Tag: United States

  • Altria to webcast results

    Altria to webcast results

    The Altria Group is due to host a live audio webcast from 09.00 Eastern Time on October 25 to discuss its 2018 third-quarter business results. The company will issue a press note containing its business results about 07.00 the same day.
    During the webcast, which will be in listen-only mode, Howard Willard, Altria’s chairman and CEO, and Billy Gifford, vice chairman and CFO, will discuss the results and answer questions from the investment community and news media.
    The webcast can be accessed at altria.com or through the Altria Investor App.
    Pre-event registration is necessary and can be made at www.altria.com/webcasts.
    An archived copy of the webcast will be available on altria.com or through the Altria Investor App. The free app is available for download at www.altria.com/irapp or through the Apple App Store or Google Play.

  • Swedish Match tries again

    Swedish Match tries again

    The US Food and Drug Administration said yesterday it had posted an amendment to the modified risk tobacco product applications (MRTPAs) for General Snus products submitted by Swedish Match North America.
    The FDA said that, on December 14, 2016, it had denied the company’s request ‘to remove a currently required warning statement that products can cause gum disease and tooth loss’.
    ‘With respect to the company’s other requests to remove or revise two additional currently required warnings, FDA deferred final action and issued a response that offered the company an option to amend its applications,’ it said in a note issued through the Center for Tobacco Products.
    ‘FDA will post any future amendments to the application on the Center for Tobacco Products’ website on a rolling basis as the materials are redacted.’
    More information is available here.

  • Smoke, pets little danger

    Smoke, pets little danger

    While it has been suggested that second-hand factors in asthma, such as environmental exposures to pets and tobacco smoke, impact disease control, a study conducted by investigators at the Nationwide Children’s Hospital suggests otherwise, according to a story in MD Magazine.
    The study, Impact of Environmental Exposures (Second-hand Smoking and/or Pets) on Long-Term Asthma Control in Children was presented at the 2018 Annual CHEST Meeting in San Antonio, Texas, US.
    In their three-year prospective cohort study, the team of investigators sought to evaluate the impact of environmental exposures in asthma control among children whose asthma is managed per National Asthma Education and Prevention Program (NAEPP) guidelines.
    Ultimately, 395 children aged 2-17 years were included in the sample, with the majority of children having a diagnosis of either mild persistent asthma or moderate persistent asthma.
    In 98 (25 percent) of the children, exposure to second-hand smoke was documented, while exposure to a pet (cat or dog at home) was recorded in 215 (55 percent) children.
    Among the children with or without pet exposure or with or without second-hand tobacco exposure, no significant difference in demographics was recorded.
    By 3-6 month follow-up visits, acute care need scores were said to have improved significantly, and throughout the thee-year follow-up, improvements persisted.
    Covariation was measured through the inclusion of the two measured environmental exposures (second-hand cigarette smoke and/or animal exposure, such as cats and dogs).
    From baseline, significant improvements were observed in both groups, which persisted throughout the three-year follow-up.
    In asthma improvement over time, environmental exposures to second-hand smoke or animals were not significant covariates.
    From their data, the study authors concluded that environmental exposures to pets or second-hand smoke were not significant factors in overall asthma improvement over time once asthma guidelines were followed. Consequently, the team ruled better asthma control over time required compliance with asthma guidelines.

  • Wellness at a cost

    Wellness at a cost

    Employees of a US city who use tobacco products can expect to pay more for their health insurance starting in 2019, according to a WPXI story.
    From January 4, tobacco-using employees of the City of Pittsburgh, Pennsylvania, will be the subject of a $50 monthly premium surcharge.
    According to a letter sent to employees, they must complete and sign an affidavit, stating whether or not they are tobacco users.
    The letter states that the city informed employees of the coming changes in October 2017.
    According to the letter, employees who do not use tobacco for at least three months, or who participate in a cessation program, will not pay tobacco-user payroll contributions.
    The letter introduced a new wellness platform administrator and said all employees’ wellbeing was valued by the City of Pittsburgh.
    It said, in part, under a ‘What to look forward to’ heading: ‘The wellness program is designed to meet your specific wellness needs using these four wellness dimensions: mind, body, heart and spirit’.
    ‘This program is based on a points system and sets goals for employees to improve their wellbeing. These are called “MOJO Points” and when you earn a total 750 points you will be eligible for a reward,’ the letter said.

  • E-cigarettes most promising

    E-cigarettes most promising

    A man who helped invent stop-smoking products such as nicotine patches and the prescription drug Chantix says that electronic cigarettes are one of the most promising developments in the field of smoking cessation, according to a story by Rishi Dasgupta published at dukechronicle.com.
    Dr. Jed Rose, who is director of the Duke Center for Smoking Cessation, Durham, North Carolina, US, and a professor of psychiatry and behavioral science, said that currently more than 500,000 people in the US died every year of smoking related disease, a number that continued to rise. Cigarette smoking imposed a completely unacceptable burden of death and disease, he added.
    Rose, who has studied nicotine since 1979, said smokers didn’t just crave nicotine; they also craved the physical action of smoking a cigarette.
    “We’ve done studies where we’ve intravenously administered smokers with the same dose of nicotine they would get from a cigarette and found that this doesn’t satisfy their craving,” Rose said. “On the other hand, if they smoke a denicotinized cigarette, their craving is relieved quite a bit.”
    Unlike other cigarette alternatives such as nicotine gum and patches, e-cigarettes replace the physical behavior of smoking and deliver nicotine in a way familiar to smokers.
    Rose said the Duke Center for Smoking Cessation was doing a Juul trial and that there was “good reason to believe” it could help people quit smoking. And while the Food and Drug Administration claimed that e-cigarettes were introducing minors to nicotine, it was worth the risk.
    “The ‘epidemic’ of youth addiction is greatly exaggerated,” Rose said. “This isn’t good, but it has to be weighed against the 500,000 preventable deaths that can be lessened using e-cigarettes.”
    Rose said later that while e-cigarettes were less harmful than traditional ones, they still posed risks, including not just the obvious risk of addiction, but also the unknown effects of nicotine on adolescent brains and the trace amounts of cancer-linked compounds.
    Nevertheless, Rose maintained that e-cigarettes were a much safer alternative to paper-and-tobacco cigarettes.
    “Ultimately, if you’re going to do something, do the thing that’s less harmful,” Rose was quoted as saying. “We do that with things like safe sex and clean-needle exchanges for heroin users, so it should also apply to cigarette smoking—which kills more than all those other things put together.”
    Rose was skeptical about e-cigarettes being gateways to tobacco. “If anything, restricting e-cigarettes may incentivize youth to try combustible cigarettes instead,” Rose said.

  • Flight ban

    Flight ban

    A ban on vaping electronic cigarettes on aircraft is one of the provisions of a five-year, US Federal Aviation Administration (FAA) Reauthorization Act, according to a press note issued by the Association of Flight Attendants – CWA (AFA) through PR Newswire.
    The Act, which was said to have received overwhelming bipartisan support, included a large number of provisions such as, in respect of air quality, the introduction of technologies to combat contaminated bleed air; the safe transport of lithium batteries; and a study of oxygen-mask design.
    ‘Flight Attendants cheer the passage of the FAA Reauthorization Act of 2018 with a provision to combat flight attendant fatigue by increasing minimum rest from eight hours to 10 hours,’ AFA International president Sara Nelson said in a statement.
    ‘This bill closes a safety loophole while improving Flight Attendant health and achieving equal minimum rest with our flight deck counterparts.’

  • E-cigarettes not cigarettes

    E-cigarettes not cigarettes

    The word ‘cigarette’ might appear in the term ‘e-cigarette’, but that is as far as their similarities extend, according to a Northwestern Medicine report published on Friday in the journal Nicotine & Tobacco Research.
    Assuming e-cigarettes were equal to cigarettes could lead to misguided research and policy initiatives, said a Northwestern University story that reported on the paper’s findings at eurekalert.org.
    “Comparing cigarettes to e-cigarettes can give us a false sense of what dangers exist because it misses the gap in understanding how people use them and how they can make people dependent,” first author Matthew Olonoff, a PhD student at Northwestern University Feinberg School of Medicine, was quoted as saying. “Before we start making policy changes, such as controlling nicotine or flavor options in e-cigarettes, we need to better understand what role these unique characteristics have.”
    The commentary is said to distill articles and published studies that compare e-cigarettes to cigarettes and supports the importance of investigating e-cigarettes as a unique nicotine delivery system.
    “There are enough key differences between cigarettes and these products, especially newer-generation devices, to show that they are not interchangeable nicotine delivery systems,” Olonoff said.

  • Juul sales rocket-powered

    Juul sales rocket-powered

    US sales of the electronic cigarette Juul rose from 2.2 million in 2016 to 16.2 million in 2017, according to a HealthDay story quoting the results of a study by the Centers for Disease Control and Prevention (CDCP).
    The CDCP study took in e-cigarette purchases from regular retail stores, but did not include sales through the internet or from vape shops; so the sales figures comprise an underestimate.
    Juul had captured the biggest share of the US e-cigarette market as of December 2017, accounting for nearly one in three of the e-cigarettes sold nationwide.
    Juul is said to have among the highest nicotine content of any e-cigarette sold in the US, a concern for the CDCP, which, according to the HealthDay story, says that nicotine is ‘highly addictive’ and can harm brain development in teens and young adults.
    The Food and Drug Administration on September 12 demanded that, within 60 days, five electronic-cigarette manufacturers, including Juul Labs, accounting for 97 percent of the market for these products, come up with robust ways of addressing what the agency described as an ‘epidemic’ of teenage vaping or face market restrictions on their products.
    ‘There are no redeeming benefits of e-cigarettes for young people,’ Corinne Graffunder, director of the CDCP’s Office on Smoking and Health, said in an agency news release. ‘The use of certain USB-shaped e-cigarettes is especially dangerous among youth because these products contain extremely high levels of nicotine, which can harm the developing adolescent brain.’
    The CDC findings were published on October 2 in the Journal of the American Medical Association.
    HealthDay reported that Juul had issued a statement on the same day defending its product.
    ‘Juul Labs is focused on its mission to improve the lives of the world’s one billion adult smokers,’ the company said in its statement. ‘When adult smokers find a satisfying alternative to cigarettes, they tell other adult smokers. Juul Labs has helped more than one million Americans switch from cigarettes.’

  • Understanding sought

    Understanding sought

    The US Food and Drug Administration said yesterday it had seized from Juul Labs more than a thousand pages of documents related to the company’s sales and marketing practices, according to a story by Ankur Banerjee and Tamara Mathias for Reuters.
    The seizures were said to have come during a surprise inspection.
    The inspection, completed on Friday, followed a request in April for documents that the FDA believed would help it better understand the high levels of Juul’s appeal and use among young people.
    The FDA said it had conducted also inspections of several of Juul’s contract manufacturing units earlier this year.
    Meanwhile, Juul Labs CEO Kevin Burns was quoted as saying in a statement that the company had handed over to the FDA since April more than 50,000 pages of documents that supported its public statements, before adding that the meeting with the regulator had been constructive and transparent.
    “We want to be part of the solution in preventing underage use, and we believe it will take industry and regulators working together to restrict youth access,” said Burns.

  • Research funding

    Research funding

    The US Food and Drug Administration says that the Tobacco Centers of Regulatory Science’s (TCORS) 2.0 program will continue to provide data on the following scientific domains related to its regulatory authority for tobacco products:

    • Approaches that test the toxicity of tobacco smoke, aerosol, or specific constituents
    • Effects of tobacco product characteristics on addiction and abuse liability
    • Short- and long-term health effects of tobacco products
    • Understanding of knowledge, attitudes and behaviors related to tobacco product use
    • Understanding of how to effectively communicate the health effects of tobacco products
    • Influences of tobacco marketing
    • Understanding of the impact of potential FDA regulatory actions.

    ‘Findings from TCORS research are expected to inform the FDA’s mission to protect public health through regulation of the manufacture, distribution, and marketing of tobacco products,’ the FDA said in a note issued through its Center for Tobacco Products.
    ‘The TCORS program is one example of research supported by the Tobacco Regulatory Science Program, a partnership between FDA and NIH [National Institutes of Health] to foster tobacco regulatory research.’
    Meanwhile, in the same note, the FDA said that ‘the following research investigators and organizations had been awarded TCORS for fiscal years 2018-2022’:

    • Thomas E. Eissenberg. Ph.D., and Alison Breland, Ph.D., Virginia Commonwealth University, Richmond
    • Stanton A. Glantz, Ph.D., University of California-San Francisco
    • Stephen T. Higgins, Ph.D., University of Vermont and State Agriculture College, Burlington
    • Suchitra Krishnan-Sarin, Ph.D., and Stephanie S. O’Malley, Ph.D., Yale University, New Haven
    • Rafael Meza, Ph.D., and David T. Levy, Ph.D., University of Michigan, Ann Arbor
    • Richard J. O’Connor, Ph.D., and Maciej Goniewicz, Ph.D., PharmD., Roswell Park Cancer Institute Corporation, Buffalo
    • Mary Ann Pentz, Ph.D., and Adam M. Leventhal, Ph.D., University of Southern California, Los Angeles
    • Rose M. Robertson, M.D., and Aruni Bhatnagar, Ph.D., American Heart Association, Dallas
    • Andrew A. Strasser, Ph.D., and Cristine Delnevo, Ph.D., University of Pennsylvania, Philadelphia

    Awarded by the NIH with funding from FDA, this second round of TCORS represented a significant investment in federally funded research, with more than $151 million total funding planned for the next five years, the FDA said.
    ‘With co-ordination from NIH’s Office of Disease Prevention, these awards are administered by three NIH institutes — the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung, and Blood Institute,’ it said.