Category: People

  • Michele Mital to Serve as Acting Director of CTP

    Michele Mital to Serve as Acting Director of CTP

    Mitch Zeller, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), will officially retire on April 8, Zeller confirmed during the 103rd annual TMA meeting this week.

    Today, the FDA confirmed to Vapor Voice that Michele Mital will serve as acting director of the CTP when Zeller retires. Mital has served as the deputy director of the CTP since 2018, according to the FDA.

    In this position, Mital is responsible for assuring that CTP accomplishes its public health goals and for operationalizing the Center’s vision and mission as it implements the Family Smoking Prevention and Tobacco Control Act.

    MItal will have some big shoes to fill. Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest.

    The news was first reported Wednesday afternoon in a tweet by FDA Tracker and confirmed by Filter reporter Alex Norcia after speaking with FDA sources. No formal announcement has been made.

    This story will be updated when more information is available.

  • E-LiquiTech Parent, TTI, Appoints New President

    E-LiquiTech Parent, TTI, Appoints New President

    Credit: Gajus

    Tobacco Technology has appointed David Johnson as president and chief scientific officer of the company and its wholly owned subsidiaries, E-LiquiTech and Emerald Green Technology. He will be replacing Richard Howell who retired earlier this month after 43 years of service.

    Johnson joined Tobacco Technology as the director of regulatory affairs in 2021. He brings more than 30 years of scientific, regulatory and management experience, including over 20 years in the tobacco industry, to the Tobacco Technology family of companies.

    He received his Ph.D. in chemistry from the University of Mississippi specializing in physical analytical chemistry. In addition, he earned postdoctoral training at the University of North Carolina in Chapel Hill in the mass spectrometry group of Maurice Bursey.

    Johnson acquired much of his tobacco experience at Swedish Match North America, where he was the director of analytical, and at Turning Point Brands, where he was the senior director of scientific and regulatory affairs. Johnson also has a wealth of sales, marketing and Six Sigma experience from his years working with DuPont.

  • FDA Nominee, Califf Faces Stiff Senate Opposition

    FDA Nominee, Califf Faces Stiff Senate Opposition

    Robert Califf

    U.S. President Joe Biden’s nominee to lead the Food and Drug Administration is facing stiff opposition in the Senate.

    According to an article in The New York Times, abortion foes are urging Republican lawmakers to reject Robert Califf, who previously led the agency during the final year of the Obama administration. Meanwhile, key Democrats are withholding support over Califf’s opioid policies and industry ties.

    At least five Democrats are publicly opposing his nomination, so Califf needs at least five Republicans to support him in the evenly divided Senate, where Vice President Kamala Harris has a tie-breaking vote.

    The FDA commissioner role has been subject to Senate confirmation since 1988, unlike the director of the Centers for Disease Control and Prevention, who is a presidential appointee. The nominee tends to be subject to sharp questioning, but observers say the decision has never been so wrapped up in national politics unrelated to the nominee’s qualifications.

    With no confirmed leader, Janet Woodcock, the interim commissioner, can serve while the nomination is pending. If Califf’s nomination is voted down, she could lead the agency for 210 more days, according to the Government Accountability Office.

  • FDA Seeking Applicants for New CTP Director

    FDA Seeking Applicants for New CTP Director

    Credit: Sean Locke Photography

    The U.S. Food and Drug Administration is now accepting applications for the position of director, Center for Tobacco Products (CTP). The current director, Mitch Zeller, plans to retire in April.

    The CTP director is responsible for planning, managing, directing and coordinating major tobacco program objectives to implement the Tobacco Control Act and related regulations.

    This senior-level FDA position advises the FDA Commissioner, senior FDA officials and others on all matters involving tobacco product regulation that have an impact on policy development and execution and long-range program goals. The director develops and executes the strategies for compliance outreach, enforcement, regulations and guidance formulation, science-based application review and other product regulation activities.

    The individual selected for this position will represent the agency and establish/maintain relationships in meetings and conferences with top level FDA and Health and Human Services officials, national industry representatives, members of Congress, counterparts from federal, state, local and foreign governments.

    Candidates must complete their applications by 11:59 p.m. on Feb. 25, 2022.

  • Respira Technologies Creates Scientific Advisory Board

    Respira Technologies Creates Scientific Advisory Board

    Respira Technologies has created a scientific advisory board and appointed Jasjit S. Ahluwalia as its chair.

    According to Respira, the scientific advisory board to strengthen the company’s connection to the constantly evolving body of scientific evidence on the issues of tobacco use, harm reduction, nicotine and smoking cessation being generated by public health to guide the development of its technology and pipeline for current and future new drug applications.

    “As a biotechnology company whose goal is to end the death and disease caused by smoking through the development of a breakthrough smoking cessation therapy, we must be guided by and have a deep understanding of the constantly evolving data and science generated by public health on issues important to our business,” said Respira Technologies CEO Mario Danek in a statement.

    “We are thrilled to name Dr. Ahluwalia as Chair and the founding member of our scientific advisory board. He represents one of the best and brightest scientific minds with decades of experience in studying nicotine addiction and cessation. Having guidance and perspective from the most distinguished researchers in this space will be critical to Respira achieving its goal of contributing to eliminating preventable morbidity and mortality, and achieving health equity.”

    Ahluwalia is a leader in academic research and public health focused on studying tobacco use, nicotine addiction and smoking cessation. He is a physician and public health scientist at Brown University.

    Through his research, he has also investigated issues of health disparities and minority health broadly across multiple areas of substance use, cancer prevention and public health.

    At Brown University, he is a professor, associate director of the Legoretta Cancer Center and deputy director of the Center for Addiction and Disease Risk Exacerbation, a NIH funded Center of Biomedical Research Excellence. Ahluwalia’s work has generated over 350 publications in leading scientific journals, and he has received over $100 million in research funding as a principal and co-investigator.

    As chair of Respira’s Scientific Advisory Board, Ahluwalia will be engaged in the company’s scientific strategy, development of clinical research and leading engagement within the nicotine, addiction and cessation public health community. His broad healthcare research background will guide Respira’s current application and inform the company’s development pipeline to expand application of its proprietary drug delivery platform across a diverse spectrum of indications and patient populations.

    “I have dedicated the last 30 years of my career to understanding nicotine addiction, cessation and the complex issues they create in our society, especially among ethnic minority and other vulnerable populations,” said Ahluwalia. “Respira has the potential to create a very significant impact on this important public health crisis.  I am thrilled to be leading Respira’s scientific advisory board and look forward to assisting the company in its efforts to improve the lives of hundreds of millions of smokers looking to quit around the world.”

    Respira Technologies is preparing to submit an investigative new drug application to the U.S. Food and Drug Administration in 2022, which will allow the company to begin human clinical studies. The company is pursuing a prescription designation for its portable handheld combination drug device for the indication of smoking cessation therapy.

  • UKVIA Director General to Appear on China National TV

    UKVIA Director General to Appear on China National TV

    John Dunne (Photo: UKVIA)

    The U.K. Vaping Industry Association’s (UKVIA) director general has been invited to talk on national TV in China to give his thoughts on recent proposed regulation changes in China and their potential impact on the Chinese vaping industry both domestically and globally.

    China recently amended its tobacco laws to include e-cigarettes, meaning they will now be regulated like conventional tobacco products.

    The regulation of e-cigarettes in China is of critical importance to the international vaping industry because over 95 percent of e-cigarette hardware is manufactured in that country, leaving the sector keen to see whether this latest regulation change will reshape that global industry.

    To look at these questions, John Dunne will be interviewed on the China Global Television Network to offer his perspective based on many years immersed in both U.K. and international regulatory environments for the vaping sector.

    Speaking ahead of his interview, Dunne described “reasonable regulation” as a “good thing,” adding, “However, while regulation has the ability to raise standards, ensure products are safe for consumers and restrict minors access, in its current form, it could have a massive detrimental influence both domestically and internationally.”

    The UKVIA, together with several other organizations, has outlined its concerns and suggestions to make the regulation more effective and less restrictive in a letter that is being submitted to the State Tobacco Monopoly Administration to consider.

    During the interview, Dunne will also get the chance to speak to the Chinese media about the latest vaping developments in the U.K., such as it being potentially the first country in the world to prescribe e-cigarettes.

    “We know here in the U.K. that what kills people is the combustion and the tar and not nicotine,” he said in a statement. “Our government sees vaping as the solution to a smoking problem and not the problem itself.”

    He added, “I hope the Chinese government and STMA [State Tobacco Monopoly Administration] are open to listening to the industry leaders both domestically and internationally to help shape these regulations so that China can, like the U.K., seize the public heath prize that vaping offers without damaging a very large and vital export business.”

  • Turning Point Brands Names Efremov As New CEO

    Turning Point Brands Names Efremov As New CEO

    Larry Wexler, the leader of Turning Point Brands, will retire as CEO in January. Former Liberty Media executive Yavor Efremov has been named as the company’s new CEO. Wexler will remain on the Board of Directors and serve as a consultant to the company following his retirement.

    Wexler who has been with the company for more than 18 years and serving as president and CEO since 2009, transformed the company into a industry leader by embracing next-generation tobacco products and a growing legal cannabis market. Wexler was instrumental in helping Turning Point Brands create a high-cash generating engine, with iconic brands and extensive distribution capabilities that reach millions of consumers across more than 210,000 retail outlets and e-commerce platforms.

    “It has been my sincere privilege to serve Turning Point Brands and its stakeholders during this period of significant growth as we increased EBITDA fivefold over the past 18 years,” said Wexler in a press note. “I want to thank both the Board for the opportunity to serve our shareholders, and my colleagues for their dedication, hard work and, most importantly, their resiliency during my tenure. Turning Point Brands is well-positioned with highly recognizable brands and a strong management team. I look forward to working with Yavor and the next generation of leaders to build upon the success we have achieved.”

    Larry Wexler (Credit: TPB)

    Prior to joining Turning Point Brands, Efremov served as the CEO of Motorsport Network, where he was responsible for upgrading the IT infrastructure, processes, and company strategy to support the integration of more than 30 businesses around the world. He also served as a senior executive at Liberty Media Corp., where he was instrumental in sourcing, financing, and growing Liberty’s investments in multibillion-dollar businesses, including Charter Communications and Formula 1. Prior to that, Efremov worked as an investment banker at Goldman Sachs & Co. and as a corporate lawyer at the law firm of Cleary, Gottlieb, Steen & Hamilton. Efremov holds a J.D. from Yale Law School and a Ph.D. in economics from Yale University. He also has a B.S. in mathematics and a B.A. in economics from Furman University.

    “During my time as a board member, I have been impressed by the company’s prospects across all divisions,” said Efremov. “In my new role as CEO, I look forward to working alongside this dynamic team of industry leaders to tackle large, compelling opportunities in our existing business and adjacent categories as continued regulatory developments open new avenues for future growth. Our unique organizational infrastructure and strong financial position gives us the flexibility to pursue a variety of large organic and inorganic opportunities to increase shareholder value.”

  • Pyxus Picks Landsberg as New Chief Financial Officer

    Pyxus Picks Landsberg as New Chief Financial Officer

    Photo: akub Jirsák | Dreamstime.com

    Pyxus International has appointed Flavia Landsberg as its new executive vice president and chief financial officer.

    Landsberg joins Pyxus with more than 20 years of financial experience, most recently serving as CFO of High Ridge Brands, a private equity-backed company. Throughout the course of her career, she has also served as CFO of Westminster Foods, EOS Products, and Bunge Limited’s Food & Ingredients division. Landsberg began her career in investment banking and holds a Master of Business Administration from the New York University Stern School of Business.

    “On behalf of Pyxus and the Board of Directors, I am pleased to welcome Flavia to the company. Her impressive background in global agricultural finance, strategic planning and data-driven analytics, coupled with her proven track record of delivering profitable growth, makes her the ideal candidate as we continue to execute on opportunities to drive the business forward,” said Pyxus president and CEO Pieter Sikkel in a statement. “I am confident that Flavia’s invaluable financial leadership experience will complement the company’s vision for the future.”

    Landsberg reports to Sikkel and is responsible for all aspects of the company’s financial strategy and operations, including financial planning and analysis, investor relations, treasury, financial reporting, tax and accounting. She succeeds Joel L. Thomas, who announced his retirement in June. Thomas will remain with the company in an advisory capacity through June 30, 2022, to help ensure a smooth transition.

    “The Board and I would like to thank Joel for providing his financial leadership and dedication to the Company for the past 16 years, including the seven years he has served as CFO,” said Sikkel. “Joel has been pivotal in our company’s transformation, positioning the business for long-term success. It has been a privilege to work with him and we wish him all the best in his retirement.”

  • Biden Taps Ex-FDA Boss Califf To Lead Agency Again

    Biden Taps Ex-FDA Boss Califf To Lead Agency Again

    Robert Califf

    U.S. President Joe Biden today announced that he would nominate Robert M. Califf, a former commissioner of the Food and Drug Administration, to lead the agency again, reports The New York Times.

    A cardiologist and long-time consultant to drug companies, Califf ran the FDA during the last year of the Obama administration

    “Dr. Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement.

    Califf has been a forceful advocate for tobacco control; before he was the FDA commissioner, he was the agency’s deputy commissioner for medical products and tobacco. In an appearance with other former commissioners this year, he said, “I have never seen more capable or nastier lawyers than what I experienced in trying to deal with the tobacco industry. It was awesome and quite frightening for public health.”

    After stepping down as the vice chancellor for clinical and translational health at Duke University, Califf has worked as a senior adviser to Verily Life Sciences, a health technology firm, and its sister company Google Health. Califf, who remains an adjunct professor of medicine at both Duke and Stanford University, is on the corporate board of Cytokinetics, a biopharmaceutical company, according to its website.

    Califf said he was honored to be nominated for the position “at a critical time for our country,” adding, “There’s a lot of work to do, and if confirmed I look forward to rejoining the great team at the FDA to help in their inspiring mission to serve the public.”

    The FDA has had seven different commissioners, including Califf, since 2012, when Margaret Hamburg left the post.

  • Foundation for a Smoke-Free World Changes Leadership

    Foundation for a Smoke-Free World Changes Leadership

    From left to right, Derek Yach, David Janazzo and Heidi Goldstain

    Foundation for a Smoke-Free World today announced that Derek Yach will no longer serve as president and board director. Heidi Goldstein, general counsel, and David Janazzo, chief financial officer and executive vice president of operations and finance, will serve as interim co-presidents, effective immediately, while the board conducts a search for a new president to lead the foundation and its vital mission forward.

    “After careful consideration, the board has determined that now is the right time for a new leader to guide the essential efforts of the Foundation, its team and its work with partners around the world,” said Pamela Parizek, chair of the Foundation’s board of directors, in a statement. “As we continue to take urgent action to accelerate progress toward ending smoking in this generation, we look forward to this opportunity to take the Foundation to the next level of achievement.

    “The Foundation remains squarely focused on its mission to improve global health by reducing death and disease caused by smoking, and Heidi and David, together with the rest of our talented team, will continue advancing our global research grantmaking, range of innovative programs and powerful public health collaborations without interruption.”

    Parizek continued, “On behalf of the board, I want to thank Derek for helping to establish and build the Foundation. We deeply appreciate the contributions he has made to this team’s work and to communities around the world through decades of ground-breaking efforts in tobacco control and public health. We wish him all the best.”

    “The Foundation’s ongoing work to end the world’s largest single preventable cause of death could not be more needed today,” said Yach. “I leave the Foundation with deep satisfaction that we now have an emerging cadre of hundreds of researchers, advocates and industry scientists dedicating themselves to this goal. My future efforts aim to complement them.”