Tag: industry briefs

  • Top Doctor: ‘Insufficient Evidence for E-cigs’

    Top Doctor: ‘Insufficient Evidence for E-cigs’

    There is presently inadequate evidence to conclude that e-cigarettes promote smoking cessation, according to a recent report by the U.S. Surgeon General.

    “E-cigarettes, a continually changing and heterogeneous group of products, are used in a variety of ways,” the report states. “Consequently, it is difficult to make generalizations about efficacy for cessation based on clinical trials involving a particular e-cigarette, and there is presently inadequate evidence to conclude that e-cigarettes, in general, increase smoking cessation.”

    However, during a press conference, Surgeon General Jerome Adams acknowledged anecdotal evidence for the efficacy of e-cigarettes as a quit-smoking aid.

    “I’ve heard powerful accounts from individuals who have used e-cigarettes to quit smoking traditional combustible cigarettes, and there are some studies that are actually reviewed in this report documenting that certain types of e-cigarettes may be associated with quitting in some adult smokers,” he told reporters.

    “But it’s also important that we use the entire body of available science to guide our current recommendations,” said Adams.

    Released on Jan. 23, the new Surgeon General report is the first since 1990 to focus solely on quitting smoking, which it says is beneficial at any age.

  • Jeroen Slobbe Leaves Tembo

    Jeroen Slobbe Leaves Tembo

  • The FDA May Lose Its Tobacco Remit

    The FDA May Lose Its Tobacco Remit

    The Trump administration wants to remove the Center for Tobacco Products (CTP) from the U.S. Food and Drug Administration’s (FDA) authority.

    In his 2021 budget proposal, released on Feb. 10, President Donald Trump envisions the CTP as a stand-alone agency with a Senate-approved director.

    The budget proposal states that making the CTP its own agency would allow the FDA to “focus on its traditional mission of ensuring the safety of the nation’s food and medical products supply” while “a new agency with the singular mission on tobacco and its impact on public health would have greater capacity to respond strategically to the growing complexity of new tobacco products.”

    Public health advocates reacted strongly against the proposal, saying it would roll back any forward motion the FDA has had in terms of regulating tobacco products. Creating “a new stand-alone agency to handle tobacco regulation is the wrong idea at the wrong time,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.

    Public health advocates already feel that Trump’s recently enacted flavor ban is too weak because it allows for single-use disposable flavored products to remain on the market, which they believe youth will gravitate toward in the absence of other flavored products. The ban removes flavored pod products with the exception of tobacco and menthol flavors from the market.

    Some fear that having a Senate-approved director of this new agency would politicize the regulation of the industry—it could “greatly politicize its management and activities,” said Eric N. Lindblom, senior scholar at the O’Neill Institute for National and Global Health Law at Georgetown Law and a former director of the FDA CTP’s Office of Policy.

    The FDA was granted oversight of tobacco in 2009 under the Obama administration. The CTP was then created within the FDA to regulate the industry. The CTP would remain under the Department of Health and Human Services under the new budget proposal.

  • Zimbabwe Postpones Selling Season

    Zimbabwe Postpones Selling Season

    The start of Zimbabwe’s 2020 tobacco marketing season will be delayed due to late rains, according to Patrick Devenish, chairman of the Tobacco Industry and Marketing Board (TIMB).

    Last year, the marketing season commenced on March 21. Tobacco deliveries hit an all-time high of 259 million kg in 2019 but, at $2 per kg, average prices were the lowest in years.

    As of Dec. 20, farmers had planted 81,977 hectares of tobacco against 79,708 hectares planted during the same period last year, according to TIMB data. Output for this year is estimated at 225 million kg.

    Tobacco is one of the country’s top earners of foreign exchange, which is necessary for the importation of raw materials, fuel and pharmaceuticals among other products.

  • Hahn Confirmed as FDA Head

    Hahn Confirmed as FDA Head

    The U.S. Senate on Dec. 12 confirmed Stephen Hahn as head of the Food and Drug Administration, reports AP. Hahn will succeed Scott Gottlieb, who left the federal agency in April.

    A specialist in treating lung cancer, Hahn most recently worked as the top medical executive at the MD Anderson Cancer Center in Houston.

    His appointment comes as key decisions about regulating e-cigarettes, including how to restrict underage access, remain unresolved.

    More than three months ago, President Donald Trump and his top health officials said they would clear the market of virtually all flavored e-cigarettes because of their appeal to children and teens. But that effort has stalled after vapor lobbyists pushed back and White House advisers told Trump the ban could cost him votes with vapers.

    In his confirmation hearing, Hahn repeatedly sidestepped questions about the fate of the flavor ban. When lawmakers tried to pin down his preferred approach to regulating vaping, Hahn said only that he would follow the “science and evidence.”

  • PMTA Contracts Signed

    PMTA Contracts Signed

    Avail Vapor has signed nine major brand U.S. Food and Drug Administration (FDA) regulatory contracts. As a result, Avail Vapor will take the lead in submitting an array of products for the FDA’s premarket tobacco product application (PMTA) process, with the first of those applications being submitted in early in 2020 and completing the portfolio before the May 2020 deadline.

    “We are thrilled these major brands are placing their trust in us as we move forward together to provide leadership in raising the standards of our industry to help build trust in our products,” said Russ Rogers, chief operating officer of Avail Vapor.

    “We have spent significant time, focus and energy in building our regulatory ISO 17205 analytical lab and manufacturing teams to position our company for success with regard to the FDA’s public health expectations. Collaborating with great U.S. e-liquid companies and international device manufacturers on such a critical initiative as PMTAs will validate the value Avail [Vapor] can add in ensuring the appropriateness of these products on the market. Ensuring the highest quality standards in the ENDS [electronic nicotine-delivery system] and CBD industries is at the forefront of our mission.”

    All e-liquid and device manufacturers have until May 2020 to submit PMTAs for ENDS products under section 910 of the Federal Food, Drug and Cosmetic Act. This includes liquids, devices and any affiliated products related to electronic nicotine-delivery systems. From there, the FDA has six months to review applications.

    If the product application provides scientific data “to demonstrate that marketing the new tobacco product is appropriate for the protection of public health,” the FDA will issue a marketing order, which means the product can continue to be sold to consumers. Avail Vapor plans to submit its first batch of PMTAs to the FDA for its own e-liquid brand of products very early in 2020.

    “When an e-liquid company signs on with us for contract manufacturing, we are able to assure them that roughly 40 percent of the PMTA process is already complete based on the work we have done to develop our manufacturing and quality systems,” said Vince Angelico, director of regulatory affairs for Avail Vapor.

    “We can provide a turnkey solution to meet their needs with a science-driven approach to testing for harmful and potentially harmful constituents—demonstrating good manufacturing practices—as well as additional analytical lab testing critical to the PMTA process. This provides a cost-effective path for e-liquid brand holders who are committed to remaining on the market and may otherwise have to exit in 2020.”

    To further service the regulatory contracts, Avail Vapor has plans to open a facility in Southern California.

  • Green Light for Low-Nicotine Cigarettes

    Green Light for Low-Nicotine Cigarettes

    The U.S. Food and Drug Administration (FDA) has issued marketing orders to permit the sale in the U.S. of 22nd Century Group’s proprietary low-nicotine Moonlight and Moonlight Menthol cigarettes.

    After reviewing the premarket tobacco product applications (PMTA) submitted by 22nd Century Group in December 2018, the FDA concluded that the marketing of Moonlight and Moonlight Menthol cigarettes is “appropriate for the protection of the public health.”

    Among other things, the agency determined that nonsmokers, including youth, are unlikely to start smoking Moonlight and Moonlight Menthol cigarettes, and those who experiment with the low-nicotine cigarettes are less likely to become addicted than people who experiment with conventional cigarettes.

    According to the FDA, conventional cigarettes made in the U.S. on average contain tobacco with a nicotine content of 10 mg to 14 mg per cigarette. Moonlight and Moonlight Menthol have nicotine content between 0.2 mg to 0.7 mg per cigarette.

    “Conventional cigarettes are designed to create and sustain addiction to nicotine,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement announcing the authorization.

    “In announcing the FDA’s comprehensive plan to regulate tobacco and nicotine in July 2017, we noted our commitment to taking actions that will allow more addicted smokers to reduce their dependence and decrease the likelihood that future generations will become addicted to cigarettes.

    “Today’s authorization represents the first product to successfully demonstrate the potential for these types of tobacco products to help reduce nicotine dependence among addicted smokers,” stated Zeller.

    “FDA authorization of 22nd Century’s proprietary Moonlight and Moonlight Menthol brand cigarettes is a major milestone in our efforts to drive meaningful change in the tobacco industry,” said Michael Zercher, president and chief operating officer of 22nd Century Group.

    “22nd Century joins just two other companies in having marketing orders granted under the FDA’s PMTA regulatory pathway. Those other companies, Philip Morris International and Swedish Match, are very large, global tobacco companies with significant financial, scientific and regulatory affairs resources, so we are extremely proud of the world-class work done by our regulatory team to successfully secure this marketing authorization from the FDA.”

  • Tobacco Shares Rise on Flavor Ban Announcement

    Tobacco Shares Rise on Flavor Ban Announcement

    Shares in British American Tobacco (BAT) and Imperial Brands rose after the U.S. Food and Drug Administration (FDA) exempted menthol and tobacco from a list of e-cigarette flavors that it has banned under new guidelines.

    “Following a significant period of disruption and uncertainty, this regulatory clarity is a welcome step towards returning the U.S. vapor market to stability,” BAT wrote in a statement.

    The new FDA guidelines would also allow tobacco makers to bring back some of the banned flavors if their marketing applications passed a substantive review by the FDA.

    “In addition to exempting menthol, the FDA guidance is clear that flavored products will return to the market once they have been approved through the premarket tobacco product application (PMTA) process,” said Simon Evans, spokesman for Imperial Brands.

    BAT submitted a marketing application for its Vuse Solo e-cigarette to the FDA in November while Imperial Brands said it would submit its applications for its Blu e-cigarettes before May.

    The Campaign for Tobacco-Free Kids (CTFK), however, said the Trump administration had broken its promise to eliminate the flavored e-cigarettes that are driving youth nicotine addiction.

    “By leaving menthol flavored e-cigarettes widely available and completely exempting liquid flavored products, this policy will not stop the youth e-cigarette epidemic,” said Matthew L. Myers, president of the CTFK.

    By contrast, Michael Siegel, a professor at the Boston University School of Public Health, described the decision to exempt open system products from the ban as a huge victory for public health.

    “By allowing vape shops to continue selling flavored vape liquids, the FDA is preventing hundreds of thousands of ex-smokers from being forced to return to smoking,” he said.

    But Robin Koval, CEO and president of the Truth Initiative, said that the argument that flavored e-cigarettes and vape shops are necessary for smokers to switch from cigarettes ignores the data.

    “The data show that the majority of adult e-cigarette users either never previously used cigarettes or continue to smoke, thereby undermining any potential public health benefit,” she said.

    Vapor industry representatives, meanwhile, expressed concern about the FDA’s determination that makers of the nicotine liquids are manufacturers and thus required to submit PMTAs for their products by the court-ordered deadline of May 12.

    According to Gregory Conley, president of the American Vaping Association, there has been little “chatter” about liquid manufacturers actually filing such applications.

    If they fail to do so by the deadline, many small vapor shops dependent on large nicotine liquid makers could begin closing in mid-May from lack of product from legal sources.

  • Bates: ’95 Percent Safer’ Stands

    Bates: ’95 Percent Safer’ Stands

    Contrary to its claim, a recent critique does not debunk the statements made by Public Health England (PHE) and the Royal College of Physicians (RCP) that vaping is at least 95 percent less risky than smoking, according to Clive Bates, director of Counterfactual Consulting.

    Writing on his blog, Bates examined the authors’ propositions and found them wanting.

    “Not a single word of their paper addresses the supposed foundation of their critique—that PHE/RCP are wrong, and the risks of vaping are likely to exceed 5 percent of those of smoking,” Bates wrote.

    While the paper contains several baseless assertions that are irrelevant to the “at least 95 percent lower” relative risk claim (gateway effects, smoking cessation efficacy and secondhand aerosol exposure), it says nothing about the relative magnitude of smoking and vaping risks, according to Bates.

    “No analysis, no data, no evidence—nothing that discusses relative risk and why PHE/RCP are supposedly wrong. Niente. Nada. Rien. Nichts. Nothing,” he wrote.

  • PMI Topman Sounds Alarm About Harm Reduction

    PMI Topman Sounds Alarm About Harm Reduction

    The historical opportunity offered by smoke-free alternatives to reduce the health impact of smoking is in jeopardy due to misinformation and calls for prohibition, according to Andre Calantzopoulos, CEO of Philip Morris International (PMI).

    Writing in Fortune, Calantzopoulos said that thanks to rapid advances in science and technology, better alternatives now exist for adults who would otherwise continue to smoke.

    However, the opportunity for trajectory-shifting progress in public health is endangered by public confusion and prohibitionist legislation.

    Calantzopoulos pointed to the U.S. where recent incidents of lung illness attributed to black market THC products have been conflated with the use of unadulterated legal e-cigarettes. At the same time, media have been widely reporting on the valid concerns around the use of e-cigarettes by youth, he said.

    “This combined coverage has left many men and women who smoke confused about smoke-free alternatives,” Calantzopoulos wrote.

    Compounding the issue, he added, a handful of tobacco control NGOs in several countries have seized the opportunity to call for legislation that either prohibits some or all smoke-free alternatives or severely restricts smokers’ access to and ability to learn about these products.

    “If regulators respond to these calls by choosing a prohibitionist route over a science-based approach, the opportunity for progress in public health may be lost,” Calantzopoulos cautioned.