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Tag: Bret Koplow

  • FDA Tobacco Chief Highlights Progress, Challenges in Product Reviews and Enforcement

    FDA Tobacco Chief Highlights Progress, Challenges in Product Reviews and Enforcement

    Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products (CTP), sat down for a fireside chat to kick off the second day of the American Tobacco and Nicotine Forum (ATNF) in Leesburg, Va. Christopher Greer, president and CEO of the Nicotine Resource Consortium, led the discussion on behalf of industry leaders eager to hear more about the inner workings of the regulatory agency.

    Koplow said the agency has made significant progress in reducing its backlog of premarket tobacco applications, cutting it by roughly 70% over the past year and eliminating the acceptance queue. He noted that while the FDA has reviewed approximately 27 million applications, only a small number have been authorized, largely because most submissions lacked the scientific data required to demonstrate public health benefits.

    Koplow said the agency is working to improve transparency and guidance for applicants, including plans to share lessons learned from the review process to help companies better meet regulatory standards. He also pointed to efforts to streamline evaluations in certain product categories, such as nicotine pouches, where a pilot program enabled faster authorizations and is expected to inform broader regulatory approaches.

    On enforcement, Koplow highlighted increased action against illicit products, including major seizures of unauthorized e-cigarettes in coordination with federal agencies, with most originating from China. He acknowledged ongoing challenges in balancing harm reduction for adult smokers with youth protection, noting declines in youth vaping but continued concerns about public understanding of nicotine risks and the need for stronger evidence on comparative benefits of alternative products.

  • Acting CTP Director Offers ‘Groundbreaking’ Views at FDLI

    Acting CTP Director Offers ‘Groundbreaking’ Views at FDLI

    Bret Koplow, Acting Director of the FDA Center for Tobacco Products (CTP), outlined a notable change in the agency’s approach to tobacco regulation, emphasizing tobacco harm reduction as a central principle, as he opened the Food and Drug Law Institute (FDLI) Tobacco and Nicotine Policy Conference on October 28.

    Chris Allen, CEO of UK-based consultancy Broughton, called the keynote “one of the most significant speeches we’ve heard in years,” marking the FDA’s first public acknowledgment of harm reduction as a principle embedded in its regulatory framework in years, while public health expert Cliff Douglas posted on X that the speech was “refreshing and potentially groundbreaking,” noting Koplow’s clear articulation of the benefits of switching from cigarettes to alternative products.

    According to social media posts from the two experts, Koplow highlighted the importance of streamlining review and authorization processes to make harm reduction measures effective, and said the FDA will soon provide guidance on the continuum of risk for tobacco and nicotine products and signaled potential support for expanding flavored e-cigarettes using age-gating technology if they serve public health goals. He also stressed the need for a regulated marketplace of authorized reduced-risk products, warning that without proper oversight, unregulated alternatives could dominate the market.

    “This is encouraging, but we will need to see what form this takes and how well it is executed. The follow-up panel on the future of tobacco policy in the context of #MAHA [Make America Healthy Again] correctly highlights the welcome change in tone in Director Koplow’s remarks,” Douglas wrote, referencing the conference’s opening panel,
    The Future of Tobacco Policy: Aligning CTP’s Present with MAHA’s Vision, which featured industry experts Beth Oliva, Cheryl K. Olson, Jeff Weiss, Jeffrey Willett, and Robyn Gougelet. “This should not be overlooked, as his clear articulation of the benefits of switching from cigarettes to pouches and vapes, for example, is refreshing and potentially groundbreaking.”

    Allen agreed, saying that the industry has sought FDA clarity for years.

    “This was more than a language shift. It was a reframing of how CTP interprets the ‘appropriate for the protection of public health’ standard at the heart of the Tobacco Control Act,” Allen wrote. “This shift opens the door for more transparent communication on relative risk, more efficient regulatory pathways, and ultimately, a more pragmatic approach to reducing smoking-related disease and death.

    “It’s not just a policy update, it’s a philosophical evolution.”

    After speaking on the MAHA panel that followed Koplow’s remarks, Olson said it was a pleasure hearing the director’s talk about shifting schemes.

    “Government framing of nicotine is overdue for a rethink,” Olson wrote on LinkedIn. “Smoking rates are stuck among vulnerable groups such as older adults. If you look at what government websites say about smoking cessation, they mostly give the same advice they’ve given for decades. The old HHS Framework assumes that people who smoke are passive victims of industry manipulation. 

    “If MAHA is about empowering people to make choices…that could help create a new framework that puts the needs of people who use nicotine at the center.”

  • FDA Denies Marketing for blu Disposable E-Cigarette

    FDA Denies Marketing for blu Disposable E-Cigarette

    Today (August 19), the U.S. Food and Drug Administration (FDA) issued a Marketing Denial Order (MDO) for Fontem US, LLC’s blu Disposable Classic Tobacco 2.4% e-cigarette, prohibiting its marketing or sale in the United States. The decision bars the product due to insufficient evidence that it would help adult smokers quit cigarettes—and raises concerns about dual use increasing overall toxicant exposure. FDA emphasized that only e-cigarettes supported by robust evidence showing reduced harm or smoking cessation benefits have been granted market authorization.

    “While FDA-authorized e-cigarettes are a lower-risk alternative for adults who smoke cigarettes – especially if they completely switch – not all e-cigarettes are equal,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “FDA’s rigorous scientific review ensures authorized e-cigarettes provide a net benefit to public health.

    “In this case, the company did not provide sufficient evidence of a benefit that outweighs the risk, particularly given evidence that adults who smoke generally do not stop or significantly curtail consumption of cigarettes when using this product.”

    Tobacco products that receive an MDO from the FDA may not be introduced or delivered for introduction into interstate commerce and must be removed from the market. Manufacturers, distributors, and retailers who sell or distribute this product in interstate commerce are violating the law and are at risk of enforcement action. The company may submit a new application for the product subject to this MDO.

    Industry observers interpret today’s decision as part of an increasingly stringent FDA posture, where even incumbent market players face rejection unless they clearly demonstrate both consumer and public health benefits. FDA-authorized products to date are limited to those with compelling evidence, and remain largely within tobacco-flavored, closed-system formats

    Fontem joins smaller U.S.-based e-cigarette companies ECS Global, Texas Select Vapor, Fumizer, and American Vapor Inc. that received MDOs in the last month.

    See the FDA’s notification.

  • 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.