Author: Staff Writer

  • BAT: Scientific Committee Must Enhance Review Quality

    BAT: Scientific Committee Must Enhance Review Quality

    Credit: Ousa Chea

    The largest tobacco in Europe wants the European Commission scientific committee to enhance the quality of its ongoing review into e-cigarettes. British American Tobacco (BAT) highlighted several serious flaws in the committee’s research.

    “The results of the review may pave the way for revisions to rules that affect millions of vapers across the EU,” BAT stated in a press note. The e-cigarette maker’s response highlights major flaws with the methodology and conclusions of the review.

    The company states that, among other issues:

    • Fails to contextualize the risks of e-cigarettes relative to those associated with continued smoking.
    • Makes inaccurate claims regarding e-cigarettes many of which have been widely debunked by the scientific and public health communities.
    • Contains false assumptions that e-cigarette aerosol is the same as tobacco smoke.
    • Neglects landmark independent studies showing that many smokers view e-cigarettes as an acceptable alternative to smoking.
    • Relies on data from non-EU markets and studies on products pre-dating the current Tobacco Products Directive that are not relevant to the current EU context.

    The SCHEER Committee (Scientific Committee on Health, Environmental and Emerging Risks) is an advisory body that was tasked with producing a scientific review of the health effects of e-cigarettes as part of the European Commission’s forthcoming review of the Tobacco Products Directive.

    “If future regulations on vaping were to be based on the review as it stands now, they would be based on flawed evidence. We call on the SCHEER Committee to address the serious gaps in the review and reflect the weight of evidence supporting the harm reduction potential of e-cigarettes relative to continued smoking,” said Eric Sensi-Minautier, VP EU Affairs at BAT. “It’s important that the Commission bases any change to the rules on vaping on accurate scientific advice that has been conducted to the highest standards, to make sure the millions of European vapers who use e-cigarettes as an alternative to smoking can continue to access them. We take the science around e-cigarettes seriously and are leading our own weight of evidence review to advance understanding of this growing product category.”

    BAT highlights the need for greater transparency and cooperation between all stakeholders including industry, government, scientists, public health bodies and academics.

  • Juul Labs Shrinks Valuation to $10 Billion

    Juul Labs Shrinks Valuation to $10 Billion

    Juul starter kit

    Juul Labs has cut its valuation to about $10 billion from $12 billion at the end of last year, reports Reuters.

    Juul was valued at $38 billion in December 2018, when Altria Group took a 35 percent stake in the company.

    The latest write down follows recent decisions to exit certain markets and related restructuring costs, according to the memo sent to Juul employees by chief executive officer K.C. Crosthwaite.

    “Today’s valuation does not surprise me, and I expect other investors to also arrive at lower valuation marks that factor in our recent restructuring,” he reportedly said.

    Juul has faced heightened regulatory scrutiny following a rise in teenage vaping and a ban on the sale of popular flavors.

    In September, the company said it would make a significant cut to its global workforce and explore pulling out of some European and Asia-Pacific markets to save cash.

    Earlier this month, the company announced its exit from Germany.

  • Heated Products Help Japan’s Record-Low Smoking Rates

    Heated Products Help Japan’s Record-Low Smoking Rates

    Photo: Colleen Williams

    Japan’s smoking rate fell to a record low last year, reports NHK World, citing to a government survey.

    The health ministry surveyed about 5,700 people aged 20 or over last November.

    The percentage of men and women who regularly smoke stood at 16.7 percent. That’s down 1.1 percentage points from a year earlier, and the lowest since the survey began in 1986.

    The ratio for men was 27.1 percent, down 11.1 points over the past decade. The figure for women was 7.6 percent, down 3.3 points over the same period.

    During the recent virtual Global Tobacco & Nicotine Forum, experts attributed Japan’s rapid decline in traditional smoking to the emergence of heated tobacco products.

    Of male smokers who participated in the recent survey, 27.2 percent said they use heated tobacco products, while 25.2 percent of female smokers said they do so.

    The health ministry aims to lower the smoking rate to 12 percent by fiscal 2022.

  • New U.S. FDA Draft Guidance for Perception Studies

    New U.S. FDA Draft Guidance for Perception Studies

    fda

    The U.S. Food and Drug Administration (FDA) has released a draft guidance for tobacco product perception and intention (TPPI) studies. The studies must be submitted as part of a modified risk tobacco product application (MRTP), a premarket tobacco product application (PMTA) or a substantial equivalence report (SE Report).

    The guidance is aimed at helping applicants design and conduct the studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products.

    It is possible for a TPPI study to also include an actual use component (e.g., an actual product utilized in a simulated use setting or a real environment of use); however, a discussion of actual use research is beyond the scope of this draft guidance, according to the FDA.

    This draft guidance addresses the following scientific issues for applicants to consider as they design and conduct TPPI studies to support tobacco product applications:

    • Developing TPPI study aims and hypotheses
    • Designing quantitative and qualitative TPPI studies
    • Selecting and adapting measures of TPPI study constructs
    • Determining TPPI study outcomes
    • Selecting and justifying TPPI study samples
    • Analyzing TPPI study results

    The administration is accepting public comments related to the draft guidance through Dec. 28. The application deadline was Sept. 9 for deemed new tobacco products that were on the market as of Aug. 8, 2016, and the FDA said it intends to make a public list of what products were submitted on time. 

  • Juul Labs Class Action Continues to Woo Plaintiffs

    Juul Labs Class Action Continues to Woo Plaintiffs

    Credit: Sebastian Pichler

    The multi-district federal class-action lawsuit against defendant Juul Labs continues to grow. South Carolina-based Lexington One School District joined the class action on Oct. 14.

    Attorneys around the country continue to woo school districts to join the suit. In a recent presentation to the Leon County School District in Florida, attorneys for the Romano Law Group asked the public school district to join the lawsuit that alleges vaping manufacturers and distributors are targeting young adults in their marketing.

    Attorney Eric Romano told the Leon board this week that if the district didn’t join the suit, schools would face extra costs to battle what has been termed a vaping “epidemic.” Recent reports from the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), however, have found that youth vaping is on the decline.

    The multi-district federal lawsuit, first filed October 2019 in the Northern District of California, has hundreds of plaintiffs, ranging from unnamed minors to school districts in several states, including Pennsylvania, Maryland and California.

  • Rogers: Anti-Science War Being Waged on Vapor

    Rogers: Anti-Science War Being Waged on Vapor

    scientist holding vial
    Credit: Science in HD

    The coronavirus pandemic has taught us for certain that public health experts should stick to public health. After suffering through months of the COVID-19 lockdowns and surges, Americans are fully aware how politics and misinformation can negatively impact public health.

    The fact is that when the medical and health communities lose their focus on data and science – distracted by partisan advocates and social justice campaigns – Americans pay the ultimate price in terms of their health and well-being.

    Just in the last several months, the American public has been bombarded with conflicting reports over the effectiveness of wearing masks to combat COVID-19; whether Hydroxychloroquine is a safe therapy for coronavirus; and the safety of a COVID-19 vaccine. Health and science have been politicized and weaponized for political purposes.

    Outside of coronavirus, we have witnessed other “campaigns” that put ideology over science: the anti-vaxxer movement, the anti-GMO movement, and the ongoing disinformation over e-cigarettes.

    The Center for Medicine in the Public Interest’s Robert Goldberg recently wrote: “… for all the harm anti-vaccination fabrications have had on public health, a more recent campaign of medical disinformation about the dangers of e-cigarettes is likely to be more damaging by far.”

    The U.S. Centers for Disease Control and Prevention (CDC) notes “nearly half a million Americans die prematurely of smoking or exposure to secondhand smoke. (That is about one of every 5 deaths.) Another 16 million live with a serious illness caused by smoking. Smoking-related illness in the United States costs more than $300 billion each year in health care spending and lost productivity.”

    E-cigarettes, while not a cure for nicotine dependence, can help reduce the death and disease caused by combustible tobacco. Public Health England (PHE), the United States equivalent of the CDC, concluded best estimates show e-cigarettes are 95% less harmful to your health than normal cigarettes, and when supported by a smoking cessation service, help most smokers to quit tobacco altogether.”

    When politics takes precedence over science, we are left with both bad policy and bad science. How does Senator Dick Durbin, D-IL, erroneously declaring on the floor of the United States Senate that “vaping doesn’t guarantee any end to tobacco addiction” help the millions of Americans desperately trying to quit tobacco? What’s more, how does the Democratic leader in the Senate, Chuck Schumer, D-NY, calling vaping devices “ticking time bombs” offer clarity and confidence to smokers looking for alternatives that will help them quit the habit? Senator Schumer actually went so far as to demand that the U.S. Consumer Product Safety Commission take an active role in a “war on vaping.” These assertions betray an anti-corporate ideology (companies that manufacture e-cigs are greedy, evil), not a pro-science stance.

    Almost 40 million Americans are addicted to smoking cigarettes. According to the CDC, smoking tobacco is the “leading cause of preventable disease, disability, and death in the United States’ resulting in 480,000 deaths annually in the United States” – which breaks down to 1,300 smoking-related deaths per day, 54 deaths per hour, or almost one death per minute. One dead American every minute and we are playing politics with adult vaping. It is irrational and anti-science.

    Are e-cigarettes healthy? Should young people who do not smoke pick up a vaping habit? No, of course not. But these are the wrong questions and not the issue up for public discussion. Rather, the more relevant questions are: “Is vaping a safer alternative to smoking?” “Does vaping help smokers quit tobacco?” And here the answer to both questions is the same: an unequivocal, loud “yes.”

    Politicians and ideologically-driven advocates should not be explicitly working to scare tobacco users from using a product that, relative to smoking, does less harm to their health, and is proven to be an effective means in helping them quit smoking altogether.

    In 1983, U.S Senator Daniel Patrick Moynihan, declared to his opponents in a policy debate that “you are entitled to your own views, but you are not entitled to your own facts.” What was true in 1983 is still true in 2020. The facts are clear. Vaping bans and politicized attacks on vaping devices hurt those who want to kick the smoking habit.

    Here are the facts. Millions of Americans are dying from cigarette smoking because quitting tobacco is extraordinarily difficult. Research, published last year in the New England Journal of Medicine, offers powerful evidence that vaping can help smokers quit cigarettes. Anti-smoking activists and government regulators promoting vaping bans and, in Senator Schumer’s words, fighting a ‘war on vaping’ are not advancing science or good public-health policy. On the contrary, these advocates and politicians are fighting technologies and products that could save millions of American lives.

    Let’s stop the war on vaping; let’s take the politics out of health.

    This column initially appeared at realclearhealth.com.Jerry Rogers is the editor of RealClearHealth and the host of the ‘Jerry Rogers Show’ on WBAL NewsRadio.

  • MIssoula Flavored Vapor Ban Sent Back to Committee

    MIssoula Flavored Vapor Ban Sent Back to Committee

    Girl holding vaporizer
    Credit: Vaporesso

    The City of Missoula, Montana’s proposal to ban the sale of all flavored tobacco products was sent back to committee for further review. The Missoula City Council made that decision Monday night after some legal questions arose.

    The proposed ordinance would ban the sale of all menthol, candy and mint flavored tobacco, smokeless tobacco and e-cigarette products. Missoula took up the proposal after the state health department earlier this year offered and then pulled back a more limited state-wide proposal on banning flavored e-cigarette products.

    Proponents of Missoula’s proposal say the products are designed to attract and ultimately hook young people on nicotine. But opponents say the ordinance would devastate local retailers, who point out they already only sell to adults over the age of 21, according to Montana Public Radio (MTPR).

    Mirtha Becerra, a member of the city council’s Public Safety and Health Committee, said the committee will soon take a second look at the proposal. Becerra tells MTPR the committee has no intention of watering the proposal down into a resolution with no legal weight behind it.

    “The reason behind sending it back to committee is to ensure that we reinforce the ordinance, clarify some definitions, make sure that our data is the most up to date, but keeping it true to the north star, if you will, of that ordinance, which is preventing youth from getting addicted to a life of nicotine problems.”

    The committee will again discuss the proposal to ban flavored tobacco product sales in Missoula, next Wednesday, November 4.

    A public hearing before the full city council would follow on Monday, November 09.

  • Australian C-Stores Want Ability to Sell E-Cigarettes

    Australian C-Stores Want Ability to Sell E-Cigarettes

    Shell gas station in Australia
    Credit: Simona Sergi

    Retailers in Australia want the government to allow small businesses that sell cigarettes and other nicotine products to also be allowed to sell less harmful alternatives such as vaporizers and e-cigarettes.

    The Australasian Association of Convenience Stores (AACS) and the National Retailers Association (NRA) both claim that the federal Government’s decisions regarding the sale of smoke free tobacco products will hurt Australian retailers.

    NRA Chief Executive Officer Dominique Lamb said that after the government’s reversal on its previous ban on vapor products, its policy position was getting weirder by the day, Convenience and Impulse Retailing.

    “Last month, smoke-free tobacco products were deemed so harmful that the government decided they could only be sold at a chemist, by prescription, with visits to a doctor every three months,” Lamb said. “The same government says it will reverse its looming ban on importing vaping products, so individuals will be free to buy them from overseas dealers and have them shipped into Australia.”

    Lamb said that the laws confuse consumers by regulating e-cigarettes and vaping products as controlled substances, yet anyone one can purchase them online from overseas retailers. “The only people who will be banned from selling smoke-free tobacco products will be the tens of thousands of mum-and-dad retailers who currently rely on cigarette sales but are desperate to offer their customers a less harmful alternative,” he said. “This government clearly supports overseas retailers as much as it supports big-box corporate pharmacy. It’s just a shame that it won’t support small, local Australian businesses.”

    AACS has also pointed towards a growing black market for e-cigarettes and has highlighted the urgent need for Government to regulate the sale of these products through legitimate and responsible channels, according to the story.

    “There are positive health outcomes available to Australians through the regulated, legal sale of e-cigarettes, given they are significantly safer for people to use than traditional tobacco. Unfortunately, by restricting the legal sale of products which are clearly in demand, the health impacts of the Government’s approach are decidedly negative,” AACS CEO Jeff Rogut says. “This refusal to catch up with the rest of the world in making safer choices easier for consumers has allowed the black market for vaping products of unknown ingredients and from dubious sources to grow in Australia.”

    “Clearly, consumers are looking for safer alternatives to smoking. If health authorities are serious about helping people quit tobacco, they need to make vaping products legally available through responsible retailing channels urgently.

    The recent interim decision by the Therapeutic Goods Administration (TGA) to make vaping products only available to people from pharmacies with a prescription is both dangerous to health and a missed opportunity for responsible retailers, the AACS says.

    “Australia’s approach of making it harder for our citizens to access products that are safer for them is unique in a global context,” Rogut says.

  • Dosist Gets $15 Million Strategic Investment From TPB

    Dosist Gets $15 Million Strategic Investment From TPB

    Credit: Dosist

    A $15 million strategic investment in leading global cannabinoid company Dosist was announced today by Turning Point Brands (TPB). The manufacturer, marketer and distributor of branded consumer products said the agreement includes an exclusive co-development and distribution agreement of a new national CBD brand, created in partnership with Dosist’s THC-free business unit.

    Additionally, TPB has an option to invest another $15 million at predetermined terms within the next 12 months.

    “The cannabis market is exploding and now is the opportune time to invest in the space and significantly expand our addressable market. With its leadership in results-oriented plant-based formulas and dose control technology, global recognition, consumer trust and scalability, Dosist was the clear choice to be our new partner in this critical growth market,” said Larry Wexler, president and CEO of TPB. “We couldn’t be more pleased to enter into this agreement with Dosist, to not only help fuel its exciting new business and co-create a completely new CBD brand for our retail partners, but also to leverage their expertise as a marketing powerhouse to help build the future of both our companies.

    Gunner Winston, CEO of Dosist, a pre-eminent and globally recognized cannabis brand, said his team is extremely proud to partner with TPB on its next phase of growth and distribution. “Turning Point’s leadership team has demonstrated remarkable foresight and vision about the future and opportunity for federally legal cannabinoid products,” said Winston. “The synergy between our brands around this scope and mission is incredible and we are excited by what we will achieve together with this partnership.”

  • Turning Point Brands Announces 3rd Quarter Results

    Turning Point Brands Announces 3rd Quarter Results

    Turning Point Brands (TPB) increased its net sales 7.6 percent to $104.2 million. The manufacturer, marketer and distributor of branded consumer products today announced financial results for its third quarter ended September 30, 2020.

    “While we still expect short-term disruption related to the [premarket tobacco product application] PMTA process to impact our fourth quarter, the extensive portfolio of products submitted through the PMTA process has us increasingly optimistic about our outlook going forward as the market consolidates,” said Larry Wexler, TPB president and CEO.

    Highlights from the report include gross profit increase of 12.8 percent to $48.3 million and a net income increase of $1.5 million to $7.8 million, despite costs associated with PMTA submissions.

    “Streamlining and repositioning the business at the end of 2019 has paid dividends throughout 2020. The NewGen [next generation tobacco products] segment navigated admirably through significant market disruption caused by the PMTA application deadline,” said Wexler. “Overall, we are seeing ongoing benefits from re-shaping our business towards a more growth-oriented mindset and are able to raise our outlook once again for the remainder of the fiscal year.”