Category: Regulation

  • Australia’s New Vape Rules Boosts Black Market

    Australia’s New Vape Rules Boosts Black Market

    The Australian government’s plan to make pharmacies the gatekeepers of vaping will push more young people onto the black market, experts on the illicit trade say, as new data shows nicotine use is rising.

    Nicotine levels found in wastewater in December were almost the highest since authorities started recording them in 2016, a worrying trend that the health department attributes to the rise of vaping among young people.

    An Australian Criminal Intelligence Commission report last week found that nicotine consumption was highest in regional areas, and had risen from August in capital cities to be the second highest since 2016. The peak use of nicotine was in December 2022, according to media reports.

    Federal Health Minister Mark Butler announced in May last year that the government would increase tobacco excise by five percent a year for three years to deter smoking.

    “Studies have confirmed that the rise in vaping over the last decade has driven more young Australians to nicotine consumption,” a federal health department spokesman said, adding the nicotine data also captured people using nicotine patches and gum to quit smoking.

    But former Australian Federal Police officer Rohan Pike, who created and led the Australian Border Force’s tobacco strike force, warns that many of the country’s 1.7 million vape users could actually be pushed into smoking.

    Pike, who is speaking at a Victorian parliamentary inquiry into vaping and tobacco controls on Monday, says this would represent a “public health disaster.”

    Since July 1, vape sales require a doctor’s prescription, nicotine levels are regulated, and flavors are limited to tobacco, menthol, and mint. Another requirement restricts products to plain packaging.

  • Risk of Secondhand Exposure Lower for Vaping: Study

    Risk of Secondhand Exposure Lower for Vaping: Study

    Photo: pavelkant

    Children exposed to vaping indoors absorb less than one-seventh the amount of nicotine as children who are exposed to indoor smoking but more than those exposed to neither, according to a new study led by UCL researchers.

    The study, published in JAMA Network Open and funded by Cancer Research U.K., looked at blood tests and survey data for 1,777 children aged three to 11 in the United States.

    The researchers said that secondhand exposure to harmful substances in e-cigarettes would likely be much lower still, as e-cigarettes deliver similar levels of nicotine to tobacco but contain only a fraction of the toxicants and carcinogens.

    The researchers looked at nicotine absorption in children, but they said the findings were likely to be similar for adults.

    “Our study shows, using data from the real world rather than an artificial lab setting, that nicotine absorption is much lower from secondhand vapor than from secondhand smoking,” said lead author Harry Tattan-Birch of the UCL Institute of Epidemiology and Health Care in a statement.

    “Nicotine itself is of limited risk, but it shows what the highest possible exposure might be from secondhand vaping. Exposure to harmful non-nicotine substances present in vapor will likely be substantially lower still.”

    “This paper suggests that concerns about secondhand vaping may be somewhat overstated, with secondhand exposure to toxic substances likely to be very low,” said senior author Lion Shahab of the UCL Institute of Epidemiology and Health Care.

    “The findings confirm the risks of smoking indoors around children, which should be avoided at all costs. However, as secondhand vaping still exposes children to more harmful substances than no vaping or smoking exposure at all, it is best to avoid indoor vaping around children too.”

    The study used data from a nationally representative sample of children in the U.S. collected between 2017 and 2020 as part of the annual U.S. National Health and Nutrition Examination Survey.

    Blood tests that detected the concentration of cotinine were used to assess how much nicotine the children had absorbed. Cotinine is a chemical the body produces after exposure to nicotine. Survey responses indicated if the children had been exposed to smoking or vaping indoors in the past week.

    The researchers focused on data from children as, unlike adults, children were unlikely to have vaped or smoked themselves, meaning higher nicotine absorption was a result of secondhand vapor or smoke only. However, two children were excluded from the analysis for having a cotinine concentration that suggested they had vaped or smoked directly. Children exposed to both indoor smoking and vaping were also excluded from the analysis.

    The team found that children exposed to indoor vaping absorbed 84 percent less nicotine than children exposed to indoor smoking while children exposed to neither absorbed 97 percent less.

    The lower levels of nicotine among those exposed to secondhand vaping were consistent with previous laboratory studies finding that people retained 99 percent of the nicotine they produced during vaping. With tobacco cigarettes, smoke is generated both by smokers breathing out as well as by the lighted end of the cigarette. E-cigarettes, however, do not generate aerosol aside from when vapers exhale.

    The researchers said their findings had implications for whether vaping should be allowed indoors, providing further evidence that the impact of vaping on bystanders’ health will be much less than smoking.

    However, the researchers said there were other factors to consider when assessing whether indoor spaces should be made vape-free. In particular, if vaping commonly occurs indoors, this may normalize the behavior, encouraging people to start vaping and making it harder for them to stop.

    Previous research from the same team showed that adults in England were much more likely to vape than smoke indoors, with nine in 10 vapers found to vape inside while only half of smokers smoked inside.

  • Kentucky Judge Hears Vape Registry Bill Case

    Kentucky Judge Hears Vape Registry Bill Case

    Credit: Adobe

    Franklin Circuit Judge Thomas Wingate heard arguments Monday in a case challenging the constitutionality of a 2024 law banning the sale of some vaping products.

    This comes as the defendants — Allyson Taylor, commissioner of the Kentucky Department of Alcoholic Beverage Control, and Secretary of State Michael Adams — filed a motion to dismiss the case.

    Should Wingate grant that motion, the plaintiffs — the Kentucky Vaping Retailers Association, the Kentucky Hemp Association and four vape shops — will appeal the decision, their lawyer told the Lantern. The plaintiffs have also filed a motion for judgment, according to media reports.

    Either way, the case is far from settled. It’s unclear when a decision could come, as Wingate said it will “take a while” for him to review.

    The lawsuit centers around House Bill 11 passed during the 2024 legislative session. Backers of the legislation said it’s a way to curb underage vaping by limiting sales to “authorized products” or those that have “a safe harbor certification” based on their status with the U.S. Food and Drug Administration (FDA).

    Opponents have said it will hurt small businesses and lead to a monopoly for big retailers.

    According to Legislative Ethics Commission records, Altria, the parent company of tobacco giant Phillip Morris, lobbied for the Kentucky bill. Based in Richmond, Virginia, the company is pushing similar bills in other states.

    Greg Troutman, a lawyer for the Kentucky Smoke-Free Association, which represents vape retailers, told the judge Monday that among his issues with the new law is the way it defines “vapor products” and “other substances,” looping e-cigarettes and vapable hemp and marijuana products together. He argues that combination makes the law too broad and arbitrary to pass constitutional muster.

  • CTP Brings Updates to Tobacco Compliance Website

    CTP Brings Updates to Tobacco Compliance Website

    The Food and Drug Administration’s Center for Tobacco Products (CTP) has announced an enhancement to its website, which will more easily present information about tobacco compliance check outcomes.

    The agency noted in a statement that the database is designed to be a resource for various audiences, including the general public, public health groups, and the tobacco industry.

    The new database offers the ability to search for various compliance and enforcement outcomes among brick-and-mortar and online retailers, including warning letters, civil money penalties, and no-tobacco-sale orders.

    Previously, this information lived in various locations across the FDA website, so the enhancement will allow site visitors to more easily find outcomes from the FDA’s compliance and enforcement efforts of retailers in one centralized location, according to reports.

    This centralized database will be updated monthly with the latest compliance check outcomes. “The enhancements to this database reflect CTP’s continued efforts to optimize transparency and communication with stakeholders,” the statement continued.

    To view the database, click here.

  • Ireland to Raise Sales Age for Vaping Products

    Ireland to Raise Sales Age for Vaping Products

    Photo: Vasyl

    Ireland will to raise the minimum age for tobacco sales to 21.

    With the measure, the government hopes to accelerate the decline in adult smoking prevalence, which has plateaued at 18 percent for several years, and reduce underage smoking prevalence to zero.

    “My goal with this measure is to assist our young people to avoid a lifetime of addiction and illness from tobacco smoking. The modelling shows us that this measure will not only protect the targeted age group and but will also protect those under 18 as they will be less likely to be in social groups with 21 year olds who can legally purchase cigarettes,” said Health Minister Stephen Donnelly in a statement.

    “Countries around the world are looking at endgame measures for smoking. We are no longer regulating it; we are seeking to eliminate it from our lives and the lives of our children. I’m very proud that Ireland is continuing its tradition of leading the way on this issue, and today’s measure is another important step on our journey towards a tobacco-free Ireland.”

    Ireland will be the first EU country to raise the smoking age to 21. The measure will be phased in so that that those already entitled to be sold tobacco products—that is, persons over 18 but under 21—will not be affected.

  • Maryland Indoor Vaping Ban Goes Into Effect

    Maryland Indoor Vaping Ban Goes Into Effect

    Credit: Glynnis Jones

    A new amendment to Maryland’s Clean Indoor Air Act takes effect today, officially banning vaping in nearly all indoor public spaces and workplaces.

    First passed in 2007, the Clean Indoor Air Act originally prohibited smoking in public indoor spaces to “preserve and improve the health, comfort, and environment of the people of Maryland by limiting exposure to environmental smoke.”

    Beginning July 1st, 2024, that law now includes vaping after an amendment was passed in Maryland during the 2024 legislative session, according to WBOC.

    According to Maryland’s Department of Health, smoking and vaping of tobacco, cannabis, or hemp-derived products is banned in indoor areas open to the public, specifically public meeting places, public vehicles and indoor places of employment.

  • SCOTUS to Hear Vaping PMTA Suit FDA v. Triton

    SCOTUS to Hear Vaping PMTA Suit FDA v. Triton

    supreme court of USThe U.S. Supreme Court agreed on Tuesday to hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.

    The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

    The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.

    Two e-cigarette liquid makers, Triton Distribution and Vapetasia LLC, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

    An FDA rule that took effect in 2016 deemed e-cigarettes to be tobacco products, like traditional cigarettes, subject to agency review under a 2009 federal law called the Tobacco Control Act. The rule said manufacturers of the products would need to apply for approval to continue selling them.

    The FDA rejected the applications by the two companies, along with more than one million other products, according to court records. The FDA has approved only 27 e-cigarette products, all tobacco or menthol flavored.

    Triton and Vapetasia in 2021 asked the New Orleans-based 5th U.S. Circuit Court of Appeals to review the FDA’s denial of their applications.

    In January, the full slate of 5th Circuit judges ruled 10-6 that the FDA had been arbitrary and capricious, in violation of a federal law called the Administrative Procedure Act, by denying the applications without considering plans by the companies to prevent underage access and use.

  • Australia’s Vape Sales Restrictions Begin Today

    Australia’s Vape Sales Restrictions Begin Today

    Credit: Alexander

    Australia became the first country to restrict the sale of vapes to pharmacies when its new laws surrounding vaping products came into effect on Monday, stipulating sentences of up to seven years in prison and million-dollar fines.

    The law forces nicotine consumers who want a therapeutic vape to help quit smoking combustible cigarettes to consult their general practitioner and obtain a prescription to buy a therapeutic device from pharmacies.

    These products, whose access will be tightly controlled, will have plain packaging, and the flavors will be limited to tobacco, menthol and mint, according to media reports.

    “Australia has led the world in pushing back on Big Tobacco and fighting for the health of our citizens and we’re proud to continue that effort,” Australian Home Affairs Minister Claire O’Neil said in a statement released on Monday.

    Consumers over 18 years of age will be allowed to buy vapes with a maximum nicotine concentration of 20 mg/ml without a prescription until Oct. 1.

    Under the new reforms, businesses or individuals selling vapes will face a maximum sentence of seven years in prison and a fine of up to AU$2.2 million ($1.47 million), while companies that produce them would be subject to a maximum fine of around AU$22 million.

    The measures are part of amendments to the Therapeutic and Other Products (Vaping Reforms) Legislation 2024, which prohibits importing, manufacturing, distributing, and commercial possessing these devices, except with a license and special permit.

    The Australian government appointed Erin Dale as Commissioner for Tobacco and Illicit Electronic Cigarettes. Dale will assume the position on an interim basis on Monday until a formal appointment is made to intensify the fight against the expected rise in nicotine products on the black market.

    “Illegal tobacco is no different to any other illegal product – if you attempt to bring it into our country, you will be met by the full force of our border protection agencies,” O’Neil said.

    Several major pharmacy chains in Australia have stated that they will not stock vapes once their sale is prohibited outside of pharmacies and a prescription requirement for adults is lifted.

  • Australia: Major Pharmacies Against Vape Sales

    Australia: Major Pharmacies Against Vape Sales

    Credit: Jackie Davies

    Several major pharmacy chains in Australia have stated that they will not stock vapes once their sale is prohibited outside of pharmacies, and a prescription requirement for adults is lifted.

    In communications with their stakeholders, TerryWhite Chemmart, Priceline Pharmacy, National Pharmacies in South Australia, and 777 Group in West Australia all voiced strong disagreement with new laws allowing the sale of vapes without prescriptions.

    In a statement, The Pharmacy Guild of Australia said Blooms and thousands of independent pharmacies had also opposed the government’s deal with the Greens to open access for adults from October.

    Chemist Warehouse has told the ABC it is still looking at the implications of the decision and seeking more information on how it will work.

    While those pharmacies have indicated they will not be moving to stock vapes, franchisors under the brands are technically able to make an independent decision to do so.

    Many pharmacies under those brands already supply vapes nationwide or are licensed to do so. The key dispute raised by them is the “down scheduling” of vapes from October from requiring scripts to being available behind the counter for adults once they have had a conversation with their pharmacist.

    Health Minister Mark Butler said pharmacies would not be forced to stock vapes earlier this week, and the government did not expect that all pharmacies would.

  • Reynolds Files PMTA for Age-Gated Vuse Pro System

    Reynolds Files PMTA for Age-Gated Vuse Pro System

    R.J. Reynolds Vapor Co. has filed the final pre-market tobacco product application submissions with the U.S. Food and Drug Administration for its Vuse Pro age-gated device. The electronic nicotine delivery system device platform connects to a mobile application that verifies the consumer’s age through a third-party provider.

    Once verified, the device will unlock. It uses a unique design to only allow compatible Vuse Pro pods to be used. The technology and mobile application also enable features such as auto-lock and proximity lock to further secure device access.

    “Our PMTA submissions to the FDA underscore our commitment to both offering adult tobacco and vapor consumers choices as well as underage access prevention,” said Reynolds Executive Vice President of Scientific Research and Development Tim Nestor in a statement. “We don’t want our products in the hands of youth, period. The Vuse Pro ENDS platform provides a solution that limits access to adult consumers while also offering flavors that appeal to current adult smokers and a unique vapor experience.”