Tag: news

  • Doctors Decry Tobacco’s Pharma Investments

    Doctors Decry Tobacco’s Pharma Investments

    Photo: Hero Images

    Pulmonologists are concerned about the tobacco industry’s investments in the pharmaceutical business, according to a Nieuwsuur report relayed by the NL Times.

    Confronted with declining sales in their traditional line of business, cigarette manufacturers have been exploring adjacent activities, including in the medical sector. For example, Philip Morris International in 2021 acquired the Vectura Group, a British manufacturer of inhaled treatments, and Fertin Pharma, a Danish developer and manufacturer of pharmaceutical and well-being products based on oral and intra-oral delivery systems.

    British American Tobacco and Japan Tobacco, too, have medical interests.

    Nieuwsuur journalists looked at 87 pharmaceutical products and medicines the tobacco industry is investing in. They found that half of the products are intended to treat diseases linked to smoking, including lung diseases, heart disease and diabetes.

    Frits Franssen, pulmonologist and professor of COPD at the University Medical Center in Maastricht in the Netherlands, worries about tobacco companies’ growing presence in the pharmaceutical business. He called their investments into medicines that treat smoke-related illnesses “uncomfortable,” pointing out that they’re earning twice from the smoker—once from the packet of cigarettes, then from treating the diseases caused by smoking.

    Tobacco companies insist that their diversification efforts fit with their strategy to reduce the health toll of tobacco use. By investing in noncombustible products, for example, they are offering smokers a less harmful way to consume nicotine.

  • FDA Grants $3.9 Million to Study Effects of Flavors

    FDA Grants $3.9 Million to Study Effects of Flavors

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration has given the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers, according to News Medical Lifesciences.

    The study will be co-led by Theodore Wagener, director of Ohio State’s Center for Tobacco Research, and Tracy Smith from the Medical University of South Carolina Hollings Cancer Center.

    Wagener says, “the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.”

    “The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data,” Wagener said. “Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers.”

    The national, randomized, controlled trial will recruit up to 1,500 cigarette users from across the country, and researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior. Combination nicotine-replacement therapy will be used as a comparator to determine potential increased benefit of e-cigarettes versus nicotine-replacement therapy.

    “If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision-making,” Wagener said.

  • Kentucky School District to Criminally Charge Vaping Youth

    Kentucky School District to Criminally Charge Vaping Youth

    Credit: AIJohn784

    A western Kentucky school system will issue criminal citations to kids vaping on school grounds. The zero-tolerance policy will begin during the next school year.

    Vaping on school grounds in Christian County will now be a criminal offense, according to media reports.

    Under a new policy adopted on Monday by Christian County Public Schools, any student in possession of a vape will be cited by law enforcement for drug paraphernalia.

    If the vape contains a controlled substance, the student will also be charged with drug use, possession, or distribution.

    “In middle and high school, students go through critical changes in their developing brains,” said Kim Stevenson, Director of Alternative Programs for the district. “Nicotine and other controlled substances impairs the growth of neurons and directly harms the portion of the brain responsible for learning, memory, and attention.”

    Sometimes, vapes are laced with fentanyl, which is deadly in the smallest amounts, media reports stated.

  • Chemular Adds Carignan as Chief Commercial Officer

    Chemular Adds Carignan as Chief Commercial Officer

    Jason Carignan

    Jason Carignan has joined Chemular, an FDA regulatory consultancy group, as its chief commercial officer.

    Carignan will lead the company’s revenue generation initiatives, strategic partnerships, and intellectual property monetization strategies across its diverse portfolio of business units, according to a press release.

    “Carignan brings a wealth of experience and expertise to Chemular, having held various leadership positions in the tobacco and nicotine industry. He most recently served as president of Phillips & King and the Total Product Expo (TPE), both part of the Kretek International Inc. family of companies,” the release states. “Prior to that, he served as president of DRYFT Sciences, overseeing the successful development of the DRYFT line of nicotine pouches before selling the company to British American Tobacco in late-2020.”

    With an impressive track record of driving growth and creating strategic alliances, Carignan is well-positioned to play a pivotal role in expanding Chemular’s market presence and further establishing the company as a leader in FDA regulatory matters.

    Kevin Burd, CEO of Chemular. said he is thrilled to welcome Carignan to the Chemular team. “His deep industry knowledge and proven leadership in revenue generation and partnership strategies will be instrumental in driving our growth and expanding our client base,” said Burd. “We believe Jason’s appointment will advance our mission of providing comprehensive regulatory solutions to our clients and partners.”

    Carignan will work closely with Chemular’s executive team to develop and execute business development strategies, identify new revenue opportunities, and forge strategic partnerships that enhance the company’s market position, according to the release.

    Carignan said he was excited to join the Chemular team.

    “Chemular has established itself as a trusted and innovative partner for clients navigating the complex landscape of FDA regulations,” Carignan said. “I look forward to leveraging my experience and expertise to drive revenue growth, establish impactful partnerships, and contribute to Chemular’s continued success.”

  • Korean Ministry Urges Group to Cancel Vape Show

    Korean Ministry Urges Group to Cancel Vape Show

    Photo: Taco Tuinstra

    South Korea’s Ministry of Health and Welfare (MOHW) has urged events organizer The Fairs to cancel its Korea Vape Show 2023, reports Korea Biomedical Review.

    The exhibition is scheduled to take place July 21-23 in Goyang, Gyeonggi Province.

    “We sent a letter asking for the event to be canceled because we had concerns from a health promotion perspective,” a MOHW official was quoted by Yonhap News as saying. “We are also concerned that adolescents may visit the show if access to the convention is not properly controlled.”

    The ministry also expressed worries about advertised vaping contests that it said would violate indoor smoking restrictions. South Korea allows indoor smoking only in separate, fully enclosed areas.

    The MOHW said it plans to inspect the venue on the day of the event and impose penalties if the organizers fail to create a fully enclosed smoking room inside the venue.

    The organizers said they had submitted plans to resolve the issues raised by critics and said it would not cancel the convention.

    The official also stressed that previous conventions had been held without problems. “During the past three conventions, officials from the local public health center visited the convention and found no wrongdoings,” she said. 

  • New Report Urges Ban on Disposable Vape Products

    New Report Urges Ban on Disposable Vape Products

    Credit: Iama Sing

    The only solution to curb the plastic and battery waste created by disposable vaping products is to ban the products entirely, according to a report released Tuesday from the U.S. Public Interest Research Group (PIRG) Education Fund.

    “It doesn’t make any sense to manufacture electronics with rechargeable batteries, ship them across the world, and throw them out within a few days,” the report states.

    The report explores the environmental impacts of disposable products and found that the devices are difficult to recycle properly due to a lack of infrastructure and regulation around e-waste recycling.

    Disposable vaping devices also contain lithium-ion batteries as well as small plastic parts. They also contain nicotine, which is considered a toxic chemical.

    “According to CDC Foundation sales estimates, lining up the disposable vapes sold in a year would stretch for 7,000 miles—long enough to span the continental U.S. twice,” a PIRG report states. “This vape waste is becoming more common while cigarette butts become less common as the trash that litters our beaches and waterways.”

    The report advocates for federal and state legislation banning or restricting disposable vapes to keep them out of landfills and waterways and prevent fires.

    It also calls for the U.S. Food and Drug Administration to make enforcement of vape marketing restrictions a priority, particularly for disposable products.

  • Broughton Grows into Extractables and Leachables

    Broughton Grows into Extractables and Leachables

    Photo courtesy of Broughton

    Broughton has launched a new extractables and leachables (E&L) testing service for the reduced-risk nicotine industry. The new service will offer tailored E&L studies for products aimed at the premarket tobacco product application (PMTA) and the marketing authorization application (MAA) pathways. 

    According to Broughton, regulatory bodies increasingly focus on the interactions between manufacturing components, nicotine delivery devices and container-closure systems, and the final product formulation. Producers must identify and assess any toxicological risks that could arise via such interactions via E&L studies.

    Aimed at supporting reduced-risk nicotine product categories such as electronic nicotine delivery systems, Modern Oral nicotine pouches and nicotine replacement therapy, the service is available across all stages of the product development lifecycle.

    The new testing service includes study design, extractables studies, extractables toxicology assessments, leachables method development and validation, leachables shelf-life studies and leachable toxicology evaluation.

    “Extractable and leachable studies are essential to the PMTA and MAA regulatory pathways for reduced-risk nicotine products to ensure their safety and demonstrate evidence of mitigating risk. Even in emerging categories, where regulations may not exist, such as nicotine pouches, they should be adopted as a best practice approach to product understanding and stewardship,” said Chris Allen, CEO of Broughton.

    “Our scientific experts and toxicologists have years of combined experience conducting E&L studies across a range of reduced-risk nicotine product and device categories. By offering a one-stop solution for E&L studies, we can ensure a fully integrated approach across study design, extractables study delivery, leachables method development and toxicology assessment with our specialized consultants available to troubleshoot, problem-solve and develop analytical solutions to issues that may arise.”

  • Germany Readies to Ban Flavored Vape Products

    Germany Readies to Ban Flavored Vape Products

    Image: Tobacco Reporter archive

    The German Bundesrat approved a third amendment to the Tobacco Products Act, which would ban flavored heated-tobacco products, according to Dokumentations und Informationssytem fur Parlamentsmaterialien.

    The amendment includes “alignment of EU rules banning flavorings and distinctive flavors in heated-tobacco products; definition of the heated-tobacco product and its classification as a smoking tobacco product or smokeless tobacco product, extended labeling requirements in the form of combined text and image warnings and an information message, extension of the ban on placing cigarettes and roll-your-own tobacco with a characteristic flavor on heated-tobacco products; [and] amendment of various sections of the Tobacco Products Act,” according to the German Bundestag website.

  • New York City Accuses Vape Distributors of Racketeering

    New York City Accuses Vape Distributors of Racketeering

    Credit: Maria Kray

    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, FDV 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 law guidelines.

  • U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

    U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

    The U.S. Food and Drug Administration has issued a marketing denial order (MDO) for myblu Menthol 2.4%. Fontem US, a subsidiary of Imperial Brands, is banned from marketing or distributing the product in the United States, or they risk enforcement action by FDA.

    The company may resubmit a new application to address the deficiencies of the product subject to this MDO, according to an FDA press release.

    “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 outweigh the known risks.”

    The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the impact of the product on the population as a whole, including benefits (i.e., complete transitioning to the product or significant reduction in combustible cigarette use among adults who smoke) and risks (e.g., initiation among youth).

    “After reviewing the company’s PMTA, FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act,” the release states. “For example, among other deficiencies, the application did not present sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.”

    The FDA has not authorized for sale of any flavored vaping product other than tobacco. Fontem is expected to challenge the denial order in court.

    In April of last year, The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu.