Author: Timothy Donahue

  • Doctor Says EVALI is Often Used in Wrong Context

    Doctor Says EVALI is Often Used in Wrong Context

    E-cigarette and vaping-associated lung injury (EVALI) is a term that is coming up more often in countries like Malaysia that are just beginning the journey towards regulating next-generation tobacco products.

    Dr. Kumar Subaramaniam, based in Malaysia, says he finds the increased usage of the term EVALI worrisome, as it is often discussed in the wrong context, according to the New Strait Times. Kumar said that the issue lies with certain parties, who bring up EVALI at the mention of vaping, while repeating and spreading mistruths about vaping.

    Credit: Fotolia Premium

    When the U.S. Centers for Disease Control and Prevention (CDC) identified the real culprit behind the EVALI outbreak, the presence of vitamin E acetate that was added into illegal tetrahydrocannabinol (THC) products, Kumar said the CDC’s slow reaction to announcing the cause caused the mishap that left a bad reputation on vaping, which was touted to give many smokers a chance to quit smoking tobacco products for good.

    “So, it was not vaping that was the problem, rather the misuse and abuse of the products. But the damage has been done and the half-baked truths surrounding EVALI live on to this day,” he says. “The EVALI saga should not be used as a ‘boogeyman’ to dissuade us from seeking to regulate vaping and adopt a ‘zero-tolerance’ attitude. In fact, the EVALI saga in the U.S. shows above all the importance of regulations.”

    Kumar believes that Malaysia needs to regulate vaping for the safety of its users. Regulations will allow the authorities and consumers themselves to be sure that the e-liquids in the market meet regulatory standards.

    Perhaps regulations will pave the way for a greater understanding of how vaping, which is scientifically proven to be a less harmful alternative to smoking, can help the estimated five million smokers in the country kick the habit, he says. “If we are to move forward in this country and put an end to the menace that is smoking, we need to arm ourselves with good science, facts and data,” said Kumar. “

  • US Science Council Cries Foul on Cessation Study

    US Science Council Cries Foul on Cessation Study

    A recent study that found that vaping doesn’t prevent smokers from relapsing to cigarettes has a major flaw, according to Cameron English, writing for the American Council on Science and Health. The results seem to undermine the efficacy of e-cigarettes as smoking-cessation tools—”until you take a closer look at the definition of relapse.”

    At first glance, the study seems to undermine the case for e-cigarette use as a smoking cessation tool. But first glances, as we all know, rarely tell the whole story, according to English. A closer look at the paper indicates that its authors improperly assessed how smokers utilize e-cigarettes, thus generating results that don’t reflect reality.

    The researchers analyzed data on 3,578 previous-year smokers who had recently attempted to quit and 1,323 recent former smokers from the Population Assessment of Tobacco and Health (PATH) Study between 2017-2019. Participants self-reported their use of e-cigarettes or other products to quit cigarettes. The researchers then investigated who among the study participants had abstained from smoking or any tobacco products in 2019.

    Credit: Aleksej

    “The significance of this study is limited by the same flaw we found in an earlier paper by two of the same authors: relapse to tobacco use was measured by the question ‘In the past 12 months, have you smoked a cigarette/(used product), even one or two puffs/times?’ Using this metric, an individual who has almost entirely quit smoking, save for “even one or two puffs” of a cigarette, and someone who has gone back to smoking a pack a day would be counted as having relapsed,” English writes.

    “This definition ignores the fact that many smokers gradually switch from combustible cigarettes to their electronic counterparts. This is known as ‘dual-use,’ and properly designed epidemiological studies (even those based on PATH data) and clinical trials try to account for this behavioral shift, correctly noting that replacing even some cigarette smoking with vaping is desirable because vaping is the far safer option.”

    Additional high-quality research would be very helpful, but “preventing relapse” is an all but useless outcome, states English. “Unless the researchers evaluate how e-cigarettes are used in the real world, the only thing their next paper will confirm is that asking the wrong question inevitably leads to the wrong answer, he writes.

     

  • EU Parliament Endorses Vapor as Cessation Tool

    EU Parliament Endorses Vapor as Cessation Tool

    Credit: Savvapanf Photo

    The EU Parliament has adopted, by a margin of 652 votes to 15, a report on Cancer prevention and Treatment that recognizes the potential contribution of vapor products to smoking cessation. The report notes that “electronic cigarettes could allow some smokers to progressively quit smoking.”

    In adopting the report, the EU Parliament has become the world’s first elected chamber to endorse tobacco harm reduction, according to the Independent European Vape Association (IEVA).

    “This is a landmark declaration by the European Parliament, which should go a long way to reassuring smokers of the health benefits that a switch to vaping can bring,” said IEVA President Dustin Dahlmann in a statement. “We now encourage the other EU institutions—and in particular, the European Commission—to take this on board and ensure that policy follows science, not the other way around.”

    In addition to measures to reduce cancer incidence, the committee’s report places a special focus on the serious health effects of smoking.

    The report also stresses the need for further research on vaping to be viewed in relative terms, given that tobacco smoking kills and vaping does not.

    The final text of the report also includes a mention of further assessment of flavors “particularly attractive to minors and non-smokers” and a possible ban on them in the context of the review of the Tobacco Products Directive.

    The IEVA says its crucial to avoid a flavor ban because the variety of flavors is one of the top reasons for adult smokers to switch to e-cigarettes and for vapers not to return to smoking.

    Research into the impact of flavor bans shows that many vapers return to smoking as a result [of a ban],” said  Dahlmann. “This must be prevented. We agree that steps must be taken to curtail inappropriate marketing, while recognizing the crucial role flavors play in helping smokers quit.”

     

  • Trade Group: ‘Hasty’ Flavor Ban Study Has Major Flaw

    Trade Group: ‘Hasty’ Flavor Ban Study Has Major Flaw

    Photo: kurgu128

    A recent study that found flavor ban-induced sales declines also reduced youth vaping is flawed, according to the Canadian Vaping Association (CVA).

    A recent CDC Foundation analysis examining the change in vape product sales in Massachusetts, New York, Rhode Island and Washington after flavor bans found that statewide restrictions on nontobacco-flavored sales were associated with reductions of 25.01 percent to 31.26 percent in total unit sales compared with total sales in states without restrictions.

    However, the “hasty” conclusion that the reduction in total sales has also reduced youth vaping prevalence “does not hold up,” according to the CVA, because the authors were unable to assess the age of purchasers.

    Darryl Tempest

    According to the CVA, the most common way for youth to access vaping products is through social sourcing. “Even if the age of the purchasers could be verified, a reduction in youth vaping could only be determined through additional studies,” the CVA wrote in press note.

    “The problem with taking a micro view to regulation and forming policy based on individual studies is [that] the bigger picture is neglected,” said Darryl Tempest, government relations council to the CVA Board. “If we take this study at face value and assume the conclusion is accurate and less youth are vaping, on the surface it seems like this type of regulation is logical. Yet, we know from reviewing the full scope of evidence that flavor restrictions result in smoking-related illness and death.”

    Massachusetts’ ban of flavored tobacco products is not the success its proponents make it out to be, according to Ulrik Boesen of the Tax Foundation.

    A study published in JAMA Internal Medicine found that while the sale of flavored tobacco in Massachusetts decreased more than sales in the 27 control states in the wake of the state ban, the authors failed to consider the impact of cross-border trade.

    According to Boesen, increased sales in neighboring New Hampshire and Rhode Island almost completely made up for the decrease in Massachusetts.

  • Irish Vape Group Defends Flavor Preferences of Adults

    Irish Vape Group Defends Flavor Preferences of Adults

    Ireland’s Oireachtas Health Committee yesterday heard testimony from three members of the Irish Vape Vendors Association (IVVA) as politicians continued scrutiny of the general scheme of the Public Health (Tobacco and Nicotine Inhaling Products) Bill. The three members of the IVVA, who all have ties to the vaping industry, argued that flavors should be retained as people seeking to give up smoking using vapor products “want to move away from the flavor of tobacco.”

    Credit: Юлия Кравченко

    Social Democrats TD Róisín Shortall asked the IVVA about a number of vape flavors that she said would be “particularly attractive to under 18s.” Addressing the committee, Shortall named a number of the flavors listed on their websites including Dr Frost Lemonade Fizz, Apple Berry Crumble and Purple Slush. “Surely there isn’t a demand for adults from those for those flavors, they very much sound like flavors that are designed to appeal to children,” she said. Shortall also said that some products are sold with “cartoon-like packaging” such as “Vampire Vape”.

    In response, Joanna O’Connell of Vapourpal said their website “only stocks flavors that our adult customers request,” according to The Journal. “They’re not attracted by the packaging, they are attracted by the flavor. That specific flavor that you’re speaking of that’s on our website is one of the most popular fruit flavored e-liquids among adults,” she said.

    O’Connell agreed that the packaging was “cartoon-like” and added that they have “been onto the manufacturer regarding that.” Shortall also sought clarity from the IVVA on online age verification for buying e-cigarette products online. One IVVA member said that there are no “foolproof” age verification systems for online e-cigarettes websites.

  • Robert Califf Confirmed, Returns as FDA Commissioner

    Robert Califf Confirmed, Returns as FDA Commissioner

    He’s back. The U.S. Senate on Feb. 15 narrowly confirmed Robert Califf as commissioner of the U.S. Food and Drug Administration, reports The New York Times.

    The vote was 50-to-46, with six Republicans crossing the aisle to support him while five senators who caucus with Democrats opposed him. One senator voted present.

    Credit: Bill Clark/CQ Roll Call

    A cardiologist who has served as the deputy commissioner of the FDA’s Office of Medical Products and Tobacco, as President Barack Obama’s FDA commissioner and as the head of medical strategy at Alphabet, Google’s parent company, Califf takes over the position from Janet Woodcock, the acting commissioner since President Joe Biden assumed office more than a year ago.

    According to Vaping360, Califf has been generally antagonistic toward vaping as a consumer product. He was at the FDA helm in 2016 when the agency rolled out the Deeming Rule, which gave the FDA authority over e-cigarettes and other tobacco-free nicotine products.

    Tellingly, the Campaign for Tobacco-Free Kids (CTFK) enthusiastically welcomed Califf’s appointment. “Dr. Califf is highly qualified and prepared on day one to address the enormous challenges facing the FDA, including the most significant decisions on tobacco in the agency’s history,” wrote CTFK President Matthew L. Myers in a statement.

    Califf is expected to be sworn in this week. He faces a looming flurry of decisions, including reviews of premarket tobacco applications from leading e-cigarette companies, such as Juul Labs. He will also have to contend with litigation from vapor companies over marketing denial orders (MDOs).

    After issuing MDOs to hundreds of manufacturers for hundreds of thousands flavored product, the agency has been challenged in court by more than 30 companies that claim their PMTAs were denied based on a standard that was not in place when the applications were submitted.

    One of the new commissioner’s first tasks will be working with Health and Human Services Secretary Xavier Becerra to find a replacement for Center for Tobacco Products Director Mitch Zeller, who plans to retire in April.

  • Irish Vape Group to Urge Health Officials Against Flavor Ban

    Irish Vape Group to Urge Health Officials Against Flavor Ban

    Members of the Irish Vape Vendors Association (IVVA) will argue today that flavored nicotine vaping products should not be restricted in newly proposed tobacco control legislation.

    The Joint Committee on Health is meeting with representatives from the IVVA for pre-legislative scrutiny of the general proposals included in the Public Health (Tobacco and Nicotine Inhaling Products) Bill.

    The proposed legislation would prohibit the sale of vaping and tobacco and heat-not-burn (HnB) products to persons under the age of 18. It will also make it illegal for under-18s to sell such products, according to The Journal.

    Credit: a4stockphotos

    The committee previously heard concerns from the Irish Heart Foundation that teen smoking rates are increasing for the first time in ten years due to an “explosion” of vaping among this age group.

    “Research from the Health Research Board has found that teenagers who vape are up to five times more likely to take up smoking citing the gateway effect. We welcome the opportunity to discuss these and other related matters with representatives,” a committee member said.

    A spokesperson for the IVVA argues that e-liquid flavors are of vital importance to adult vapers. The IVVA says it is “deeply concerned” by the negative effects a flavor ban could have on tobacco harm reduction and consumer choice.

    “The main argument in favor of banning flavored e-liquids is the potential risk of making vaping products more attractive to minors with child-friendly flavorings & packaging. The association between vaping flavors and subsequent smoking initiation is not substantiated. Banning flavored e-liquids would also run counter to vape consumers’ interest. IVVA members observe daily that the choice of e-liquid flavors is one of the reasons that encourages an adult smoker make the switch to vaping.” the IVVA will tell the committee.

    Ireland hopes to be tobacco-free by 2025.

  • U.S. Army Article Wrongly Places EVALI Cause on E-Cigs

    U.S. Army Article Wrongly Places EVALI Cause on E-Cigs

    Credit: Media VN

    It doesn’t stop. Since the U.S. Centers for Disease Control and Prevention and U.S. Food and Drug Administration wrongly blamed nicotine vaping products as the cause of e-cigarette or vaping use-associated lung injury (EVALI) numerous news outlets continue to spread the misinformation.

    The official website for the U.S. Army yesterday published an article wrongly blaming EVALI on nicotine vaping products. The article states that “vaping has been commercially available since the early 2000s, and there have been hundreds of reports” of EVALI since then. “Public Health officials advise against the use of e-cigarettes, but highly recommend purchase from known vendors, if consuming … Washington says an estimated 200,000–300,000 active duty service members are diagnosed with acute respiratory issues annually.”

    After the CDC announced that vitamin E acetate in black market marijuana vaping products was the cause EVALI more than two years ago, many media outlets continue to falsely blame nicotine vaping products for the lung illness that was first identified in 2019.

    Credit: Master1305

    A study published in January 2020 in the journal Toxics provided important insight into the lung intoxication epidemic. The study presented, for the first time, a comprehensive analysis of products used by EVALI patients. Vitamin E acetate was the main finding in cannabinoid liquids. No compound that could be linked to EVALI was found in the two nicotine products tested.

    Some tobacco control experts said the CDC created panic with its refusal to directly blame the actual causes of EVALI, vitamin E acetate in illegal THC vapes. Following CDC’s lead, state health departments spread the word that using an e-cigarette to quit smoking could be life-threatening — so much so that seven states issued emergency bans on the sale of most or all electronic cigarettes.

    “Throughout its investigation of the first outbreak, CDC created public hysteria over the dangers of electronic cigarettes by attributing the outbreak to all vaping products, whether they contained nicotine or THC and whether they were purchased at a highly regulated vape shop or from a drug dealer on the street,” wrote Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, where he has conducted research on tobacco for 25 years, at the time. “The very name that CDC attached to the outbreak directly implicated electronic cigarettes, which are nicotine-delivery devices that are effective in helping adult smokers to quit smoking. Following CDC’s lead, state health departments spread the word that using an e-cigarette to quit smoking could be life-threatening — so much so that seven states issued emergency bans on the sale of most or all electronic cigarettes.”

  • Califf Confirmation as New FDA Chief Expected Today

    Califf Confirmation as New FDA Chief Expected Today

    The FDA is expected to have a new leader today. Robert Califf will likely be confirmed as the next commissioner of the U.S. Food & Drug Administration (FDA) by midday Tuesday.

    On Monday night, the Senate voted 49-45 to advance his nomination as part of a cloture vote, a key procedural hurdle that can also show whether or not Senate leadership has enough votes to succeed. Technically, cloture simply streamlines the vote by limiting down the time a matter can be discussed and also restricting Senators from certain actions such as amendments that are unrelated to the vote.

    Robert Califf / Credit: Modern Healthcare

    While this vote was close—five Republicans and one Democrat did not vote—Senate leadership typically does not call for cloture unless it believes it has the votes to pass a measure, writes Charlie Minato, an editor with Halfwheel.

    He garnered the support of five Republicans, while simultaneously having five members of the Democratic caucus vote against his nomination. 

    The five had opposed him due to concerns over his close to ties to the pharmaceutical industry and FDA’s lack of action(s) regarding the opioid crisis. According to an article in The New York Times, abortion foes also are urging Republican lawmakers to reject Califf, who previously led the agency during the final year of the Obama administration.

  • Australia: More than $2 Million Worth of Vape Pens Seized

    Australia: More than $2 Million Worth of Vape Pens Seized

    Credit: Belyay

    Australian authorities have seized tens of thousands of nicotine vapes illegally being sold in the country over the past 18 months. Between July 2020 and December 2021, the New South Wales Department of Health seized more than 100,000 illegal vaping products, with a street value of more than $2 million.

    Since October, Australian vapers have been required to obtain a doctor’s prescription for nicotine-containing e-cigarettes and liquids. Doctors are supposed to prescribe the products only as a last resort when more proven quit treatments fail. The law changes were prompted by concerns about the health impacts of vaping, and data showing children are increasingly using the products.

    Over the past year, local public health units had been springing convenience stores, petrol stations and tobacconists who were selling vapes to children, enlisting undercover teenagers to attempt to purchase the products, according to news reports.

    Consumers who fail to include a nicotine prescription with their order will be subject to a fine of up to $222,000. The new system will work if enough doctors, pharmacists, smokers and vapers are willing to comply and are provided with sufficient information.