Author: Staff Writer

  • EU Taxation Consultation Split Over Vapor Issues

    EU Taxation Consultation Split Over Vapor Issues

    Image: mazhor

    Participants in the public consultation organized by the European Commission on the review of the Tobacco Taxation Directive are split on many questions relating to e-cigarettes and e-liquids, according to the Independent European Vape Alliance (IEVA).

    Following the publication of the raw data by the European Commission, the IEVA conducted a preliminary analysis of the first results.

    According to the group, the participation rate to this public consultation was higher than usual. The survey gathered 7,262 answers, 89.2 percent originating from EU citizens, 6 percent from companies and business organization and 1.1 percent from business associations.

    Most active respondents were based in France (26.9 percent), Greece (23.2 percent), Germany (7.9 percent), Poland (6.5 percent), Italy (5.8 percent), Romania (5 percent) and Spain (4.3 percent).

    Regarding specific questions on e-cigarettes and e-liquids, the results provide some light trends but the answers remain overall even split:

    Harmonization of tax rules for e-liquids containing nicotine:

    45.6 percent against, 44.8 percent in favor, almost 10 percent undecided  

    Harmonization of tax rules for e-liquids that do not contain nicotine:

    50.8 percent against, 40 percent in favor, almost 10 percent undecided

    Establishment of a minimum tax on e-cigarettes:

    46.7 percent answered “none,” 41.6 percent answered “€0.10/ml,” 5.6 percent answered “€0.30/ml,” 6.1 percent said either “don’t know” or provided no answer.

    According to the IEVA, The main question to be answered now is how the Commission will interpret the 10 percent indecisive parties for the first and the second question, as those 10 percent could tilt the balance in a way or another.

    Following the closure of the public consultation, the European Commission may now complete drafting of the proposal to revise the tobacco taxation directive. The IEVA expects the document to be presented in the fourth quarter of 2021 or the first quarter of 2022.

  • Kate Wang Resigns from RLX Audit Committee

    Kate Wang Resigns from RLX Audit Committee

    Photo: RLX Technology

    RLX Technology founder Ying (Kate) Wang has resigned as a member of the audit committee of the company’s board of directors to help the RLX comply with the relevant New York Stock Exchange’s listing requirements on audit committee’s independence.

    Going forward, the audit committee will be composed entirely of independent directors—Zhenjing Zhu and Youmin Xi—RLX technology announced in press note.

  • U.S. FDA Issues Two Final Rules for PMTAs and SEs

    U.S. FDA Issues Two Final Rules for PMTAs and SEs

    The U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports—two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.

    According to the agency, the finalization of these rules helps ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. It also formalizes the general procedures the FDA follows when evaluating PMTAs, including application acceptance, application filing and inspections. 

    It also outlines, among other things, requirements for submitting application amendments, the time for review, withdrawal of applications, postmarket reporting requirements for applicants that receive marketing granted orders, the FDA’s communications with an applicant and the FDA’s disclosure procedures and electronic submission requirements. It also allows for a supplemental PMTA as opposed to a new submission in cases such as authorization for a modified version of a tobacco product for which they have already received a PMTA marketing granted order.

    “These final rules are important components of the FDA’s comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions,” said acting FDA Commissioner Janet Woodcock, in a statement. “The FDA is committed to protecting Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review to determine if they meet the public health standards set by law. If new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States.”

    “Conducting review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country.”

    On Jan. 19, 2021, the PMTA and SE final rules were displayed in the Federal Register but did not publish. On Jan. 20, 2021, a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules were withdrawn at that time. The rules displaying today reflect clarifying changes made from the previous versions, but no significant substantive changes. Both final rules will publish on Oct. 5 and are effective Nov. 4. Beginning on the effective date, applications submitted through these pathways must meet the requirements described in these final rules.

  • Turning Point, 2 Other Firms Sue FDA Over Market Denials

    Turning Point, 2 Other Firms Sue FDA Over Market Denials

    At least three suits stemming from marketing denial orders (MDOs) issued by the U.S. Food and Drug Administration in response to premarket tobacco product applications (PMTAs) have been filed in the 2nd, 6th and 11th circuits courts of appeals (possibly more) against the FDA. Turning Point Brands (TPB) filed first a petition for review (a statutory review) with the United States Court of Appeals for the Sixth Circuit. TPB then filed an emergency motion to stay the FDAs order to remove TPB’s products from the market. Bidi Vapor and at least one other company have filed similar suits.

    Credit: Vitalii Vodolazskyi

    The TPB petition forced the FDA to provide an administrative record for its decisions on PMTAs. TPB sells various flavored e-liquids marketed under the Solace, VaporFi and Vapor Shark brands. TPB is now asking the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.” The company requests the court “vacate or modify” the FDA order and asks that TPB be allowed to “continue to market the products subject to the challenged order.”

    In an explanation for its actions, the FDA’s director for its Center for Tobacco Products (CTP), Mitch Zeller, stated in a release that many of the accepted applications ultimately received an RTF letter at the filing stage of the review process because the application did not include required information. “For example, companies received RTF letters for not including required content such as ingredient listings, labels for each product to be marketed, or adequate environmental assessments,” he wrote.

    In a joint news release with Zeller and acting FDA commissioner Janet Woodcock, the FDA explained that the applications from many MDO recipients “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the levels of youth use” of electronic nicotine-delivery systems (ENDS) products.

    The PMTAs submitted by TPB and denied by MDO included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use, according to the motion to stay filed by TPB on Sept. 30. The stay contained responses from the FDA’s response to TPB’s petition for review. “TPB’s studies demonstrated that TPB’s products help adult smokers transition away from riskier traditional cigarettes. Those studies confirmed that youth users do not currently purchase TPB products and there is virtually zero likelihood that they will in the future,” the motion states.

    TPB accuses the FDA of moving the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far,” according to the stay. TPB noted that the “North Star of administrative law” is that agencies cannot induce regulated parties to rely on “agency representations about regulatory requirements,” then penalize them using the previously unannounced criteria after-the-fact.

    “But that is precisely what FDA did here,” the stay motion states. “[The] FDA reasoned that TPB failed to conduct ‘a randomized controlled trial and/or longitudinal cohort study’ or other studies performed ‘over time’ to show that TPB’s specific flavored products help adult users stop smoking more than tobacco-flavored products do. Yet FDA previously deemed these studies unnecessary.”

  • Australian Crackdown on Nicotine Imports Starts Today

    Australian Crackdown on Nicotine Imports Starts Today

    Beginning today, the importation of nicotine e-liquids will be closely monitored by the Australian Border Force. Currently Australians can import nicotine liquid for vaping from overseas or purchase it from a small number of participating pharmacies, provided they have a valid doctor’s prescription.

    Credit: Belyay

    Consumers who fail to include a nicotine prescription with their order will be subject to a fine of up to $222,000. The new system will work if enough doctors, pharmacists, smokers and vapers are willing to comply and are provided with sufficient information, according to the Sydney Morning Herald. The article reports that very few are interested in complying with the rules and most are poorly informed. Little effort has been made to disseminate information about the new arrangements.

    More than 2.5 million Australians still smoke. The National Drug Strategy Household Survey estimated that the number of Australians vaping was 240,000 in 2016 and 520,000 in 2019. If the number of Australians vaping is still increasing, as many as 600,000 may be vaping now, according to the article.

    At present, only a very small number of people vaping have a prescription as is required. Most nicotine supplies are imported without a prescription or purchased from the black market. If compliance with the new arrangements is poor, then some will return to smoking while others will purchase supplies from the black market. Neither are good outcomes.

  • U.S. House Committee Advances Legal Marijuana Bill

    U.S. House Committee Advances Legal Marijuana Bill

    The U.S. House Judiciary Committee approved a bill Thursday that would decriminalize and deschedule marijuana by a vote of 26-15. The move ended a two-day markup period in which the panel also approved a series of bipartisan measures designed to lower drug prices.

    Credit: EKKAPON

    The measure, sponsored by Judiciary Chairman Jerrold Nadler, passed the chamber last year but stalled in the GOP-controlled Senate, according to rollcall.com. Senate Majority Leader Charles E. Schumer proposed a similar measure in July, sparking hopes among advocates that the legislation would finally make it into law.

    The bill would decriminalize and deschedule cannabis, and implement a federal tax on marijuana products to fund grants for communities hardest hit by the nation’s war on drugs. The bill would also allow most individuals convicted of nonviolent cannabis offenses to expunge their records, with the exception of those considered to be “kingpins,” or those who helped oversee a criminal drug ring.

    The outlook for final passage is still uncertain. Schumer and co-sponsors, including Sen. Cory Booker, have not yet formally introduced their draft bill, and Congress is currently consumed by a debate to pass trillions of dollars in spending on infrastructure and social programs, including a first-ever e-cigarette tax.

  • Smoore, FEELM Recommit to Innovation at UK Media Day

    Smoore, FEELM Recommit to Innovation at UK Media Day

    During its UK Media Day at Silverstone Circuit, held yesterday, Shenzhen Smoore Technology Co. announced that its flagship atomization brand, FEELM, is reinforcing its commitment to innovations in atomization technology. The company stated that its atomization coil is the key to the vape product performance and vaping experience.

    Credit: FEELM

    “Our Group has also made satisfying inroads in the research and development of medical and healthcare vaping products, with more than 1,000 scientists and experts from different backgrounds,” said Smoore’s Chief Scientist Dr. Shi Zhiqiang.

    FEELM coil technology features instant and highly efficient atomization, which produces a smooth and pure taste, authentic flavor and high nicotine delivery efficiency, according to FEELM. In 2019, FEELM launched its “FEELM Inside” global authentication trademark. The trademark serves as a symbol of an excellent vaping experience. Today, the “FEELM inside” symbol is on the closed system pods of many of the market-leading vapor brands around the world, such as RELX, NJOY, HAKA, HEXA, and VAPO.

    “With the global launch of FEELM in 2016, FEELM has a significant impact on the research and manufacturing of closed vaping products, changing the global vaping industry landscape. The ‘FEELM inside’ symbol today is widely recognized by our partners and consumers as a certification of our commitment to quality, authenticity and high-quality vaping experience,” said Zhiqiang Shi. “Our Group has also made satisfying inroads in the research and development of medical and healthcare vaping products, with more than 1,000 scientists and experts from different backgrounds.”

    FEELM alos announced it had opened the industry’s first fully automated closed-pod production line in 2019, realizing zero-staff inspection of product quality. To date, the productivity of a single line can produce 7,200 standard pods per hour, and the annual production capacity of FEELM now surpasses three billion pieces.

    As the world’s largest vaping device manufacturer in terms of revenue, Smoore has accounted for 18.9 percent of the total global market share in 2020, according to Frost & Sullivan.

  • NYTS: Youth E-Cig Use Down 40% From Pre-Covid Results

    NYTS: Youth E-Cig Use Down 40% From Pre-Covid Results

    Photo: flydragon

    A study released by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) found that youth use of e-cigarettes fell sharply in 2021, the second consecutive year of major declines, according to the government’s annual National Youth Tobacco Survey (NYTS). An estimated more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021, with more than 8 in 10 of those youth using flavored e-cigarettes.

    The study shows that an estimated 11.3 percent (1.72 million) of high school students and an estimated 2.8 percent (320,000) of middle school students reported current e-cigarette use, lower than the 19.6 percent (high school) reported in 2020 and substantially lower than the 27.5 percent reported in 2019 (high school), according to previous FDA statements. Middle school vaping fell to 2.8 percent this year from 4.7 percent in 2020—a 40.4 percent decline. Middle school past 30-day vaping in 2020 fell 55.2 percent from 2019.

    The report, published in the CDC’s Morbidity and Mortality Weekly Report, was based on data from the 2021 NYTS, a cross-sectional, self-administered survey of U.S. middle (grades 6–8) and high (grades 9–12) school students. The study assessed current (used on one or more of the past 30 days) e-cigarette use; frequency of use; and use by device type, flavors and usual brand.

    Credit: CASAA

    Among youth who currently used e-cigarettes, the study found the most commonly used e-cigarette device type was disposables (53.7 percent), followed by prefilled or refillable pods or cartridges (28.7 percent), and tanks or mod systems (9.0 percent). Some in the industry have pointed out that “for the record, past-30-day ever use was 7.6%. The real numbers are: Disposables: 4.1%, Pods or cartridges: 2.2%, Tanks or mod systems: 0.7%,” a vaping advocate (@phil_w888) tweeted.

    The FDA and CDC are also being accused of using the data to further an anti-vaping agenda. The Consumer Advocates for Smoke-free Alternatives Association (CASAA) tweeted that “Past-month HS vaping declines dramatically–down 47% from 3.6 million to 1.72 million–with daily vaping down from 4.4% to around 3%. Yet the general public wouldn’t know that from the negative spin made by Public Health.”

    Administered Jan. 18- May 21, 2021, thus NYTS was the first to be fully conducted during the Covid-19 pandemic. Data were collected using an online survey to allow eligible students to participate in the classroom, at home or in some other place to account for various school settings during this time. Prior to the pandemic, the survey was conducted in person, inside the school classroom. Because of the changes in the way the survey was conducted this year, the FDA claims results of the 2021 NYTS cannot be compared to findings from previous surveys.

    Robin Koval, president and chief executive of Truth Initiative, a nonprofit anti-nicotine advocacy group, emphasized that the sharp drop in youth vaping may be attributable to pandemic restrictions that kept youth at home. “Kids were not in school, they were not seeing friends,” Koval said. There was no mention of the drop from 2019 numbers that were measured before the Covid-19 pandemic began.

    “These data highlight the fact that flavored e-cigarettes are still extremely popular with kids. And we are equally disturbed by the quarter of high school students who use e-cigarettes and say they vape every single day,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The FDA continues to take action against those who sell or target e-cigarettes and e-liquids to kids, as seen just this year by the denial of more than one million premarket applications for flavored electronic nicotine delivery system products. It is critical that these products come off the market and out of the hands of our nation’s youth.”

  • ITC: IQOS Infringes on BAT Patents, U.S. Sales to End

    ITC: IQOS Infringes on BAT Patents, U.S. Sales to End

    Photo: theaphotography

    The International Trade Commission (ITC) has upheld an initial determination from May 2021 that Philip Morris International’s IQOS device infringes on two patents owned by BAT subsidiary Reynolds American Inc. (RAI).

    The agency has instituted an import ban and a cease-and-desist order preventing IQOS consumables and devices from being sold in the U.S. in 60 days. PMI’s U.S. partner, Altria Group, plans to continue to sell IQOS through the 60-day period in its existing markets.

    BAT welcomed the ruling. “Infringement of our intellectual property undermines our ability to invest and innovate and thereby reduce the health impact of our business,” the company wrote in a statement. “We will therefore defend our IP robustly across the globe.”

    The patents relate to an electronically powered device with a heater to generate an aerosol and expire in October 2026 and November 2031. BAT has filed similar cases globally, including in Germany, the U.K., Japan and Italy.

    Morgan Stanley said the ruling would have limited financial impact on PMI and Altria, as IQOS in the U.S. is not a meaningful contributor to the companies’ earnings. The outcome of similar cases brought by BAT against PMI internationally, however, could have a greater impact. But so far, PMI has been successful defending cases in the U.K. and Greece.

    The investment bank also noted that the IQOS ban applies to imported product, suggesting it may be overcome by shifting production to the U.S.

    The ITC decision will now be reviewed by the U.S. Trade Representative. If the decision is not vetoed within 60 days (only a handful have ever been vetoed), it can be appealed to the U.S. Court of Appeals, but the import ban would still be in effect throughout an appeals process.

  • Long Awaited Juul2 Device Launches in U.K. Market

    Long Awaited Juul2 Device Launches in U.K. Market

    Photo: steheap

    Juul Labs has unveiled its JUUL2 device in the U.K.

    The device features a more consistent vapor experience, a longer battery life and anti-counterfeit technology.

    Launching initially on the Juul.co.uk website on Sept. 30, the JUUL2 system has been updated from previous versions with new technology and features based on feedback from smokers.

    Among other features, the JUUL2 features a more consistent vapor experience, a longer battery life and a smart light system communicating e-liquid level and battery life.

    The JUUL2 also comes with newly designed tobacco and menthol JUUL2 pods (18 mg/mL nicotine strength) and technology to prevent unauthorized use. The device will not work when it detects counterfeit pods.

    “We are pleased to launch the next-generation JUUL2 in the U.K.,” Juul Labs’ EMEA vice president, Dan Thomson, said in a statement. “A key part of our mission is to transition adult smokers away from cigarettes, the leading cause of preventable death in the world, killing some 90,000 Britons annually.

    “We believe the best method to switch adult smokers from combustible cigarettes to a potentially less harmful noncombustible alternative is to provide a product that closely resembles the consistency and experience of smoking. With JUUL2, we believe we are taking another step in that direction as we aim to transition even more adult smokers.”

    A retail roll-out is planned for early 2022, and all U.K. retailers stocking JUUL products will continue to uphold the company’s Challenge 25 age verification policy, which includes continued mystery shopping audits.