Author: Staff Writer

  • Status Report Confirms FDA Time Changes to PMTAs

    Status Report Confirms FDA Time Changes to PMTAs

    Credit: Fizkes

    The U.S. Food and Drug Administration has submitted a new timeline for its expected finish to the review of premarket tobacco product applications (PMTAs) in a court-mandated status report. As previously reported by Vapor Voice, the agency doesn’t expect to complete PMTAs for the most popular vaping products until the end of the year.

    In prior status reports, the FDA indicated that it expected to finalize actions on all covered applications by June 30, 2023. Filed with the Maryland Federal District Court on Jan. 24, 2023, the agency’s fourth report states that it now expects to have taken action on PMTAs as follows:

    • 52 percent of Covered Applications by March 31, 2023
    • 53 percent of Covered Applications by June 30, 2023
    • 55 percent of Covered Applications by Sept. 30, 2023
    • 100 percent of Covered Applications by Dec. 31, 2023

    The FDA is expected to give its next status update to the court on April 24.

    The FDA is under a Maryland Federal District Court order to file regular status reports on the agency’s review of PMTAs. The court case that ended in a court-imposed deadline for the FDA was filed by health groups seeking a timeline for the review of the PMTAs that were filed with the agency by Sept. 9, 2020.

    In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.

    The original completion date was Sept. 9, 2021, however, the FDA was unable to meet it due to the extremely large number of PMTAs filed by manufacturers.

    The most recent delay is partially being caused by ongoing litigation and by the agency accepting some amendments to already filed PMTAs that the agency now needs to review, according to the report.

    Credit: JHVEPhoto
  • IQOS Iluma One Makes Debut in South Korea

    IQOS Iluma One Makes Debut in South Korea

    Photo: PMI

    Philip Morris International has introduced its IQOS Iluma One in South Korea, reports The Korea Times. The launch comes three months after the debut of IQOS Iluma and IQOS Iluma Prime models in the country.

    According to Philip Morris Korea Managing Director Paik Young-jae, the launch of ILUMA One completes the Iluma platform family.

    “The first two ILUMA models have received a good response from the market and if this continues, I am hoping that we will reclaim the leading position in the e-cigarette market here,” Paik said.

    Since the launch of the IQOS device in 2017, Philip Morris Korea had maintained the No.1 spot in the domestic heat-not-burn for five years. However, in the first quarter of 2022, KT&G took over market leadership in the first quarter of last year.

    IQOS Iluma One retails in South Korea for KRW69,000 ($54.74), which is about 30 percent cheaper than the IQOS Iluma.

     The new device is made with an all-in-one lightweight design that can be held in one hand. A single charge can be used to smoke 20 tobacco sticks.

    Like other IQOS ILUMA models, the IQOS ILUMA ONE uses “Terea Smartcore” sticks, which heat tobacco with an induction system adopted inside its body so that users don’t have to clean any residue afterward.

     

     

  • Hong Kong Makes First CBD Arrest Since Start of Ban

    Hong Kong Makes First CBD Arrest Since Start of Ban

    Credit: Proxima Studio

    Customs officers have made Hong Kong’s first arrest over cannabidiol (CBD) products after taking a clubhouse worker into custody when he showed up to collect a parcel from Denmark containing two bottles of the recently banned oil.

    Officers found two more used bottles of the same CBD skin oil and four grams of cannabis buds from the man’s locker at the clubhouse of a residence in Yau Ma Tei on Wednesday, according to SCMP.

    Combined with the banned CBD product, the haul was worth about HK$5,000 ($637).

    The case was the first such arrest and seizure since CBD was added to the Dangerous Drug Ordinance, according to Isaac Tsang Yau-chuen, a senior investigator from the customs airport investigation division.

  • Cleveland, Ohio Considering Vapor Flavor Ban Bill

    Cleveland, Ohio Considering Vapor Flavor Ban Bill

    Credit: pabrady63

    Cleveland, Ohio is considering a proposal that would ban the sales of flavored cigars and most other tobacco products within Ohio’s second-most populous city.

    At a City Council Meeting this week, Council President Blaine A. Griffin, Ward 6, and Council Member Kevin Conwell, Ward 9, introduced a proposed ordinance that would ban the sale of almost all flavored tobacco products within Cleveland city limits.

    Ordinance No. 184-2023 has one exception, it would allow hookah bars to sell flavored shisha tobacco for on-site consumption. There are no exemptions for flavored cigars of any kind, reports Charlie Minato of Halfwheel.

    The law defines a flavored tobacco product as one “that imparts a taste or smell, other than the taste or smell of tobacco, that is distinguishable by an ordinary consumer either prior to, or during the consumption of, a Tobacco Product, including, but not limited to, any taste or smell relating to fruit, menthol, mint, wintergreen, chocolate, cocoa, vanilla, honey, or any candy, dessert, alcoholic beverage, herb, or spice.”

    It would also ban retailers and manufacturers from advertising products as having a taste or smell other than tobacco, presumably targeting things like the cooling sensation of menthol cigarettes.

    While the bill passed the Republican-controlled legislature during a lame-duck session, it was vetoed by Gov. Mike DeWine, also a Republican, who called for a statewide ban on flavored vaping products. DeWine’s veto allows for laws like the one proposed in Cleveland to be enacted.

  • Georgia to Vote on Two Bills That Include Vaping Tax

    Georgia to Vote on Two Bills That Include Vaping Tax

    Georgia State Capitol Building in Atlanta, Georgia, USA. (Credit: F11 Photo)

    A bill in the General Assembly of the U.S. state of Georgia would raise the state tax on vaping and other tobacco products and use the proceeds to improve health care.

    Introduced by House Representative Ron Stephens, two bills in the contention could make the tax possible, according to 13WAMZ.

    House bills 191 and 192 have the same language but their numbers are different. Bill 191 states a $0.57 tax per pack of 20 cigarettes and a $0.05 per fluid milliliter for vapor products in a closed system. For an open system, it would be a 7% tax on the wholesale cost price.

    Bill 192 states a $0.37 tax per pack of 20 cigarettes and a 15% on vapor products at the wholesale cost.

    Shabbir Hussain is a smoker himself and says using the money to help fund Georgia’s healthcare programs is a good thing.

    “And $0.20 is not something people would worry about, and if that would benefit the health system, they should go for it,” Hussain said.

    Last month, House Speaker Jon Burns said he was open to another healthcare proposal that has gone nowhere in the past – raising the state’s tax on tobacco products.

  • Surfing while Juggling

    Surfing while Juggling

    Five types of innovation

    By Clive Bates

    Where does innovation in the tobacco and nicotine field come from? Is it the far-sighted senior executive assessing the needs of the evolving market and committing R&D budgets to realize the corporate vision? Or is it the genius scientists and engineers toiling 24/7 in the labs to invent the wonder product that will become The Next Big Thing?

    Both are caricatures, of course, but neither explains how innovation really works.

    In his brilliant book, How Innovation Works, author Matt Ridley points out that “Innovation is not an individual phenomenon but a collective, incremental and messy network phenomenon.” For those involved, I would say it is more like surfing while juggling than a straightforward path from idea to implementation. To see why, let’s look at five types of innovation in the tobacco and nicotine market.

    First, disruptive innovation. The most prominent recent case of disruptive innovation in the tobacco and nicotine field is the rise of electrical heating as an alternative to tobacco combustion to create an inhalable nicotine-bearing aerosol. Though the Chinese inventor Hon Lik is usually credited with inventing the e-cigarette, the truly disruptive innovation came before and from outside the tobacco and nicotine industry. It is what makes the e-cigarette and modern heated-tobacco products possible. The critical disruptive innovation was the lithium-ion battery. By the 2000s, battery technology had steadily progressed to achieve a sufficiently high power and energy density, allowing rapid heating and an adequately long life between recharges within a compact form factor. Developments in battery technology were driven by the demands of the giant and ultra-competitive markets for mobile devices like smartphones and tablets.

    For decades, the intense heat, complex reactions and chemical cocktail generated by the combustion of tobacco leaf at 900 degrees Celsius in the burning coal of a cigarette were unmatched and unmatchable as a means of delivering nicotine to the lungs. The combination of electrically heated coil and e-liquid to generate an aerosol is now competitive. The disruption of the dominance of the cigarette, currently underway and likely to last two decades to three decades, is driven by a fundamental energy transition that degrades the advantage of combustion.

    I refer to the second type as system innovation. This is the consequential economic, regulatory and public health reaction to the initial disruption and may involve hundreds of innovative responses. For example, the emergence of e-cigarettes triggered a creative response in the Stop Smoking Service in the city of Leicester, U.K. Under the leadership of its manager, Louise Ross, the service changed its practice to embrace vaping as a low-risk alternative to smoking that could appeal to many smokers who had previously been beyond the service’s reach. Through the power of example, that experience led to further innovation at the National Centre for Smoking Cessation and Training and with the government’s support to guidance on e-cigarettes issued by the National Health Service.

    But this innovation did not happen linearly, driven only by personal inspiration. It is best seen as “emergent,” arising from a wide range of concurrent changes and influences triggered within the public health ecosystem. The disruptive innovation also led to system innovations in regulation, such as the 2014 European Union Tobacco Products Directive. In 2016, the U.S. Food and Drug Administration’s deeming rule brought vaping products into the definition of tobacco products and under the jurisdiction of the Tobacco Control Act. The initial disruptive innovation also led to innovation in the business models of tobacco companies, but also in the tactics of their traditional adversaries. Tobacco companies started moving their business toward a future in noncombustible nicotine products, and the anti-tobacco groups shifted their focus from preventing disease to fighting nicotine addiction.

    For tobacco and nicotine companies, the disruptive innovation and the system responses it triggers are like a “big wave,” both prized and feared by top surfers. Like a wave, the companies didn’t create it and can’t control it, but their challenge is to catch it, ride it well and not wipe out. The case of Kodak and its destruction under the breaking wave of digital photography is probably the most cited case of an innovation wipeout. But it doesn’t have to be a technology shift. In the 1970s, deregulation in the aviation sector enabled the emergence of the innovative low-cost airline business model. It wasn’t long before major airline incumbents were going under as that big wave gathered pace.

    The disruptive and systems innovations generate a changing paradigm: a big wave of opportunity or destruction that businesses must learn to surf. But why does innovation feel like juggling while surfing? The juggling reflects the frenetic activity of keeping a company moving, in financial balance and ahead of its rivals while it navigates a radically changing context. This brings us to three further types of innovation: the innovation occurring within the changing paradigm.

    So, the third type of innovation is evolutionary. It resembles the Darwinist process of evolution in nature. Here, the consumer provides what evolutionary biologists call selection pressure, and innovation emerges from incremental improvement through trial and error, mirroring what biologists recognize as mutation and natural selection. It will usually be incremental, but its impact will not always be gradual. Evolutionary innovation can make radical inroads into a market by solving a particular problem or exploiting an opportunity.

    A good example is pod-based vaping products using nicotine salts. Salts change how nicotine is absorbed in the airways and allow users to consume smaller volumes of higher strength liquids. The effect of the salts is to allow high-strength nicotine liquids to be used without undue harshness with a smaller battery and tank, enabling a compact and convenient device. This addressed the challenge of providing a convenient and discreet product with effective nicotine delivery. It was wildly successful—at least where regulators allowed it.

    I have seen much handwringing about the recent rise of disposable vaping products. But this is another case of evolutionary innovation. The disposables solve the problem of finding a quick and convenient way into vaping for smokers in the early or tentative stages of switching away from smoking. They are simple to use, low cost and convenient. They don’t require an upfront investment in a device, so they lower the cost of consumer trial and experimentation. Like many innovations, these products have downsides, such as the waste generated. But this is manageable and must be set against the potential benefits and in context with other waste material flows.

    The fourth type of innovation is adaptive. This is a variation of evolutionary innovation, but it arises in response to regulation. Ultimately, it is driven by meeting consumer preferences, but it is triggered by regulatory interventions that would otherwise compromise the consumer experience—ether by design or as an unintended consequence. One example is the mentholation cards that emerged after the European Union ban on menthol-flavored cigarettes. These are inserted into cigarette packs to infuse nonmenthol cigarettes with menthol flavor. Another case is the “shortfill” e-liquid containers that became popular as a workaround to overcome the European Union ban on e-liquid containers of more than 10 mL volume. Much larger containers of nicotine-free vaping liquid are sold only partially filled, allowing the nicotine to be added later—often from nicotine liquids stronger than permitted in the EU.

    As the FDA imposed ever more burdensome regulation on nicotine vapes, small companies introduced synthetic nicotine products because the law confined FDA jurisdiction to nicotine derived from tobacco. This example also illustrates the arms race fought between adaptive innovators and responsive regulators. By March 2022, the FDA had prompted Congress to amend the Tobacco Control Act to apply to nicotine derived from any source, not just tobacco. Adaptive innovations can come with novel risks. For example, regulated bans on flavored e-liquids may lead to consumers adding food or aromatherapy flavoring agents not necessarily intended for vaping.

    The fifth type of innovation is user-driven. The early vaping enthusiasts were hybrid producer-consumers, interacting on user forums with a strong problem-solving ethos and a hands-on approach to product design and construction. Users created innovations like “squonkers” or “squonk mods” to facilitate dripping, a niche style of vaping, by incorporating a flexible liquid bottle into the design of the vaping device. But the most impressive innovations from the user side have been social and community in nature. The vaping forums and vape meets created an elaborate technical and moral support infrastructure. This online community blossomed into vape shops as centers of expertise, personalization and encouragement. The vape shops are now de facto cutting-edge stop-smoking services but with a very different offer to the more clinical settings of traditional services. Even the biggest corporate beasts benefit and learn from user innovation. They should take care not to crush it.

    Innovation is a fluid and dynamic business phenomenon with many simultaneously moving parts embedded in an unpredictably evolving, threatening or promising context. Surfing while juggling is hard and risky, but it is no longer a choice in the tobacco and nicotine business.

  • Zinwi to Unveil New Logo at TPE Show in Las Vegas

    Zinwi to Unveil New Logo at TPE Show in Las Vegas

    E-Liquid manufacturer Zinwi Bio-Tech is set to unveil its new logo at the Total Products Expo (TPE) in Las Vegas from Feb. 22 – 24. The company will also be highlighting 15 of its most popular e-liquid flavors for TPE attendees to experience. 

    Zinwi, a global integrated e-liquid solutions provider, upgraded its branding in December to better reflect the company’s dedication to providing high-quality products and the brand’s entry into a new development phase.

    “In this new phase, Zinwi will place more emphasis on product research and development, and provide diversified products to meet the needs of global markets,” a Zinwi spokesperson told Vapor Voice. “Zinwi is committed to continuing to explore e-liquid technology, pursue innovation and provide cutting-edge integrated e-liquid solutions.”

    Zinwi’s new logo resembles a drop of e-liquid oil, which alludes to the company’s unwavering commitment to product research and development. The Zinwi “Z” and oil design are integrated to symbolize the company’s dedication to continuous product research and development, according to a press release. The light blue color of the logo features Zinwi’s laboratories that conduct its scientific product research and development in the background.

    Currently, new nicotine salt and glycerol alternatives are two major topics of research for Zinwi. The company’s product research and development team has produced a new nicotine salt that has distinct advantages compared with the traditional benzoic acid nicotine salt.

    “This new innovation brings with it a significant reduction in the number of impurities released. Zinwi is also in the process of researching and developing glycerol alternatives,” the spokesperson said. “The research and development of glycerol alternatives is an effort to reduce the toxins released during atomization and to allow the products to be more environmentally friendly.”

    The 15 e-liquid products Zinwi is set to showcase at TPE include five tobacco flavors and 10 non-tobacco flavors. They are Zinwi’s best-selling flavors and have been widely recognized by the company’s global client base. One of the flavors, Caramel Tobacco, has a distinctive caramel flavor along with a mild tobacco accent.

    In order to allow the show attendees to experience the different flavors, Zinwi will provide disposable vaping devices pre-filled with the Zinwi e-liquids in the 15 flavor profiles. “Trade show attendees will be able to try out the different flavors in different devices with a variety of settings, enabling them to reach the optimal puff experience,” the spokesperson said.

  • ElF Bar Pulled From UK Shelves for E-Liquid Volumes

    ElF Bar Pulled From UK Shelves for E-Liquid Volumes

    Elf Bar vapes are being sold with e-liquid volumes more than 50 percent over the UK’s legal limit, an investigation has found, according to reporting in Metro.

    The Chinese vaping giant admitted “inadvertently” breaking the law and ‘wholeheartedly apologized’ following lab tests of its 600 brand of disposable vape pens.

    E-cigarettes bought at branches of Sainsbury’s, Tesco and Morrisons contained between 3ml and 3.2ml of e-liquid, when the legal limit is 2ml (the article states the liquids were over nicotine limits, but there is no evidence of that. The UK limits nicotine strength to no more than 20mg/ml).

    The brand, which only launched in 2021, sells 2.5 million Elf Bar 600s in the UK every week, accounting for two in three of all disposable vapes. The devices cost £5.99 each.

    An Elf Bar spokesperson insisted the “highly regrettable situation” did not affect the safety of its vapes.

    Mark Oates, director of the consumer advocacy group We Vape, said, “The Mail’s findings on Elf Bars are deeply worrying, and it is clear there have been failings on multiple levels.

    “Not only are the levels of e-liquid too high, but checks to make sure these guidelines are adhered to either haven’t occurred or are insufficient. Anyone supplying vapes in the U.K. market should be following the legislation.

    “It is incredibly frustrating when major players in this sector appear to behave in a way that damages the reputation of something as beneficial as vaping, and we expect the matter to be fully investigated by the Medicines and Healthcare products Regulatory Agency (MHRA).”

  • Australia Legalizes Medical Psilocybin and MDMA

    Australia Legalizes Medical Psilocybin and MDMA

    Credit: 24K Production

    The Australian government has rescheduled the psychedelics psilocybin and MDMA to provide access to people with post-traumatic stress disorder (PTSD) and treat-resistant depression.

    The substances aren’t being legalized for broad use, but by placing them in Schedule 8 for therapeutic use under the country’s drug code, psychiatrists who meet the required standards will be able to prescribe the psychedelics. The drugs will remain in the stricter Schedule 9 for unauthorized use.

    “The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses,” Australia’s Therapeutic Goods Administration (TGA) said in a notice on Friday, reports Marijuana Moment.

    The new rules mean that psilocybin and MDMA can be used therapeutically in a controlled medical setting starting on July 1, according to TGA. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.

    The decision follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.

    There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy. However, this amendment will allow authorized psychiatrists to access and legally supply a specified “unapproved medicine containing these substances to patients under their care for these specific uses.”

  • Kaival’s Fiscal 2022 Hit by Marketing Denial Order

    Kaival’s Fiscal 2022 Hit by Marketing Denial Order

    Photo: Kaival Brands

    Kaival Brands Innovations Group reported revenues of $3 million for the fourth quarter that ended Oct. 31, 2022, compared with revenues of $100,000 million for the prior fourth fiscal quarter. Revenues for the full fiscal year were approximately $12.8 million, down from $58.8 million for fiscal year 2021.

    Kaival attributed the full-year decrease to the U.S. Food and Drug Administration’s marketing denial orders (later overturned), which temporarily prevented the company from selling its products, and to increased competition in general, which Kaival suspects resulted from lax enforcement by federal and state authorities against subpart and low-priced vaping products that continued to enter the market illegally without FDA authorization.

    “Fiscal 2022 was an exceptionally challenging year for us, primarily due to regulatory action by the FDA that was ultimately overturned in August,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.

    “For a portion of fiscal 2022, we were prohibited from selling our flavored Bidi Sticks, and our 2022 revenues reflect the significant extended impact of this. The good news is that this impediment is behind us. Moreover, despite the challenges, we accomplished several important milestones during the year which we believe has laid the foundation for renewed growth and progress in 2023, including expanding existing sales channel relationships and initiating significant new ones. We expect and hope that the FDA will continue to pull bad actors from the marketplace, paving the way for companies like ours to provide our products to adult smokers deserving of premium e-cigarette product and experience.”