Author: Staff Writer

  • Market Watch: Philippines

    Market Watch: Philippines

    The Philippines is set to approve the most progressive and risk-proportionate vaping legislation in Asia-Pacific.

    By VV Staff

    There are an estimated 17 million smokers in the Philippines. An estimated 117,000 of them die every year from smoking-related diseases, according to Quit for Good, a nonprofit organization that advocates “real, practical and tangible” solutions to smoking cigarettes. However, next-generation tobacco products, like electronic nicotine-delivery systems (ENDS), which studies have shown can be up to 95 percent safer than combustible cigarettes, have had a challenging path to market in the country.

    In November 2019, Philippines President Rodrigo Duterte announced a ban on the use and sale of e-cigarettes. It was a sudden and unexpected decision that was made in part due to the rising number of cases of e-cigarette or vaping use-associated lung injury (EVALI) impacting the U.S.. A 16-year-old Filipino girl was also diagnosed with EVALI after using e-cigarettes for six months, prompting the country’s Department of Health to raise concerns.

    “I will ban it,” Duterte declared at the time. “The use and importation. You know why? Because it is toxic, and government has the power to issue measures to protect public health and public interest.”

    In February of 2020, Duterte signed an executive order that prohibited the use, sale or purchase of cigarettes or other tobacco products by anyone under the age of 18 or ENDS or their components by a person below 21 years old. Then there were proposals to raise the purchase age to 25 for ENDS and ban all vape flavors other than menthol and tobacco.

    The U.S. Centers Disease for Disease Control and Prevention (CDC) then finally admitted publicly that EVALI was caused by black market marijuana vaping products rather than nicotine products. As the news spread, the Philippines began to reconsider its position of less-risky alternatives to cigarettes like vapor and heated-tobacco products (HTPs).

    Consumer advocates in the Philippines began to promote the regulation of e-cigarettes as a consumer product. They pointed out that the age one can purchase tobacco, alcohol and get married in the Philippines is 18, so the 21-years-of-age requirement to purchase vaping products was nonsensical. At the same time, they argued that adult smokers keen to quit tobacco need reasonable access to safer alternatives, and restricted advertising should be permitted. Product safety standards were also critically important to the consumer advocates.

    Earlier this year, the Philippine House of Representatives proposed the Noncombustible Nicotine-Delivery Systems Regulation Act (House Bill 9007). The bill is a massive legislative achievement for tobacco harm reduction advocates in the Philippines, according to Nancy Loucas, executive coordinator of the Coalition of Asia-Pacific Tobacco Harm Reduction Advocates (CAPHRA), a regional alliance of consumer tobacco harm reduction advocacy organizations.

    If the measure becomes law, it will authorize the country’s Department of Trade and Industry, in consultation with its Food and Drug Administration, to set rules, regulations and standards on packaging, ingredients and graphic health warnings on ENDS products. The bill also includes the following provisions:

    • Only retailers can sell ENDS, electronic non-nicotine-delivery systems (ENNDS) or HTPs. Selling to minors is prohibited. Retailers will have to ask buyers for a valid government-issued ID.
    • Manufacturers, importers and distributors must comply with certain packaging and health warning requirements.
    • The use of alternative products will be prohibited in all enclosed public places except in designated vaping areas. Indoor use of the products is prohibited in schools, hospitals, government offices and facilities intended for minors.
    • The sale or distribution of these products within 100 meters from any point of the perimeter of a school, playground or other facility frequented by minors is prohibited.
    • Manufacturers are prohibited from sponsoring any sport, concert or cultural or art event. 

    In May, House Bill 9007 passed the House with 192 of its 300 representatives in favor—with only 34 voting against it and four abstaining. The Senate bill is expected to be voted on in September, although as of Aug. 2, it was still in the Philippines’ Senate trade subcommittee, which is deliberating four separate bills seeking the regulation of vaping products.

    Several of the country’s health experts and advocates have asked senators to keep the current law with a purchase age of 21 or raise the age to 25 to purchase or use vape, e-cigarettes and vapor products in order “to curb its harmful effects on minors.”

    In a press release, Philippine College of Physicians Executive Director Encarnita Blanco-Limpin stated that under the Republic Act No 11467 (a bill based on Duterte’s executive order), the age of purchase for vaporized nicotine products and heated-tobacco products is 21 years old and that should not change. She added that lowering the access of e-cigarettes from those 21 years old to those 18 years old is a retrospective act.

    Clarisse Virgino and Peter Dator – Credit: CAPHRA

    “Scientific studies have shown the age of maturation actually occurs at the age of 25 years. Now, if we are thinking of changing the minimum age of purchase, maybe what we should do is even increase it to 25 years,” she said. “To be consistent, since all of these [are] addictive substances, maybe it is wise to consider that we put the minimum age of purchase for all the vaporized products, heated-tobacco products, all the regular tobacco products and even alcohol at the age of 21, or even perhaps at the age of 25, so that we will be able to prevent our young from taking up [this] addiction at an earlier age.”

    Peter Dator, president of consumer group Vapers PH and a CAPHRA member, hopes the Senate will pass the legislation, and he is confident a clear majority of senators realize just how much is at stake.

    “This needs to get passed to ensure millions of Filipino smokers continue to have access to safer nicotine products. At the same time, existing vapers must maintain access to their product of choice to keep them from going back to cigarettes,” he says. “We would like to thank our congressmen for looking at scientific evidence in coming up with a bill that would provide Filipino adult smokers a choice to switch to less harmful alternatives to combustible cigarettes.”

    The Philippine representative of CAPHRA, Clarisse Virgino, is also hopeful the Senate will give its approval, which is required to enact the legislation. She says the legislation will legitimize the fact that tobacco harm reduction is “a real thing backed by science,” adding that international evidence continues to put vaping at 95 percent less harmful than smoking.

    “It’s vital this legislation gets Senate approval. It will give consumers better protection, enabling them to choose genuine THR products at a reasonable price. Fair regulation will also eradicate any black markets or any sellers who are not authorized to sell THR products, prioritizing the safety of consumers,” she says. “I am confident that like our House representatives, our senators have listened. Without doubt, vaping has proved to be [the] world’s most effective smoking cessation tool. Legitimizing it will go a long way to helping many more Filipino smokers quit cigarettes and protect the rights of consumers to access safer alternatives.”

    Loucas says the Philippines’ goal of adopting best practice tobacco harm reduction policies will hopefully be emulated by other Asia-Pacific governments. She says that many of the region’s territories suffer from desperately high smoking rates, and in some countries, such as Thailand, vaping remains illegal.

    “This move will only strengthen the Philippines’ independence as it shakes off any remaining vestiges of foreign influence on its public health policies. In recent years, we’ve seen American billionaires and their so-called philanthropic foundations fueling anti-vaping sentiment around the world. It’s well established that the Philippines has been a target,” she said. “As this landmark legislation nears its final hurdle, outside pressure will again pile on, but senators can be confident their positive action will undoubtedly save thousands of Filipino lives.”

    According to 6W Research, vaping products are growing in popularity in the Philippines and are “anticipated to witness profound market growth” throughout the forecast period of 2020–2026. The group is predicting a compound annual growth rate of 26 percent.

    In April of this year, YOOZ, a major Chinese e-cigarette brand, opened its first store in the Philippines. There are now 31 YOOZ stores nationwide. Willy Lim, a YOOZ franchise owner in Manila, said YOOZ stores in the Philippines have seen a surge in sales, according to a press release. “I am very happy to have made the right decision to join YOOZ,” Lim said. “With such a trustworthy partner, I am very confident in the future of this industry.”

  • Approaching Issues

    Approaching Issues

    The PMTA process has had some errors and challenges as the FDA’s decision deadline looms.

    By Timothy S. Donahue

    The U.S. Food and Drug Administration’s process for premarket tobacco product applications (PMTAs) has not been perfect. The regulatory agency has less than three weeks to complete its review of the more than 2 million PMTA submissions that remain of the more than 6 million received (the FDA refused to file more than 4 million submissions from the JD Nova Group). Given the unprecedented number of applications and other factors, the likelihood of the FDA reviewing all the applications by Sept. 9, 2021, is low.

    “We will continue to allocate our resources with the goal of working as quickly as possible to transition the current marketplace for deemed products to one in which all products available for sale have undergone a careful, science-based review by [the] FDA,” an FDA spokesperson told Vapor Voice. “With that being said, as with all unauthorized products generally, if products are not authorized by Sept. 9, 2021, and do not come off the market at that time, they risk FDA enforcement.”

    A court ruling requires the FDA to complete review of all submitted PMTAs by Sept. 9, 2021. Only a positive order issued by the FDA would allow a company to continue to be marketed according to the terms specified in the order letter.

    “At a recent House hearing, acting FDA Commissioner Janet Woodcock pledged the FDA would make every effort to conclude review of the PMTAs from the top five vaping companies by the fall deadline,” said Gregory Conley, president of the American Vaping Association. “The FDA does not exactly have the best track record on keeping to their pledges, but it seems likely that decisions will be made on, at minimum, the tobacco and menthol varieties of Juul, Vuse, NJOY, etc., by September.”

    Unfair warning

    Complicating matters further, the regulatory agency has also recently been accused of issuing unwarranted warning letters, of leaving companies off its list of accepted PMTAs and of having technical issues with its PMTA filing software. As of July 26, the FDA had issued 135 warning letters for the marketing of illegal vaping products. The majority of those letters centered on e-liquids produced and sold online by small-sized vape shops. As the FDA continues its blitz, however, some companies who submitted PMTAs by the Sept. 9, 2020, deadline have allegedly received warning letters in error.

    According to Facebook posts from the American Vaping Manufacturers Association (AVM), at least two companies have received warning letters for products for which they had submitted timely PMTAs. Posts acknowledged that the FDA corrected its mistake in a follow-up letter after receiving complaints from the companies. While the number may be small, it does suggest that the regulatory agency is overwhelmed by the number of submissions it is reviewing.

    Credit: Chris Titze Imaging

    According to the FDA spokesperson, there has been only one instance where the regulatory agency removed a warning letter from its website after it was discovered that the company had submitted a timely PMTA. The agency did not mention the company by name and said the error had been corrected.

    The FDA said the list may change as some companies may not have responded to requests or have not had their PMTA accepted yet. It should be noted that in its guidance document released in January 2020 that identified its enforcement priorities for electronic nicotine-delivery system (ENDS) products, the FDA stated that it “may prioritize enforcement of certain new deemed tobacco products that are marketed without market authorization, including as warranted based on changed circumstances, new information or to better address minors’ use of those products.”

    The FDA also recently started listing closeout letters for companies that had responded to warning letters on its website. When the FDA completes an evaluation of corrective actions via a follow-up inspection, it may issue a closeout letter if the agency’s evaluation shows that the issues noted in the warning letter have been addressed.

    Recently, however, the agency removed those letters from its website. The FDA offered no explanation for the removal of the closeout letters. Companies such as Dr. Crimmy’s V-Liquid, Bulldog Vapor and CC Apothacary had closeout letters posted, but then it seemed they were removed.

    The FDA spokesperson said that the letters are still on the website; however, accessing them changed slightly. Users must now use the search functions to access response and closeout letters. “Any closeout letters issued to firms since Sept. 9, 2020, including Dr. Crimmy’s V-Liquid, Bulldog Vapor [and] CC Apothecary, are still posted on [the] FDA’s website,” the spokesperson said. “On [the] FDA’s ‘Warning Letters’ page, you can find the closeout letters by listing ‘Center for Tobacco Products’ under ‘Issuing Office’ and filtering for ‘Closeout Letter’ under ‘Letters with Response or Closeout.’”

    The FDA often lists only a few illegal products in a warning letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA.

    Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale and/or distribution of the products. The response must also detail the company’s plan for maintaining compliance with the Food, Drug and Cosmetic (FD&C) Act in the future.

    Warning letters are expected to continue to be issued for illegal vapor products as the deadline for FDA action moves closer, and their volume is likely to pick up after the Sept. 9 deadline. The FDA has not said if it intends to ask for an extension on the deadline; however, the U.S. Small Business Administration recently sent a letter to the FDA asking the regulatory agency to request an extension.

    Making the list

    There are other issues with the FDA PMTA process as well. Recently, the FDA released a list of products that are legal for sale in the U.S. As of Aug. 9, 372 companies had submitted PMTAs for more than 6 million products. Of those products, 99.9 percent are standalone e-liquid products—and of those, 80 percent of the e-liquid submissions were from a single company, according to ECigIntelligence, a vapor industry data and research firm.

    At least five companies that filed PMTAs were allegedly erroneously left off the list, according to social media posts by an AVM representative. In its own investigation, Vapor Voice found that Humble Juice Co. had submitted a timely PMTA, received an acceptance letter and was subsequently left off the FDA’s list of approved products. The FDA has corrected the error for Humble. The AVM did not name what companies were left off the list or had falsely received warning letters.

    The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on the current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed. It is possible companies were left off the list because they did not respond to the FDA before publication of the list.

    As stated on the FDA’s website, the lists are not comprehensive or intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute or sell without risking FDA enforcement. The FDA stated that it was making the list available to the public to be transparent and increase stakeholder knowledge of these products. However, the list is only one source of information, and retailers should discuss with their suppliers the current status of any particular tobacco product’s application and marketing authorization, according to the FDA.

    “Due to the large volume of information that needed to be processed to generate the list, it is likely that some information may have been inadvertently excluded during the development of the list. After initial posting of the list, FDA has received inquiries from companies about certain products they believe should have been included on the public list,” the spokesperson said. “We are reviewing these requests, and will update the list, if appropriate, to ensure accuracy. In general, due to the large amount of data in the files, FDA has also stated minor edits and corrections may be made to the list files to ensure accuracy, and the files will also be updated to reflect actions taken on the applications for the products.”

    Shaky submissions

    The PMTA submission process has also suffered from technical problems. Several companies have complained that the FDA’s software that manufacturers must download to submit PMTA data has randomly left out some files that the companies are uploading. At least two companies that have helped prepare more than 500 PMTAs have acknowledged the issue and have presented the problem to the FDA.

    “We did 15 PMTAs for various clients and just all of a sudden had somebody come up and they got a deficiency letter asking for information that was included in their submission. We started looking through it, and it’s missing. We then spent a bunch of time going through every single one and found several others that were missing one or two files,” one of the companies that discovered errors told Vapor Voice. “We reached out to the FDA, got a basic response … ‘we’re aware of this; we’ll get back to you’ type of thing. We believe it’s a bug in the agency’s eSubmitter program.”

    The FDA spokesperson said that the agency’s Center for Tobacco Products (CTP) submitters have three options for electronic submissions:

    1.   FDA hosts the Electronic Submission Gateway (ESG) used by all FDA centers for the past 20-plus years. It requires registration and maintaining a security certificate, which has an associated fee. CTP receives electronic submissions directly through the ESG from a small number of companies.

    2.   CTP provides a simpler zero-cost alternative to using the ESG directly with the FDA eSubmitter software and the CTP Portal. Using the CTP Portal requires obtaining a free account and using the FDA eSubmitter tool to create a valid package of files, which the CTP Portal will upload. Submitters must download the FDA’s eSubmitter software if they intend to use the free CTP Portal. Instructions for use are on the FDA webpage, and detailed technical specifications for creating valid eSubmitter packages can be found under Electronic Submission File Format and Technical Specifications.

    3.   Electronic files can be mailed to CTP Document Control Center (DCC) on physical media such as CD, DVD or flash drive.

    Credit: Yuri Hoyda

    The eSubmitter errors that some companies have found may be user error, according to the FDA. The inclusion of invalid file types in the upload package may make it appear as if certain files were left off. A common invalid file type users attempt to include are zero-sized files, according to the FDA.

    “A user may unintentionally include *.tmp files, which are temporary files of zero size that the user’s computer creates when it is moving files from one location to another. If a user moves files they are uploading during the loading process, the .tmp file their computer created will become part of the package manifest and appear in the eSubmitter file count,” the spokesperson said. “A user may think they are sending 500 application files, but if one is a .tmp file, they are only sending 499 files related to the application.”

    The CTP eSubmissions help desk recommends submitters create a file list and review the file types to be used in the submission against the list of invalid file types. After uploading to the CTP Portal, they can compare the list of valid files against the CTP Portal upload manifest to ensure all files were included. If files were found to not be included, they could be submitted separately, according to the FDA.

    “In general, FDA intends to send only one deficiency letter (if appropriate),” the spokesperson said. “It is the applicant’s responsibility to ensure all information has been submitted to FDA and to review all files that were uploaded to the software prior to submission to FDA.”

    Because of these issues, some companies are offering free PMTA deficiency reviews for companies that submitted them to the FDA. Delphinus Consulting and Blackbriar Regulatory Services have said they have programs to help companies find faults in their PMTA submissions.

    After the deadline

    How the vaping industry changes on Sept. 9 remains to be seen. Large companies may soon dominate the U.S. vapor market while e-cigarettes produced by smaller companies may disappear, according to new research by ECigIntelligence. The data firm carried out an assessment of the FDA’s “accepted” list in order to understand how the U.S. market may change in a post-PMTA regulated market.

    Analysis of PMTAs shows that more applications for simpler disposables and cigalike devices were submitted than applications for open systems. According to the research, the simpler products usually come from large companies while the open systems usually come from smaller businesses. Only about 30 open system brands have filed PMTAs, implying that 85 percent of open system brands will be removed from the market, even if all 30 filed PMTAs are approved.

    “This may indicate the discouragement nontobacco companies face when applying for PMTA approval,” said ECigIntelligence’s managing director, Tim Phillips. “The PMTA process can be a grueling one for nontobacco companies without sufficient financial means or knowhow. And if smaller brands are to become less prevalent in this category, consumers may soon only have the option of a few models provided by a handful of big companies.”

    While the industry awaits decisions from the FDA, vape sales are rising. IRI data for U.S. convenience stores shows that dollar and unit sales for electronic smoking devices each climbed approximately 14 percent for the four weeks ending June 13. A 12-week review revealed a gain of 16.3 percent in dollar sales and 18.6 percent in unit sales.

    Whether these trends will continue after Sept. 9 is anyone’s guess.

  • Group of 31 States Wants FDA to Ban Most E-Liquid Flavors

    Group of 31 States Wants FDA to Ban Most E-Liquid Flavors

    A coalition of 31 U.S. states and territories has penned a letter the U.S. Food and Drug Administration (FDA) to asking the agency to ban all flavors other than tobacco, limit nicotine levels and restrict the marketing of all electronic nicotine delivery system (ENDS) products. The group wants the regulations to also apply to oral nicotine products such as pouches, gum and lozenges.

    Credit: Balint Radu

    Led by New York Attorney General Letitia James, the group’s letter to the FDA argues that the FDA must address the epidemic of youth use of ENDS products by imposing restrictions and age verifications on traditional and digital marketing tactics aimed towards youth, according to a press release. The group claims that e-cigarettes and oral nicotine products have not received marketing authorization from the FDA, as required by federal law.

    “Flavored nicotine products attract kids to dangerous, habit-forming products that only jeopardize their health,” said James. “New York has taken important steps to protect our kids by banning non-tobacco flavored vapor products and limiting the sale of e-cigarettes, but the FDA must also do its part to curb the youth nicotine epidemic. The health and wellbeing of our kids is our top priority and the federal government must act now.”

    The FDA must make a decision by Sept. 9 on whether to allow nicotine products to stay on the market through its premarket tobacco product application (PMTA) pathway for any ENDS product that submitted the application by Sept. 9, 2020. The group’s proposed restrictions would require the FDA to deny approval for most products.

    The coalition argues that banning candy, mint, fruit, and menthol flavors, is essential to eliminating the appeal of the products to youth consumers. Other signatories to the letter are the attorneys general of Idaho, Illinois, Nebraska, North Carolina, and Tennessee. Additional states joining the letter include Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Guam, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Utah, Vermont, Washington, and Wisconsin.

    James has a long history of challenging the ENDS industry. In April 2019, she led a coalition of seven states in urging the FDA to take stronger action in addressing “the scourge of e-cigarette use among youths” by taking proposed measures such as strengthening guidance, beginning enforcement earlier and banning online sales of e-cigarettes.

    Later that year, James filed a lawsuit against the electronic cigarette company JUUL Labs for deceptive and misleading marketing of its e-cigarettes, which “contributed to the ongoing youth vaping epidemic in New York state.” In December 2020, James ordered dozens of retailers across New York state to immediately stop selling e-cigarette products to underage customers and to stop selling flavored vaping products in violation of New York state law.

    Several recent studies have found that banning flavored vaping products boosts sales of combustible cigarettes and youth use. If vapor product sales were restricted to tobacco flavors, one-third of U.S. vapers between the ages of 18 and 34 would switch to smoking combustible cigarettes, according to at least three known studies.

  • Biodegradable Filter Maker to Supply Poda

    Biodegradable Filter Maker to Supply Poda

    Photo: ASDF

    Poda Lifestyle and Wellness has entered into a supply agreement with biodegradable filter manufacturer Greenbutts.

     Greenbutts has developed a natural filter technology that was created to provide an alternative to the common nonbiodegradable cellulose acetate cigarette filter. Greenbutts created a natural, rapidly degrading cigarette filter using a proprietary blend of food-grade fiber materials including flax, cotton and manila hemp with no artificial compounds or chemical residues. The unique blend of materials is designed to allow for the same sensory experience and filter manufacturing run rates as acetate filters. Greenbutts filters will disperse in water within a few minutes and will degrade in compost within seven days as opposed to 10–15 years as is the case with traditional cellulose acetate filters.

    “Poda is committed to ensuring that the company contributes to a brighter future for all of our stakeholders,” said Ryan Selby, Poda CEO, in a statement. “As CEO, I take this responsibility very seriously, and I am devoted to ensuring that Poda delivers industry-leading performance on our core principles of strong environmental management, responsible societal impacts and robust corporate governance. Pursuant to this commitment, I am very pleased to announce today that Poda has entered into a supply agreement with Greenbutts, one of the world’s leading manufacturers of biodegradable cigarette filters.”

    “This supply agreement will provide the company with access to 100 percent biodegradable filters for use in our Beyond Burn Poda Pods. The inclusion of Greenbutts’ biodegradable filters into our already biodegradable and compostable Poda Pods allows Poda the ability to offer a completely biodegradable and truly compostable heat-not-burn product, something that has never been done in the heat-not-burn tobacco market. … We are thrilled to have secured this supply agreement.”

     “We have spent the last 10 years relentlessly pursuing the perfect biodegradable cigarette filter,” said Tadas Lisauskus, co-founder and CEO of Greenbutts. “Now that our patented product is ready for commercialization, we are very pleased to have entered this supply agreement with Poda. Traditional cellulose acetate cigarette filters are among the single most commonly littered items globally, and we are committed to the goal of eliminating environmental pollution caused by improperly discarded cigarette butts. Greenbutts’ biodegradable filters are made from natural sources and quickly biodegrade in natural settings. Combining our proprietary biodegradable filters with Poda’s unique and proprietary biodegradable heat-not-burn cigarettes is surely a winning combination.”

  • Canadian Vaping Group Wants End to Flavor Ban Proposal

    Canadian Vaping Group Wants End to Flavor Ban Proposal

    The Canadian government has proposed restrictions on flavored vape products, which Health Canada acknowledges will result in increased combustible cigarette smoking. The justification for the flavor ban is that flavor restrictions will lessen youth vaping rates, according to the Canadian Vaping Association (CVA). However, youth rates are already in decline.

    Credit: Kristina Blokhin

    The Canadian Tobacco and Vaping Survey, 2020, found that youth vaping has declined since 2019. Currently, youth daily vaping is 4.7 percent and Health Canada expects the recently implemented nicotine ceiling will further reduce use and experimentation.

    “Youth daily vaping and addiction rates are actually quite low and expected by tobacco control experts to continue to decline. Generally, youth vaping rates are discussed using data on the amount of youth that have tried vaping over the past 30 days,” said Darryl Tempest, executive director of the CVA. “This is a poor metric to base regulation on because it represents experimentation and not habitual use. Young people that try vaping once at a party are included in this figure. These surveys are also misleading because they include age of majority respondents. If these respondents were excluded from the survey, daily vaping among minors is around 2 percent.”

    In a press release, Tempest stated that if other adult products were regulated consistently with the same concern as past 30-day vape use, both cannabis and alcohol would require severe restrictions, as both daily and past 30-day use prevalence are greater than nicotine vaping.

    “Alcohol is considerably more harmful than nicotine vaping and despite its use being significantly more prevalent than vaping among youth, flavor restrictions have not been considered. This is likely because like vaping, youth are not drinking for flavors,” Tempest states. “Canada has set a goal to reduce tobacco use prevalence to 5 percent or less by 2035. Restricting flavors will push thousands of vapers back to smoking and jeopardize current smoking reduction targets. The CVA calls on Health Canada to forgo the flavor ban and instead focus on proven methods such as increased enforcement and education programs.”

  • Bantam Non-Tobacco Flavors Head to Scientific Review

    Bantam Non-Tobacco Flavors Head to Scientific Review

    The U.S. Food and Drug Administration has informed e-liquid manufacturer Bantam Vape that its non-tobacco flavored electronic nicotine delivery system (ENDS) products are now in the agency’s formal scientific review stage of the premarket tobacco product application (PMTA) process, according to a press release. Scientific review is the final step in the PMTA process prior to FDA’s decision to grant a marketing order.

    Bantam e-liquids
    Bantam is seeking marketing orders from FDA for its suite of e-liquid products. Credit: Bantam Vape

    “Following the receipt of Bantam’s filing letter, it has waited in anticipation for FDA to begin the next step in the PMTA process – formal scientific review,” said Bantam spokesperson Anthony Dillon. “As we approach the one-year anniversary of the filing deadline, this action represents a critical stage in FDA’s consideration of Bantam’s request for a marketing order.”

    The FDA completed a preliminary review of Bantam’s PMTAs in November 2020, making its applications eligible for formal substantive review. During the substantive review phase, FDA will conduct an in-depth evaluation of Bantam’s scientific studies and other materials it submitted in conjunction with the brand’s applications.

    This includes FDA’s consideration of Bantam’s product testing for harmful and potentially harmful constituents (HPHCs) and physical characteristics of the e-liquids and aerosol at multiple time points; an analysis of leachable chemicals and stability testing of its e-liquids at multiple time points; microbial testing of the final e-liquids at multiple time points; in vitro toxicity testing including Ames, micronucleus and neutral red uptake (NRU) studies; four pharmacokinetic and topography studies for multiple flavors at various nicotine concentrations; and consumer surveys to understand the demographic and usage patterns of its e-liquids. Multiple comprehensive, quantitative risk assessments across many areas of potential risk for the Bantam products were also provided to FDA, demonstrating that Bantam products are appropriate for the protection of public health.

    Additionally, to ensure Bantam’s ongoing ability to provide consumers with “high-quality, science-based e-liquid products” following the Sept. 9, 2021 deadline, the brand submitted a formal extension request to FDA. Bantam is hopeful that FDA will grant the extension, which would provide the regulatory agency with additional time to review Bantam’s complete applications and allow the brand’s products to remain on the market while the applications are under review.

    “Entering the coveted scientific review phase is a significant development. This is especially true given FDA’s growing enforcement actions against non-compliant brands,” said Dillon. “Bantam remains confident in its PMTA submissions and will continue to engage with FDA in order to obtain the marketing orders needed to stay on the market moving forward.”

  • PMI Launches ‘Cleaner’ Bladeless IQOS in Japan

    PMI Launches ‘Cleaner’ Bladeless IQOS in Japan

    Photo: Kuznietsov Dmitriy

    Philip Morris International has launched IQOS Iluma, the brand’s first tobacco-heating system based on induction-heating technology, in Japan.

    The device’s Smartcore induction system heats the tobacco from within the new Terea Smartcore Stick. These newly designed sticks are to be used only with IQOS Iluma, which features an auto-start function that detects when the Terea stick is inserted and automatically turns on the device.

    According to PMI, the bladeless IQOS devices offer a cleaner way to heat tobacco from the core without burning it. They also provide a more consistent experience and leave no tobacco residue, eliminating the need to clean the device. Additionally, the devices generate no combustion and no smoke. PMI says its market research indicates that IQOS Iluma provides a more pleasurable experience compared to previous IQOS generations.

    “IQOS Iluma is our most innovative offering to date and the new flagship in our portfolio of science-backed, smoke-free products. Its breakthrough induction-heating technology heats tobacco from within, without burning, so there’s no smoke, no ash and, like previous IQOS devices, it emits, on average, 95 percent lower levels of harmful chemicals compared with cigarettes,” said Michele Cattoni, vice president of heated-tobacco platforms at PMI, in a statement.

    “However, unlike our previous tobacco-heating systems, IQOS Iluma has no blade. That means no tobacco residue or cleaning—ever. With this, and other product features, we aim to address consumer pain points that may have hindered some adult smokers from beginning or maintaining their journey away from cigarettes in the past.”

    IQOS Iluma is available in two versions—IQOS Iluma Prime and IQOS Iluma. Both devices use new induction-heating technology but offer different designs. IQOS Iluma Prime and IQOS Iluma are available in Japan for pre-order on IQOS.com beginning Aug. 17, 2021, and for purchase at IQOS stores on Aug. 18, 2021.

    As of June 30, 2021, PMI’s smoke-free products are available in 67 markets. The company has stated its ambition to be present in 100 markets with its smoke-free products by 2025. There are more than 20 million users of the IQOS tobacco-heating system globally, and PMI estimates that more than 73 percent (approximately 14.7 million) of these men and women have switched completely to IQOS and stopped smoking with the balance in various stages of switching. PMI’s ambition is that by 2025, at least 40 million PMI cigarette smokers who would otherwise continue to smoke will have switched to smoke-free products. Furthermore, the company’s ambition is that more than half of its net revenues will come from smoke-free products by 2025.

  • Columbia, Missouri Considers Flavored E-Liquid Ban

    Columbia, Missouri Considers Flavored E-Liquid Ban

    City council members in Columbia, Missouri will review a report from the Missouri Board of Health concerning banning flavored vaping products in an effort “to reduce the number of youth vaping in Boone County.”

    Credit: Spirit of America

    According to an agenda memo, the Board of Health began studying the issue of youth vaping and its impact on mental and physical health in October 2019. Now, the board has sent the report to council, requesting assistance to prevent teen vaping, according to ABC17 News.

    The report details three recommendations that could help decrease youth vaping, including zoning restrictions on vape shops, since vape shops can currently operate near schools. Health officials also recommend a ban on flavored vaping products since currently e-cigarettes are “sold in over 15,000 flavors.”

    The board is also recommending the council explore higher taxes on vaping products to increase the cost and hopefully reduce use by youth. Multiple studies have found that flavor bans actually boost youth use of tobacco and vaping products.

    No vote is expected on the report Monday night.

  • Vapers Urged to See Doctor Ahead of New Rules

    Vapers Urged to See Doctor Ahead of New Rules

    Photo: Taco Tuinstra

    The Therapeutic Goods Administration (TGA) is urging Australian vapers to make appointments with their general practitioners to discuss their smoking cessation options ahead of new vaping rules.

    Effective Oct. 1, Australian consumers will need a valid prescription to legally obtain nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine, from an overseas website. A valid prescription is already required to purchase nicotine vaping products from Australian pharmacies.

    Purchase of nicotine vaping products from other Australian sources will remain illegal, the TGA said in guidance documents released on Aug. 12.

    From Oct. 1, Australian Border Force officials can stop an import at the Australian border and destroy the product if they suspect that it is unlawful and there is not a prescription available.

    According to the TGA, the new rules balance the need to prevent adolescents and young adults from taking up nicotine vaping (and potentially smoking) while enabling current smokers to readily access these products for smoking cessation with appropriate medical advice.

    While the TGA has not yet registered any nicotine vaping products, the agency says it is working closely with several potential applicant companies.

  • Vape Sector Welcomes NZ ‘Smoke-Free’ Law

    Vape Sector Welcomes NZ ‘Smoke-Free’ Law

    Photo: Duh84bk | Dreamstime.com

    Vaping activists have welcomed New Zealand’s new “smoke-free” law, which they say strikes a balance between ensuring that safe, good-quality products are readily available for adult smokers while minimizing appeal to young people.

    According to the U.K. Vaping Industry Association (UKVIA), New Zealand’s Smoke-free Environments and Regulated Products (vaping) Amendment Bill is “a breath of fresh air.”

    “New Zealand has taken a huge leap forward in its efforts toward a smoke-free society in a move that brings its laws on vaping in line with the U.K.’s—and in many ways surpasses them,” the UKVIA wrote in a statement. “Not only does this move pave the way for many more smokers to be able to access vaping products with confidence, [but] it also puts its near neighbor Australia’s vaping policies to shame.”

    In Australia, nicotine e-liquid is regulated like tobacco. However, the New Zealand government views vaping as a safer alternative to smoking and allows retailers to provide the following messages: “Completely replacing your cigarette with a vape will reduce harm to your health” and “If you smoke, switching completely to vaping is a much less harmful option.”

    Among other provisions, New Zealand’s new legislation requires manufacturers to notify health authorities that a product has met the safety and quality standards before it can be sold; sets nicotine limits at 20 mg/mL for freebase nicotine and 50 mg/mL for nicotine salt products; and limits container sizes to 120 mL and requires them to be protected against breakage, leakage, spilling and have child-resistant closures.

    In addition, the law sets a minimum sales age of 18 and restricts retail outlets to sell only tobacco, mint or menthol e-liquids. Vape shops, by contrast, will be allowed to sell a range of flavored products.

    “We applaud New Zealand’s bold and brave approach to vaping, now enshrined into law, and can only encourage Australia and other countries with regressive, anti-harm reduction attitudes toward vaping to look again at the enormous role vaping can play in helping smokers to give up combustible tobacco for good,” the UKVIA wrote.