Author: Staff Writer

  • Smoore’s Feelm Brand Wins Gold at Muse Design Awards

    Smoore’s Feelm Brand Wins Gold at Muse Design Awards

    Illustration: Smoore

    Smoore’s flagship brand, Feelm, has received a gold award in the product design category of 2021 Muse Design Awards for its ultra-slim disposable vape with ceramic coil, TA15. Feelm is the only brand winning a 2021 Muse Design Award in the atomization field. The Muse Design Awards is an international competition for designers whose craftsmanship leads to paradigm shifts.

    As the world’s first disposable ultra-slim pod product equipped with ceramic coil, TA 15 marks the opening of a new ceramic era of disposable vapes, according to Smoore. The Feelm atomization coil inside TA 15 guarantees low power consumption, a stronger vapor and a stable vaping experience. Despite its ultra-slim body, TA15 offers over 300 puffs.

    Moreover, TA15 adopts an anti-condensation structure to control the dynamic condition of e-liquid, minimizing leakage and offering a premium user experience.

    The slightly arc surface wraps the inner structure compactly forming a 7.5 mm thinnest body. The vertically textured surface makes it comfortable to hold and resists fingerprints. The raised part of TA 15 prevents the mouthpiece from contact with desks and other surfaces for hygiene. It also features a concealed air inlet.

    Meanwhile, the highlighted “pixel block” is actually a metal sticker, whose color is changed with flavors and supports customization.

    By virtue of unique design and innovation technology, this product has effectively solved the industry’s pain point of leakage without a silicone plug, according to Smoore. Thanks to a breakthrough in materials and structural science, there’s no burnt taste, offering more delicate vapor and purer taste.

    “I always put users first and attempt to deeply understand and explore their potential needs,” said Qing Ling, ID Designer of TA15, in a statement. “Driven by design thinking, we combine practicability and minimalism, highlighting the performance of our ceramic coil while making other parts as thin as possible.”

    The Muse Design Awards is a part of the Muse Awards Program, which was created by the International Awards Associate (IAA) in 2015. IAA’s aims to honor, promote and encourage creativity by providing a new standard of excellence for evaluating media design production and distribution.

  • Zanoprima Begins Commercial Production of SyNic

    Zanoprima Begins Commercial Production of SyNic

    Zanoprima Lifesciences announced the commercial production of its SyNic brand of synthetic (S)-nicotine. The company said SyNic is produced using a patented process that does not involve the use of tobacco or any synthetic racemic mixture. The company manufactures “high purity (typically 99.9 percent), synthetic (S)-Nicotine for commercial use” that is free of tobacco-specific nitrosamines(TSNAs), toxins, carcinogens, odor and harsh taste.

    “This is a landmark development for the trillion-dollar tobacco industry and its 1.3 billion consumers as it heralds the arrival of a superior, substantially lower-risk, cost-effective, and greener alternative to a global industry that is arguably the single biggest avoidable cause of death globally, a press release states. “SyNic Protonated (S)-Nicotine e-liquid for e-cigarettes is without any potentially harmful ingredients such as organic acids and propylene glycol. It is pure, stable and has a long shelf life. E-cigarettes that use SyNic offer a smooth taste and enhanced nicotine experience, a distinct advantage given the nicotine limit guidelines/rules in e-liquids in the EU and other geographies.”

    SyNic (S)-nicotine conforms to and exceeds European Pharmacopeia (EP) and United States Pharmacopeia (USP) specifications. The company states that its “Green Chemistry” principles compliant production process minimizes the environmental impacts of nicotine production. Applications include:

    Zanoprima owns patent applications or registration for its revolutionary manufacturing process in several countries, including the United States, Europe, Great Britain, Australia, China, India and others, according to the release.

    SyNic is also available in products such Znus, a tobacco-free white snus that is completely sodium and tobacco-free and next-generation chewing gum and lozenges that “contain a new proprietary nicotine complex with superior bioavailability and taste,” according to the release.

    The company has also announced it will soon release tobacco-free heated nicotine products unlike existing tobacco-based heat-not-burn products and skin-friendly transdermal patches for use with Alzheimer’s and dementia patients. As a responsible synthetic nicotine (SyNic) manufacturer Zanoprima will distribute SyNic in strict compliance with regulations in each of its markets, globally.

    “Zanoprima offers the entire range of products including SyNic (S)-nicotine bitartrate (Nicotine Bitartrate Dihydrate), SyNic (S)-Nicotine polacrilex resin/Nicotine resinate and its novel proprietary (S)-Nicotine complex,” the release states.

  • U.K. Urged to Use Brexit Rights to Tout Vaping at WHO

    U.K. Urged to Use Brexit Rights to Tout Vaping at WHO

    Photo: sea and sun

    David Jones, a former Welsh Secretary and Brexit minister, has urged Britain to use its Brexit freedoms to tout the health benefits of e-cigarettes during the next summit on tobacco organized by the World Health Organisation, reports The Express.

    The parties to the WHO Framework Convention on Tobacco Control are set to meet virtually in November to discuss tobacco control policies.

    Delegates will debate the success and failure of recent and ongoing tobacco control initiatives. They will discuss how best the world can be convinced to give up traditional cigarettes, and they will debate matters such as law enforcement’s involvement in the illicit tobacco trade.

    Both the WHO and the EU have taken a dim view of e-cigarettes, pushing for ever-tighter restrictions. The WHO has claimed on its website that there is growing evidence of risk from e-cigarettes.

    Britain has taken a pragmatic approach to the category, allowing vapor products to remain on the market within a comparatively light regulatory framework.

    “Unlike previous COPs, the U.K. does not have to join the EU’s position,” said Jones. “We are not bound by Brussels, we are independent and free to back the science, back Public Health England, and back our own health experts, over the WHO.

    “We must not fall into bad habits and simply join the EU position because it would be the easy thing to do. Brexit meant control over our own policies. This is our chance to show the electorate what that means in reality. We must use our freedom to save lives.”

    There are concerns however that the WHO will not recognize the U.K. as an independent voice at its summit. Instead, it may defer to the EU as the voice for the Europe region.

  • Triton Distro FDA Lawsuit Decision Expected This Week

    Triton Distro FDA Lawsuit Decision Expected This Week

    Triton Distribution filed a motion to stay the U.S. Food and Drug Administration’s decision to issue the company marketing denial orders (MDOs) for its premarket tobacco product applications (PMTAs). The company requested a decision from the judge by Oct. 15.

    “Black-letter rules of administrative law prevent an agency from retroactively changing legal requirements and from doing so without accounting for reliance interests. FDA failed to satisfy these requirements when it executed an about-face on the evidence it required to support a premarket tobacco product application (“PMTA”) for a marketing order for flavored electronic nicotine delivery system (“ENDS”) products almost a year after such applications were due,” the motion states. “FDA also acted arbitrarily and capriciously by ignoring relevant evidence found in Petitioner Wages and White Lion Investments, LLC d/b/a Triton Distributions (“Triton”) PMTA and applying a double standard to its consideration of that evidence when it issued Triton a marketing denial order (“MDO”). Further, by imposing a new, across-the-board requirement that flavored ENDS products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (“FDCA), 21 U.S.C. § 387j, and not in accordance with law.”

    Triton states that it has been irreparably harmed as a result of the FDA’s actions and faces an imminent shutdown of its business in approximately two weeks. This is why Triton entered an emergency stay of the “FDA’s MDO for Triton’s products by October 15, 2021, and order expedited merits briefing. Respondent FDA consents to the proposed expedited merits briefing schedule but opposes a stay.”

    At least six companies have filed lawsuits challenging the agency’s decision to make the companies remove their products from the market. Last week, the FDA rescinded the MDO issued to Turning Point Brands (TPB) and the company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).

    The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”

  • FDA Admits Error, Rescinds Turning Point Brands MDOs

    FDA Admits Error, Rescinds Turning Point Brands MDOs

    Turning Point Brands (TPB) has had its marketing denial orders (MDOs) rescinded by the U.S. Food and Drug Administration. The company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).

    “We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, president and CEO, Turning Point Brands. “It is important that the PMTA process is transparent, purposeful, and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance. We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”

    Credit: Momius

    The FDA admitted it made an error in TPB’s PMTA review and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”

    The letter comes after TPB filed a petition with the court that forced the FDA to provide an administrative record for its decisions on PMTAs. TPB sells various flavored e-liquids marketed under the Solace, VaporFi and Vapor Shark brands. TPB then filed a stay motion asking the the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.”

    Avail Vapor and several other companies that received MDOs have also now filed petitions for information related to their PMTA reviews. After the FDA rescinded TPB’s MDOs, the company dropped its lawsuit against the regulatory agency.

    “In light of the unusual circumstances,” the FDA’s Center for Tobacco Products (CTP) Director Matt Holman stated in the letter. “FDA has no intention of initiating an enforcement action” against TPB’s products that had previously received an MDO.

  • Study Claims Many Unknown Chemicals In E-Cigarettes

    Study Claims Many Unknown Chemicals In E-Cigarettes

    Photo: pavelkant

    E-cigarettes and other vapor products contain thousands of unknown chemicals and substances not disclosed by manufacturers, according to a study published on Oct. 6 by Chemical Research in Toxicology.

    The authors noted that the aerosols produced by vapor products contain more than 2,000 chemicals, the vast majority of which are unidentified. The researchers, who are from Johns Hopkins University, reported that the findings suggest people who vape are using a product whose risks have yet to be fully determined and could be exposing themselves to chemicals with adverse health effects.

    The researchers used a chemical fingerprinting technique based on liquid chromatography and high-resolution mass spectrometry, which can identify organic compounds in wastewater, food and blood. The team evaluated four popular products: Mi-Salt, Vuse, Juul and Blu, testing only tobacco-flavored products.

    The examined e-liquids contained hydrocarbon-like compounds, typically associated with combustion, which manufacturers claim are not produced during vaping. “More and more young people are using these e-cigarettes, and they need to know what they’re being exposed to,” study co-author Carsten Prasse was quoted as saying by Johns Hopkins Magazine. “E-cigarette aerosols contain other completely uncharacterized chemicals that might have health risks that we don’t yet know about. People just need to know that they’re inhaling a very complex mixture of chemicals when they vape. And for a lot of these compounds, we have no idea what they actually are.”

  • FDA Issues First Warning Letters for MDO Violations

    FDA Issues First Warning Letters for MDO Violations

    The U.S Food and Drug Administration today issued warning letters to 20 companies for unlawfully continuing to market electronic nicotine-delivery system (ENDS) products that are the subject of marketing denial orders (MDOs).

    These are the first warning letters issued for the marketing of products subject to MDO determinations on their premarket tobacco product applications (PMTAs), according to an FDA statement. The FDA has also issued warning letters for the unlawful marketing of tobacco products to one company that received Refuse to File (RTF) determinations on their PMTA, one company that received both RTF and MDO determinations on their PMTA, and six companies that did not submit any premarket applications.

    “Collectively, these 28 companies have listed a combined total of more than 600,000 products with the FDA. All new tobacco products sold, distributed, or imported in the United States without FDA authorization are marketed unlawfully and risk FDA enforcement,” the statement reads. “On FDA’s Warning Letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.”

    Products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.

    Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA.

  • Costa Rica Readies to Ban Vaping in Public Spaces

    Costa Rica Readies to Ban Vaping in Public Spaces

    Costa Rican lawmakers this week approved in a second debate a bill that will the ban the use of vaping products such as e-cigarettes in public spaces. The bill, Project 21.658, passed with 33 votes in favor and seven against. Seventeen deputies did not participate in the vote and the bill must still be signed into law and published in La Gaceta before it takes effect, according to the Tico Times.

    Credit: Zerophoto

    In addition to banning vaping in most public spaces, the bill also sets the grounds for the country to implement a tax on vaping devices and accessories, such as coils and e-liquids. The Health Ministry endorses the bill, which was first introduced prior to the coronavirus pandemic.

    “I think this project is extremely important for the country. It has the full support of the Ministry of Health,” a lawmaker supporting the bill said. “It is completely in line with the health alert we already issued regarding the use of vaping devices, where we have even been very clear that there is no study that can show e-cigarettes are a smoking cessation therapy. On the contrary, we have to disincentivize the use of cigarettes and the use of vaporizers.”

    The taxes would be allocated to the Costa Rican Social Security Fund (CCSS) and be earmarked for the treatment of diseases related to tobacco consumption.

    The Red Nacional Antitabaco (RENATA) – National Anti-Smoking Network – expressed its satisfaction with the approval of the law. Nydia Amador, president of that organization, assured that the new regulations will give substantial support to the Ley de Control de Tabaco (Tobacco Control Law).

    “It is important to consider the vulnerability of all consumers of tobacco products, including electronic devices or vapers, to any disease of the respiratory system, since the first studies on the effects of the use of vaporizers and heated tobacco products show negative consequences for the lungs and the immune and cardiovascular systems,” said Amador.

    RENATA also stated that vaping advocates “tried to confuse public opinion by claiming that vaping is 95 percent less harmful than tobacco use.”

    Many organizations such as the United Kingdom’s Royal College of Physicians and Public Health England (PHE) have released studies that show vapor products have been scientifically proven to be 95 percent less harmful than cigarettes and related tobacco products. This is supported by the U.S. Academies of Science which has also found that e-cigarettes have a lower harm profile compared to their combustible competition. 

  • E-cigarette Market To Reach $84.43 Billion by 2025

    E-cigarette Market To Reach $84.43 Billion by 2025

    Photo: lezinav

    The global e-cigarette market is expected to reach $84.43 billion in 2025, progressing at a compound annual growth rate (CAGR) of 17.65 percent over the period 2021–2025, according to a new report in Research and Markets.

    Growth in the e-cigarette market has accrued due to the changing consumer perception toward combustible cigarettes, upsurge in working population, decline in consumption of cigarettes, mounting-up prices of tobacco cigarettes and peer influence on youth.

    The market is anticipated to experience certain trends like upswing in Gen Z income, emergence of flavored e-cigarettes, increasing influence of social media and rise in technological developments by e-cigarette manufacturers. However, the growth of the market would be challenged by stringent regulations, nicotine exposure in e-cigarettes and surging concerns over side effects of e-cigarettes and vapor products.

    The fastest-growing regional market is the U.S. due to increasing awareness of safer tobacco alternatives, continuous efforts of anti-smoking organizations shifting the tobacco consumers to alternative forms, i.e., e-cigarettes and increased customer acceptance due to cost-efficiency of these devices.

    Further, the sudden outbreak of Covid-19 is causing an adverse disruption on the overall economy through halted production and logistics activities, affecting the demand and supply of e-cigarettes across the world.

     

     

  • Fierce Opposition to Legalizing E-Cigarettes in Thailand

    Fierce Opposition to Legalizing E-Cigarettes in Thailand

    Photo: 1STunningART

    A proposal to legalize e-cigarettes in Thailand has run into fierce opposition, reports the Bangkok Post

    Digital Economy and Society Minister Chaiwut Thanakamanusorn said on Tuesday he is exploring ways to permit the sale of e-cigarettes, citing their potential to help people quit smoking and economic opportunities.

    At least 67 countries have approved e-cigarettes as a less harmful alternative to smoking, while Thailand still refuses to accept them, Chaiwut noted. More importantly, if it is possible to turn tobacco grown in Thailand into e-cigarette products and export them, both the Tobacco Authority of Thailand and tobacco growers will benefit, he said.

    The National Alliance for a Tobacco-Free Thailand (NATFT) responded by calling on the government to increase efforts to protect the public from all forms of tobacco products. “Various elements of society, both government and non-government, have been working hard to reduce the number of smokers, so legalizing e-cigarettes will only exacerbate the situation,” said NATFT chairwoman Somsri Pausawasdi.

    E-cigarettes are not safer choices for people who want to quit smoking while knowledge about their long-term effects on health remains limited for now, echoed Ronnachai Kongsakon, director of Tobacco Control Research and Knowledge Management Center.

    The Medical Association of Thailand too has come out strongly against Chaiwut’s proposal.

    The organization sent an open letter to Prime Minister Prayut Chan-o-cha asking him to caution the minister. The letter was signed by Amorn Leelarasamee, president of the Medical Association of Thailand, and supported by heads of other organizations, including 14 royal colleges and the National Alliance for Tobacco-Free Thailand.

    The president of the Royal College of Surgeons of Thailand, Pramuk Mutirangkura, also voiced his opposition.

    Responding to the minister’s assertion that at least 67 countries had approved e-cigarettes as being less harmful than smoking tobacco, Pramuk said that each of those countries had allowed the sale with conditions attached. They were not sold without restrictions, he noted. 

    Many other countries still banned e-cigarettes because they wanted to protect the people’s health, preferring the “prevention is better than cure” principle, he added.

    There are at least 10 million smokers in Thailand.