Author: Timothy Donahue

  • New UK Study Offers Insights Into Youth Vaping

    New UK Study Offers Insights Into Youth Vaping

    Photo: Daisy Daisy

    A new study has provided an in-depth look into the rising trend of disposable vape use among young people in the U.K.

    Led by the University of East Anglia and published in Addiction, the research reveals that young people see smoking and vaping as interchangeable, but are far more aware of the potential harms of vaping than they are of the dangers of smoking.

    The findings also suggest that banning disposable vape products or increasing their prices could lead young people to revert to smoking tobacco.

    Many of the young people questioned also believed that if disposable vapes were banned, they would be able to continue using them by stockpiling or purchasing illegally.

    “Youth use of disposable vapes has surged in recent years in the U.K.,” said lead researcher Caitlin Notley, a professor of addiction sciences at UEA’s Norwich Medical School, in a statement.

    “Despite this increase, little was previously known about the motivations behind this trend and the experiences of young people who use these products.

    “This study aimed to explore these aspects, providing valuable insights into the factors influencing youth vaping behavior.”

    The study recruited 29 young people aged between 16 and 20 and a range of methods were used to probe their motivations, experiences and perceptions of using disposable vapes.

    Each approach was chosen to best suit the needs of the participant—from individual interviews with researchers, to recorded conversations in friendship pairs using prompt cards without a researcher present, to small group interviews designed to support those with special educational needs.

    The key findings include:

    • Individual motivations: Participants highlighted key characteristics of disposable vapes that appealed to them, such as affordability, ease of access, and the attractive designs, colors, names, and flavors.
    • Behavior patterns: Many young people engaged in both vaping and tobacco smoking, viewing these behaviors as interchangeable based on the context. There was a common misconception about the relative harms of vaping compared to smoking.
    • Social and emotional factors: Experimentation with vapes was prevalent, and many young people used vapes to manage stress and anxiety. Vaping was also identified as a social activity, widely accepted among peer groups. Notably, participants were more informed about the potential harms of vaping than those associated with smoking.
    • Regulation: Strict regulatory measures, such as banning disposable vape products or increasing their prices, could lead young people to revert to smoking tobacco. Many of the young people believed that if disposable vapes were banned, they would be able to continue using them by stockpiling or purchasing illegally.

    “Disposable vapes are particularly attractive and accessible to young people in the U.K, contributing to the normalization of vaping within this demographic,” said co-author Ian Pope, from UEA’s Norwich Medical School. “Despite recognizing the potential health risks, young people continue to engage in both vaping and smoking, often interchangeably.

    “The widespread availability of underage vape sales and availability of illicit vapes further exacerbates this issue.”

    The researchers say the study suggests that young people’s use of disposable vapes could be reduced by tighter enforcement of age of sale and restricting packaging and marketing.

    However, they also say the evidence suggests these sorts of interventions have the potential for significant unintended consequences, including increased use of illicit vapes and increased tobacco use amongst young people.

    “Therefore any interventions to combat use of disposables may need to be accompanied by policy interventions to reduce access to illicit vapes and tobacco and increase awareness of the relative harms of tobacco compared to vapes,” said Notley.

    The research was conducted in partnership with the Norfolk and Norwich University Hospital and the Nicotine, Tobacco and Vaping Research Group at London South Bank University.

    The study was funded by the Norfolk and Norwich University Hospital Foundation Trust through the National Institute for Health and Care Research’s Research Capability Fund.

  • FDA Bans Boosted From Doing Vape Business in US

    FDA Bans Boosted From Doing Vape Business in US

    The United States District Court for the District of Colorado entered a consent decree of permanent injunction against Boosted (who also does business as Boosted E-Juice, Boosted and Live Boosted) and Cory Vigil, owner of Boosted LLC.

    To avoid litigation, the defendants signed a consent decree, which is a written agreement signed by a federal judge and entered as a court order. Under the consent decree, the defendants have agreed not to manufacture, sell, or distribute any new tobacco products until they meet certain requirements.

    These requirements include that the new tobacco products receive FDA marketing authorization, that FDA inspect the defendants’ facilities to determine compliance with the law, and that FDA notify defendants in writing that they appear to be in compliance with the law.

    According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, defendants were previously warned that failing to obtain marketing authorization from FDA violated the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling, and distributing new tobacco products.

    The agency’s warnings noted that continued violations could lead to further action, including an injunction, according to a release.

    “FDA remains steadfast in our work to enforce the law, especially after we’ve given a crystal-clear warning and explanation of what firms need to do to comply,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “Those who flout the law are responsible for the consequences, and we are committed to using the full force of our authorities to hold them accountable.”

    This case represents the ongoing collaboration among federal partners—which will continue and expand under FDA and DOJ’s newly announced task force—to address unauthorized e-cigarettes in the United States. This is the eighth time FDA and DOJ have initiated injunction proceedings, the first of which occurred in October 2022, to enforce the FD&C Act’s premarket review requirements for new tobacco products.

    DOJ institutes judicial enforcement actions under the FD&C Act in court. Accordingly, DOJ, on behalf of FDA, filed the consent decree of permanent injunction against the defendants in the District of Colorado, the manufacturer’s respective U.S. District Court.

    “FDA has made clear it is committed to working with our federal partners, including the U.S. Department of Justice, to take enforcement actions, like seeking permanent injunctions, against those who violate the law,” said Jill Atencio, acting director of CTP’s Office of Compliance and Enforcement. “A coordinated, all government approach that brings together collective federal resources and experiences is critical to the success of these enforcement actions.”

    The action is part of FDA’s comprehensive approach to enforcing the law in coordination with federal partners. Last year, FDA coordinated with U.S. Customs and Border Protection to seize more than $18 million in unauthorized e-cigarettes during a joint operation at LAX airport.

  • ‘Carcinogens On Permitted Vapor Additives List’

    ‘Carcinogens On Permitted Vapor Additives List’

    Photo: New Africa

    Canada’s proposed list of permitted vapor product additives includes dangerous ingredients, according to Imperial Tobacco Canada (ITCAN).

    “To put it bluntly, the list contains at least one known substance that could cause cancer,” said ITCAN Vice President, Corporate and Regulatory Affairs Eric Gagnon in a statement.

    According to ITCAN, several ingredients on the flavor ban proposal list of permitted ingredients are substances that its parent company, British American Tobacco, categorically avoids in its vaping products.

    The company says BAT’s toxicological risk assessment prevents the use of substances classified as having carcinogenic, mutagenic or reprotoxic (CMR) properties, as per the Globally Harmonized System for classification and labelling of substances.

    “It is shocking that the government would include a proven and classified CMR substance in its lists of permitted additives for vaping products,” ITCAN wrote on its website. “The effect of a regulation that formally permits such ingredients is simply an encouragement to manufacturers—particularly smaller producers with limited access to scientific literature—to use an inherently unsafe substance in a product that is designed to be inhaled into the lungs.”

    Gagnon cited isophorone as an example. “This substance is classified by the European Union as cancer-causing and acutely toxic. It is also banned by Canadian food and drug regulations from use in human cosmetics,” he said.

    “We encourage Health Canada to reconsider the list and consult with experts to determine the best way forward.”

  • UK: Labour Vows to Implement Generational Ban

    UK: Labour Vows to Implement Generational Ban

    Photo: sezerozger

    Britain’s opposition Labour Party, which is favored to win the July 4 national elections, has reiterated its commitment to the generational tobacco ban proposed by Tory Prime Minister Rishi Sunak, reports Reuters.  

    The plan would make it illegal to sell tobacco products to anyone born on or after Jan. 1, 2009, after they turn 18. It would also provide powers to address vaping among young people.

    The generational tobacco ban passed its first parliamentary hurdle in April but was put on hold after Sunak called a national election.

    Labour leader Keir Starmer, whose party is far ahead in opinion polls ahead of the vote, published its planned policies on June 13, vowing to provide political and economic stability, and to improve health outcomes.

    “We must take preventative public health measures to tackle the biggest killers and support people to live longer, healthier lives. That starts with smoking,” the manifesto document said.

    “Labour will ensure the next generation can never legally buy cigarettes … Labour will ban vapes from being branded and advertised to appeal to children to stop the next generation from becoming hooked on nicotine.”

  • Switzerland Set to Ban Disposable Vape Products

    Switzerland Set to Ban Disposable Vape Products

    Photo: twinsterphoto

    Swiss lawmakers voted on June 12 to ban sales of disposable vapes, reports the Swiss Broadcasting Corp.

    The motion calls on the government to amend the Federal Act on Tobacco Products and Electronic Cigarettes so that single-use vapes may no longer be offered for sale in Switzerland.   

    “’Puff bars’ are attractive to young people due to their many flavors and bright colors and are therefore becoming increasingly popular, said Green Party parliamentarian Christophe Clivaz, using the brand name of a popular vape brand to refer to all cigarettes.

    Switzerland imported 10 million units in 2022, he added. 

    Clivaz lamented the environmental impact of improperly disposed vapes and the addictive nature of nicotine products. Clean-up efforts cost millions and the health effects of disposable cigarettes have been insufficiently researched, he noted.

    Interior Minister Elisabeth Baume-Schneider voted against the House of Representatives’ motion, which the Federal Council, Switzerland’s executive body, considers premature.

    The proposal will now move the Senate.

  • FDA Warns Sellers of ‘Drug Bottle’ Vaping Devices

    FDA Warns Sellers of ‘Drug Bottle’ Vaping Devices

    The US Food and Drug Administration has sent warning letters to six online retailers for selling unauthorized e-liquid products from the Bad Drip brand that imitate prescription drug bottles.

    The retailers were also warned for selling unauthorized flavored, disposable vaping products, including those under the brand names Funky Republic and HQD, according to an FDA release.

    “It boggles the mind that someone thought it was a good idea to package a tobacco product to look like a prescription drug bottle,” said Brian King, director of FDA’s Center for Tobacco Products. “There’s no place for this gratuitous and blatantly dangerous packaging, and FDA is committed to taking action against the illegal sale of these products.”

    In a Senate Judiciary meeting yesterday, King noted that products like Elf Bar cannot legally be sold in China because the government there has banned non-tobacco flavored e-cigarettes. Outraged that brands banned in China are sold in the U.S., Texas Senator John Cornyn vowed to introduce legislation to rectify that situation.

    Jefferies analyst Owen Bennett said the Congressional testimony could spur the FDA to approve more products from British American Tobacco and Juul. “This hearing is another example of increasing political pressure for the FDA to act” against unauthorized products, he said in a research note quoted by Bloomberg.

  • FDA, DOJ Grilled for ‘Unserious’ Action on Illegal Vapes

    FDA, DOJ Grilled for ‘Unserious’ Action on Illegal Vapes

    Photo: Katherine Welles

    U.S. Senators criticized top health and law enforcement officials for their failure to tame the rapidly growing illicit e-cigarette market, reports the Associated Press.

    During a hearing on June 12, lawmakers on the Senate Judiciary Committee questioned officials from the Food and Drug Administration and Department of Justice (DOJ) about attempts to manage the vaping market, which has grown to include thousands of flavored, unauthorized e-cigarettes imported from in China.

    To date, the agency has approved only a handful of e-cigarettes as alternatives for adult smokers. All other products on the market, including popular products like Juul, are pending review or considered illegal by regulators.

    “I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application,” said the committee’s chairman, Dick Durbin.

    Brian King, director of the FDA Center for Tobacco Products, said the agency has been slowed by a backlog of applications submitted by vape companies seeking approval to sell their products in the U.S. The FDA received millions of premarket tobacco product applications, each of which must be scientifically reviewed.

    An industry lobbyist told the committee that the FDA has created an untenable marketplace by rejecting more than 99 percent of applications submitted by companies.

    I simply do not understand how FDA and DOJ have permitted thousands of products to remain on store shelves when their manufacturers have not received authorization, or, in some cases, even filed an application.

    Ahead of the congressional hearing, several government agencies, including the FDA and the DOJ established a task force to better coordinate the fight against illegal e-cigarettes. Republican Senator Thom Tillis called the timing of the announcement “a political stunt,” and criticized the absence of other federal agencies from the initiative, including Customs and Border Protection (CBP).

    “If the timing of the task force formation wasn’t evidence of how unserious the FDA is about tackling the flood of illicit e-cigarettes, FDA’s exclusion of CBP from the task force makes it crystal clear,” said Tillis, who represents North Carolina, a major tobacco-producing state. He urged officials to concentrate enforcement on Chinese brands, rather than large domestic manufacturers like Reynolds American, which is based in North Carolina.

    The FDA can conduct investigations and recommend cases, but only the Justice Department can bring lawsuits. The FDA has sent hundreds of warning letters to vape shops and e-cigarette manufacturers in recent years. But the letters have done little to dissuade companies from flouting FDA rules and introducing new vapes.

    Disposable vapes account for an estimated 30 percent to 40 percent of the roughly $7 billion-dollar U.S. vaping market. The two best-selling disposables—Breeze and Elf Bar—generated more than $500 million in sales last year, according to Nielsen retail sales data analyzed by Goldman Sachs.

    Both brands have been sanctioned by FDA regulators but remain widely available, in some cases with new names, logos and flavors.

    King noted that products like Elf Bar cannot legally be sold in China because the government there has banned non-tobacco flavored e-cigarettes. Outraged that brands banned in China are sold in the U.S., Texas Senator John Cornyn vowed to introduce legislation to rectify that situation.

    Jefferies analyst Owen Bennett said the Congressional testimony could spur the FDA to approve more products from British American Tobacco and Juul. “This hearing is another example of increasing political pressure for the FDA to act” against unauthorized products, he said in a research note quoted by Bloomberg.

  • US Senate Hearing on Vaping ‘Epidemic’ Today

    US Senate Hearing on Vaping ‘Epidemic’ Today

    Senator Dick Durbin
    Credit: Dick Durbin

    The US Senate Judiciary Committee plans to conduct hearings today at 10 am on “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E‑Cigarettes.” The hearing will be chaired by Senator Dick Durbin, a longtime opponent of vaping products.

    The hearing will take place just two days after the Justice Department and Food and Drug Administration announced they have created a multi-agency coalition of law enforcement organizations, including the Bureau of Alcohol, Tobacco, Firearms, and Explosives, the US Marshals Service, the Federal Trade Commission, and the US Postal Service, to pursue the underground trade in vaping materials.

    The federal task force will focus on several topics, including investigating and prosecuting new criminal, civil, seizure and forfeiture actions under the PACT Act; the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA); and other authorities.

    “The U.S. Marshals Service Asset Forfeiture Division stands ready to work with our Task Force partners in the seizure of unauthorized e-cigarettes from domestic distributors seeking to sell them unlawfully,” said Ronald Davis, director of the U.S. Marshals Service.

    Both the legislative and executive branches are in a hurry to solve the teen vaping epidemic before the public realizes that there isn’t one, according to media reports.

    As Michelle Minton wrote for the Reason Foundation last December, “The youth vaping epidemic, declared by the Food and Drug Administration in 2018, appears now to have been more of a teenage fad—one possibly partially fueled by media attention on the issue. But, while the vaping fad may be subsiding, the hysteria surrounding it continues unabated.”

  • Coresta THR Congress Registration Opens

    Coresta THR Congress Registration Opens

    Photo: Anthony Brown

    Registration is open for the 2024 Coresta Congress in Edinburgh, Scotland, Oct. 13–17.

    The theme for the congress is Advancing Tobacco Harm Reduction Through Scientific Collaboration.

  • Regulators Urged to Embrace Harm Reduction

    Regulators Urged to Embrace Harm Reduction

    More than 1.8 million lives could be saved within the next 40 years by replacing World Health Organization-directed tobacco control efforts with products like vapes and e-cigarettes, snus and nicotine pouches, a new study has found. Urgent action is required to tackle continuing prevalence of smoking as global efforts to end smoking have stalled and current approaches to tobacco control have proven insufficient, the researchers said.

    Instead of current measures, researchers found that tobacco harm reduction (THR) products that replace smoking with nicotine alternatives promise to make a significant improvement in health outcomes in the Middle East and save millions of lives.

    The researchers studied the impact of tobacco use in seven countries in the Middle East including Pakistan, Egypt, Lebanon, Jordan, Kuwait, Saudi Arabia and the UAE, and determined that more than 384,000 die prematurely annually due to tobacco use. Tobacco use contributes to several major causes of death in these countries including lung and oral cancer, COPD, heart disease, and stroke, which are all set to increase in prevalence over the next few decades.

    The ideal means of reducing this burden is through THR products which use nicotine without the deadly byproducts that cause disease. THR products like e-cigarettes/vapes, heated tobacco products, snus, nicotine pouches and charcoal free shisha are rapidly gaining traction among consumers in the Middle East and are considerably safer than smoking. However, these innovations have not yet been embraced by physicians and governments as means of cutting premature deaths. 

    Embracing THR, cessation, and improved lung cancer treatment represents a major opportunity for the Middle East to dramatically improve the health of its populations.

    The report comes as the quality of evidence on the benefits of smoking cessation and THR has strengthened. Stopping tobacco use at any age is associated with longer survival, and switching to THR products is almost twice as effective for cessation as nicotine replacement therapies. While long-term studies on the health benefits of switching to THR are still needed, results of studies using biomarkers of future diseases are promising.

    The report comes at a critical time as many Middle East countries’ reverse bans on some THR products and liberalize their approach to tobacco alternatives. Meanwhile, new and innovative THR products are being developed for the Middle East signaling the growing acceptance of the value of THR and the demand for them by consumers.

    To benefit from the promise of these products the authors recommend educating physicians to communicate the benefits of THR to patients in all clinical encounters, countering disinformation about nicotine and the value of THR, and developing a regional equivalent of the Royal College of Physicians report on THR and vapes. The authors also recommend that policymakers revise regulations to improve access to THR products and invest in national science and research to replace tobacco with THR and establishing independent science-based consumer groups to advocate for their needs. The authors  encourage religious leaders to guide their communities to quit smoking and support tobacco harm reduction.

    “Embracing THR, cessation, and improved lung cancer treatment represents a major opportunity for the Middle East to dramatically improve the health of its populations,” said Derek Yach, lead author of the report, global health consultant and former senior WHO official. “The prevalence of smoking is projected to only decrease by less than 2 percentage, from 33.3 percent in 2020 to 31 percent in 2025. This preventable disaster should engender outrage and immediate action. This report aims to provide an alternative vision of what is possible.”

    Figure: Projected deaths from tobacco in 2060

    This figure shows the number of tobacco deaths expected to occur in 2060 using three scenarios: WHO projections using FCTC and MPOWER measures; WHO projections adding THR products; and WHO projection adding THR, smoking cessation and, lung cancer innovations.