At their annual meeting in Columbus, Ohio, the U.S. Conference of Mayors approved a resolution that supports prohibiting all flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars.
The Campaign for Tobacco-Free Kids (CTFK) welcomed the move. “We are grateful for the strong leadership provided by the sponsors of this resolution, including Mayors Andy Schor of Lansing, Michigan, Justin Bibb of Cleveland, Ohio, Satya Rhodes-Conway of Madison, Wisconsin, and Alix Desulme of North Miami, Florida,” said John Bowman, the CTFK’s executive vice president for U.S. programs, in a statement.
According to the CTFK, youth e-cigarette use remains a public health crisis driven by flavored products. In 2022, over 2.5 million U.S. youth were current e-cigarette users, and 85 percent of them reported using flavored products.
The resolution also supports prohibiting menthol cigarettes.
The FDA’s reluctance to permit flavored e-cigarettes may be hindering adult smokers’ conversions to less harmful products.
By Neil McKeganey and Andrea Patton
If there is one phrase that must keep e-cigarette and e-liquid company executives awake at night, it must surely be “flavor ban.” In their public statements, U.S. Food and Drug Administration officials have always denied pursuing a ban on e-liquid flavors, encouraging e-cigarette manufactures instead to “show us the data” where e-cigarette flavors are compared to tobacco flavor in terms of their effectiveness in assisting adult smokers in quitting.
The reality of the premarket tobacco application process, however, tells a rather different story. Of the more than 6.7 million applications submitted—over 99 percent of which the FDA has adjudicated upon—not a single flavor other than tobacco has been awarded a marketing authorization. On the basis of those numbers, whether admitted or not, there is an e-cigarette flavor ban in the U.S. in all but name.
But why have flavors drawn such restrictive regulatory action from the FDA? The answer, of course, lies in youth vaping. So great has been the concern at the increase in youth vaping that politicians, public health officials, the media, parents and others have found themselves asking the questions “why are so many kids vaping, and how can we stop it?” When Scott Gottlieb was the director of the FDA, he offered an answer to that question in railing against “kid-appealing flavors.” In the years following Gottlieb’s tenure, it seems the phrase “kid appealing” has been dropped in reference to characterizing flavors per se as the villain of the piece when it comes to youth vaping.
But how can we be sure that it is indeed e-liquid flavors that are driving youth vaping? A surprising answer to that question can be found in the latest results from the 2022 National Youth Tobacco Survey. This survey draws upon data from over 28,000 middle school and high school pupils from across the U.S. and is one of the leading influences on government policy when it comes to e-cigarettes.
When youth who had ever tried an e-cigarette were questioned about the reasons why they first used an e-cigarette, flavors were the ninth most frequently cited reason among middle school pupils and the seventh most frequently cited reason among high school pupils. In explaining their reasons for starting to vape, both middle school and high school pupils much more commonly mentioned curiosity about e-cigarettes, the fact that e-cigarettes were being used by friends or family members, or that they felt anxious, stressed or depressed.
A very similar picture emerged in relation to the reasons youth participants in the survey offered for why they were currently using e-cigarettes. In this case, flavors were the ninth most frequently cited reason among middle school pupils and seventh among high school pupils. Again, much more influential in explaining their current e-cigarette use were the fact that these devices were seen to be a way of reducing stress, the fact that they were used by friends and the attraction of the nicotine buzz. Flavors may be part of the choices that youth make when they are using an e-cigarettes, but that does not mean that they are the key factor in the reason why youth start vaping or continue vaping.
On the basis of those results, one would have to say that flavors may well have been miscast as the cause of youth vaping. There is, however, a further problem with restrictive regulatory action targeted on flavors apart from the fact that it may well not be flavors that are driving youth vaping—the fact that flavors might actually be an important part of adult smokers’ journeys away from combustibles. By reducing the range of tobacco flavors adult smokers can use in their e-cigarettes, regulators may be weakening the capacity of these devices to assist adult smokers in quitting.
With an e-cigarette flavor ban in all but name being applied in the U.S., it is important that e-cigarette companies, and others, monitor the extent to which the reduced range of available flavors may be resulting in fewer adult smokers using e-cigarettes and fewer smokers managing to quit smoking with these products. It is important to remember that the ratchet of restrictive regulatory prohibition can move both up and down depending upon the evidence. If evidence shows that flavors are not driving youth vaping and that those flavors are helping adult smokers to quit, then a case can be made for allowing flavors to reenter the world of adult vaping. In the meantime, attention needs to be focused on how manufacturers and others can work together to ensure that flavored e-cigarettes, while available for adult use, are inaccessible to youth.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.
Andrea Patton, is a behavioral epidemiologist and head of prevalence research within the Centre for Substance Use Research, Glasgow, U.K. Patton has over 15 years of experience working in public health for academia, regulatory bodies and industry leaders in Europe and the United States.
The U.K. will embrace a New Zealand-style generational tobacco ban if the Labour Party wins the next elections, reports the Daily Mail, citing a BBC interview with Shadow Secretary of State for Health and Social Care Wes Streeting.
Interviewed by BBC Radio 4, Streeting said he was keen to adopt a plan that would be workable if Labour won the next election.
“The question for me on the New Zealand-style smoking ban isn’t whether it’s desirable because I think in policy terms, and in terms of public opinion, interestingly, I think there is an appetite and a policy driver there to do it,” he said.
Ministers have previously set an objective for England to be smoke-free by 2030. An independent review by Javed Khan, ordered by former Health Secretary Sajid Javid, was published in August and recommended a series of actions to help eradicate smoking in England.
Khan warned that, without further action, England will miss the 2030 target by at least seven years, and the poorest areas in society will not meet it until 2044.
Smoking rates in the U.K. have fallen from about half of the population in the 1970s to around just 15 percent now.
Vaping industry representatives are unimpressed by the U.S. Food and Drug Administration’s plan, announced Feb. 24, to address the shortcomings in the operations of its Center for Tobacco Products (CTP) identified by independent evaluators working through the Reagan-Udall Foundation.
“While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” Tony Abboud of the Vapor Technology Association told AP News.
The CTP has come under fire from various sides, with health advocates urging the agency to more aggressively police regular cigarettes and flavored e-cigarettes, and tobacco companies complaining that the FDA is unwilling to approve new products, including e-cigarettes, which might help adults quit smoking.
On Dec. 19, 2022, the Reagan-Udall panel issued a blistering report. Evaluators described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.
In response, the FDA pledged a reset to the agency’s tobacco program. The CTP director promised to develop a five-year plan by the end of 2023 outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.
Nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product.
Vaping industry representatives expressed disappointment with the FDA announcement, which they said would continue to result in denials for most vaping products.
“After the scorching findings from the Reagan-Udall report, the FDA should be issuing a mea culpa to the American public for the calamity created by the agency’s insistence on crushing the nicotine vaping market,” the American Vapor Manufacturers Association wrote in a statement.
“But instead of taking responsibility, the agency is proposing yet more task forces, more bureaucrats and even a so-called ‘five-year plan,’ which is government shorthand for punt, retreat, and see you later. It’s not good enough, not by a long shot, and the millions of Americans relying on vaping products to stay off cigarettes have once again been bast to the wind by the FDA’s chronic negligence and indifference.”
Americans for Tax Reform described the CTP’s response as “inadequate,” saying it fails to address the critical issues highlighted by the Reagan-Udall Foundation. “Since [CTP] Director King and FDA are clearly unwilling to step in and fix the problems plaguing the Center for Tobacco Products, this falls upon Congress, and specifically the new Republican House Majority, to use oversight powers to reestablish trust in FDA and improve public health,” the group wrote in a statement.
Vaping industry representatives are unimpressed by the U.S. Food and Drug Administration’s plan, announced Feb. 24, to address the shortcomings in the operations of its Center for Tobacco Products (CTP) identified by independent evaluators working through the Reagan-Udall Foundation.
“While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” Tony Abboud of the Vapor Technology Association told AP News.
The CTP has come under fire from various sides, with health advocates urging the agency to more aggressively police regular cigarettes and flavored e-cigarettes, and tobacco companies complaining that the FDA is unwilling to approve new products, including e-cigarettes, which might help adults quit smoking.
On Dec. 19, 2022, the Reagan-Udall panel issued a blistering report. Evaluators described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.
In response, the FDA pledged a reset to the agency’s tobacco program. The CTP director promised to develop a five-year plan by the end of 2023 outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.
Nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product.
Vaping industry representatives expressed disappointment with the FDA announcement, which they said would continue to result in denials for most vaping products.
“After the scorching findings from the Reagan-Udall report, the FDA should be issuing a mea culpa to the American public for the calamity created by the agency’s insistence on crushing the nicotine vaping market,” the American Vapor Manufacturers Association wrote in a statement.
“But instead of taking responsibility, the agency is proposing yet more task forces, more bureaucrats and even a so-called ‘five-year plan,’ which is government shorthand for punt, retreat, and see you later. It’s not good enough, not by a long shot, and the millions of Americans relying on vaping products to stay off cigarettes have once again been bast to the wind by the FDA’s chronic negligence and indifference.”
Americans for Tax Reform described the CTP’s response as “inadequate,” saying it fails to address the critical issues highlighted by the Reagan-Udall Foundation. “Since [CTP] Director King and FDA are clearly unwilling to step in and fix the problems plaguing the Center for Tobacco Products, this falls upon Congress, and specifically the new Republican House Majority, to use oversight powers to reestablish trust in FDA and improve public health,” the group wrote in a statement.
While welcoming the CTP’s new commitment to transparency, the Premium Cigar Association (PCA) expressed concern that the CTP continues to view industry engagement as an afterthought rather than a means to better understand how its approach can be better designed in the developmental phase of regulations, guidance or strategic planning.
The PCA also questioned the CTP’s desire to increase its workforce and raise more funds through user fees. “Until the systemic failures are addressed, growing an agency that already spans over 1100 employees will only complicate and compound its problems,” the PCA wrote in a statement. “Rather, CTP should embrace Congressional oversight, as does every other Federal Agency, to ensure that its ongoing efforts remain in-line with its statutory mission and public demands.
Vaping industry representatives are unimpressed by the U.S. Food and Drug Administration’s plan, announced Feb. 24, to address the shortcomings in the operations of its Center for Tobacco Products (CTP) identified by independent evaluators working through the Reagan-Udall Foundation.
“While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” Tony Abboud of the Vapor Technology Association told AP News.
The CTP has come under fire from various sides, with health advocates urging the agency to more aggressively police regular cigarettes and flavored e-cigarettes, and tobacco companies complaining that the FDA is unwilling to approve new products, including e-cigarettes, which might help adults quit smoking.
On Dec. 19, 2022, the Reagan-Udall panel issued a blistering report. Evaluators described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.
In response, the FDA pledged a reset to the agency’s tobacco program. The CTP director promised to develop a five-year plan by the end of 2023 outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.
Nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product.
Vaping industry representatives expressed disappointment with the FDA announcement, which they said would continue to result in denials for most vaping products.
“After the scorching findings from the Reagan-Udall report, the FDA should be issuing a mea culpa to the American public for the calamity created by the agency’s insistence on crushing the nicotine vaping market,” the American Vapor Manufacturers Association wrote in a statement.
“But instead of taking responsibility, the agency is proposing yet more task forces, more bureaucrats and even a so-called ‘five-year plan,’ which is government shorthand for punt, retreat, and see you later. It’s not good enough, not by a long shot, and the millions of Americans relying on vaping products to stay off cigarettes have once again been bast to the wind by the FDA’s chronic negligence and indifference.”
Americans for Tax Reform described the CTP’s response as “inadequate,” saying it fails to address the critical issues highlighted by the Reagan-Udall Foundation. “Since [CTP] Director King and FDA are clearly unwilling to step in and fix the problems plaguing the Center for Tobacco Products, this falls upon Congress, and specifically the new Republican House Majority, to use oversight powers to reestablish trust in FDA and improve public health,” the group wrote in a statement.
While welcoming the CTP’s new commitment to transparency, the Premium Cigar Association (PCA) expressed concern that the CTP continues to view industry engagement as an afterthought rather than a means to better understand how its approach can be better designed in the developmental phase of regulations, guidance or strategic planning.
The PCA also questioned the CTP’s desire to increase its workforce and raise more funds through user fees. “Until the systemic failures are addressed, growing an agency that already spans over 1100 employees will only complicate and compound its problems,” the PCA wrote in a statement. “Rather, CTP should embrace Congressional oversight, as does every other Federal Agency, to ensure that its ongoing efforts remain in-line with its statutory mission and public demands.
The Supreme Court of Texas has agreed to hear a lawsuit by a vaper burnt by an exploding battery to determine if Texas courts have jurisdiction over LG Chem America, a subsidiary of South Korea-based LG Chem, which made the battery, reports Law360.
In 2016, Texas resident Tommy Morgan bought an 18650 lithium-ion battery manufactured by LG Chem. He claims it unexpectedly exploded and caught on fire, leading to him suffering permanent and severe injuries, according to his lawsuit filed in 2019 in Brazoria County District Court.
The companies are facing other lawsuits by Texas residents with similar claims concerning batteries exploding. But intermediate appeals courts have come to different conclusions on whether LG Chem has enough contacts in the state to face claims.
LG Chem America and LG Chem have argued that Texas courts lack jurisdiction because the companies don’t sell individual batteries in Texas nor directly to Texas customers. LG has consistently stated in litigation throughout the country that this battery was never intended to be used in e-cigarettes or vaping devices.
Morgan told the Texas high court that the company deliberately shipped its products to Texas customers who were later injured, therefore Texas courts have jurisdiction.
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) on Feb. 24 outlined the steps it plans to take in response to an external evaluation of its operations conducted by evaluators working through the Reagan-Udall Foundation.
The expert panel issued its final report on Dec. 19, 2022, and included 15 recommendations across a number of areas.
To address concerns raised in the report about transparency, the CTP said it would appoint internal transparency liaisons within each CTP Office, who will be responsible for objectively identifying areas for transparency enhancement. The center will also create a new webpage to feature its responses to citizen petitions and will resume posting scientific policy memos and reviewer guides “when appropriate.”
To enhance efficiency of its premarket tobacco product application review process, the CTP said it has started developing a more efficient framework for high-quality reviews. The center said it aims to better communicate on scientific issues and practices; hire additional staff and increase internal communication to improve scientific engagement and deliberation. Among other activities, the CTP said it will resume posting of scientific policy memos and reviewer guides, along with communication through public events, such as workshops and listening sessions.
The CTP also expressed its intention to hold more frequent meeting of the Tobacco Products Scientific Advisory Committee to obtain input on scientific issues.
To improve its operations in the areas of regulations and guidance, the CTP said it will create a new policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination across the CTP.
The FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products.
Recognizing opportunities to enhance its compliance and enforcement work, the CTP said it will convene a summit related to enforcement with senior officials from the Department of Health and Human Services, the FDA, and the Department of Justice (DOJ). The CTP will consider whether statutory changes are needed to assist the center in enforcing the law. It will also explore approaches to achieve compliance outside of judicial enforcement actions through DOJ.
The CTP said it plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization; routinely reach out to industry stakeholders to keep them apprised of new enforcement priorities and updates; and enhance the FDA’s tobacco product marketing order webpage. Planning has already begun for development of a searchable public database of all tobacco products that have an FDA marketing order, according to the center.
To improve engagement on its public education campaigns, the CTP said it will develop, publish and promote resources that describe the mechanisms it currently uses to solicit and consider public input on its campaigns. It will also explore new ways for soliciting and considering public input on its campaign program.
Consistent with the Reagan-Udall report recommendation, the CTP is also engaging with relevant entities within FDA, the Department of Health and Human Services, and the Office of Personnel Management to identify solutions to facilitate more timely and efficient hiring of professionals that match CTP’s needs.
To achieve its goals, the CPT stressed the importance of having appropriate resources, which it suggested could be raised through additional user fees for regulated products, including e-cigarettes. “Since the agency’s fiscal year 2020 budget request, the FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products,” said FDA Commissioner Robert Califf in a statement.
A detailed description of the CTP’s plan for addressing the Reagan-Udall recommendations is available at the center’s new website.
Tobacco Reporter (Vapor Voice‘s sister publication) will be celebrating its 150th anniversary next year, and, understandably, no one today was present for its beginning. However, for Tobacco Reporter’s “modern era”—that is, when its headquarters moved to Raleigh, North Carolina, USA, in 1982—the magazine has been fortunate to enjoy an extraordinarily consistent existence in terms of its personnel. In fact, though many people have contributed over the years, we can easily point to a small handful who have been fundamental and foundational to the evolution of what Tobacco Reporter has today become. Our Mount Rushmore, if you will.
One of those people, without question, was Evelyn O’Neill. She was better known to the industry, her colleagues and friends simply as Kay. Kay joined Tobacco Reporter in 1991 and served numerous roles for the magazine and its family-like parent companies. On Jan. 17, 2023, after battling illness for far too long, Kay passed away surrounded by her loving family.
In her professional life, Kay did everything you can imagine on the sales side, developing relationships and fostering partnerships around the globe. She eventually earned the title of associate publisher, but to those who worked with her, her most important role was always being the “sales coordinator.” To translate that term, Kay was the buffer between the editors and designers back at the office who cared way too much about when the magazine was scheduled to go to the printer and the salespeople out on the road who were unfamiliar with the concept of deadlines. Kay handled each side with a magical blend of charm, humor and force as only she could, kept the peace and helped everything move forward with the big picture in mind.
As her former colleagues shared stories, it became apparent that Kay was the true definition of dichotomy. On one hand, she was a Carolina girl—that is to say, she came off as small-town country with the beautiful Southern twang in her voice—but she was as sharp and worldly as they came. She was equally comfortable networking with industry executives at five-course dinners as she was sharing a plate of Carolina barbecue with tobacco farmers at local extension meetings.
She wasn’t shy about mincing words and wouldn’t hesitate to kick you in the butt when needed but would protect you like a mother lion in her next breath. Each September, she would travel to one of the world’s great cities as part of the Global Tobacco and Nicotine Forum, staying in lush accommodations, then just a few weeks later, she would be in a giant tent standing over a space heater trying to stay warm as she worked a booth at the fairgrounds for the North Carolina Farm Show. Each of those moments was pure Kay. She was a professional, and she was a friend.
Those who knew her will not only miss her generous personality and infectious laughter but also her ability to disarm the moment and bring perspective. While Kay appreciated the value of hard work, she never lost sight of what truly matters: health, friends and family.
Kay is survived by her husband, Don Michael “Mike” O’Neill; her daughter and son-in-law, Laura and Erin Douna; her son and daughter-in-law, Ryan and Meghan O’Neill; her stepson and daughter-in-law, Don Michael and Marie O’Neill; her brother and sister-in-law, David and Regina Peebles; and her grandchildren, Abigail, Finley, Webb, Aubrey, Regan and Michael Wayne—along with a group of grateful friends from more than three decades at Tobacco Reporter.
The U.S. Food and Drug Administration’s proposal to a menthol flavored cigarettes will improve public health only if there are viable menthol and flavored vapor products on the market, according to the Vapor Technology Association (VTA).
In April, the FDA announced a plan to ban the sale mentholated cigarettes, which account for about one-third of the U.S. market. The public was invited to share its thoughts on the measures and the official comment period ended Aug. 2.
In its official comment submission to the agency’s proposed product standards, the VTA urges the FDA to continue to build an “offramp” to menthol and flavored vaping products for smokers to access effective smoking alternatives.
“The menthol cigarette rule “has the potential to dramatically reducing cigarette smoking—the leading cause of death and disease of Americans—but only if the agency heeds the warning of scientists that menthol smokers must have access to less harmful vaping and other alternative nicotine products,” the VTA wrote in a statement.
“These limitations threaten to take what should be a public health victory and turn it into a half measure that, in the absence of other decisive action from the FDA, will fall far short of the benefits the agency claims.”
“FDA’s own proffered scientific experts acknowledge that at least 50 percent, and in some cases a larger percentage, of smokers will continue to smoke cigarettes or other combustible products after the menthol cigarette rule is put into effect unless provided access to effective alternatives.
“To fulfill its own harm reduction mission, the agency must use its PMTA process to ensure a rational, regulated legal marketplace with suitable less harmful non-combustible alternatives,” the VTA wrote.
The U.K. will embrace a New Zealand-style generational tobacco ban if the Labour Party wins the next elections, reports the 
