Author: Staff Writer

  • Vaping and ED Study has Several Potential Data Flaws

    Vaping and ED Study has Several Potential Data Flaws

    It appears there’s another negative consequence of vaping that may not be true. Alongside bone damage, depression and smoke, vapers can add erectile dysfunction to list of medical maladies supported by faulty research, according to the American Council on Science and Health. Major media outlets have broadcast the results of the suspect study globally.

    Credit: Catalin Pop

    A major issue with the ED study is that participants were classified as current someday (“i.e., not every day or occasional”) or daily vapers, or smokers if they consumed cigarettes “every day or some days.” Beyond this self-reported information, the researchers didn’t know how much or which e-liquids the vapers in their study used, nor did they know how many cigarettes each smoker consumed.

    “This is a common problem in vaping research: e-cigarette use is defined so broadly that there’s no way to establish a dose-response relationship between vaping and the health outcome in question,” Cameron English writes.

    Men were similarly classified as having ED based on a 1-item question: “Many men experience problems with sexual intercourse. How would you describe your ability to get and keep an erection adequate for satisfactory intercourse?” As a result, the study may have erroneously identified participants as having ED who actually don’t or missed others with mild symptoms. The researchers summed up the problem with these data gaps towards the end of the paper, writing: “… the analyses were based on both self-reported covariate data, ENDS use status, and ED status, all of which are subject to misclassification, recall, and social desirability bias …”

    The recent study, published in the American Journal of Preventive Medicine, found those who reported daily e-cig use were 2.2 times more likely to report having erectile dysfunction compared to men who had never vaped, regardless of their other risk factors. In a smaller sample of men younger than 65 with normal BMIs and no history of cardiovascular disease, the trend persisted: vapers were 2.4 times more likely to experience ED compared to non-vapers.

    Additionally, another critical issue is that the study only provided a snapshot of people who reported vaping and experiencing ED. “There’s nothing wrong with this cross-sectional study design; it can help answer a number of important questions, but it’s not useful if you’re trying to assess the long-term risks of a given exposure, vaping in this case,” English states. “To highlight one potential issue, did the participants develop ED before they began vaping? If so, that means electronic cigarettes aren’t to blame, though this study can’t account for that possibility.”

    The researchers also did not question whether other factors contribute to the frequency of ED reported in the present study, such as smoking combustible cigarettes. “Nevertheless, this study failed to detect an association between cigarette smoking and ED, also when accounting for current daily smoking versus nondaily smoking (data not shown),” the researchers wrote.

    However, nicotine has long been called a factor in erectile disfunction. Men who smoked more than 20 cigarettes daily had a 60 percent higher risk of erectile dysfunction, compared to men who never smoked, according to the American Heart Association (AHA). Smoking, according to the AHA, and erectile dysfunction have often been associated — individually — with plaque build-up in the arteries, called atherosclerosis.

  • 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.”

  • Report: Flavored Vapes Remain Widely Available

    Report: Flavored Vapes Remain Widely Available

    Photo: kurgu128

    Three months after a court-ordered deadline for the U.S. Food and Drug Administration to decide what e-cigarette products can stay on the market, FDA delays have left e-cigarettes in kid-friendly flavors widely available across the country, according to a new report released by the Campaign for Tobacco-Free Kids (CTFK).

    Under a federal court order, e-cigarette manufacturers were required to submit marketing applications to the FDA by Sept. 9, 2020, and products that were the subject of timely applications were allowed to stay on the market for up to one year while the FDA reviewed the applications, a period that expired Sept. 9, 2021. The CTFK and other public health groups have urged the FDA to deny marketing applications for all flavored e-cigarettes because of “the clear evidence that flavored products have fueled an epidemic of youth e-cigarette use and nicotine addiction.”

    The FDA has denied marketing applications for more than 1 million flavored e-cigarette products. However, the FDA has yet to issue decisions about the e-cigarette brands that have the largest market share or are most popular with kids, such as Juul, most Vuse products, NJOY, Blu, Smok and Suorin.

    The FDA is also considering whether to authorize any menthol-flavored e-cigarettes despite the popularity of menthol products with kids, according to the CTFK.

    In addition, more than 40 e-cigarette companies have filed lawsuits challenging the FDA’s marketing denial orders, and other companies—including Puff Bar, the flavored disposable e-cigarette that is now the most popular brand among kids—have started using synthetic nicotine because that substance is currently not regulated by the agency.

    To assess the impact of the FDA’s actions to date on the availability of flavored e-cigarettes, the CTFK scanned five top online e-cigarette retailers and 43 brick-and-mortar stores in eight cities across the U.S. The group notes that the scan provides a snapshot of the current e-cigarette market and is not intended to be a representative sample of stores nationwide or online.

    Key findings include that kid-friendly flavored e-cigarettes and nicotine e-liquids are still widely available; that the bestselling e-cigarette brands remain available for purchase; and that the most popular e-cigarette brands among youth are still available in flavors that appeal to youth, according to the CTFK.

    The group has called on the FDA to act quickly on all remaining e-cigarette applications and deny authorization to all flavored e-cigarettes, including menthol-flavored products.

  • KT&G’s Lil Now Available in 20 Countries

    KT&G’s Lil Now Available in 20 Countries

    Photo: KT&G

    KT&G has launched its heat-not-burn product Lil in more than 20 markets within two years after signing a supply agreement with Philip Morris International for overseas sales of Lil in early 2020, the South Korean company announced on its website

    Last year, KT&G and PMI launched Lil Solid 1.0 in Russia and Ukraine, and Lil Hybrid 2.0 in Japan. This year, the two companies expanded into other markets including Kazakhstan, Serbia and Armenia, with Lil Solid 2.0 as the flagship product. This August, an announcement was made that Lil was launched in a total 10 markets globally, Albania being the latest market at the time.

    KT&G added additional markets in the fourth quarter this year. In November, Lil debuted in Guatemala, the first market in Central America, and the company expanded into the Asian market further, launching Lil in Malaysia after Japan. Additionally in the same month, Lil Solid 2.0 and its dedicated stick Fiit were launched in Italy.

    Lil Solid 2.0 is a second-generation model of KT&G’s heat-not-burn products. It boasts improved battery performance and induction heating technology, and it comes in two colors, “stone grey” and “cosmic blue” outside Korea.

    The dedicated sticks come in a total of eight variants including Fiit Regular and Fiit Crisp, and a new variant, Fiit Alpine, has been launched in the fourth quarter this year. Two to five variants have been launched in each country‒tailored towards consumer taste preference.

    “Lil was able to quickly expand internationally thanks to Lil’s innovative technology in addition to PMI’s commercial resources and infrastructure,” said Wang Seop Lim, chief of KT&G’s next-generation products division. “We will continue to provide high quality products to consumers outside Korea through strategic collaboration with PMI going forward.”

  • Juul Labs Sues Reeha for Trademark Infringement

    Juul Labs Sues Reeha for Trademark Infringement

    JUUL Labs, Inc filed a suit against defendant Reeha LLC in the District of Connecticut alleging trademark infringement and unfair trading practices on their vaping products for purportedly selling counterfeit JUUL products, according to lawstreetmedia.

    The complaint, filed Dec. 15, states that “wrongdoers have counterfeited JUUL products by illegally manufacturing, selling and distributing fake, copied, and non-genuine versions of JUUL products and related packaging bearing JUUL trademarks.”

    Allegedly the defendant did not have JUUL’s “authorization to produce, manufacture, distribute, market, offer for sale, and/or sell merchandise bearing the JUUL marks.” The plaintiff also claims that the defendant hurt the JUUL brand by selling lower quality products to unsuspecting customers who believed these to be true JUUL products.

    Reeha allegedly used the trademarked words “JUULpods” in some of their products as well as the plaintiff’s company name “JUUL.”  

    The Juul contends that Reeha sold “unlawful Grey Market Goods,” which are only meant to be sold in foreign markets because they do not comply with U.S. regulation. According to the complaint, this became more obvious to the plaintiff when it looked at some of these counterfeit products that contained foreign language warnings on them, which are never found on JUUL products legally sold in the United States. 

    According to the plaintiff, it sent a cease-and-desist letter to the defendant to end the sales of the “unlawful Grey Market Goods,” yet the sales continued after the letter had been sent to the defendant.

    The defendant is facing six counts, including trademark infringement – counterfeit goods, false designation of origin, unfair competition, trademark infringement – grey market goods, statutory unfair trade practices and common law unfair competition.

  • Avail Vapor Closes Remaining Stores, Sells Off Assets

    Avail Vapor Closes Remaining Stores, Sells Off Assets

    Avail Vapor has sold the majority of its retail locations and closed its remaining stores. The company has also sold or closed its ancillary businesses. James Xu, founder of Avail, said the decision was motivated by multiple factors over several years, including what he called unclear and convoluted federal regulatory processes.

    Credit: Avail

    At one time, Avail Vapor was the largest family-owned vapor retailer in the U.S. with more than 100 stores in a dozen states. In January of 2020, the company split into regulatory compliance and consulting business, and a major wholesale distribution company. Those businesses have also been sold or closed.

    Xu said the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) pathway was a major factor in the decision after the agency arbitrarily changed the requirements to get a PMTA approved. “It’s completely just a mess with FDA policy making and policy strategy. It just did not make any sense from day one,” Xu said. “Everything is really in this gray area. It was totally different from what our mission was and COVID is not helping any retailer.”

    Xu said Avail spent more than $10 million in its bid to get regulatory approval since 2016, when the FDA set forth new compliance standards for vaping products. But the FDA rejected Avail’s applications in September and the company sued the government agency in federal appeals court. However, the FDA then stayed enforcement of the MDO on Nov. 1, pending an administrative appeal.

    The economic impacts of COVID-19 also created challenges for the company, which began downsizing in August when it sold an estimated 30 of its stores to North Carolina-based competitor AMV Holdings, parent to Kure and Madvapes. It then shuttered or sold its remaining 20 stores, including five in the same city as the company’s headquarters, Richmond, Virginia, Xu said in an interview with Richmond Biz Sense.

    Avail was an early entry into the vapor market, opening its first stores in 2013. By 2015, the company was producing its own e-liquids in its 37,000-square-foot office and manufacturing facility. It soon began also producing e-liquids for several other major brands. Xu said that he is not leaving the vapor industry and an announcement concerning a new project would be announced soon.

  • Philippines Senate Approves Proposed Vaping Bill

    Philippines Senate Approves Proposed Vaping Bill

    Photo: Oleksii

    The Philippine Senate on Dec. 16 approved the proposed Vaporized Nicotine Products Regulation Act, reports The Philippine Inquirer.

    Senate Bill 2239 transfers regulatory authority over vapor products from the Philippines Food and Drug Administration’s authority to the Department of Trade and Industry.

    ,The move was prompted partly by outrage over news that groups supported by Bloomberg Philanthropies had funded the FDA in an effort to influence the agency to impose harsh vaping restrictions.

    The legislation prohibits the sale of vapor products to people below the age of 18 and bans e-cigarette sales within 100 meters from “any point of the perimeter of” a school, playground, or other facilities frequented by minors.

    The bill also prohibits celebrities or social media influencers from endorsing vapor products.

    Physical and online retailers or distributors must register with the Department of Trade and Industry and the Securities and Exchange Commission.

    Senate President Pro Tempore Ralph Recto, the sponsor of the bill, said shifting to vaporized nicotine products “is a good public policy.”

    “There will be less death and less expense on the part of society in treating patients. And that is the direction where many countries, more developed economies are moving toward,” Recto added.

    The Philippines House of Representatives overwhelmingly passed a similar bill in May. The two bills will now go to a conference committee where they will be reconciled, and both houses will vote on the final version. Then the unified bill will go to President Rodrigo Duterte to sign into law or veto.

    Tobacco control groups are lobbying the president to veto the bill when it reaches his desk. A veto can be overridden with a two-thirds vote of both houses.

  • 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.”

  • Vuse Quickly Narrowing Market Share Gap With Juul

    Vuse Quickly Narrowing Market Share Gap With Juul

    Vuse is now only 4.2 percent of the market behind Juul. According to a Nielsen analysis of convenience store data, covering the four-week period ending Dec. 4, Juul was at 38.2 percent, down from 38.8 percent in the previous report. Vuse, however, held steady with 34 percent of the market.

    Credit: Overland Park Vape Shop

    NJoy was at 3 percent, unchanged from the previous report, while Fontem Ventures’ blu eCigs was at 2.4 percent, also unchanged, according to a Winston-Salem Journal report. Overall, sales of electronic cigarettes were up 6.7 percent year over year for the latest four-week period, boosted by recent price hikes.

    Juul’s four-week dollar sales have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 9.7 percent decline in the latest report. By comparison, Reynolds’ Vuse was up 50.1 percent in the latest report, while No. 3 NJoy was down 23.2 percent and No. 4 blu eCigs down 13.8 percent.

    Goldman Sachs analyst Bonnie Herzog has said that NJoy “refutes Nielsen’s data and methodology.”

    On Oct. 12, the FDA issued a landmark ruling in approving a Vuse Solo product as appropriate to market to smokers from a public-health standpoint. The FDA’s order covers the tobacco flavor of the Vuse Solo closed electronic nicotine delivery system, its power unit and two replacement cartridges.

    However, the FDA rejected submissions for 10 flavored Vuse Solo products. It said it “is still evaluating” the company’s application for menthol-flavored products for Vuse Solo.

    Reynolds has said the FDA’s orders “confirm that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers age 21+ have access to innovative and potentially less harmful alternatives to traditional tobacco products.”

  • U.S. Youth Nicotine Vaping Down Significantly in 2021

    U.S. Youth Nicotine Vaping Down Significantly in 2021

    Photo: eldarnurkovic

    Nicotine vaping among U.S. adolescents was down significant in 2021, according to the most recent Monitoring the Future survey of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States.

    Among eighth graders, 12.1 percent reported vaping nicotine in the past year in 2021, compared to 16.6 percent in 2020. Among 10th graders, 19.5 percent reported vaping nicotine in the past year in 2021, compared to 30.7 percent in 2020. For 12th graders, the share reporting nicotine vaping in 2021 was 26.6 percent, compared to 34.5 percent in 2020.

    Youth cigarette smoking fell to record lows this year, with past-month smoking rates of 4.1 percent for 12th graders, 1.8 percent for 10th graders and 1.1 percent for eighth graders.

    Youth consumption of alcohol and illicit substances declined as well. “We have never seen such dramatic decreases in drug use among teens in just a one-year period. These data are unprecedented and highlight one unexpected potential consequence of the Covid-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” said Nora Volkow, director of the National Institute on Drug Abuse in a statement.

    Despite the decrease in consumption, anti-vaping activists insisted that youth vaping remains a problem. “While this is a decline since youth e-cigarette rates peaked in 2019, it is nearly the same level as in 2018 (20.9 percent) when the U.S. Surgeon General, the FDA and other public health authorities declared youth e-cigarette use to be a public health epidemic,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids in a statement.

    The authors of the Monitoring the Future survey said this year’s results should be treated with caution due to the Covid-19 pandemic and remote learning. “Students who took the survey at home may not have had the same privacy or may not have felt as comfortable truthfully reporting substance use as they would at school, when they are away from their parents,” they noted.