Tag: news

  • French Vape Organization SOVAPE to Shutter Doors

    French Vape Organization SOVAPE to Shutter Doors

    French consumer vaping organization SOVAPE announced this week it will dissolve. The group has been active since 2016.

    Best known for organizing three Vape Summits in France between 2016 and 2019, SOVAPE also co-founded the European Tobacco Harm Reduction Advocates (ETHRA) umbrella organization. Since 2019, the group has commissioned annual surveys of French public opinion on vaping and nicotine conducted by major market research firm BVA.

    However, this year BVA notified SOVAPE that it could no longer participate due to a health industry client’s contract prohibiting BVA from also working with nicotine-associated organizations, according to media reports.  

    The abrupt cancellation of the survey followed other recent blows, including news articles accusing SOVAPE and other consumer groups of connections to the tobacco industry, and attacks on scientists and health professionals who supported SOVAPE’s mission.

    In an Oct. 6 website post, SOVAPE explained it can no longer carry out its mission due to the current climate of “censorship, threats, lies, denigration and slander, to which can be added the dissemination of fake news and the denial of scientific data.”

    “Dialogue in this context is impossible,” SOVAPE wrote, “and clearly, it is now even ‘forbidden’ to provide information, such as a banal survey, on reducing the risks of smoking in France.”

    SOVAPE will donate the balance of its funds equally to the Pasteur Institute and fellow vaping groups AIDUCE and La Vape du Cœur. SOVAPE has paid to keep its website available for 10 years, and maintains videos of Vape Summit proceedings on its Youtube channel.

    “We regret that we are no longer able to cultivate a dialogue to promote the risk reduction approach against the main cause of preventable diseases and premature deaths in France,” SOVAPE said in its post. “We do not regret having tried, but must acknowledge that it is no longer possible for us to lead this fight that is dear to us, and which has nevertheless contributed to saving lives!”

  • Supreme Court to Hear Avail, Reynolds PMTA Case

    Supreme Court to Hear Avail, Reynolds PMTA Case

    TR Archives

    The Supreme Court of the United States has agreed to consider another case involving federal approval of vapes at the request of the Biden administration on Friday.

    The case arose after the Food and Drug Administration denied R.J. Reynolds Vapor Company’s request to introduce three flavored vapes on the market. The FDA said the company failed to meet federal requirements concerning tobacco products’ marketing, but the company contends that the decision was arbitrary and capricious.

    Reynolds is based in North Carolina, and the federal appeals courts located there and in D.C. already had precedent on the books unfavorable to the manufacturer.

    Under federal law, companies can challenge the FDA denying of a marketing order for a new tobacco product in Washington, D.C., or where the company’s principal place of business is located, reports The Hill.

    The 5th U.S. Circuit Court of Appeals has been more sympathetic to the industry, making it an attractive place for companies to contest their products being denied.

    The 5th Circuit’s rule effectively enables it to host any tobacco company’s challenge, so long as its lawsuit is joined by a convenience store or other retail seller within the 5th Circuit’s borders—which span Louisiana, Mississippi and Texas.

    Reynolds instead filed its challenge in the 5th Circuit alongside Avail Vapor Texas and the Mississippi Petroleum Marketers and Convenience Stores Association. The federal government attempted to move venues, but the 5th Circuit said the additional challengers meant the case was properly brought.

    No matter which way the justices rule, they are not expected to address the merits of the FDA’s denial. The Supreme Court only took up the question of whether the 5th Circuit was a proper venue.

    “There is no circuit conflict over the meaning of this venue provision. And other vehicle problems abound,” the company wrote in court filings urging the justices to turn away the appeal. 

  • Regulations Decimate Philippine Vape Sector

    Regulations Decimate Philippine Vape Sector

    Image: freshidea

    Onerous government regulations have forced about one-fifth of Philippine vaping companies out of business, according to Philippine E-Cigarette Industry Association President Joey Dulay. Importers, he added, have found it easier to comply than their domestic counterparts.

    “But we are pushing them to try and comply,” Dulay was quoted as saying by Business World.

    Under the Vaporized Nicotine and Non-Nicotine Products Regulation Act, manufacturers or importers must register their products and secure licenses to operate.

    They are also required to adhere to packaging standards and pay duties and taxes.

    Manufacturers, distributors and importers were given an 18-month transition period to comply with the regulations laid down in the vape law.

    Dulay noted that many vape brands and manufacturers have yet to secure their Philippine standard quality and/or safety mark and import commodity clearance sticker.

    By the end of August, the Bureau of Customs had confiscated PHP6.5 billion ($115.21 million) worth of illegal vape products, mostly from China.

    The government is estimated to miss around PHP5 billion yearly from illicit vape products.

  • DKiss Menthol Flavoring to Exhibit at Intertabac

    DKiss Menthol Flavoring to Exhibit at Intertabac

    Menthol cigarettes and menthol-flavored heated tobacco sticks are strictly banned in multiple countries, including Canada, Ethiopia, the European Union, Moldova, Turkey, the United Kingdom, and specific regions of the United States like California, the District of Columbia, and Massachusetts.

    In an effort to satisfy menthol consumers, Dekang Biotech Co. Ltd., an established player in the vaping industry, developed the DKiss menthol flavor roll-on. According to the company, the innovative product is set to transform the smoking experience in several ways.

    “It is the easiest way to flavor cigarettes. The DKiss Menthol Flavor Roll-On is distinguished by its innovative roll-on design, ensuring a clean and convenient application process while allowing users to adjust the intensity based on their preferences,” a Dekang representative said.

    The DKiss menthol flavor roll-on can be used with both traditional cigarettes and heated tobacco sticks for heat-not-burn nicotine delivery systems. It caters to a diverse audience by providing a wide variety of flavor options, including flavors specifically designed for individuals sensitive to cigarette odors.

    DKiss menthol roll-on allows smokers to flavor their own cigarettes. In addition to menthol, the Dkiss line offers several other mixed flavors derived from plant extracts, such as loquat and ginseng, blended with menthol. This helps remove the bad breath caused by smoking. It brings the most satisfying fragrance to add a new dimension to your inhalation experience, according to Dekang.

    “This product effectively eradicates cigarette odors and bad breath caused by smoking, serving as a discreet solution for smokers,” the representative said. “Mint enthusiasts will appreciate the refreshing mint flavor variant, which cleverly balances the taste of the cigarette and the unpleasant smell it creates, making it an ideal choice for menthol cigarette lovers.”

    Dekang will showcase its DKiss menthol roll-on brand and its other innovative product lines during the Intertabac industry trade show (booths 5.D14 and 1B.A28), which will be held in Dortmund, Germany, from Sept. 19 – 21, 2024.

  • BAT to Host 2024 CORESTA Congress

    BAT to Host 2024 CORESTA Congress

    The UK-based company will host the 2024 CORESTA Congress in Edinburgh, UK, from 13 – 17 Oct.

    • The Congress will bring together leading scientists, tobacco and related product experts, and regulators from over 165 member organizations to focus on the theme of “Advancing Tobacco Harm Reduction through Scientific Collaboration.”
    • Participants will share, discuss, and collaborate on tobacco and related product
      science.

    BAT has volunteered to host the upcoming Cooperation Centre for Scientific Research Relative
    to Tobacco (CORESTA) Congress 2024, set to take place from 13 – 17 October at the Edinburgh
    International Convention Centre, UK.

    This year’s congress will bring together over 165 member organizations, from over 30 countries
    and non-members, including companies, research institutes, laboratories, associations, and
    regulatory bodies under the theme of “Advancing Tobacco Harm Reduction through Scientific
    Collaboration”.

    Formed in 1956, CORESTA is committed to exploring the latest scientific research to facilitate
    positive change in the tobacco industry. This year’s iteration continues this ambition, specifically
    seeking to advance the knowledge and understanding of the science related to Tobacco Harm
    Reduction (THR) among its membership and attendees.

    To achieve this goal, leading scientists from across the world will attend and present their work, bringing their expertise in a diverse range of disciplines to allow participants to explore all aspects of THR. Thanks to the collaborative work of the most experienced scientists in their field, CORESTA has gained international recognition.

    With increasing regulatory requirements, CORESTA’s scientific work and outputs have become a worldwide reference point for tobacco policymaking and support the development of testing standards, such as ISO Standards.

    As host, BAT looks forward to facilitating the conversations necessary to grasp the public health opportunity presented by THR to significantly reduce the risks for the estimated 1bn consumers who smoke and address misperceptions of alternative tobacco and nicotine products with the potential to reduce risks compared to cigarettes.

    To learn more about the event and request an invitation, visit the official congress website: www.corestacongress2024.com. Registration is open until Sept. 20, 2024.

  • FDA Issues Final Rule for Tobacco 21

    FDA Issues Final Rule for Tobacco 21

    The U.S. Food and Drug Administration announced a final rule raising the minimum age for certain restrictions on tobacco product sales. The requirements are in line with legislation signed in December 2019, which immediately raised the federal minimum age for the sale of tobacco products in the United States from 18 to 21.

    Once implemented, the requirements are expected to help decrease underage tobacco sales.  

    Beginning Sept. 30, retailers must verify with photo identification the age of anyone under the age of 30 who is trying to purchase tobacco products, including e-cigarettes. Previously, this requirement applied to anyone under the age of 27. It’s important for retailers to request and examine photo IDs to verify age from anyone under 30, regardless of appearance, as research has shown that it is difficult for retailers to accurately determine the age of a customer from appearance alone. 

    Additionally, starting Sept. 30, retailers may not sell tobacco products via vending machines in facilities where individuals under 21 are present or permitted to enter at any time. Previously, this prohibition applied to facilities where individuals under 18 were present or permitted to enter at any time.

    These changes, and the other changes made by the final rule, aim to maximize the public health impact of the original December 2019 legislation, according to an agency press release.

    “Today’s rule is another key step toward protecting our nation’s youth from the health risks of tobacco products,” said Brian King, director of the FDA’s Center for Tobacco Products. “Decades of science have shown that keeping tobacco products away from youth is critical to reducing the number of people who ultimately become addicted to these products and suffer from tobacco-related disease and death.”

    The Further Consolidated Appropriations Act, signed into law on Dec. 20, 2019, increased the federal minimum age for selling tobacco products from 18 to 21 across the United States. Since then, it has been illegal to sell tobacco products, including e-cigarettes, to anyone under 21. The law also directed the FDA to take action today, increasing the age of certain requirements for tobacco product sales, as explained above.

    The agency also continues to provide retailers with resources to improve compliance with tobacco laws and regulations, including age of sale restrictions. For example, the FDA has developed a voluntary education program, “This is Our Watch,” which offers free resources to assist retailers in calculating the age of customers, including a digital age verification calendar and an age calculator app. Retailers can also find information on tobacco products that may be legally marketed in the United States through the Searchable Tobacco Products Database. Updated resources, including further information on these latest requirements, will be made available on the FDA’s website in the near future.

  • PMI to Further Expand U.S. Zyn Production

    PMI to Further Expand U.S. Zyn Production

    Photo: PMI

    Philip Morris International’s Swedish Match affiliate will invest $232 million to expand the production capacity of its Owensboro, Kentucky, USA, manufacturing facility, which produces the popular Zyn nicotine pouches.

    The expansion is expected to create an additional 450 direct jobs with an ongoing annual economic impact of $277 million and 410 indirect jobs for the Commonwealth of Kentucky.

    “Philip Morris International’s Swedish Match affiliate has been an important partner and job creator in this region for many years, and I’m excited to see this incredible new investment and the 450 great job opportunities it is creating for families in Owensboro and the surrounding region,” said Kentucky Governor Andy Beshear in a statement.

    Construction of the expanded facility is already underway, including adding more production space. Progressive production increases are expected during the project, which is targeted for completion by the second quarter of 2025. The construction phase alone is expected to create nearly 2,800 jobs and have an economic impact of about $414 million.

    In addition to facility expansion and ongoing optimization of processes to increase capacity progressively over the coming quarters, the Kentucky facility will move from a 24-hour, five-days-per-week schedule to a 24-hour, seven-days-per-week schedule to boost production, starting in the fourth quarter of this year.

    The Swedish Match Owensboro facility currently has about 1,100 employees. The ongoing expansion of the facility in Kentucky is expected to provide around 900 million cans of capacity by 2025.

    In July, PMI announced an investment of $600 million over the next two years through its U.S. affiliate to open a nicotine pouch manufacturing facility in Aurora, Colorado. The Aurora facility and Owensboro expansion are designed to provide the capacity needed in the near term and midterm to meet the ferocious U.S. demand for Zyn.

  • U.S. Drug Agency Schedules Cannabis Hearing

    U.S. Drug Agency Schedules Cannabis Hearing

    The U.S. Drug Enforcement Administration (DEA) has scheduled a Dec. 2 hearing on its proposal to lower the classification of marijuana to the less dangerous level of Schedule III, according to a public announcement late Monday.

    The DEA had never issued any timeline for its process to potentially change the Schedule I classification of cannabis for the first time since the Controlled Substances Act went into effect in 1970. Still, some in the cannabis industry had hoped for a final decision before the U.S. election.

    The DEA had already received 43,000 comments on its proposal, initially made on May 21, with a comment period that closed late in July. The DEA said the comments included requests to hold a public hearing.

    DEA administrator Anne Milgram said she would determine who will participate in the hearing and name a presiding officer to run the meeting, which will take place on Dec. 2 at 9 a.m. Eastern Time at 700 Navy Drive, Arlington, Virginia.

    The government said the meeting may also be moved to a different location, continued from day to day, or recessed to a later date without notice.

  • Agencies Want Closer Tracking of Imports

    Agencies Want Closer Tracking of Imports

    The U.S. Food and Drug Administration and the Department of the Treasury have announced a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number (STN) of electronic nicotine delivery system (ENDS) products into the electronic imports system operated by U.S. Customs and Border Protection.

    The new requirement will help streamline the process of reviewing the admissibility of ENDS products into the United States, according to the FDA’s website.

    After an applicant submits a marketing application for a new tobacco product, FDA assigns a unique identifier called an STN. Under the proposed rule, if finalized, any ENDS product, including e-cigarettes, for which the STN is not submitted may be denied entry into the U.S.

    An FDA-issued STN is one data element that is important to FDA’s admissibility review and determination, which also includes review of other information about the product as well as possible sampling and examination of the product, according to the agency.

    “Beginning tomorrow, the docket for the proposed rule, titled ‘Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products,’ will be open for public comment through October 15, 2024.

    Visit the rulemaking docket at regulations.gov to learn more and comment on the proposed rule.”Beginning tomorrow, the docket for the proposed rule … will be open for public comment through October 15, 2024.

    Visit the rulemaking docket at regulations.gov to learn more and comment on the proposed rule.

  • Fifth Circuit Vacates Denials Citing ‘Triton’

    Fifth Circuit Vacates Denials Citing ‘Triton’

    The 5th Circuit Court of Appeals granted petitions for review to five vaping companies, citing its own decision in the Triton Distribution case as precedent.

    The court sent the company’s marketing denial orders (MDOs) back to the U.S. Food and Drug Administration for additional scientific evaluation. As a result, the manufacturers may keep selling their products until the agency completes new reviews of their premarket tobacco applications (PMTAs), or until the Supreme Court takes action.

    “Specifically, the court determined that (1) FDA did not give e-cigarette manufacturers fair notice of the rule requiring long-term studies for PMTAs; (2) FDA did not acknowledge or adequately explain its change in position; and (3) FDA ignored reasonable and serious reliance interests that manufacturers had in the pre-MDO guidance,” the 5th Circuit wrote in its ruling.

    Five companies, Cloud House, Paradigm Distribution, SWT Global Supply, Vaporized and SV Packaging first challenged their MDOs in court in October 2021. The court consolidated the five cases, and in November 2021, all petitioners were granted stays pending review.

    In January, the 5th Circuit found in favor of Wages and White Lion Investments (doing business as Triton Distribution) in the e-liquid manufacturer’s appeal of an MDO. The FDA later petitioned the Supreme Court to review the 5th Circuit’s ruling, and last month the Supreme Court agreed to hear the agency’s appeal.

    The FDA challenged the Triton decision, and the U.S. Supreme Court agreed to hear that case. “But now another panel of the Fifth Circuit has applied the same rationale as in Triton to hold that these five, small-business manufacturers prevail for the same reason: FDA pulled a surprise switcheroo,” wrote the United States Vaping Association on X.

    The 5th Circuit found that the recent petitions posed the same issues as Triton’s. “Petitioners spent substantial time and resources preparing their PMTAs based on FDA guidance that they would not need to submit long-term clinical studies,” the court wrote.

    “Nevertheless, FDA rejected their PMTAs using the same boilerplate language it used for the Wages petitioners’ denials, as well as those of thousands of other e-cigarette manufacturers. Accordingly, for the reasons amply explained by the en banc court in Wages, we hold that FDA acted unlawfully here as well by denying Petitioners’ PMTAs based on the absence of long-term clinical studies.”