Category: Harm Reduction

  • Juul warned

    Juul warned

    The U.S. Food and Drug Administration has issued a warning letter to Juul Labs for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising and/or other activities directed to consumers, including a presentation given to youth at a school.

    The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding Juul’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers.

    “Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” said Acting FDA Commissioner Ned Sharpless.

    The FDA has requested that Juul provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug and Cosmetic Act, including its plan to prevent the same or similar violations.

    Read the FDA statement announcing the warning.

  • Michigan bans flavors

    Michigan bans flavors

    The U.S. state of Michigan has imposed a six-month ban on the sale of flavored e-cigarettes to curb teen smoking, reports CNBC. The ban can be extended for another six months, but Governor Gretchen Whitmer said she hopes state lawmakers will make it permanent by writing the ban into law.

    Whitmer directed the state health department to issue emergency rules to ban the sale of flavored nicotine vaping products in stores. She will also restrict marketing, preventing companies from advertising vaping products as “clean,” “safe,” “healthy” and other terms that portray the products as “harmless.”

    Michigan is the first U.S. state to ban sales of flavored e-cigarettes.

    Earlier this year, San Francisco became the first U.S. city to prohibit the sales of flavored e-cigarette products. Lawmakers in Boulder, Colorado, passed a similar measure last week.

    Vaping is generally considered less harmful than smoking, but health activists are concerned about an increase in underage use of e-cigarettes. Many blame flavors for attracting teenagers.

    Greg Conley, president of the American Vaping Association, called the ban “a shameless attempt at backdoor prohibition. He warned the measure would close down several hundred Michigan small businesses and could send tens of thousands of ex-smokers back to deadly combustible cigarettes.

    “These businesses and their customers will not go down without a fight,” he said.

    Last year, an attempt by the New York Department of Health to ban flavor was withdrawn for further legal review.

    “Governor Whitmer’s order will effectively wipe out tobacco harm reduction in the Great Lakes State,” said Lindsey Stroud, state government relations manager at The Heartland Institute, a free market think tank. “There is little to no evidence flavor bans actually reduce youth use. In fact, after similar bans in California, youth use of e-cigarettes actually increased.”

    Stroud also took issue with Whitmer’s suggestion that vapor companies are marketing their products as safe.

    “Per the U.S. Food and Drug Administration’s 2016 deeming regulations, no vaping manufacturer or retailer is allowed to assert any health claim about these products unless they have obtained a modified risk tobacco product certification,” she said.

    Michigan’s ban follows numerous claims of vaping-related hospitalizations that are increasingly being linked to black market cannabis products. According to The Heartland Institute, the Wisconsin Department of Health Services stated last week that 89 percent of their vaping-related hospitalizations were caused by such products. The Centers for Disease Control and Prevention have also found that most of these hospitalizations are linked to black market cannabis products.

     

     

  • Teen use ‘unintended’

    Teen use ‘unintended’

    Juul co-founder James Monsees testified before the U.S. House Oversight and Government Reform subcommittee last week and said his company never intended its electronic cigarettes to be adopted by underage teenagers.

    “Juul Labs isn’t big tobacco,” Monsees told the House subcommittee, adding that “combating underage use” is the company’s highest priority.

    The two hearings convened last week after launching an investigation last month into Juul’s marketing, technology and business practices.

    During his testimony, Monsees reiterated past steps taken by Juul, including shutting down its Facebook and Instagram pages and pulling several of its flavored pods out of retail stores to keep Juul out of the hands of teens. Monsees said he understands the negative scrutiny of his company, but assured lawmakers Juul’s aim is to “eliminate cigarettes for good.”

  • WHO in no doubt

    WHO in no doubt

    E-cigarettes are “undoubtedly harmful,” according to a new report by the World Health Organization (WHO).

    “Although the specific level of risk associated with ENDS (electronic nicotine delivery systems) has not yet been conclusively estimated, ENDS are undoubtedly harmful and should therefore be subject to regulation,” the WHO wrote in its report.

    The report, funded by Bloomberg Philanthropies, also highlighted that progress has been made in the fight against tobacco, but more action is needed such as raising taxes, enforcing bans on advertising, and protecting others from tobacco smoke.

    The report showed that while only 23 countries have implemented cessation support policies at the highest level, 116 more provide fully or partially cost-covered services in some or most health facilities, and another 32 offer services but do not cost-cover them, demonstrating a high level of public demand for support to quit.

    Tobacco use has also declined proportionately in most countries, but population growth means the total number of people using tobacco has remained high. Currently, there are an estimated 1.1 billion smokers, around 80 percent of whom live in low- and middle-income countries.

  • Juul ban sought

    Juul ban sought

    Schlesinger Law Firm has filed a motion for preliminary injunction asking a U.S. federal court in Florida to ban the sale of Juul electronic cigarettes across the United States. The firm says it wants halt “an epidemic of youth nicotine addiction that has surged due to the skyrocketing growth of Juul.”

    Juul and other e-cigarette makers have not applied for or received FDA premarket authorization to sell their electronic nicotine devices, as required under the Tobacco Control Act.

    “Under the law, companies must have regulatory permission before they can sell new tobacco products in the public space,” said Scott P. Schlesinger, an attorney at Schlesinger Law Offices in Fort Lauderdale.

    “In 2017, the FDA granted makers of e-cigarettes a five-year extension to file for approval. Since then, sales of the product have exploded and created an epidemic.”

    A federal judge in Maryland recently ordered the FDA to shorten that time “but that relief is insufficient to end the dramatic increase of nicotine addiction among youth,” says Schlesinger.

    Citing independent research, the FDA says that 3.62 million middle and high school students used e-cigarettes in 2018. E-cigarette use jumped 78 percent among high school students from 2017 to 2018 and 48 percent among middle school students during the same time period.

    “The motion to enjoin Juul from selling its products seeks only to treat the company as it should have been all along,” said Jonathan R. Gdanski, an attorney at Schlesinger. “You don’t get to sell a tobacco product, take over the marketplace and then ask for permission for that product after it is engrained in society.”

    The FDA says that five brands, including Juul, control 97 percent of the U.S. market for e-cigarettes. Juul had 72 percent of the market in August, according to Nielsen. The company has forecast $3.4 billion in revenue this year, triple that in 2018.

    In April, Schlesinger Law Firm filed a class-action lawsuit on behalf of a Sarasota County teenager, age 15, and her parents against Juul Labs and Altria Group, which owns Philip Morris USA, which claims in part that the plaintiff is addicted to the nicotine in Juul e-cigarettes. Altria holds a 35 percent interest in Juul.

    The lawsuit, filed in U.S. District Court for the Middle District of Florida, seek damages under the RICO Act and for fraud, product liability and deceptive trade practices. It says that Juul and Altria/Philip Morris are violating federal racketeering laws by intentionally exploiting adolescents while falsely denying they are doing so.

    According to Jeffrey Haberman, an attorney at Schlesinger Law Offices, “Juul knew that its e-cigarettes were unsafe for non-smokers and that the product posed a risk of aggravating addiction in those addicted to cigarettes.”

  • Advocating scientific transparency

    Advocating scientific transparency

    Philip Morris International (PMI) has created an open online platform for sharing data, software and scientific protocols.

    Called Intervals, the platform has been built to address what PMI describes as a scientific reproducibility crisis, and gather in a single place scientific data relating to modified risk tobacco products, also known as reduced-risk products.

    Open to scientists from both academia and industry, and designed to enable third-party collaboration and analysis, Intervals follows the “FAIR” guiding principles for data sharing, i.e., data should be findable, accessible, interoperable and reusable.

    Scientists are encouraged to add their own independent research to Intervals, thereby contributing to transparency in the field and increasing the visibility of their work.

    “Across the life-sciences we see consistently low rates of the reproducibility of scientific research,” said Stéphanie Boué, scientific data transparency, PMI.

    “Sharing data in a way that enables reanalysis and reuse is not yet done in a systematic manner, despite the fact that doing so would clearly benefit the scientific community and society in general.

    “This is particularly true where the quality of science may be questioned due to the affiliations of researchers, funding sources or research topics. Tobacco harm reduction is one such area, and Intervals is a crucial resource to ensure full transparency and reproducibility of the scientific research being conducted in the field.”

    Intervals includes full, standardized and extensively annotated datasets from a number of clinical and pre-clinical studies that PMI has conducted as part of the assessment of its MRTPs. These range from large in vivo inhalation studies, to novel in vitro studies using three-dimensional human tissue cultures, to clinical studies investigating the pharmacokinetics of different nicotine delivery systems.

    The platform provides detailed information on study protocols and interoperable data files that allow independent reanalysis of key findings, meta-analyses and efficient data reuse. Alongside raw data, rich metadata are also provided to describe experiments, data production, data processing and additional relevant information. Each study, protocol, and dataset are assigned a unique DOI, making them easily findable and citable.

    Many of the PMI-conducted studies that are included on Intervals have been reviewed through a novel and comprehensive panel review process organized independently by SciPinion of Bozeman, Montana, USA.

    This has been done in addition to the traditional peer-review of study publications. Seven panels of five to 12 anonymous experts scrutinized publications and raw data, resulting in consistent support of the robustness of methods and results, and the validity of conclusions. Intervals facilitates such detailed reviews, allowing any interested party to independently evaluate data, methodologies and conclusions. In doing so, the platform is able to contribute to the review processes of regulatory bodies such as the U.S. Food and Drug Administration, while also allowing the reuse of data in the generation and testing of new hypotheses.

    Scientists who wish to add their own research and data to Intervals can do so with no word or figure limit. Storage space is virtually unlimited, and they will be assigned DOIs as appropriate for the individual aspects of their contributions.

    By sharing their research in the standardized Intervals format, scientist have the opportunity to make their data part of future meta-analyses and contribute to a new vision and strategy for transparency and reproducibility. Intervals also includes direct links to a number of powerful computational tools and resources, which are free for contributors to use for their own research purposes.

    “Intervals is set to become an international hub for scientists with a common interest in tobacco harm reduction,” said Manuel C. Peitsch, chief science officer, PMI. “This includes scientists from industry, academia, not-for-profit research organizations and regulatory bodies. In working collectively, and with a commitment to transparency and reusability, the community can establish standards in data sharing and management which will lead to the optimization of research funds and the leveraging of research findings to enable effective evidence-based decision making.”

    According to PMI, the need for innovative and concerted efforts to improve reproducibility is being increasingly acknowledged across the scientific community. The U.S. National Academies of Science, Engineering, and Medicine has recently published a report—Reproducibility and Replicability in Science—calling on researchers to “convey clear, specific, and complete information about any computational methods and data products that support their published results.” The Intervals concept can be applied in many other areas of societal concern. According to PMI, any field that deals with large and complex data could benefit from this approach as the issues concerning transparency, data reusability and reproducibility are general across the sciences.

     

  • Conclusions questioned

    Conclusions questioned

    Brad Rodu

    Brad Rodu, a University of Louisville professor, has asked the Journal of the American Heart Association to retract a recent study by Stanton Glantz, a professor of medicine at the University of California at San Francisco (UCSF).

    The study, co-authored by Dharma Bhatta, associates adult vaping with a doubled risk of heart attack.

    However, when Rodu examined the data, he found the majority of the 38 patients in the study who had heart attacks had them before they started vaping—by an average of 10 years earlier.

    Glantz retorted that Rodu has a history of “slicing and dicing” his and other’s research “to make effects go away.”

    Glantz calls Rodu a “tobacco industry apologist” and points to documents UCSF has collected that show Rodu’s connections to the tobacco industry.

    Rodu says he sought industry funding after the National Cancer Institute treated him as if he was unethical to suggest that smokeless tobacco was safer than cigarettes when he applied for funding there in 1995.

    The spat between the researchers is detailed in USA Today.

  • Sales ban contemplated

    Sales ban contemplated

    San Francisco city supervisors are considering whether to ban all sales of electronic cigarettes a part of an effort to crack down on youth vaping, reports PBS.

    If they move forward, San Francisco would become the first city in the United States to do so.

    Supervisors on Tuesday were set to weigh a ban on the sale and distribution of e-cigarettes in San Francisco until the FDA completes a review of the effects of e-cigarettes on public health, as well as ban manufacturing e-cigarettes on city property. If supervisors approve the measures, they will require a subsequent vote before becoming law.

    “Young people have almost indiscriminate access to a product that shouldn’t even be on the market,” said city attorney Dennis Herrera. “Because the FDA hasn’t acted, it’s unfortunately falling to states and localities to step into the breach.”

  • Smoking rate falling slowly

    Smoking rate falling slowly

    The incidence of smoking has been declining on the Chinese mainland, but more tobacco-control efforts are needed, according to a story by Wang Xiaodong in the China Daily citing the findings of a survey published on Thursday.

    Last year, 26.6 percent of the mainland’s population 15 years of age or older were smokers, according to the survey, which was conducted by the Chinese Center for Disease Control and Prevention (CDCP) between July and December.

    A similar survey conducted by the CDCP in 2014 and 2015 showed 27.7 percent of this age group smoked.

    The survey reportedly found that there was increasing public support for tobacco control efforts. More than 90 percent of those surveyed said they supported a total ban on ‘tobacco in the workplace’, and more than 95 percent said they supported banning smoking in hospitals, in middle and primary schools, and on public transport. Nearly 80 percent said they hoped to see a ‘ban on tobacco’ in restaurants.

    But the survey found too that adult smokers ‘generally lack the willingness to quit’, with 16 percent planning to quit within the year.

    Zhi Xiuyi, vice-president of the Chinese Association on Tobacco Control, said China faced severe challenges in protecting people from the effects of tobacco use, despite the progress made.

    “To achieve the government target of bringing down the percentage of adult smokers to 20 percent by 2030, we have a lot of work to do,” he said.

    Wang reported that the biggest obstacle to tobacco control in China was the powerful tobacco industry, which was one of the biggest tax contributors to the government.

  • E-cigs to be legalized

    E-cigs to be legalized

    The Seychelles is to legalize the use of electronic cigarettes with a new regulation that will place ‘alternative nicotine products’ (ANDs) under the country’s tobacco control law, following the approval of Cabinet Ministers, according to a Seychelles News Agency story.

    Bharathi Viswanathan, program manager within the Prevention and Control of Cardiovascular Diseases unit at the Seychelles Hospital, was said to have told the news agency that currently all ANDs were banned in the Seychelles.

    But the agency reported that, under the new regulation, ANDS would be classified as tobacco products so that nearly all provisions in the Seychelles tobacco control law would extend to their manufacture, distribution, sale and use.

    ANDs were not on the market when the Seychelles’ first Tobacco Control Act was drafted in 2009, said Viswanathan; so amending the law would ensure that a ‘framework’ existed for consumers and sellers. Under the new regulation, sellers would need a license.

    Viswanathan said that the only difference in treatment of traditional tobacco products and ANDs would be in respect of labeling. The warning labels would not be the same as those on cigarette packaging, but the details were still being worked out.

    Presumably, ANDs warning labels will reflect the comparative risks because Viswanathan said that ANDs comprised a good option to help smokers who wanted to quit smoking.

    “It is a good way to help smokers quit the habit and it is also less detrimental to health as it contains less nicotine and other harmful substances found in real cigarettes,” she said.