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Tobacco Company Reynolds Blames Teen Vaping Crisis On Juul In Fighting FDA Plan To Rein In E-Cigarettes Source from: CNBC 05/05/2019  US: FDA Allows Sale Of New Electronic Tobacco Product An electronic tobacco device may now hit the US market after getting a green light from the US Food and Drug Administration, the agency announced Tuesday. The agency made clear that it has not deemed the device -- Philip Morris International's IQOS "tobacco heating system" -- to be safe. And its decision to permit sales is not tantamount to FDA approval. The device is not an e-cigarette or vape like the ones that have surged in popularity among middle and high school students. Rather, it's a noncombustible device that heats, without burning, "tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol," the FDA said. The agency said the move followed "a rigorous science-based review," after which it decided that the product may have public health merit in part because the device contains "fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke." Critics have expressed concerns about such research being widely company-funded. "Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public, particularly youth, and to reduce tobacco-related disease and death," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in a statement Tuesday. Moira Gilchrist, vice president of strategic and scientific communications for Philip Morris International, said the FDA's decision was a "milestone" that would allow the company to bring its product -- which is sold in other countries -- to US smokers. The company says it expects to be distributing and marketing IQOS in approximately 90 to 120 days, starting in Atlanta. But the FDA's decision raised eyebrows among health advocates. Some are concerned that the product could spread among kids, similar to vaping devices such as Juul. The decision also comes less than a month after Dr. Scott Gottlieb, who took a strong stance against underage tobacco use as the agency's commissioner, stepped down, prompting questions about how aggressively the agency would continue to pursue the issue under new leadership. Without strict FDA oversight, "there is a serious risk that IQOS will become the next Juul and worsen the current youth epidemic," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement Tuesday. He said his organization has repeatedly "raised concerns with the FDA that Philip Morris International has marketed IQOS in other countries in ways that clearly appeal to kids, including through social media, sponsorships of events like beach parties and fashion shows, and slick stores and kiosks that look like they're selling tech gadgets, not addictive tobacco products." Robin Koval, president and CEO of the Truth Initiative, said in an e-mailed statement that "the introduction of another nicotine delivery device to the U.S. market while we are in the midst of a youth e-cigarette epidemic is concerning." Harold Wimmer, president and CEO of the American Lung Association, said in a statement that he's "deeply concerned" about the product's potential health impacts. "The Lung Association urges the FDA to carefully monitor how this product is actually being used -- and by whom," Wimmer said. "FDA must take steps to protect youth from beginning a tobacco addiction with this product." The FDA said it will keep tabs on what happens as the device hits the market, including any uptake among youth. If this happens, it could be grounds for the agency to reverse its decision. "We'll be keeping a close watch on the marketplace, including how the company is marketing these products," Zeller said. This includes complying with regulations intended to prevent kids from being exposed to the product -- on websites and social media, for example. The agency will also require that package labels and ads warn about the product's addictiveness. And the tobacco company can't market the devices "with claims of reduced exposure or reduced risk," the FDA said. In order to do that, the company has a separate application in the works. Philip Morris International has put its weight behind IQOS as more smokers have ditched traditional cigarettes, affecting sales. In the first quarter of 2019, the company had "more than 10 million IQOS users worldwide," CEO André Calantzopoulos previously said in a statement. In that period, the shipment volume of its so-called heated tobacco units grew 20.2%. The company's interest in smoke-free alternatives to cigarettes is part of a sector-wide shift. Last year, tobacco giant Altria took a 35% stake in Juul in a deal worth $12.8 billion. Altria, which spun off Philip Morris International years ago, will now be distributing IQOS under an exclusive agreement with the company. Enditem
Tobacco company Reynolds is fighting the Food and Drug Administration's proposal to curb teen vaping, singling out one competitor it says the agency should rein in instead: e-cigarette maker Juul. The FDA in March proposed limiting sales of fruity e-cigarette flavors to websites, vape shops and other retailers that impose age restrictions in response to federal data showing huge increases in teenagers vaping. The public comment period closed Tuesday. Reynolds, a unit of British American Tobacco, in its response said it opposes the plan. The "FDA has already identified the main driver of youth interest: Juul," said Reynolds, which makes Newport cigarettes and Vuse vapes. "As the agency's public statements confirm, underage users disproportionately prefer Juul to all other products. ... Armed with such knowledge, we believe the agency can take appropriately tailored steps to curb youth use." Former FDA Commissioner Scott Gottlieb repeatedly blamed the teen vaping "epidemic" on Juul, the clear market leader. The agency is looking into Juul's marketing practices and conducted a surprise inspection of its San Francisco headquarters in the fall. Yet faced with a surge in teen e-cigarette use, the FDA demanded plans from the top five e-cigarette manufacturers, including Reynolds, Altria and others. For its part, Juul says categorywide action is the best way to curb youth use. "It is disappointing but not surprising to see a legacy tobacco company whose core business remains combustible cigarettes — the very product we intend to eliminate by offering adult smokers an alternative — attempting to thwart the category-wide regulation that's needed," Juul said in an emailed statement, adding that it supports the FDA's draft regulation as a "starting point." Reynolds says the FDA's plan to limit where the fruity flavors can be purchased will hurt adults who want to switch to e-cigarettes because they'll be harder to find and won't curb teen use because minors can always get them from older friends. It also says those restrictions would overstep the FDA's legal authority. Instead, Reynolds wants the FDA to tamp down on "irresponsible" marketing. "At the end of the day, we are encouraging the FDA to use more appropriate regulatory action," Dr. James Figlar, Reynolds' executive vice president of research and development and scientific and regulatory affairs, said in an interview. Critics often point to Juul's early ad campaigns, which featured youthful looking models and bright colors regulators said appealed to teens. Juul has said it regrets the ads and has since rolled out new ads that feature older adults who share their stories of switching to the e-cigarette from cigarettes. Reynolds debuted a commercial for its Vuse Alto e-cigarette earlier this year. Vapor products are not subject to restrictions barring cigarette ads from television and radio. Juul and Marlboro cigarette maker Altria, which owns a 35% stake in Juul, have both said they support the agency's proposal. Juul in November stopped selling its fruity flavors to retailers, instead saying it would only sell them directly to consumers on its age-verified website. The FDA said in response to Reynolds' letter that it "appreciates" all the comments that were submitted and will review them. The agency said it's "committed to ensuring all tobacco products, including e-cigarettes, aren't being marketed to, sold to or used by kids." Enditem
Health Secretary Francisco Duque III yesterday pushed anew for an increase in tobacco taxes to P60 per pack of cigarette, citing a survey that showed three in four Filipinos agreed that there should be higher taxes on tobacco products. Duque said there is a need to hike taxes on cigarettes to at least P60 per pack to make smoking tobacco products less affordable and less accessible to the youth. “We are very happy with the recent results of the Pulse Asia’s Ulat ng Bayan survey, showing increased public support for our proposed reform. Three out of four Filipinos agree that tobacco taxes should be raised,” said Duque in a statement. He was referring to the Pulse Asia survey conducted last March that showed higher public approval for increasing tobacco taxes, with 75 percent of Filipinos now supporting the increase in tobacco taxes. Duque noted this is higher compared to the results of the same survey conducted last September 2018 wherein 67 percent of Filipinos agreed. According to him, this shows that “more and more people are joining our call to save the lives of the people from the harms of tobacco use.” “Even among current tobacco smokers whom we expect to oppose the proposed measure, more than half of them (54 percent) supports the increase in tobacco taxes,” he added. However, the survey also showed that current number of tobacco smokers is now at 24 percent, marginally higher compared to the 23 percent smoking prevalence reported in the September 2018 survey, and close to the 22.7 percent current tobacco smokers recorded in the 2015 Global Adult Tobacco Survey (GATS). Duque said that based on the smoking prevalence data from different systematically conducted and nationally representative surveys such as the GATS, National Nutrition Survey, Social Weather Stations and Pulse Asia, the smoking prevalence has already plateaued at around 23-24 percent. “The Sin Tax Law of 2012 has been very effective in decreasing the number of smokers in the country,” he added. Enditem
22nd Century Group, Inc. (NYSE American:XXII), a plant biotechnology company that is a world leader in tobacco harm reduction, Very Low Nicotine Content tobacco, and hemp/cannabis research, announced today that last week the U.S. Food and Drug Administration (FDA) conducted a comprehensive inspection of the Company’s manufacturing facility in North Carolina as a part of the FDA’s review of 22nd Century’s Pre-Market Tobacco (PMT) application for the Company’s VLN? cigarettes. 22nd Century’s proposed VLN? cigarettes are made with the Company’s proprietary Very Low Nicotine Content (VLNC) tobacco. In December of 2018, the Company submitted Modified Risk Tobacco Product (MRTP) and related PMT applications to the FDA for the Company’s VLNC cigarettes. Together, these important applications seek the FDA’s authorization to commercialize the Company’s VLN? cigarettes and to communicate to consumers that VLN? cigarettes contain at least 95% less nicotine as compared to the 100 leading cigarette brands in the United States. The FDA’s inspection was a highly anticipated component of the third phase of the FDA’s four phase review process for the PMT application. The FDA’s stated goal for the inspection was “to verify the information and data contained in the [PMT] application.” As such, the FDA inspectors witnessed production of 22nd Century’s proprietary VLN? cigarettes. In addition, FDA inspectors reviewed 22nd Century’s raw material receiving and storage procedures, quality control processes, manufacturing equipment and systems, tobacco processing methods, and finished-products analyses procedures. Concurrent with the FDA’s review process for 22nd Century’s MRTP and PMT applications, the FDA is pursuing a proposed rule that, when finalized and effective, would limit the amount of nicotine in all cigarettes sold in the United States to “minimally-addictive or non-addictive levels.” Officials from the FDA have previously indicated a “minimally-addictive or non-addictive” level of nicotine in cigarettes could be achieved at approximately 0.3 to 0.7 mg nicotine per gram of tobacco. The World Health Organization (WHO) has similarly recommended that all member nations adopt “a [tobacco] policy of limiting the sale of cigarettes to brands with a nicotine content that is not sufficient to lead to the development and/or maintenance of addiction.” Importantly, in its published report, Global Nicotine Reduction Strategy, the WHO referred specifically to 22nd Century and to the Company’s proprietary VLNC tobacco. 22nd Century’s proposed VLN? cigarettes – with a target concentration of 0.5 mg nicotine per gram tobacco – fall squarely within the nicotine range that public health officials anticipate will be mandated by the FDA, and that will simultaneously enable the WHO to advance its global nicotine reduction agenda. For these reasons, when 22nd Century’s proprietary VLNC cigarettes achieve MRTP status, they could serve as a powerful tool and precedent in support of the FDA’s broader national nicotine reduction mandate. “Our extraordinary VLN? cigarettes contain at least 95% less nicotine than any of the 100 leading cigarette brands in the U.S.,” explained Henry Sicignano III, President and Chief Executive Officer of 22nd Century Group. “The FDA’s inspection of our manufacturing facility is another important milestone in the FDA review process that we expect will ultimately result in VLN? cigarettes becoming the world’s first FDA-approved MRTP combustible tobacco cigarettes.” Enditem
UK and Dubai Customs seize 450 metric tons of illicit tobacco. Criminal gangs supplying illegal tobacco in Norfolk, UK. More than 1 million euros of smuggled cigarettes seized by Irish Revenue officials. Danish police arrest seven in raid on smuggling network. UK fake cigarettes: how to tell what’s real. Malaysia is world’s largest consumer of illegal cigarettes. Malaysian man jailed for trying to smuggle millions of cigarettes into Australia. Australian authorities stub out illegal cigarette market. Policing the illicit trade of tobacco in Australia. Super big data and multi-stage information spatial system estimates of coastal tobacco smuggling in Taiwan. Philippines government cracks down on cigarette smuggling, counterfeiting. The Western Balkan region is notorious for tobacco smuggling. Time to Quit: Tobacco tax increase and household welfare in Bosnia and Herzegovina. South African Revenue Service seeks to track illegal cigarettes to their source. Tackling South Africa illegal tobacco trade could bring in 55% of recent tax shortfall. A decade of cigarette taxation in Bangladesh: Lessons learnt for tobacco control. The myth of Pakistan‘s illicit cigarette trade. Philip Morris Pakistan closes factory due to rising illicit trade. Menthol cigarette smokers react to Ontario‘s menthol cigarette ban. Ontario is finally ready to bust contraband tobacco. Here’s how Quebec did it. Japan Tobacco wins court protection in Canada over $1.32 billion smoking suit. Economic determinants of smoking prevalence and regulation in high- to low-income countries: is corporate power the smoking gun? Hong Kong Customs haul of illicit electronic smoking devices jumps 32% after announcement of ban. Jordan charges 29 in fake smokes scandal. Enditem
A year-long study to assess the health effects of switching from smoking cigarettes to using Tobacco Heating Products has been launched by British American Tobacco (BAT). Tobacco Heating Products (THPs), such as BAT's glo, heat tobacco to release an aerosol containing nicotine but do not burn the tobacco, meaning many of the toxicants produced by combustion of tobacco are not present in the THP aerosol. For the first time, scientists at BAT are conducting a year-long, randomised, multi-center, controlled study to see what impact switching from cigarettes to glo in a real-world setting will have on markers of smoking-related disease development. The study protocol is published today in the Journal of Internal and Emergency Medicine. Current smokers who do or don't want to quit smoking, and never smokers, will take part in the study. The smokers who don't want to quit will be randomised to either continue smoking cigarettes or switch to using only glo for a year, while smokers who want to quit will receive nicotine replacement therapy and/or nicotine addiction medicine; the never smokers will serve as controls. The subject groups will consist of UK residents aged 23-55, who are in general good health, and groups will be balanced for gender and age range. During the year, participants will go about their normal lives but will visit the clinic every 30 days for samples of blood, urine and other physiological measurements to be taken, and to complete health-related questionnaires. Subjects' levels of biological markers of the early processes believed to be involved in the development of smoking-related diseases will be measured and compared among the glo users, smokers, quitters and control groups. It is critical to the utility of the resulting data that participants are completely compliant in not smoking cigarettes if they are in the glo or smoking cessation arms of the study. In order to ensure and measure compliance, participants will use an electronic diary to self-report activity. Also, participants' blood will be tested for signs of exposure to cigarette smoke during visits to the clinic. Furthermore, glo users will visit the clinic every month for new supplies, at which point all empty, part-used, and unused packs of glo consumables will be counted. "This is BAT's first long-term study to investigate the exposure and potential health effects associated with THP use over a 12-month period and will enable us to observe if any favourable changes are sustained and whether or not they return to levels observed in never smokers," said George Hardie, Head of Clinical Research at BAT. "This carefully designed study will generate a dataset from which the public health community, regulators and consumers can gain insight into whether or not THPs may provide a viable and less risky alternative to cigarette smoking." Full results are expected to be published from 2020. Enditem Related Updates |