults by keeping a cigarette alternative off the market.

    The vape companies argued the FDA failed to review the company’s own scientific evidence, which demonstrates its flavored products were crucial to getting smokers to switch from combustible cigarettes to e-cigarettes. The Fifth Circuit Court agreed with the e-cigarette maker, ruling that “the agency’s rejection was arbitrary and capricious because the FDA relied on conflicting evidence requirements.” The court also faulted the FDA for dismissing “out-of-hand companies’ strategies to keep their products away from minors.” The agency said such efforts haven’t proven to be effective.

    Public health groups had already sued the FDA for not moving fast enough to review the products after the agency, in 2016, finalized rules for regulating them under the 2009 Family Smoking Prevention and Tobacco Control Act. Under the Act, vape companies were forced to submit applications to the FDA in order to bring new vape flavors to market, and the FDA was to assess the public health effects of those products. A rift, however, emerged over the agency’s criteria for approving or denying those applications, which culminated in the Fifth Circuit.

    The fight was brought to the Supreme Court in November with the FDA contending it correctly applied the Tobacco Control Act, saying it considered both the “likelihood that existing users of tobacco products will stop using such products” and the “likelihood that those who do not use tobacco products will start using such products.”

    Oral arguments in front of the Supreme Court centered on whether the FDA standards are a policy position or a substantive rule imposed without notice and comment. The Biden administration argued the standards fell into the policy bucket, pushing the court to give the agency deference to interpret its role under the Tobacco Control Act. 

    Under the Biden administration, the FDA rejected more than a million flavored products, saying companies failed to show that flavored vapes will do more to benefit public health by helping smokers quit tobacco products than the harm they cause by appealing to young people.

    Vaping companies hope they’ll find a friendlier regulatory environment under the Trump administration, as the President previously promised to “save” flavored vaping.

  • Brian King, Dozens of Staffers Out at CTP

    Brian King, Dozens of Staffers Out at CTP

    The Associated Press is reporting that Brian King, the Food and Drug Administration’s chief tobacco regulator, was removed from his post this morning (April 1) amid sweeping cuts at the agency and across the federal health workforce. According to sources familiar with the situation, King sent an email to staff saying, “It is with a heavy heart and profound disappointment that I share I have been placed on administrative leave.”

    King was removed from his position and offered reassignment to the Indian Health Service, according to a person familiar with the matter who did not have permission to discuss the matter publicly and spoke on the condition of anonymity. Dozens of staffers in the FDA’s Center for Tobacco Products (CTP) also received notices of dismissal Tuesday morning, including the entire office responsible for enforcing tobacco regulations.

    In recent years, the CTP has been besieged by criticism from all sides, including politicians, anti-smoking advocates, and tobacco and vaping companies. Under King, the FDA rejected applications for millions of flavored e-cigarettes, citing insufficient data that the products would help adult smokers while not becoming popular with underage kids. Those rejections have resulted in multiple lawsuits against FDA from vape makers.

    “King, who joined the agency in 2022, has been vigorously criticized by vaping lobbyists for ordering thousands of companies to remove their fruit and candy-flavored e-cigarettes from the market,” the AP wrote. “During his time at FDA, teen vaping has fallen to a 10-year low.”

    The latest changes mean that nearly all of FDA’s top leaders overseeing drugs, food, vaccines, medical devices, and now tobacco products have resigned or retired in recent months. This comes after Robert F. Kennedy Jr.’s moves to fire 3,500 FDA staffers and push ahead with plans to scrutinize ultra-processed foods, childhood vaccines, antidepressants, and other long-established products.

  • Senate Confirms New FDA Commissioner

    Senate Confirms New FDA Commissioner

    Last week the U.S. Senate confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the U.S. Food and Drug Administration by a 56-44 vote. During his confirmation hearing, Makary said his goals for the agency were “more cures and meaningful treatments for Americans,” and offered several insights as to how he would achieve those goals throughout the hearing.  

    In the past, Makary has been critical of the FDA, in 2021 calling for “fresh leadership at the FDA to change the culture at the agency and promote scientific advancement, not hinder it.” Reporting to Health and Human Services Secretary Robert F. Kennedy Jr., Makary’s leadership of the FDA also includes its Center for Tobacco Products (CTP). However, it’s not yet clear how he will approach CTP’s looming issues of reviewing premarket tobacco product applications (PMTAs), the illicit vape market, and other tobacco-related issues.

    Much of the confirmation hearing centered around past problems, including those with Covid-19 vaccines, the pharmaceutical industry, and various other issues that have often gained headlines of late, but he did not commit to specifics in that venue.

    “I have no preconceived plans on mifepristone policy except to take a hard look at the data and to meet with the professional career scientists at the FDA who have reviewed the data,” he said at his hearing. “We now have a generational opportunity in American healthcare. President Trump and Secretary Kennedy’s focus on healthy foods has galvanized a grassroots movement in America. Childhood obesity is not a willpower problem, and the rise of early-onset Alzheimer’s is not a genetic cause. We should be, and we will, be addressing food as it impacts our health.”

    When asked about the backlog of cases the FDA has across all departments, Makary did not rule out leveraging artificial intelligence and making other regulatory changes to streamline the drug review process. He suggested FDA reviewers could use AI “to help reviewers in the review process—not to replace human reviews, but to improve efficiency.”

    National Association of Tobacco Outlets (NATO) Executive Director David Spross told CSP on Friday that “NATO looks forward to working with Dr. Makary and the team at FDA on tobacco and nicotine product regulatory issues, including for the FDA is to support tobacco harm reduction policies by authorizing more PMTA vapor and nicotine pouch product applications that provide adult smokers with more choices.”

    Spross added that there is a “need for more transparency from the agency by providing retailers more information on illicit products, specifically in the vapor and nicotine pouch categories.”

    Makary is a surgical oncologist and health policy researcher who has spent more than 20 years at Johns Hopkins.

    “I am pleased to congratulate Dr. Makary on his new role as FDA commissioner,” said Johns Hopkins University President Ron Daniels. “We are fortunate to have one of our senior faculty members at the School of Medicine undertake this critical service to the nation.

    “An accomplished clinician and widely published health policy researcher, Dr. Makary has had a storied career at Johns Hopkins that reflects the research and clinical acumen and openness to different ideas and approaches undergirded by academic freedom that are the hallmark of our great institution,” said Daniels.

    Makary founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and co-developed a surgical safety checklist used in operating rooms worldwide. He is a member of the National Academy of Medicine and has published more than 300 peer-reviewed articles and three New York Times bestselling books on healthcare.

    Senate also confirmed Jay Bhattacharya as the new director of the National Institutes on Health.