Tag: news

  • U.S. FDA Denies 22 SMOK Vape Hardware PMTAs

    U.S. FDA Denies 22 SMOK Vape Hardware PMTAs

    SMOK Osub One 50W AOI

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Shenzhen IVPS Technology Co., Ltd for 22 SMOK vaping hardware products.

    The denied products include devices, pods, atomizers, and cartridges. It’s the first time the agency has denied strictly hardware products from one company en mass.

    The products were denied because they were submitted without a specific e-liquid to be used with the devices, according to the FDA. “The denied SMOK e-cigarette products are not sold with an e-liquid. A consumer instead adds their separately purchased e-liquid into the device,” the agency wrote. “Therefore, these SMOK products have the potential to be used with any e-liquid on the market and available to the consumer, which could include tobacco-flavored and non-tobacco-flavored e-liquids.”

    The products receiving MODOs include:

    • SMOK OSUB ONE Device
    • SMOK OSUB ONE RPM Cartridge
    • SMOK RPM DC 0.8 Ω MTL Atomizer
    • SMOK OSUB ONE RPM Cartridge 3 Pack
    • SMOK RPM DC 0.8 Ω MTL Atomizer 5 Pack
    • SMOK Nfix Device
    • Nfix DC 0.8 Ω MTL Pod
    • SMOK POZZ Device
    • SMOK POZZ DC 0.8 Ω Pod
    • SMOK RPM 40 Device
    • SMOK RPM Empty Standard Cartridge
    • SMOK RPM Empty Nord Cartridge
    • SMOK RPM Mesh 0.4 Ω Atomizer
    • SMOK Nord DC 0.8 Ω MTL Atomizer
    • SMOK SCAR-P3 Device
    • SMOK SCAR-P3 Empty RPM 2 Cartridge
    • SMOK SCAR-P3 Empty RPM Cartridge
    • SMOK PRM 2 Mesh 0.16 Ω Atomizer
    • SMOK RPM Mesh 0.4 Ω Atomizer
    • SMOK Nord 2 Device
    • SMOK Nord 2 RPM Cartridge
    • SMOK Nord 2 Nord Cartridge

    After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. More specifically, the applicant failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.

    “Science is a cornerstone of FDA’s tobacco product review process, and CTP remains committed to evaluating applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of FDA’s Center for Tobacco Products. “It is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of the public health. In this case, the applicant failed to provide this evidence.”

  • Spain Bans Flavors for Heated Tobacco Products

    Spain Bans Flavors for Heated Tobacco Products

    Credit: Weyo

    The government in Spain has approved a decree that equates the regulation of heated tobacco products with that of traditional cigarettes, prohibiting products with flavorings. The rules do not apply to all vaping products, such as e-cigarettes.

    In addition, it will now be mandatory for labels to contain warnings for heated tobacco products that they products are harmful to health, according to Catalan News.

    The Ministry of Health is considering further regulations.

    “The ban will cover tobacco products with an aroma or flavor in their components (such as filters, papers, packaging, or capsules) or any other technique that allows modifying the smell or taste of the products or intensify the smoke. Filters, papers and capsules cannot contain tobacco or nicotine,” the report states.

    Heated tobacco products must include the following informative message on their outer packaging: “Tobacco smoke contains more than 70 carcinogenic substances,” with relevant accompanying photographs.

    This decree will enter into force three months after its publication in the official state gazette (Boletín Oficial del Estado).

  • Retailer Teams With Industry to Recycle Vapes

    Retailer Teams With Industry to Recycle Vapes

    Credit: William

    UK retailer B&M will soon start a vape recycling program in partnership with the e-cigarette brand Elf Bar and vaping manufacturer Supreme plc. The group hopes to reduce the environmental impact of disposable vaping products.

    The partnership will introduce more than 700 in-store vape recycling bins across B&M retail locations.

    The campaign aims to enhance vape recycling by providing consumers with a means of disposing of their used vape devices, according to media sources. The products are not collected from homes. It begins before the end of January.

    The hazardous waste management provider Wastecare Group will oversee the collection of the bins once full, ensuring the responsible disposal of the single-use devices.

    “B&M welcomes the opportunity to work in a three-way partnership with Elf Bar and Supreme to tackle the ongoing environmental damage occurring by single-use, disposable vaping products,” a B&M spokesperson said. “We want our consumers to use the products we sell in a responsible manner, and that remains even when they are no longer of use. Like many of the other products we sell, vapes should never be binned or littered – especially now they can be so easily recycled.”

    The Scottish Government has expressed intentions to consult on banning single-use vapes due to concerns about their impact on public health and the environment. The UK Government is being urged to follow suit.

    Wastecare Group’s recycling process involves the recovery and recycling of raw materials under existing disposal rules. The collected vape batteries will undergo processing to recover lithium, while the filter and nicotine elements will be sent for incineration.

    All recycling processes will take place within the UK.

    “Continuing Elf Bar’s commitment to its GreenAwareness program, this marks another step towards helping the public dispose of used vapes sustainably and responsibly,” said Elf Bar UK’s director of government affairs, Eve Peters.

  • WVA: EU Harm Reduction Approach ‘Out of Touch’

    WVA: EU Harm Reduction Approach ‘Out of Touch’

    Vapor Voice Archive

    The European Commission’s approach to tobacco harm reduction is out of touch with EU citizens’ views, according to the World Vapers’ Alliance (WVA)

    A recent public consultation on the EU Tobacco Products Directive (TPD), analyzed by Snusforumet, reveals a substantial consensus among citizens, NGOs and scientific institutions on the effectiveness of harm-reduction products in assisting smokers to quit.

    A striking 77 percent of respondents recognize these products as helpful smoking cessation tools, while a mere 9 percent of EU citizens disagree. Furthermore, an overwhelming 82 percent of respondents refute the notion that new nicotine alternatives pose a risk to public health, with only 6 percent perceiving them as a threat.

    “The EU Commission’s current stance on harm reduction is not just out of touch; it’s a blatant disregard for consumer opinions and scientific evidence,” said WVA Director Michael Landl in a statement. “It’s high time the Commission responds to the reality that harm-reduction products are not the enemy but a vital ally in the fight against smoking.”

    According to the WVA, countries like Sweden serve as living proof of the success of a consumer-friendly harm reduction approach, significantly outpacing the EU in reducing smoking rates. The EU Commission’s reluctance to embrace this approach is not only perplexing but also detrimental to public health efforts, the organization says.

    “Sweden’s success story is a testament to what can be achieved with a sensible harm reduction policy,” said Landl. “It’s baffling and frankly irresponsible for the EU Commission to continue its hostile approach towards these life-saving products. The Commission needs to align its policies with the clear evidence and public opinion, rather than clinging to outdated and ineffective methods.”

  • 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.

  • Researchers to Study Health Impact of Dual Use

    Researchers to Study Health Impact of Dual Use

    Photo: tcsaba

    A new project sponsored by the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) will investigate the consequences of the combined use of conventional cigarettes and electronic cigarettes on human health.

    Titled, “MAGnitude of cigarette substitutioN after Initiation oF e-cigarettes and its Impact on biomArkers of exposure and potenTial harm in dual users” (“Magnificat”), the study will involve more than 300 dual users.

    Using specific biomarkers, clinical endpoints and behavioral correlations, researchers will be monitoring participants’ health to quantify the impact of transitioning to combustion-free products.

    Participants will be asked to reduce the consumption of conventional cigarettes and switch to electronic cigarettes for a controlled period. According to CoEHAR, the results of the study will be of great interest in addressing questions related to smoking harm reduction in both clinical and behavioral contexts.

    Tobacco Reporter profiled the work of CoEHAR in its January 2024 issue (see “Reviewing their Peers.”)

  • 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.”

  • Innokin Launches New ‘Trine’ Vaping System

    Innokin Launches New ‘Trine’ Vaping System

    Innokin launched Trine, a redefinition of the structure of pod systems, namely atomizer, control and battery (removable), according to a press release.

    The new 3-in-1 solution improves the reusability of the battery, according to the press release. 

    Trine features removable batteries for pod systems, extending the life cycle of devices far beyond that of an individual battery while enabling safe recycling, according to Innokin.

    Trine ensures safe battery disposal by integrating EcoDrain, a battery discharge technology setting a new industry standard as an eco-safe solution for battery disposal. It addresses the challenges associated with handling discarded batteries, ensuring safe battery discharge before recycling.

    The technology minimizes fire hazards and actively reduces the detrimental environmental impact caused by battery waste, according to the company.

  • PMI Gets Appeals Court Support for Suit Dismissal

    PMI Gets Appeals Court Support for Suit Dismissal

    The United States Court of Appeals for the 2nd Circuit on Dec. 26, 2023, affirmed a district court’s dismissal of a putative class action asserting claims against Philip Morris International that the company made false or misleading statements regarding both the scientific studies it conducted in support of an application to the Food and Drug Administration and the outlook for the company’s sales growth in Japanese markets, according to Lexology.

    The district court held that the plaintiffs failed to adequately prove falsity or scienter. The 2nd Circuit affirmed the dismissal, holding that the plaintiffs failed to adequately plead falsity.

    The court decided two questions of first impression in the 2nd Circuit, holding a securities fraud defendant’s statement that its scientific studies comply with a methodological standard that is published and internationally recognized, but stated in general and inherently subjective terms, is properly analyzed as a statement of opinion rather than a statement of fact, and holding that, whereas a securities fraud defendant’s statement expresses an interpretation of scientific data that is ultimately endorsed by the FDA, such a statement is per se “reasonable” (i.e., supported by “meaningful inquiry”) as a matter of law. 

    The plaintiffs alleged that PMI made misrepresentations in securities filings and public statements about clinical studies it conducted in support of an application to the FDA to sell IQOS in the U.S. and market IQOS as reduced risk. The plaintiffs also alleged that PMI made misleading statements about its growth projections in Japan regarding IQOS. The district court found that none of the challenged statements were false or misleading because all the challenged statements were true, inactionable puffery or inactionable statements of opinion. Furthermore, the district court found that the plaintiffs failed to establish the required strong inference of scienter, either by alleging facts showing motive and opportunity to commit fraud or strong circumstantial evidence of conscious misbehavior or recklessness. Accordingly, the district court granted the defendants’ motion to dismiss the plaintiffs’ first amended complaint and denied the plaintiffs’ motion for reconsideration. After the district court dismissed the plaintiffs’ second amended complaint, this time with prejudice, the plaintiffs appealed.