Tag: vaping

  • FEELM Highlights OS Vape at InterTabac

    FEELM Highlights OS Vape at InterTabac

    The latest in vaping industry innovations made its debut during InterTabac 2023, held from September 14-16, as FEELM, a leading closed system solution provider, unveiled its OS Vape in a partnership with OS.

    It is the first time FEELM has co-exhibited with its local partner during the world’s largest nicotine and tobacco trade show held in Dortmund, Germany.

    OS, a major player in Germany’s shisha product market, recently ventured into the disposable vaping product market.

    A representative from the FEELM booth said that collaborating with clients for exhibitions is a new strategy aimed at bolstering the client’s brand presence in local markets.

    The FEELM spokesperson said the company intends to continue its co-exhibition format at major global exhibitions, joining forces with clients from various regions in a collective march towards a global presence.

    OS Vape introduced a disposable vaping solution that delivers an elevated puff count, cost-efficiency, and unmatched vapor consistency, promising German consumers a rich vaping experience reminiscent of their cherished beers.

    The OS Vape uses FEELM Max ceramic coil technology, disposable product the ability to provide 800+ puffs, a more than 30% enhancement in puff count compared to other common disposable products.

    This establishes a new standard under TPD compliance, according to the FEELM spokesperson.

    “Beyond puff count, OS Vape offers an exceptional vapor and taste consistency of over 95%. These groundbreaking advancements have undoubtedly propelled the vaping industry to new zeniths,” the spokesperson said. “Additionally, the signature transparent e-liquid tank not only alleviates e-liquid concerns but also adds a touch of aesthetic sophistication.”

  • TPMP Comment Period Extended

    TPMP Comment Period Extended

    Credit: May1985

    The U.S. Food and Drug Administration has extended the comment period on its proposed rule for tobacco manufacturing practices.  

    Stakeholders now have until Oct. 6, 2023, to share their thoughts.

    The proposed rule would place new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products. According to the FDA, these proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.

  • FDA Tobacco Chief Discusses Relative Risk

    FDA Tobacco Chief Discusses Relative Risk

    Brian King (Photo: FDA)

    In an article published in Addiction magazine, Brian King, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), explores the chances and considerations for informing adults who smoke cigarettes about the relative dangers of tobacco products, including e-cigarettes. He collaborated with Benjamin Toll, director of the Medical University of South Carolina Tobacco Treatment Program and co-director of the Lung Cancer Screening Program.

    The commentary highlights the findings of a recent survey about misperceptions of tobacco product harms, including cigarettes and e-cigarettes. The survey found that only about 20 percent of adults who smoke cigarettes believed e-cigarettes contain fewer harmful chemicals than cigarettes. While there are no safe tobacco products, the available scientific evidence indicates that tobacco products exist on a continuum of risk, with cigarettes being the most harmful. 

    The commentary notes that opportunities exist to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes. However, these efforts should be accompanied by efforts to prevent youth tobacco product use; encourage first-line use of FDA-approved cessation therapies; and for adults who both smoke and use e-cigarettes, reinforce the importance of completely transitioning to e-cigarettes.

    The commentary further emphasizes that any education efforts on the relative risks of tobacco products must be evidence-based. In particular, it is important to assess the benefits among the intended population (i.e., adults who smoke) and risks among unintended populations (e.g., youth). Currently, FDA is in the early stages of a research effort to assess messaging about the continuum of risk of tobacco products among adults who smoke.

    Last week, the FDA announced a virtual listening session opportunity to verbally provide open public comment on the development of the new strategic plan, including proposed strategic goals. After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan, including proposed goal areas.

    Registration is open for the virtual listening session on the development of the CTP’s five-year strategic plan, which will take place on Aug. 22 beginning at 10 a.m. EDT.

     

  • McKinney Regulatory Science’s New Website

    McKinney Regulatory Science’s New Website

    McKinney Regulatory Science Advisors has launch its new website that promises “a new era of innovation and transparency for their clients,” according to a press release.

    The new platform describes an array of advisory services to nicotine and cannabis clients, with an emphasis on providing McKinney clients with the best available regulatory services.

    Willie McKinney, CEO of McKinney, said the new website represents a significant milestone in journey to provide exceptional advisory services to our nicotine and cannabis clients.

    “The revamped platform reflects our dedication to innovation, transparency, and client satisfaction, making it easier for clients to explore our services and access valuable regulatory resources,” he said

    The new website offers a modern design that makes it easy for users to find the information they need quickly. It also features an intuitive navigation system that allows users to identify relevant services and access helpful resources rapidly, according to McKinney. Additionally, the site is optimized for mobile devices so that users can access the site from any device at any time.

    “McKinney RSA focuses on providing comprehensive solutions that meet complex regulatory requirements while also delivering superior customer service,” the release states. “With decades of industry experience under their belt, they are committed to helping their clients succeed by providing top-notch guidance every step of the way.”

  • Misperceptions Persist

    Misperceptions Persist

    Image: Tobacco Reporter archive

    A large portion of smokers have misperceptions about vaping, thinking it is just as harmful or more harmful than smoking, according to the most recent Action on Smoking and Health (ASH) survey data.

    The data shows that “among the 1.8 million smokers who are yet to try vaping, 43 percent believe e-cigarettes are as harmful or more than smoking, up from 27 percent in 2019.” It also shows that “among the 2.9 million smokers who have tried vaping but stopped, 44 percent believe vaping is as harmful or more than smoking, up from 25 percent in 2019.”

    Due to the large proportion of misperception, ASH feels that its swap to stop program is “threatened by growing concerns among smokers that vaping is as or more risky than smoking.”

    “The government has backed a vaping strategy as its path to reduce rates of smoking, but this approach will be undermined if smokers don’t try vapes due to safety fears or stop vaping too soon and revert to smoking. The government must act quickly to improve public understanding that vaping poses a fraction of the risk of smoking,” said Hazel Cheeseman, deputy chief executive of ASH.

    Groups such as the Independent European Vape Alliance (IEVA) and the U.K. Vaping Industry Association (UKVIA) support ASH’s stance on government action.

    “It is abundantly clear that the lack of knowledge amongst smokers about the relative risks about smoking and vaping is a public health issue that the government can no longer ignore,” said John Dunne, UKVIA director general. “The ASH report highlights that misleading and inaccurate stories and headlines about vaping in the mainstream media plays a huge part in this knowledge gap, which is preventing smokers’ switch to a much less harmful alternative to cigarettes.

    “The public needs to know that the scare stories regularly reported in the mainstream media are simply not true, and we urgently need an antidote to this highly damaging misinformation.

    “The industry is not permitted to make health claims about the relative harms of smoking and vaping, but keeping the public in the dark about this means hundreds of smokers continue to needlessly die in the U.K. every day because they don’t have the information they need to switch.

    “We must be allowed to set the record straight, and the government should launch a nationwide public information campaign so that the relative risks of smoking and vaping are accurately communicated.”

    Ann McNeill, professor at King’s College London and author of a government-commissioned review on the harms from vaping, according to Talking Retail, commented: “Anxiety over youth vaping is obscuring the fact that switching from smoking to vaping will be much better for an individual’s health. It is wrong to say we have no idea what the future risks from vaping will be.

    “On the contrary, levels of exposure to cancer-causing and other toxicants are drastically lower in people who vape compared with those who smoke, which indicates that any risks to health are likely to be a fraction of those posed by smoking.

    “We must not be complacent about youth vaping, and further regulation is needed, but so, too, is work to ensure many more adults stop smoking, and vaping is an effective means of doing that.”

  • Retracted Study Links Vapes and Liver Disease

    Retracted Study Links Vapes and Liver Disease

    Image: shidlovski

    A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research after the authors failed to reply to concerns about the researchers’ methods and findings, reports Filter.

    The retraction stated that “concerns have been raised regarding the article’s methodology, source data processing, including statistical analysis, and reliability of conclusions.” The study was published in June 2022.

    A letter was sent to the editor raising concerns, and the authors were given time to respond but failed to do so. “As is our journal and publisher’s policy, because there was no response or rebuttal from the authors, the manuscript was retracted, and the letter to the editor was not published,” said Robert Wong, editor-in-chief of Gastroenterology Research. “Typically, if there is an author response or rebuttal, we publish both the letter to the editor and the response.”

    “This is a greater problem than just one study,” said Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, noting a 2020 retraction by the Journal of the American Heart Association of a study connecting vaping to heart attacks. The 2020 retraction letter to the journal was made public, but the issue with the Gastroenterology Research paper is less clear because “there is silence around why it was retracted,” said Conley.

    It’s gratifying that the journal took the step to retract the paper. There’s just a lot of things going on with this study that make it seem kind of weird.

    The 13 co-authors of the study drew from the National Health and Nutrition Examination Survey and analyzed participants’ responses for associations between liver disease and the use of cigarettes or vaping products.

    They claimed the results showed “e-cigarette users … were associated with higher odds of having liver disease compared to nonsmokers.”

    “I already have a bunch of questions just off the top of my head, basically, just looking at this paper,” said who studies tobacco dependence and treatment. He said there were issues with the data, noting that the only survey question on vaping is broad, asking “Have you ever used an e-cigarette?” Questions on combustible tobacco included “Do you now smoke cigarettes?” and if someone has smoked “at least 100 cigarettes” in their life. 

    “That’s kind of a weak variable,” Niaura said. “What does it mean? It doesn’t mean much.”

    The data also didn’t allow for analysis around timing, which means it’s not possible to tell whether liver disease was developed before or after smoking/vaping. “What’s the resolution of the information in studies like this?” Niaura asked. “It’s tricky.”

    “It’s gratifying that the journal took the step to retract the paper,” he said. “There’s just a lot of things going on with this study that make it seem kind of weird.” 

  • Distributors Accused of Racketeering

    Distributors Accused of Racketeering

    Credit: Vitalii Vodolazskyi

    New York City has filed a lawsuit in federal court charging four vaping product distributors and six persons associated with the companies for illegally selling flavored vaping products other than tobacco in the city. It is possible more companies will be added to the suit.

    The civil lawsuit, filed Monday in the U.S. District Court for the Southern District of New York, claims the defendants violated “nearly every federal, New York State and New York City law applicable to the marketing, distribution, and sale of flavored e-cigarettes, the sales of which are prohibited under laws enacted by all three jurisdictions.”

    Named in the suit are Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. Also named were Matthew Glauser, Donald Hashagen, Russell Rogers, Nikunj Patel, Devang Koya and Nabil Hassen. The suit also mentions Puff Bar, Elf Bar and Hyde products, however, those manufacturers were not named in the suit.

    The lawsuit alleges the defendants committed mail and wire fraud, alongside violations of New York City’s Administrative Code, New York State Public Health Law, and the federal Tobacco Control Act. The city also accuses the companies of violating both the federal Racketeering Influenced Corrupt Organizations (RICO) Act and the Prevent All Cigarette Trafficking (PACT) Act.

    The suit centers on disposable flavored vapes. However, the suit alleges that is seeking relief for any type of flavored e-cigarette product on the market. This would suggest the suit could grow into anyone entity that has sold flavored vaping products in the city.

    “Although this action speaks principally about (flavored disposables), the favorite type of electronic nicotine delivery system among youth and the most intentionally directed to that market, the City seeks relief for defendants’ violation of laws applicable to e-cigarettes regardless of the type of device with which the violation is committed,” the suit states. “Any non-FDA approved [the FDA authorizes for marketing; it does not approve products] e-cigarette containing a flavored e-liquid is governed by the laws under which the City’s claims are brought and the City seeks relief with respect to all such devices.”

    The city says it “seeks to recover monetary damages and civil penalties from the defendants, potentially totaling millions,” according to a press release. The suit also alleges the sales of disposable flavored vapes created a youth use crisis. The suit alleges the largest increase in youth use ever. The claim is unsupported by any facts.

    “By distributing devices that provide larger than normal doses of nicotine in a mild aerosol formulated to reduce or eliminate the harshness of burning tobacco and tasting pleasantly of fruit, candy or desserts, [flavored vaping device] manufacturers and distributors have triggered the largest increases in youth nicotine use ever seen,” the suit claims.

    The lawsuit states the city will seek triple the damages awarded at trial under the RICO guidelines.

  • FDA Denies Marketing of Myblu Menthol

    FDA Denies Marketing of Myblu Menthol

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration on July 10 issued a marketing denial order (MDO) for Myblu Menthol 2.4 percent, an e-cigarette product made by Fontem US. The order prohibits the company from marketing or distributing this product in the United States.

    “Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweighs the known risks.”

    Among other shortcomings, the application presented insufficient scientific evidence to show that the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes, according to the FDA.

    Fontem US may resubmit a new application to address the deficiencies for the product subject to this MDO.

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. Last year, the FDA issued MDOs to Fontem US for several other Myblu products, which are the subject of ongoing litigation.

  • Flavored Vaping Ban Begins Tomorrow

    Flavored Vaping Ban Begins Tomorrow

    A ban on advertising e-cigarettes in Ukraine, including heated-tobacco products, goes into effect on July 11. Flavored electronic nicotine-delivery systems (ENDS) products are also banned.

    The advertising rule applies to all types of media, including the Internet, social media, public transportation, and public events.

    “The advertising, sales promotion and sponsorship of electronic cigarettes, liquids used in them, and devices for consumption of tobacco products without burning them (including IQOS and glo devices) will be prohibited from 11 July 2023,” according to the WHO Framework Convention on Tobacco Control (FCTC).

    “Flavored cigarettes and flavored liquids for ENDS will also be banned at that date. Further, from 11 January 2024, the combined textual plus pictorial warnings will be required to cover 65 percent of both sides of the pack of smoking tobacco products (conventional cigarettes).”

    The fine in the case of a violation is UAH30,000 ($812), and for each subsequent violation – UAH50,000. In addition, similar to the general smoking ban, the law prohibits the use of heated tobacco products in all public places and businesses.

    In 2021, Ukrainian lawmakers passed the law prohibiting the use of ENDS in public places as well as advertising, sponsorship, and promotion of e-cigarettes. The law also bans the sale of flavored e-liquids other than tobacco flavors.

  • Ghana Outlaws Vape Sales and Promotion

    Ghana Outlaws Vape Sales and Promotion

    Ghana has banned all recreational use of vaping and e-cigarette products.

    In a press release, the country’s Food and Drugs Authority (FDA) states that the “sale, advertisement and recreational use of electronic nicotine delivery systems (ENDS) such as vapes and other non-nicotine tobacco products by the public” is illegal.

    However, ENDS can be registered as a prescription-only medicine for the purposes of cessation therapy.

    The FDA claims it has sent notice to manufacturers, importers, wholesalers, and retailers to remove all advertisements on social media, billboards and neon signs immediately and refrain from the importation of the products.

    The FDA states that there “will be repercussions including sanctions” for failure to adhere to the rules.