Tag: regulation

  • Colorado Bill Would Allow Counties to Ban Flavors

    Colorado Bill Would Allow Counties to Ban Flavors

    Credit: Marek Photo Design

    A Senate bill in Colorado would grant counties the power to regulate or ban the sale and distribution of flavored vaping, cigarettes and other nicotine products.

    Senate Bill 24-022 defines flavored nicotine and tobacco products as anything with a scent or flavor other than tobacco, including products that induce a cooling or numbing sensation. 

    Citing the U.S. Centers for Disease Control and Prevention, Rep. Kyle Brown, a sponsor of the legislation, said nearly 9 out of 10 adults who smoke every day first tried smoking “before they turned age 18.”

    He said tobacco products are linked to negative health effects, including cancer, and that e-cigarettes and other vape products are “highly addictive and can harm adolescent brain development.”

    A similar bill was introduced during the 2022 legislative session but died in the Senate. At the time, Gov. Jared Polis said he opposed the bill because he thought the matter should be handled at a local level.

  • Quit for Good President: WHO Report ‘Unscientific’

    Quit for Good President: WHO Report ‘Unscientific’

    Lorenzo Mata Jr. (Photo: Quit for Good)

    A public health advocacy group based in the Philippines has criticized the latest report of the World Health Organization on the use of electronic cigarettes, saying the global body undermines the significant progress made in public health over the past two decades as smokers transitioned to smoke-free products.

    Lorenzo Mata Jr., president of Quit for Good, said the WHO’s continued demonization of e-cigarettes disregards the wealth of scientific evidence demonstrating that smoke-free alternatives such as e-cigarettes, heated tobacco and snus have helped millions of smokers in countries like the United Kingdom, the United States, Japan and Sweden successfully quit smoking.

    “The best available clinical and population studies consistently show that vaping has led to adult smoking cessation. While it is necessary to monitor youth vaping, a complete ban on e-cigarettes will only exacerbate the smoking epidemic and its associated serious health conditions,” Mata Jr.  said in a statement.

    As a Filipino physician, Mata said the WHO’s failure to differentiate between the risks of e-cigarettes and combustible tobacco is unscientific.

    Last month, the WHO issued a statement calling for urgent action to safeguard children and prevent the adoption of e-cigarettes based on what Quit for Good insists is a misrepresented account of the scientific evidence to fit its predetermined conclusion to ban e-cigarettes or regulate them as strictly as far more dangerous cigarettes.

    Additionally, the WHO provided data indicating that the global market for electronic cigarettes grew from $7.81 billion in 2015 to $22.35 million in 2022. Between 2018 and 2022, the disposable e-cigarette market expanded by 116 percent, encompassing over 550,000 different products.

    Mata said the WHO’s diagnosis of the situation is flawed, as it fails to acknowledge the significant decline in harmful substance exposure resulting from smokers switching to e-cigarettes and other smoke-free alternatives, or the fact that smoke-free products work for many smokers better than traditional smoking cessation therapies.

    “E-cigarettes do not threaten public health but provide smokers with an exit from smoking, which is the real problem. Labeling these innovative products an emerging threat to public health is worrisome because the WHO essentially tells smokers that continuing smoking is better than switching to e-cigarettes. This is patently wrong,” he said.

    Quit for Good highlights that countries that banned e-cigarettes did not eradicate vaping but instead inadvertently created an unregulated underground market that poses risks to public health due to the absence of regulatory standards.

    Mata said these bans only benefit unscrupulous criminal gangs that are happy to sell these products to anyone, including children, without any controls as to what’s in them or how they’re made.

    According to independent public health experts, e-cigarettes and other smoke-free products offer an opportunity to combat smoking-related diseases such as cancer, heart disease and lung disease by transitioning to nicotine products with significantly reduced risk and no combustion.

    Commenting on a similar WHO report published earlier, Peter Hajek, Director of the Tobacco Dependence Research Unit at Queen Mary University of London, said: “Given the tremendous benefits this transition would bring to public health, it is paradoxical that the WHO has adopted such a strident anti-vaping stance that risks impeding this progress. This new report perpetuates this tradition, calling for a ban on less risky alternatives while freely allowing the sale of tobacco. The report misrepresents evidence and should come with a prominent health warning.”

    John Britton, an emeritus professor of Epidemiology at the University of Nottingham, said the WHO still fails to differentiate between addiction to tobacco smoking, which leads to millions of deaths annually, and addiction to nicotine, which does not.

    “The WHO appears content with the inconsistency of recommending medicinal nicotine products for treating smoking addiction while advocating the prohibition of consumer nicotine products that serve the same purpose, but more effectively. The WHO is correct in discouraging non-smokers, particularly children, from using any nicotine product. However, for over a billion tobacco smokers worldwide, electronic nicotine delivery systems are part of the solution, not the problem,” Britton said.

    Mata said many countries, including the Philippines, have in fact chosen to embrace scientific evidence and regulate the use of innovative smoke-free products such as e-cigarettes to provide smokers with better options to quit.

  • Virginia Proposes Flavor Ban, Approved Product List

    Virginia Proposes Flavor Ban, Approved Product List

    Credit: FotoMak

    Virginia has long been the epicenter of the tobacco industry, Now, two bills that would ban flavored vaping products have been filed with the state’s General Assembly.

    Sponsors say Virginia should step in where Washington has been ineffective in blocking unregulated flavored e-cigarettes, such as Elf Bar disposables, off of store shelves.

    The bills, House Bill 1069 and Senate Bill 550, call for a fine of $1,000 a day for each product sold that the U.S. Food and Drug Administration has not authorized to be marketed in the U.S.

    The Attorney General would maintain a directory of legal products, much like Alabama and Louisiana. Products not listed in that directory could not be legally sold in Virginia.

    The bill states any retailer and wholesaler that sells or distributes any liquid nicotine or nicotine vapor product in the state is subject to scheduled or unscheduled compliance checks carried out by the Attorney General’s Office for enforcement purposes.

    Manufacturers must certify, in a filing with the Attorney General, that their product is covered by an FDA marketing authorization order, or is exempt from that because it was sold in the U.S. before 2016 or subject to a premarket tobacco product application dating from before 2020.

    “It’s a public health issue,” said Del. Rodney Willett, who sponsored the House of Delegates bill.

    “They’re targeting kids with the flavors,” he said, according to media reports. “When I walk into a convenience store, I’m just stunned by the number of these products that are for sale.”

  • Tobacco Tax Not a Factor in Singapore’s Vaping Ban

    Tobacco Tax Not a Factor in Singapore’s Vaping Ban

    Credit: Andreykr

    The Singapore government said that the potential loss in revenue from tobacco tax was not a factor in its decision to ban the use of e-cigarettes in 2018.

    In his reply to a question by a Workers’ Party and Sengkang Member of Parliament, Deputy Prime Minister Lawrence Wong, who is also the Minister for Finance, said, “The Government’s decision to ban the use of e-cigarettes in 2018 was based on public health considerations, to protect our population from the harms of these products. The potential loss in tobacco tax revenue from the reduced consumption of tobacco products was not a factor in this decision.”

    … our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”

     

    Lawrence Wong

    Wong added that if the government were to legalize and tax e-cigarettes “the challenges would be similar to those we encounter for cigarettes and other tobacco products today.

    “In any case, the government has no plans to change our current approach, as our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”

  • Durbin Decries FDA Vape Failures From Senate Floor

    Durbin Decries FDA Vape Failures From Senate Floor

    Senator Dick Durbin
    Credit: Dick Durbin

    U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.

    In a press release, Durbin stated that he has repeatedly criticized the FDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.

    FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.

    During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.

    “I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”

    The FDA stated in prior status reports for PMTAs that the agency would complete a review of 100 percent of the applications by the end of 2023. The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.

  • Vuse’s Market Share Lead Stays Static in December

    Vuse’s Market Share Lead Stays Static in December

    Credit: RJR Vapor Co.

    The latest Nielsen report shows that the market share of R.J. Reynolds’ top-selling Vuse e-cigarette remained flat at 42 percent in December at convenience stores.

    While Vuse’s market share was unchanged, No. 2 Juul dropped from 24.3 percent to 24.2 percent for the report covering the four-week period ending Dec. 30.

    As recently as May 2019, Juul held a 74.6 percent share in the U.S. electronic cigarette market. That’s when a series of regulatory actions led to product-reduction concessions, according to media reports.

    Meanwhile, Altria Group’s ownership of No. 3 NJoy hasn’t resulted in a meaningful market-share increase so far. Nielsen cited a research error by why it did not include an update for NJoy in the latest report. It was at 2.6 percent in the previous report.

    Fontem Ventures’ blu eCigs, an affiliate of Imperial Brands Plc, was unchanged at 1.2 percent.

    The overall e-cigarette category was down 9.9 percent.

  • Next-Generation Nicotine Market in 2024: Hardman

    Next-Generation Nicotine Market in 2024: Hardman

    Image: Vapor Voice archive

    What can the next-generation nicotine industry expect in 2024?

    By Paul Hardman

    The U.K. government’s proposal for a “smoke-free” generation and changing consumer opinions toward nicotine products are causing a shift in consumer habits. The year 2023 shone a spotlight on e-cigarette compliance, with a potential ban on disposable vapes on the horizon. So, how will this year’s events impact the manufacturing of nicotine products, and what trends and regulations are we likely to see going into 2024?

    Nicotine Pouches

    Nicotine pouches represent an extraordinary opportunity to support tobacco harm reduction in adult smokers. Sweden, the world’s most advanced nicotine pouch market, is on the brink of being smoke-free, with less than 5 percent of its population smoking.

    However, in the U.K., there is a regulatory gap that allows those under 18 to purchase nicotine pouches legally. In addition, there are concerns that nicotine pouch manufacturers could fall into the same traps as some disposable e-cigarette companies, by creating products that appeal to youth.

    If youth use becomes an issue, the easiest move for regulators is to categorize nicotine pouches in the same way as oral tobacco products like snus—rendering them illegal. An alternative response might be to categorize these products as nicotine-replacement therapies and place them under medical product regulations, which would restrict their access.

    To keep these products available to adult smokers who wish to quit, manufacturers can act as if regulation is already in place: generate data, devise safety frameworks and ensure the quality of products entering the market. Importantly, manufacturers should present and market their products in responsible ways, including avoiding bright colors, not imitating other consumer goods (e.g., soft drinks) and refraining from using any type of cartoon/video game characters.

    Non-Heated Technologies

    We have yet to witness a vape product approved via the U.K. Marketing Authorization Application (MAA) pathway, which enables nicotine products to be marketed as smoking cessation nicotine-replacement tools and prescribed by healthcare professionals. However, non-heated vape technology might facilitate MAA approval by addressing the core problem of delivered dose uniformity (DDU).

    One example of a non-heated vape technology involves ultrasound sonication, which enables the atomization of e-liquids to create an aerosol, similar to technology used in medical nebulizers. The droplet size and dosage can be predefined according to the dimensions of the mesh, ensuring uniformity in the vapor, thus improving DDU. As we go into 2024, we will likely see more manufacturers exploring this approach. In parallel, e-liquids will be developed specifically for this technology.

    Product Development

    Nicotine product manufacturers have been moving toward a quality-by-design (QbD) development process, and we will see this continue in 2024. There are no specific guidelines or requirements for the stability testing of nicotine products other than the scientific justification for shelf life. Employing a QbD approach demonstrates a higher level of due diligence, which could produce safer, higher quality nicotine-delivery systems.

    In addition, manufacturers are starting to implement extractables and leachables studies during the development process in anticipation of the new guidelines being set out by the European Committee for Standardization. Once these guidelines are published, we can expect to see a more standardized approach throughout the industry.

    Paul Hardman is a managing consultant at Broughton, an independent life sciences contract research organization offering analytical testing services integrated with scientific consultancy and global regulatory support.
  • Another Maine City Seeks Ban on Flavored Tobacco

    Another Maine City Seeks Ban on Flavored Tobacco

    Credit: Ianm35

    The city of Hallowell seeks to become the latest community in Maine to ban the sale of flavored vaping and other tobacco products.

    Monday night, the city held a public hearing on an ordinance that would do exactly that. During the meeting, 300 signatures supporting the flavored tobacco ban were delivered to the council, according to local media.

    During the hearing, people argued both for and against the ban, with those against saying the city should be looking at the bigger picture and consider enacting a smoking ban citywide. Those in favor cited not only the negative health effects, but also that it’s intentionally marketed to young people.

    If Hallowell does pass a ban, they will join the towns Falmouth, Portland, South Portland, Brunswick, Bangor and Bar Harbor in passing similar bans on selling flavored tobacco products.

  • Nevada Sheriff Wants Vapor Age Compliance Checks

    Nevada Sheriff Wants Vapor Age Compliance Checks

    After conducting its year-end alcohol compliance check last week, Carson City Sheriff Ken Furlong said his office is requesting that the Nevada Attorney General’s Office include vaping and other tobacco products that businesses shouldn’t be selling to minors in future stings.

    The CCSO’s school resource officers, in conjunction with Partnership Carson City, held their final sting on Dec. 28 to ensure local businesses aren’t selling alcoholic beverage products to minors.

    The compliance check was held with the support of three volunteers aged 16 to 18 who were sent to screen eight local businesses. Only one failed.

    Furlong told the Nevada Appeal his request for expansion is to acquire greater resources to keep vaping and tobacco products from being easily accessible to teens in storefronts.

    “I have instructed our team to proceed and coordinate with the AG’s office and determine if we can likewise add vaping and tobacco with the alcohol,” Furlong said. “(The businesses) would get a citation.”

    Furlong said he hoped to hear soon from the Attorney General’s Office on the compliance checks, which are conducted every six to eight weeks.

  • Another Study Finds Vape More Effective Than NRTs

    Another Study Finds Vape More Effective Than NRTs

    Nicotine e-cigarettes are more effective quit-smoking products than conventional nicotine-replacement therapies (NRTs), reports University of Massachusetts Amherst, citing the latest Cochrane review.

    The review found high certainty evidence that e-cigarettes lead to better chances of quitting smoking than using patches, gums, lozenges or other traditional NRTs.

    “In England, quite different from the rest of the world, e-cigarettes have been embraced by public health agencies as a tool to help people reduce the harm from smoking,” said Jamie Hartmann-Boyce, assistant professor of health policy and promotion in the School of Public Health and Health Sciences at the University of Massachusetts Amherst.

    “Most of the adults in the U.S. who smoke want to quit, but many find it really difficult to do so,” said Hartmann-Boyce, who conducted research at the University of Oxford in England before joining the University of Massachusetts Amherst earlier this year and is the senior author of the review and a Cochrane editor. “We need a range of evidence-based options for people to use to quit smoking, as some people will try many different ways of quitting before finding one that works for them.”

    The review included 88 studies and more than 27,235 participants, with most of the studies taking place in the U.S., the U.K. or Italy.

    “We have very clear evidence that, though not risk-free, nicotine e-cigarettes are substantially less harmful than smoking,” Hartmann-Boyce said. “Some people who haven’t had success in the past with other quit aids have found e-cigarettes have helped them.”

    For every 100 people using nicotine e-cigarettes to quit smoking, eight to 10 are expected to successfully quit compared to six of 100 people using traditional NRTs and four of 100 trying to quit without support or with only behavioral support, according to the review.

    “Not everything is either entirely harmful or beneficial,” Hartmann-Boyce said. “Different things can have different impacts on different populations. Evidence shows that nicotine e-cigarettes can help people quit smoking and that people who don’t smoke shouldn’t use e-cigarettes.”

    Hartmann-Boyce compared tobacco smoking versus e-cigarette use to the treatment for substance use disorders involving opioids. “We’re not going to prescribe methadone to people who aren’t addicted to opioids,” she said. “But for people addicted to opioids, we recognize that methadone is a helpful thing.”

    In 2021, a study by Queen Mary University of London, published in Addiction, shows that e-cigarettes are more effective in achieving long-term smoking reduction and cessation than NRTs.

    The U.S. Food and Drug Administration has not approved any e-cigarettes as medications to help adults quit smoking. “While certain e-cigarettes may help adult smokers transition completely away from, or significantly reduce their use of, more harmful combusted cigarettes, the law’s public health standard balances that potential with the known and substantial risk with regard to youth appeal, uptake and use of these highly addictive products,” said Robert Califf, FDA commissioner.