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Tag: center for tobacco products

  • Holman Defends CTP’s ‘Notable Improvement’

    Holman Defends CTP’s ‘Notable Improvement’

    On Feb. 24, the Wall Street Journal’s editorial board published a piece titled, “Who’s in charge of the FDA?” arguing that internal tensions at the U.S. Food and Drug Administration could be undermining efforts across all departments. The piece points to decisions affecting emerging products and suggests a broader debate within the FDA over how flexible the approval process should be.

    In response, Matthew R. Holman, vice president of U.S. Scientific Engagement & Regulatory Strategy at Philip Morris International and a former chief scientist at the FDA’s Center for Tobacco Products, wrote a letter that the WSJ published yesterday (March 5), saying that despite criticism and organizational challenges facing the FDA, the organization — and the CTP in particular — has shown notable improvement.

    “Over the past year, the FDA’s Center for Tobacco Products has become a notable bright spot — delivering real results for an agency working through significant institutional challenges,” he wrote. “The CTP has been responsive to industry experts and congressional leaders.”

    Responding to concerns raised in a 2022 Reagan-Udall Foundation report and congressional hearings about transparency and a backlog of smoke-free product applications, Holman said the center has become more receptive to industry and lawmakers, pointing to actions such as a pilot program to fast-track nicotine pouch reviews and upcoming advisory committee hearings on smoke-free products.

    “The CTP has taken several notable actions in the past year and is poised for more positive developments,” Holman wrote. “There’s still more work to be done to ensure the CTP is meeting its mission and properly regulating tobacco products in the marketplace with a focus on authorizing scientifically substantiated smoke-free products. But the progress we have seen in the first year of this administration is notable.”

  • U.S. Urged to Bolster Post-Employment Rules

    U.S. Urged to Bolster Post-Employment Rules

    Image: bluraz

    Public policy experts are calling for stronger federal post-employment regulations as U.S. regulators, including those overseeing the tobacco business, are increasingly losing talent to the private sector.   

    A recent article in The Examination details how, over the past 15 years, nearly two dozen lawyers have left the U.S. Food and Drug Administration and its Center for Tobacco Products to advise, litigate for or work with the tobacco and vaping industry.

    “It seems like every time we get sued in the tobacco industry, a former FDA lawyer is leading the lawsuit,” Commissioner Robert Califf told an FDA oversight organization last year.

    After gaining  FDA experience, lawyers can significantly increase their salaries by moving to a major law firm or corporation. While a lawyer’s salary in the FDA’s chief counsel’s office, for example, starts at around $83,000, a first-year lawyer at a firm made on average $200,000 a year in 2023, according to the National Association for Law Placement.

    Daniel Aaron, a former FDA attorney, says lawyers who’ve left the agency to work on behalf of the tobacco industry not only increase their renumeration but can also have a powerful impact on what lands on store shelves.

    “It’s a huge advantage to getting your product to market.” said Aaron, now a University of Utah law professor. “Ex-FDA lawyers know what the agency is worried about, and how a client can maximize its options. They know not just what the law is, but they know how the FDA will enforce the law.”

    Federal post-employment rules also bar former employees from communicating with or lobbying a federal employee for two years on behalf of a client or employer under certain circumstances. That said, employees are allowed to work “behind the scenes” advising clients, according to the FDA’s post-employment guidelines. 

    Genevieve Kanter, a professor at the University of Southern California who co-published a study in 2023 on the revolving door in health care regulation, believes the rules should be strengthened if society is truly interested in preserving independent government.

    Kanter’s study focused specifically on conflicts of interest of employees at the highest level of the U.S. Department of Health and Human Services; It found that 38 percent percent of the political appointees from the FDA went into private industry, the fourth highest out of roughly two dozen offices and divisions.

    Eric Lindblom, director of the Center for Tobacco Products’ Office of Policy from 2011 to 2016, proposed blocking former staff from working for the tobacco industry for at least one or two years, in all cases, after leaving the policy office. “I thought it was really important that we had that independence,” said Lindblom, now a senior scholar at Georgetown University’s O’Neill Institute.

    The proposal went nowhere.

    The Examination is a publication supported by Bloomberg Philanthropies.

  • CTP Updates Compliance Website

    CTP Updates Compliance Website

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has announced an enhancement to its website, which will more easily present information about tobacco compliance check outcomes.

    The agency noted in a statement that the database is designed to be a resource for various audiences, including the general public, public health groups and the tobacco industry.

    The new database offers the ability to search for various compliance and enforcement outcomes among brick-and-mortar and online retailers, including warning letters, civil money penalties and no-tobacco-sale orders.

    Previously, this information lived in various locations across the FDA website, so the enhancement will allow site visitors to more easily find outcomes from the FDA’s compliance and enforcement efforts of retailers in one centralized location, according to reports.

    This centralized database will be updated monthly with the latest compliance check outcomes. “The enhancements to this database reflect CTP’s continued efforts to optimize transparency and communication with stakeholders,” the statement continued.

  • Verbeten to lead CTP Compliance Office

    Verbeten to lead CTP Compliance Office

    Image: Tada Images

    John Verbeten will be the new director of the U.S. Food and Drug Administration Center for Tobacco Products’ Office  of Compliance and Enforcement, effective June 16.

    Verbeten has more than 20 years of experience leading field operations, compliance and enforcement, and national-level program management. In his latest role within Office of Import Operations, Verbeten served as the principal advisor to the Office of Regulatory Affairs’ (ORA) leadership on import operations and enforcement activities, and oversaw the FDA’s field import operations, which includes a staff of more than 700 people.

    He also provided leadership in the development, implementation and evaluation of new laws, regulations and policies related to ORA’s global and national programs and activities.

    Most recently, he led the agency’s development of a memorandum of understanding between the FDA and U.S. Postal Service (USPS), which established a framework that provides a basis for the development of bilateral data exchange and provides the FDA access to the USPS advanced electronic data for imported mail shipments.

  • CTP Launches Webpage on Relative Risks

    CTP Launches Webpage on Relative Risks

    Photo: Farknot Architect

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has launched a new webpage aimed at educating the public about the relative risks of tobacco products. The CTP will continue to update the information on this new webpage based on the best available science.

    Coinciding with the launch, CTP Director Brian King co-authored a commentary in Nature Medicine, discussing considerations for healthcare providers around talking to adults about the relative risks of different tobacco products.

    The commentary reinforces that youth should not use any form of tobacco products. Among adults who smoke, it stresses the importance of using evidence-based cessation methods, including FDA-approved pharmacotherapies, as a first line treatment.

    For adults who smoke and have tried proven cessation methods with no success, medical providers may consider educating patients about the relative risks of tobacco products and the potential health benefits of switching completely to a lower-risk product.

    Among patients who smoke, the authors note it is critical to reinforce the importance of complete transitioning away from smoking to exclusive e-cigarette use. Further, eventual abstinence from all tobacco products should be the end goal, according to King.

  • CTP Releases Strategic Plan

    CTP Releases Strategic Plan

    Image: Tada Images

    On Dec. 18, Brian King, director of the U.S. Food and Drug Administration Center for Tobacco Products, published a statement about the release of the center’s comprehensive strategic plan. The new strategic plan outlines CTP’s programmatic and workforce initiatives for the next five years.

    The CTP’s strategic plan defines five goals, 10 outcomes and several corresponding objectives. As outlined in the goals and outcomes in the plan, the center is collectively committed to issuing impactful regulations, using robust science to inform application reviews, pursuing timely and impactful compliance and enforcement strategies, and educating the public about the risks of tobacco products.

    King said the CTP will also continue to invest in its staff by advancing operational enhancements and supporting the further development of its workforce.

    In conjunction with the strategic plan, the CTP also published the center’s policy agenda of rules and guidance documents that are in development or planned for development. According to the agency, this policy agenda will create a more efficient approach to meeting the CTP’s strategic plan. The agenda will be updated annually.

  • King: Progress Implementing Reagan-Udall Suggestions

    King: Progress Implementing Reagan-Udall Suggestions

    Photo: GTNF

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has made significant progress in addressing the recommendations made by an expert panel facilitated by the Reagan-Udall Foundation, CTP Director Brian King said in a recent update.

    Key areas of focus include cross-cutting initiatives, science and application review, regulations and guidance, compliance and enforcement, public education campaigns, and resource development.

    According to King, the CTP is working on a new strategic plan set to be released by December 2023, which includes cross-cutting themes like science, transparency, stakeholder engagement and health equity. The center has solicited extensive feedback from both internal and external stakeholders, aiming to create a robust and inclusive plan.

    Regarding science and application review, the CTP has processed more than 26 million deemed products’ applications and is committed to addressing the remaining applications efficiently while ensuring scientific accuracy and legal compliance. It has also developed resources and engaged with stakeholders to enhance the premarket application review process.

    In the realm of compliance and enforcement, the CTP has taken various actions to curb the sale of illegal tobacco products, particularly those appealing to youth. They have issued warning letters and complaints for civil money penalties, demonstrating their commitment to enforcing the law.

    Public education campaigns continue to play a crucial role in preventing youth tobacco product use. The CTP is actively seeking input and aims to share updated campaign information soon.

    The CTP recognizes the importance of their staff and is working on enhancing their workforce development. They are also exploring options for securing user fees to support regulation efforts and requesting additional funding in the president’s fiscal year 2024 budget.

  • Webinar on FDA Warning Letters

    Webinar on FDA Warning Letters

    Photo: Song_about_summer

    The U.S. Food and Drug Administration has posted a new webinar to help manufacturers and vape shop owners respond to warning letters from the agency’s Center for Tobacco Products (CTP).

    The webinar outlines the appropriate items for a response to a warning letter, which should be received by FDA within 15 business days. The webinar also includes an explanation of proper documentation concerning corrective actions that entities have taken.

    In the webinar, participants will learn about:

    • Preparation for a response to CTP
    • Important items to include in a response
    • Additional compliance resources
  • CTP Hires New Office of Science Director

    CTP Hires New Office of Science Director

    Matthew Farrelly (Credit: RTI International)

    The new director of the U.S. Food and Drug Administration’s tobacco science division is Matthew Farrelly, former chief scientist and director of the Center for Health Analytics, Media, and Policy for RTI International.

    In an announcement, the FDA’s Center of Tobacco Products (CTP) stated that Farrelly’s extensive work in the field of tobacco and nicotine science for more than 25 years, and being recognized internationally as an expert with proven leadership and organizational management skills will help him succeed as the director of the CTP’s Office of Science.

    “He has led or been involved with numerous scientific endeavors related to tobacco control policies and regulatory approaches, including those related to graphic health warning labels, excise taxes, smoke-free policies, quitlines, state tobacco control programs, retail advertising, and flavored tobacco products,” the release states. “He has also extensively researched the influence of mass reach health campaigns, including FDA’s The Real Cost.”

    Farrelly also has authored or co-authored over 120 articles in peer-reviewed scientific literature, according to the release. He earned his Ph.D. in Economics from the University of Maryland at College Park.

    Farrelly joins the CTP as the agency faces a series of major tobacco-related decisions, including a potential ban on menthol cigarettes, lowering nicotine levels, and the next step in its ongoing attempt to regulate Juul and other electronic cigarettes.

    Farrelly will replace Matt Holman, who left the position last year to join Philip Morris International. Holman was hired in 2017 and took over for David Ashley.

  • FDA Seeks TPSAC Nominations

    FDA Seeks TPSAC Nominations

    Photo: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products is requesting nominations for two individuals to serve as voting members on the Tobacco Products Scientific Advisory Committee (TPSAC). According the FDA website, individuals may self-nominate or be nominated by any interested person or organization.

    Nominations received on or before Nov. 25, 2022, will be given first consideration. Nominations received after Nov. 25, 2022, will be considered as later vacancies occur.

    TPSAC advises the CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence and health issues concerning tobacco products and provides appropriate advice, information and recommendations to the FDA commissioner.

    The notice has been published in the Federal Register.