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Tag: FDA

  • Advocacy Groups Tell RFK Jr. Federal Tobacco Oversight Already Too Thin

    Advocacy Groups Tell RFK Jr. Federal Tobacco Oversight Already Too Thin

    Bloomberg is reporting that more than 80 public health organizations and advocacy groups sent a letter to Robert F. Kennedy Jr. this week voicing concern that recent cutbacks at the Department of Health and Human Services will hurt, or even reverse, decades of progress in reducing the use of tobacco products. Groups including the American Lung Association and Campaign for Tobacco-Free Kids, said the Office on Smoking and Health at the Centers for Disease Control and Prevention, as well as the Food and Drug Administration’s Center for Tobacco Products, were already stretched thin, and further layoffs would derail efforts to remove unauthorized products and hold tobacco companies accountable. The letter further argues that the FDA’s tobacco regulation is entirely funded by fees levied on the companies selling the products, so personnel cuts do not save any taxpayer money.

    The FDA is also grappling with a booming market for illegal flavored vapes, many of them imported from China. Despite lacking FDA authorization, these products have flooded US shelves, with some estimates suggesting unauthorized vapes now make up as much as 70% of the market.

    RFK Jr., who has supported shrinking the federal workforce and cutting “wasteful” public health spending, has not addressed how the layoffs will affect tobacco regulation. HHS did not immediately respond to a request for comment from Bloomberg.

  • FDA and CBP Seize $34M in Illegal E-Cigarettes in Chicago

    FDA and CBP Seize $34M in Illegal E-Cigarettes in Chicago

    The U.S. Food and Drug Administration (FDA) today (May 22) announced the seizure of nearly 2 million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million. The seizures, which occurred in February of this year in collaboration with U.S. Customs and Border Protection (CBP), were part of a joint federal operation to examine incoming shipments and prevent illegal e-cigarettes from entering the country.

    During this operation, the team uncovered shipments of various illegal e-cigarette products, almost all of which originated in China and were intended for shipment to various U.S. states. FDA and CBP personnel determined that, in an apparent attempt to evade duties and the review of products for import safety concerns, many of these unauthorized e-cigarette shipments contained vague product descriptions with incorrect values. Upon examining shipments, the team found several brands of unauthorized e-cigarettes, including Snoopy Smoke, Raz, and others.

    “The FDA, working with our federal partners, can and will do more to stop the illegal importation and distribution of e-cigarette products in the United States,” said FDA commissioner Marty Makary. “Seizures of illegal e-cigarettes keep products that haven’t been authorized by the FDA out of the United States and out of the hands of our nation’s youth.”

    In the lead up to this operation, the joint FDA and CBP team identified potentially violative incoming shipments and completed other investigative work. The team was also able to successfully implement several new internal efficiencies and procedures, building off previous operations.

    “We continue to see an increased number of shipments of vaping-related products packaged and mislabeled to avoid detection,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “However, we have been successful at preventing these shipments from entering the U.S. supply chain – despite efforts to conceal the true identity of these unauthorized e-cigarette products.”

    Most shipments violated the FDA’s Federal Food, Drug, and Cosmetic Act, while some products were also seized for Intellectual Property Rights violations for unauthorized use of protected trademarks. All of the e-cigarette products seized in this operation lacked the mandatory premarket authorization orders from the FDA and therefore cannot be legally marketed or distributed in the United States.

    Standard practice for products forfeited to the government include disposing of the products in accordance with the law. In the case of unauthorized new tobacco products, including e-cigarettes, that generally means they will be destroyed.

    FDA also sent, for the first time, import informational letters to 24 tobacco importers and entry filers responsible for importing these illegal e-cigarettes. The letters advise the recipients that it is a federal crime to make false statements or entries to the U.S. government, and the FDA seeks information on the steps they have taken to ensure compliance with applicable federal tobacco laws and regulations. Specifically, the letters advise the firms to ensure their import entries contain complete and accurate information moving forward. Failure to do so may also be viewed as an intentional attempt to circumvent the FDA’s review of the shipment. Firms are requested to respond to the letters within 30 days with the requested information.

  • Thoughts on FDA Reform

    Thoughts on FDA Reform

    Prioritizing Education on Smoke-Free Alternatives

    By Dr. Tom Price

    The recent marketing authorization by the U.S. Food and Drug Administration (FDA) of 20 Zyn nicotine pouch products is a good step forward in building a more robust market for smoke-free nicotine and tobacco products. This critical decision, coupled with the Trump administration, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and expected FDA Commissioner Marty Makary’s stated priority to “Make America Healthy Again,” foretells an emerging regulatory landscape in the U.S. that presents a meaningful opportunity to expand access to smoke-free products that can help adults who smoke make the switch away from cigarettes.

    This paradigm shift has been a long time coming, and I am thrilled to see it happening in real time. Now, it is time for the FDA to step up its education efforts—with both consumers as well as the medical community—to raise awareness of these products and how, although not risk free, they are a better choice than continuing to smoke or using other traditional tobacco products.

    In clearing the FDA’s extensive premarket tobacco product application (PMTA) process, which includes years of scientific review, ZYN became the first and only FDA-authorized nicotine pouch in the U.S. In the FDA’s announcement, the Director of the Office of Science at the FDA’s Center for Tobacco Products (CTP), Matthew Farrelly, Ph.D., noted that these “products offer greater benefits to population health than they do risks,” and the data shows that ZYN nicotine pouches “meet that bar by benefitting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

    While this should be good news for the 45 million American nicotine consumers, there is still more work for the FDA to do to clearly illustrate the potential benefits of nicotine pouches and other smoke-free products to consumers and medical experts alike. However, that will require clearing up a long history of misinformation.

    According to the FDA, it is not nicotine but a toxic mix of chemicals contained in tobacco and tobacco smoke that drives the serious health threats facing tobacco users. Despite the science proving that smoke-free products represent a better option compared to smoking, various groups, such as the American Lung Association (ALA), continue to spread misinformation about the potential benefits of Zyn nicotine pouches for smokers and other tobacco users, directly contradicting the FDA and scientific evidence.

    Even America’s medical community seems flummoxed by what should be a clear distinction between nicotine consumption and the serious side effects tied to cigarette smoking. According to one study, 60 percent of nurses mistakenly believe that nicotine causes cancer. Another one found that more than 80 percent of physicians “strongly agreed” that nicotine “directly contributes to the development of cardiovascular disease (83.2 percent), chronic obstructive pulmonary disease (COPD) (80.9 percent), and cancer (80.5 percent).”

    Of course, none of this is true, underscoring the dire need for the FDA and CTP to prioritize educating the public and medical community with accurate information about the vital role smoke-free products could play in helping Americans who smoke to reduce their exposure to harm.

    CTP Director Brian King, Ph.D., M.P.H., recently acknowledged as much, saying that “misperceptions among physicians and other healthcare professionals” may result in advising patients in a manner that is “not consistent with existing scientific evidence.” Moreover, he continued, these “misperceptions are associated with lower odds of completely transitioning from cigarettes” to a noncombustible product.

    While misinformation abounds, there is still some hope. Even passionate anti-smoking groups, such as the Truth Initiative, have—to some degree—begun to acknowledge the benefits of nicotine pouches, noting that the FDA’s authorization of ZYN nicotine pouch products “addresses an ongoing need to provide adults who smoke with access to less harmful alternatives to combustible cigarettes.”

    The FDA and CTP may be well aware of the misperceptions behind smoke-free products. Still, neither has taken meaningful action to counter the spread of misinformation with proper, accurate education for healthcare providers and adults who smoke. That must change, and it must change soon.

    The FDA has a responsibility to not only help provide adults who smoke with more smoke-free options, but also to ensure the medical community and public at large understand the benefits and risk these products provide—both in terms of personal and public health. Recent events have made me hopeful that, together, we can build a healthier country, but the FDA and CTP must lead the way there.

    Tom Price, M.D., was the 23rd Secretary of the U.S. Department of Health and Human Services and is a former member of Congress (GA06), and an advisor to PMI U.S. Corporate Services Inc.

  • Koplow Tabbed New CTP Chief

    Koplow Tabbed New CTP Chief

    U.S. Food and Drug Administration Commissioner Marty Makary announced that Bret Koplow will be acting director of the Center for Tobacco Products, according to emailed announcements reported by Bloomberg.

    Koplow has worked for the agency in various roles since 2011, serving as senior counselor to the commissioner in the Immediate Office of the Commissioner since early 2020, where he focused principally on regulatory, policy, and operational matters involving CTP, including work on e-cigarettes, cigars, and other tobacco products. Before joining the Commissioner’s Immediate Office, he served as senior counsel in the FDA’s Office of the Chief Counsel, and before that served in the FDA’s Office of Legislation as the Senior Advisor for Oversight.

    The agency is facing pressure to crack down on illicit products, improve new product submission procedures, and change how it approaches foreign inspections.

    “Bret Koplow—an attorney and longtime FDA bureaucrat,” Gregory Conley, a harm-reduction advocate posted on X. “This would seem to signal the Biden era status quo will continue for now.”

    Makary also announced Elizabeth Miller will serve as the acting associate commissioner for the Office of Inspections and Investigations, filling two high-profile vacancies. The former top tobacco regulator, Brian King, was pushed out during agency-wide layoffs in April.

  • 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.”