Tag: CTP

  • CTP Office of Management Gets Brandt as Director

    CTP Office of Management Gets Brandt as Director

    Credit: Otseira

    The U.S. Food and Drug Administration’s Center For Tobacco Products (CTP) is pleased to announce that Erin Brandt will serve as director of CTP’s Office of Management.

    Brandt currently holds the position of deputy director in CTP’s Office of Management.

    “Brandt has more than a decade of experience working in leadership positions in administrative management,” the CTP stated in a release. “She has extensive experience overseeing a wide range of administrative services, including human capital, information technology, financial management, administrative management, acquisitions and grants, ethics, facilities, and risk management and analysis.”

    Brandt joined CTP in 2013 as the Office of Management’s Management analysis officer, and became the deputy director in 2014, a position she held until assuming her current role as acting director.

    Before joining FDA, Brandt was a management analyst at the National Institutes of Health (NIH) and worked for several non-profit organizations, including Global Philanthropy Alliance, World Resources Institute, and Habitat for Humanity as an AmeriCorps VISTA.

    She earned a master’s of Public Policy from the University of Minnesota Humphrey School of Public Affairs and holds a bachelor’s of Science in Political Science from the University of Wisconsin-Eau Claire.

    Brandt was selected after an extensive nationwide search, multiple interview panels that evaluated a substantial and well-qualified applicant pool, and clearance through important FDA ethics and security processes. CTP is excited for Ms. Brandt to continue her service with CTP, with an effective date of June 16th.

  • CTP Hires Director of Health Communication and Education

    CTP Hires Director of Health Communication and Education

    Courtesy: US FDA

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has hired Anne Rancourt as its next director of CTP’s Office of Health Communication and Education.

    Rancourt comes to CTP from the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) where she serves as the Communications Director.

    Rancourt has more than two decades of experience working in strategic communications, behavior change programs and journalism, including nearly 14 years within the federal government, according to a release.

    At NIDA, Rancourt is responsible for managing the communication branch that oversees the dissemination of a nearly $2 billion scientific research portfolio on substance use and addiction, including tobacco and e-cigarette use.

    She also advises the Institute director on communication strategies, informing agency leaders on broad public health, education, and scientific policy matters and issues.

    Prior to her tenure at NIDA, Rancourt led press outreach and media strategy on HIV as a Communications Section Chief at the National Institute of Allergy and Infectious Diseases (NIAID).

    Earlier in her career, Rancourt led media and digital outreach strategies for The Heart Truth campaign at NIH’s National Heart, Lung and Blood Institute.

    Rancourt was selected after an extensive nationwide search, multiple interview panels that evaluated a substantial and well-qualified applicant pool, and clearance through important FDA ethics and security processes.

    She will begin the new position on May 19th.

  • Brian King Speaks About CTP Priorities and Progress

    Brian King Speaks About CTP Priorities and Progress

    Brian King (Photo: FDA)

    Throughout his first year as director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), the agency has maintained a steadfast commitment to its core principles of sound science, strategic partnerships, health equity and transparency, CTP Director Brian King said in a recent interview.

    King underscored the enduring importance of these principles. He emphasized that the center’s recent decisions and enforcement efforts have been grounded in comprehensive scientific analysis. This approach, he noted, ensures that product marketing and regulatory actions are well-informed and evidence-based.

    Furthermore, the director highlighted the importance of teamwork, a skill honed through his background as a scientist. Scientific thinking, rooted in objective evidence evaluation, plays a pivotal role in CTP’s work. This scientific approach is instrumental in addressing the complexities of tobacco product regulation effectively, according to King, who also emphasized the importance of effective communication in conveying scientific findings and messages.

    A significant focus of CTP’s work is promoting health equity in tobacco product regulation. King discussed efforts to address disparities in tobacco use, especially among youth and young adults. Notably, the CTP is working on product standards that would prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. King views these standards as a major step toward reducing the appeal of these products, particularly among communities disproportionately affected, such as people of color, low-income populations and LGBTQ+ individuals.

    To further advance health equity, the CTP has undertaken initiatives like the “Next Legends” campaign to educate American Indian and Alaska Native youth about the harms of e-cigarettes and providing Spanish-language adult cessation education resources.

    During his tenure, the center welcomed Charlene Le Fauve as its first senior advisor for health equity, a crucial role in integrating health equity into the center’s programmatic plans and priorities, according to King.

    Looking ahead to the next three to five years, the director stressed the importance of having a clear vision. The CTP is in the process of creating a new strategic plan with the involvement of internal staff and external stakeholders to ensure the center’s continued growth and adaptation in a dynamic regulatory landscape. The plan, to be released by December 2023, will provide a roadmap for CTP’s future, aligning its actions with changing times and the goal of reducing tobacco-related diseases and deaths in the United States.

  • U.S. FDA Seeks New Industry TPSAC Nominations

    U.S. FDA Seeks New Industry TPSAC Nominations

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) is requesting nominations by Oct. 11, 2023, for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). Individuals may self-nominate or be nominated by any interested person or organization.

    In addition, the CTP is seeking any industry organizations interested in participating in the selection of this TPSAC nonvoting representative.

    Nomination materials for prospective TPSAC candidates and letters from industry organizations interested in participating in the selection process should be sent to the CTP by Oct. 11, 2023. Please see the Federal Register notice for further details on the nomination and selection procedures.

    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.

  • Tomorrow: FDA Tobacco Center Strategic Plan Event

    Tomorrow: FDA Tobacco Center Strategic Plan Event

    Vapor Voice Archive

    Tomorrow, Aug. 22, 2023 is the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) online forum centered on developing a 5-year strategic plan to advance its mission.

    As part of an iterative, center-wide process, CTP has developed five proposed goal areas. These goal areas are intended to be interconnected with four proposed cross-cutting themes: health equity, science, transparency, and stakeholder engagement.

    The center intends to publish the strategic plan by the end of 2023, following receipt and consideration of public input.

    Beginning at 10 a.m. EDT, the CTP virtual listening session will give the public an opportunity to verbally provide open public comment on the development of the 5-year strategic plan, including proposed strategic goals.

    CTP will begin with an overview of the process used to develop the center’s strategic plan, including proposed goal areas. Registered speakers will then have approximately 4 minutes each to verbally share their comments on any topics related to the strategic plan.

    Live closed captioning and ASL interpreters will be provided during the listening session. If you have issues registering or have any questions, please email malini.runnells@fda.hhs.gov or call 1-877-CTP-1373 between 9 a.m. and 4 p.m. EDT.

    A transcript and recording will be made available after the listening session.

    Use this link to view the session.

  • U.S. FDA to Hold Public Meeting on PMTA Process

    U.S. FDA to Hold Public Meeting on PMTA Process

    The U.S. Food and Drug Administration will hold a two-day public meeting on the agency’s premarket tobacco product application (PMTA) process on Oct. 23–24, 2023.

    The meeting will be held on the FDA’s White Oak Campus in Silver Spring, Maryland, and will be in a hybrid format with the option to attend virtually.

    Staff from the Center for Tobacco Products’ Office of Science will present on topics related to the PMTA process and be available to respond to questions received from stakeholders on the topic, according to a press note.

    Additional information, including registration and question submission processes, will be available soon.

  • CTP Hires Its First Senior Advisor for Health Equity

    CTP Hires Its First Senior Advisor for Health Equity

    Charlene Le Fauve (Credit: NIH)

    The tobacco and nicotine product regulatory arm of the U.S. Food and Drug Administration has hired a senior advisor for health equity for the first time. The Center for Tobacco Products (CTP) announced Charlene Le Fauve will fill the role.

    “Beginning today, she will join CTP’s Senior Leadership Team within the Office of the Center Director,” a release states. “Dr. Le Fauve is a behavioral scientist and addiction researcher with 25 years of federal work experience related to health equity and health disparities research. She has dedicated her career to advancing health equity and the health of underserved and underrepresented populations through research and research workforce development.”

    Most recently, Le Fauve served as the senior advisor to the Chief Officer for Scientific Workforce Diversity at the National Institutes of Health (NIH). In this role, she educated national audiences about NIH’s role in scientific workforce diversity and health equity research, according to the release.

    Prior to her NIH role, Le Fauve held various leadership roles, such as the deputy director of Disparities Research and Global Mental Health at the National Institutes of Mental Health and the senior policy coordinator and lead for the Center for Medicare and Medicaid Services Team at the Department of Health and Human Services.

    “Diversity, Equity, Inclusion, and Accessibility (DEIA) are core values of CTP, and efforts are underway to ensure that the full scope of the Center’s work is reflective of these principles. In this new position, which is the first of its kind for any Center at FDA, Dr. Le Fauve will work with all of CTP’s Offices to ensure health equity is integrated into the Center’s programmatic plans and priorities,” the release states, “She also will serve as CTP’s primary representative in a variety of activities that promote and facilitate the reduction of tobacco-related health disparities, including during external meetings, conferences, and presentations.”

  • New Resources to Help Submit PMTA Amendments

    New Resources to Help Submit PMTA Amendments

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has created two new resources to help applicants prepare and submit amendments to their premarket tobacco product applications (PMTAs): Fact Sheet—Amendment Tips: Completing Form FDA 4057a and Video—Using the CTP Portal.

    The fact sheet provides quick tips for completing Form FDA 4057a—Premarket Tobacco Product Application Amendment and General Correspondence Submission. In most circumstances, the CTP can only accept PMTA amendments for review that include Form FDA 4057a. In general, when submitting amendments for a PMTA, the FDA will review the required Form FDA 4057a first. If required content is missing from the form, the FDA may not continue reviewing the amendment.

    The video provides an overview of the CTP Portal and how to use it, including how to find application submission tracking numbers online.

    Recently, CTP Director Brian King outlined several new actions to enhance the center’s efficiency, effectiveness and transparency. These activities include enhanced communication on scientific issues and practices. By providing these new resources, the CTP is aiming to better support applicants navigating the PMTA process.

  • Former CTP Director Zeller Joins Qnovia Advisory Board

    Former CTP Director Zeller Joins Qnovia Advisory Board

    Mitch Zeller
    Mitch Zeller, former director of the FDA’s Center for Tobacco Products

    Mitch Zeller, the much-maligned former head of the U.S. Food and Drug Administration’s tobacco center has joined the advisory board of a company developing a first-of-its-kind smoking cessation inhalation product.

    Zeller said Qnovia’s nicotine inhalation product, RespiRX, has the potential to be a “game changer” in lowering the use of combustible cigarettes.

    The former director of the Center for Tobacco Products (CTP) from March 2013 until his retirement in April 2022, Zeller is now providing policy and regulatory strategy consulting to Qnovia, Inc.

    The company is currently preparing an application to the FDA’s Center for Drug Evaluation and Research (CDER) for a cessation therapy which, if approved, will be the first inhaled prescription therapy to help tobacco smokers quit.

    Zeller’s addition to the company’s advisory board comes as the FDA aims to finalize proposed bans on menthol cigarettes and flavored cigars by August. The FDA also plans to propose a rule limiting nicotine levels in cigarettes and some other tobacco products.

    Zeller said access to Qnovia’s product can be one essential tool along with an administration-wide effort to provide support to those with nicotine addictions once those product standards take effect.

    “Some people will be able to quit cold turkey, but a whole bunch won’t, and they will be seeking nicotine elsewhere,” Zeller said in an interview, told Bloomberg Law.

    “The last thing that we want smokers to do if any of those policies go into effect is to simply switch to another tobacco product,” he added.

    Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, according to Qnovia CEO Brian Quigley. Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG. 

    RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal byproducts.

    RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product. 

    “The nebulizing unit (cartridge) gets replaced by the patient every one to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”

    Late last year, Qnovia raised $17 million to continue the development of its RespiRx nicotine replacement product.

    In June of 2020, the company appointed Quigley, a 16-year veteran of Altria Group, as its Chief Operating Officer. At Altria, Quigley served as CEO of its smokeless tobacco business from 2012 to 2018, a $2.3 billion business with over 800 employees,

  • House Oversight Committee to Probe CTP Failures

    House Oversight Committee to Probe CTP Failures

    The U.S. House Oversight and Accountability Committee announced its intent to investigate the practices of the Food and Drug Administration’s Center for Tobacco Products (CTP).

    Chairman James Comer is conducting the probe of the FDA’s regulation of tobacco and nicotine products through the CTP, stating that the center has failed to effectively define and administer its tobacco and nicotine regulatory programs.

    The failure has resulted in industry uncertainty and unsafe products reaching the marketplace, according to a committee press release. In a letter to FDA Commissioner Robert Califf, Comer is requesting documents, communications, and a staff-level briefing related to the CTP’s activities to ensure it is performing its regulatory function as intended.

    “The Committee on Oversight and Accountability is conducting oversight of the Food and Drug Administration’s (FDA) regulation of tobacco and nicotine products through its Center for Tobacco Products (CTP). A recent evaluation of CTP by the Reagan-Udall Foundation (RUF) found that CTP has not clearly set out the most basic elements of its tobacco and nicotine regulatory programs. This has resulted in confusion, inefficiency, litigation and suspicions of political interference. CTP has fostered uncertainty in the marketplace and has allowed unsafe and unregulated products to proliferate. Therefore, we seek documents and information regarding CTP’s activities to enable transparency and to ensure the CTP is performing required functions,” wrote Comer.

    An evaluation of the CTP by the Reagan-Udall Foundation stated that the CTP is unable to perform its basic functions and ensure that Americans have access to products that have the potential to lower the rate of smoking-related disease and death. Amidst unclear policies, stakeholders have even reported having to guess what the CTP’s regulations might be. Congressional oversight is needed to bring transparency to the CTP’s lack of clear policies that have resulted in market uncertainty, unregulated products and enforcement failures, according to the press release.

    “We have deep concerns that CTP’s decisions have been influenced by political concerns rather than scientific evidence,” wrote Comer. “Comments from FDA staff to RUF, which are no longer available on its website, reflect such concerns. For example, one commenter said, ‘[i]n cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.’ Another stated, ‘scientific disagreement is frowned upon, if not entirely suppressed,’ while a third said leadership was ‘… unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.’ FDA must clearly identify and publicize what scientific criteria are necessary for a product, to include [electronic nicotine-delivery system (ENDS) products] and smokeless products, to be authorized through the PMTA pathway and—where appropriate—the subsequent [modified-risk tobacco product applications (MRTPs)] pathway.”

    Comer specifically asked the FDA to provide: FDA staff comments to the Reagan-Udall evaluation; all communications with the White House and Department of Health and Human Services (HHS) regarding tobacco or nicotine policy; documents and communications between the FDA and the Centers for Disease Control and Prevention (CDC) regarding CTP policies; documents and communications between the FDA and “public health advocacy groups” regarding CTP policies; all documents that describe the specific analytic process the FDA uses to apply the “appropriate for the protection of public health” standard; and all documents and communications related to the FDA’s enforcement efforts to remove illegally marketed tobacco or nicotine products from retail locations.