Author: Staff Writer

  • California Flavor Ban on Hold, Voters to Decide in 2022

    California Flavor Ban on Hold, Voters to Decide in 2022

    Californians will decide next year if flavored vaping products should be banned. The California Secretary of State’s office certified a referendum challenging the state’s ban on flavored vapor and other tobacco product sales had garnered more than the minimum number of valid signatures. The referendum will head to the ballot in November, 2022.

    lady vaping
    Credit: Elsa Olofsson

    The ban is on hold and retailers can continue selling flavored e-liquids and other products until votes are cast. The ban had been set to go into effect on Jan. 1, 2021, but was delayed until the signature verification process had been completed. I

    n order to qualify for the ballot, organizers of the referendum submitted more than 1 million signatures, as they needed to get 623,212 verified signatures from California voters. On Friday, the Secretary of State’s office published a report indicating that organizers had gathered 781,885 valid signatures.

    Had the minimum number of valid signatures not been met, the law would have taken effect once the Secretary of State had verified the process was complete. The election is scheduled for Nov. 8, 2022, and those results will then need to be certified. If the law banning flavors is approved, it would go into effect on Dec. 8, 2022.

    It did not make it illegal to possess or use such products, however. In addition to the referendum, the state has also been sued over the ban by R.J. Reynolds Tobacco Co., R.J. Reynolds Vapor Co., American Snuff Co. LLC, Santa Fe Natural Tobacco Co. Inc., Philip Morris USA Inc., John Middleton Co., U.S. Smokeless Tobacco Co. LLC, Helix Innovations LLC, Neighborhood Market Association Inc. and Morija LLC, which does business under the name Vapin’ the 619. That litigation is currently ongoing.

  • Next Generation Labs Assigns Patent Rights to Nextera

    Next Generation Labs Assigns Patent Rights to Nextera

    Photo: Martinmark – Dreamstime.com

    Next Generation Labs (NGL), the world’s largest manufacturer of TFN R-S, S and R isomer nicotine, has assigned the rights of its Republic of Korea R-S nicotine manufacturing patent to NextEra Co.

    NGL said it has taken this step “to help strengthen direct in-market enforcement efforts by NextEra against unscrupulous manufacturers who have attempted to ship unauthorized synthetic, nonsynthetic and, in some instances, counterfeit or mislabeled TFN synthetic nicotine vape products into the South Korea market.”

    NextEra is NGL’s exclusive TFN partner and is the largest flavor formulator and distributor of synthetic nicotine vape products in South Korea. Under the assignment, NextEra products containing TFN will continue to be sold, and NextEra will use all means available to protect the market and prohibit violative brands from entering South Korea.

    “This is a strategic patent assignment that will give NextEra the full freedom to use all legal means at its disposal to seek enforcement of existing intellectual property rights related for TFN recreational nicotine in the market,” NGL wrote in a statement

    “Next Generation Labs fully expects NextEra to immediately take action against violators and utilize all necessary legal remedies against any business seeking to either: divert R-S nicotine product sales into South Korea from other markets, attempt to sell mislabeled tobacco-derived nicotine as a synthetic product, or to sell counterfeit TFN products in South Korea,” the company added.

    The terms of the patent transaction have not been made public, and the transaction will not impact Next Generation Labs’ other patents in South Korea or impact control of patents in any other jurisdiction worldwide.

  • USPS Mail Ban of ENDS Could Also Include Hemp Products

    USPS Mail Ban of ENDS Could Also Include Hemp Products

    Words say a lot. It’s especially true in the rule of law. When Congress approved the recent appropriations bill to keep the government running, lawmakers also passed the “Preventing Online Sales of E-Cigarettes to Children Act,” which prohibits the United States Post Office (USPS) from shipping vaping products.

    mailbox
    Credit Anne Onyme

    While the legislation was geared towards nicotine vaping products, the law is so broadly defined that hemp businesses must also prepare to comply, according to Patricia Kovacevic, founder and president of PK Regulatory Strategy. The legislation takes effect in late March – 90 days after its published in the Federal Register. The USPS then has 120 days to issue its rules.

    Speaking during a Smoke-Free Alternatives Trade Association (SFATA) webinar, Kovacevic said that the legislation states that an electronic nicotine delivery system (ENDS) is defined as any device that “delivers nicotine, flavor, or any other substance to the user inhaling from the device.”

    “It’s very broadly defined. It really is any other substance. So even if you inhale, I’m being ridiculous, the air [if inhaled from] a device is still covered,” she said. “So, unfortunately, it’s very broad. That’s actually what makes it worrisome. But that also could be its flaw. [The definition being too inclusive] could be an opportunity to challenge the rule.”

    According to the legislation, anyone selling vaping products must:

    • Register with the U.S. Attorney General
    • Verify age of customers using a commercially available database
    • Use private shipping services that collect an adult signature at the point of delivery
    • If selling in states that tax vaping products, sellers must register with the federal government and with the tobacco tax administrators of the states
    • Collect all applicable local and state taxes, and affix any required tax stamps to the products sold
    • Send each taxing state’s tax administrator a list of all transactions with customers in their state, including the names and addresses of each customer sold to, and the quantities and type of each product sold
    • Maintain records for five years of any “delivery interrupted because the carrier or service determines or has reason to believe that the person ordering the delivery is in violation of the [PACT Act]”

    Both UPS and FedEx have rules against shipping traditional cigarettes and say they will extend those rules to include ENDS products. Violators can receive up to three years in prison, face steep fines and potentially lose their business.

  • CBP Seizes 50,000 Unapproved Vape Pens in Chicago

    CBP Seizes 50,000 Unapproved Vape Pens in Chicago

    U.S. Customs and Border Protections (CBP) officers at Chicago O’Hare’s International Mail Branch seized 50,000 dragster Mountain Vape Pens on Tuesday. The shipment, originated from Hong Kong, and was destined for a residence in Alexandria, Kentucky.

    illegal vape pens
    Credit: CBP

    The U.S. Food and Drug Administration (FDA) determined the shipment violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) as misbranded consumer goods being imported by an unauthorized agent, according to a press release. Tobacco products imported or offered for import into the United States must comply with all applicable U.S. laws. Read more about the FDA’s regulations governing e-cigarettes and other tobacco products.

    The shipment was seized on January 19, and was mis-manifested as Lithium Ion Battereies, a common practice used by smugglers, CBP states. “CBP believed the shipment was intentionally improperly labeled in order to avoid detection,” the release states. “Additionally, CBP presumes the products are being sold without authorization. CBP continues to work diligently to stop non-legitimate products from entering the U.S.” The pens had an MSRP of $450,000.

    “Our officers are dedicated to identifying and intercepting these types of shipments that could potentially harm our communities,” said Shane Campbell, Area Port Director-Chicago. “Customs and Border Protection’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers, and we will continue to work with our consumer safety partners to identify and seize unsafe and illicit goods.”

    Last year the FDA announced an increased enforcement priority of electronic nicotine delivery systems, and issued detailed guidance to the industry of these new enforcement priorities that regulate the unauthorized importation of tobacco products.

    CBP provides basic import information about admissibility requirements and the clearance process for e-commerce goods and encourages buyers to confirm that their purchases and the importation of those purchases comply with any state and federal import regulations.

    CBP conducts operations at ports of entry throughout the United States, and regularly screens arriving international passengers and cargo for narcotics, weapons, and other restricted or prohibited products. CBP strives to serve as the premier law enforcement agency enhancing the Nation’s safety, security, and prosperity through collaboration, innovation, and integration.

  • Canadian Vapor Group Vows to Fight All Regulations

    Canadian Vapor Group Vows to Fight All Regulations

    The Canadian Vaping Association (CVA) has vowed to fight any regulations for the vaping industry that it views as onerous. In a press release, the CVA states that the organization has been a consistent advocate for strong youth protection measures and that a balance of youth prevention with allowing adult access to harm reduction products is necessary.canada

    “While the CVA has a history of advocating for reasonable measures to protect youth, policy that violates the right to integrity and personal security as well as freedom of expression will be challenged through the proper legal channels,” said Darryl Tempest, executive director of the CVA. “Science supports vaping as harm reduction and draconian measures have previously been found to be unconstitutional by the Superior Court, which heard the industry’s arguments against Bill 44. Our preference will always be to work with regulators to implement effective policy, however where regulators choose to ignore the data, the industry will challenge policy that is detrimental to public health.”

    Provinces such as Ontario and British Columbia have taken adult harm reduction into consideration and implemented equitable policy. Yet, provinces such as Nova Scotia and Prince Edward Island have failed to follow the science and instead have jeopardized the health of thousands of smokers, according to the release.

    The Canadian Constitution Foundation found that banning flavored vaping products or restricting nicotine content “may violate s. 7 of the Canadian Charter of Rights and Freedoms, which safeguards the right to life, liberty and the security of the person, because the nicotine ceiling and flavour restriction may potentially make vaping products a less attractive or effective quit-aid for smokers.”

    The CVA states that it will continue to provide regulators with the science supporting flavors are the driver for adoption and the key to cessation success. “Canadian’s have a constitutional right to access harm reduction products and reduce the health risks presented by traditional tobacco,” the release states. “Judge Dumais who heard the industry’s case against Bill 44 wrote that while the provisions take into account the well being of non-smokers, it seemed to forget the rest of the population, including smokers trying to quit.”

    Despite, the Canadian Constitution Foundation cautioning governments that action such as flavor bans may violate the rights of Canadians, “Nova Scotia proceeded to implement both excessive taxation and a full ban on flavors.” As a result, vape shop owner Bill McEachern has launched a constitutional challenge, that will be heard on January 25th. The CVA has given McEachern its full support and will continue to support all challenges to harmful legislation.

    “As a society, we often wrongfully look at addiction as the result of one’s own actions. By viewing nicotine addiction as a choice, smokers are dehumanized and left behind by poor policy,” the release states. “Governments must acknowledge that in Canada all citizens are equal under the Charter of Rights and Freedoms. Vaping policy must respect the rights of all citizens as the lives of adult smokers quite literally depend on it.”

  • E-Liquid Maker Plans to Join London Junior Stock Market

    E-Liquid Maker Plans to Join London Junior Stock Market

    Supreme, the manufacturer of multiple e-liquid brands, is considering a stock market listing that could value it at £180 million. The Manchester-based company that produces the Kik and 88vape brands is seeking to join Aim, London’s junior market, and has started to gauge investor interest.

    88vape e-liquid bottle
    Credit: 88vape

    Supreme attempted a flotation in 2018 but abandoned the listing, blaming market conditions, according to an article on Morningstar. Then, the company announced plans for an AIM float but less than two weeks later postponed its proposed IPO due to “market conditions” and despite “encouraging” institutional support for the listing.

    Alongside its e-liquids products, the company, the company also sells sports nutrition products, batteries and lightbulbs. It is owned by Sandy Chadha. It sells directly to retailers and wholesalers but also has its own online platform.

    The company did not disclose how much it plans to raise in connection to the float, nor did it outline an estimated market capitalisation on admission.

  • U.S. FDA Finalizes PMTA, SE Requirements for ENDS

    U.S. FDA Finalizes PMTA, SE Requirements for ENDS

    Photo: Jhvephotos | Dreamstime.com

    The U.S. Food and Drug Administration on Jan. 20 finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.

    Stephen Hahn

    “The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn.

    Mitch Zeller

    “These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law.”

    Both of these final rules are effective 30 days after publication in the Federal Register. 

    More information about the two foundational rules is available on the FDA website.

  • Activists Raise Awareness of Black-Market Vapor Products

    Activists Raise Awareness of Black-Market Vapor Products

    Photo: Tobacco Reporter archive

    The National Crime Prevention Council (NCPC) and National Intellectual Property Rights Coordination Center (IPRC) in the U.S. have released an innovative toolkit as part of their nationwide campaign to raise awareness on the dangers of black-market vapor products and empower law enforcement and adult community leaders to prevent and enforce against these illicit activities.

    The IPRC and NCPC launched this public-private partnership, with the support of Juul Labs, in October 2019, seeking to raise awareness on the consequences of illicit vapor products, with the objective of delivering tools and resources to communities grappling with this critical issue across the country. Now, the IPRC and NCPC have expanded upon this initiative by providing law enforcement and other key stakeholders with a toolkit that will aid in their efforts to educate and mobilize their communities against this dangerous illicit trade.

    The toolkit is a comprehensive resource that details the various forms of illicit vapor products, such counterfeit, compatible and diverted products, and teaches the community how to spot such products. It also contains broader educational resources, along with strategies on how best to elevate these vital messages through social media, community events and meetings, and in cooperation with local businesses.

    According to Juul, Illicit vapor products present a number of public health, economic and security consequences. Critically, they undermine underage-prevention measures because of their ease of access and may present additional health and safety risks for adult consumers given that they often are produced in unsanitary conditions without manufacturing and quality controls and lack ingredient testing and product characterization. They also may contain harmful chemicals not present in other, authentic products.

    As part of this campaign, and with the support of IPRC, NCPC will leverage its vast, nationwide network to get this toolkit into the hands of law enforcement, trade partners, and other adult community leaders.

    “It is imperative that we continue to partner across stakeholders, including law enforcement, to address the illicit market of vapor products,” Juul wrote in a statement. “Supporting public-private partnerships like the IPRC/NCPC initiative is one way we can actively fight back against illicit trade of vapor products. By empowering stakeholders through awareness and education, we can address the illicit trade of vapor products and foster a more responsible marketplace for the category.”

  • The Jones Labs Receives PMTA, MRTP Filing Letters

    The Jones Labs Receives PMTA, MRTP Filing Letters

    The Jones Labs announced it has received filing letters from the U.S. Food and Drug Administration (FDA) for both its premarket tobacco product application (PMTA) and its modified-risk tobacco product application (MRTP).

    The Jones Labs pods
    Credit: The Jones Labs

    “The Jones product family is being evaluated for safety and efficacy as alternatives to combustible cigarettes and their comparable safety to smoking the Harmful or Potential Harmful Constituents (HPHCs) of combustible cigarettes,” a press release states. “As a leader of pre-August 8 [the FDA’s deadline for a product to be on the market to be eligible to remain on the market while going through the PMTA process] compliance, The Jones Labs registered with the FDA in July 2016 in preparation for Electronic Nicotine Delivery System regulations.”

    The Jones Labs states that the potential of electronic drug-delivery systems remains at the core of its technology. “Due to our record of compliance with the Center for Tobacco Products (CTP), our products are eligible for enforcement discretion until our application process has been completed,” the release states.

    The core technology of The Jones Labs submissions are based in “Buffered Aerosol Drug Delivery,” a review article published in the inaugural edition of the United Journal of Drug
    Development and Industrial Pharmacy. “The technology submitted for review is being further
    developed in parallel to address other cessation and medicine-assisted therapeutic needs in the market,” the review states. “With this unique drug-delivery platform technology they stand to disrupt the established order of all smoking and smokeless products, cannabis or tobacco.”

    The Jones Labs offers universally compatible tobacco vapables as an alternative to
    smoking combustible cigarettes, the release states. “With multiple present and future product offerings similar to The Jones Pods (www.thejonespod.com), we are developing Rise, by The Jones (www.risebythejones.com), a state-of-the-art smoking cessation platform that utilizes the core technology for replacement and cessation therapies across the board.”

  • RLX Technology Seeks up to $1.17 Billion From IPO Offer

    RLX Technology Seeks up to $1.17 Billion From IPO Offer

    Photo: Tobacco Reporter archive

    RLX Technology is looking to raise as much as $1.17 billion from a U.S. initial public offering, reports Bloomberg.

    The Chinese vapor company, known for its RELX-branded devices in China, had earlier considered Hong Kong as a listing venue, but it ultimately opted for the U.S.

    Founded in 2018, RLX is China’s largest e-cigarette maker. The vaping industry has boomed in China even as the country banned online sales of e-cigarettes just over a year ago. The company said it plans to file a premarket tobacco product application (PMTA) with the U.S. Food and Drug Administration (FDA) to legally sell its products in the world’s largest vapor market.

    China is the world’s largest potential vaping market, with an estimated 286.7 million adult smokers in 2019, RLX said in its prospectus. But vaping products only have a 1.2 percent penetration rate, compared with 32.4 percent in the U.S.

    RLX’s revenues increased to CNY2.2 billion ($340 million) in the first nine months of 2020 from CNY1.14 billion a year earlier. It started turning a profit in 2019 and recorded net income of CNY109 million in the nine months to Sept. 2020.

    The company plans to price the IPO on Jan. 20 after the U.S. market closes, according to a term sheet. Citigroup and China Renaissance are joint bookrunners for the offering.

    Earlier reports suggested the company planned to raise up to $100 million in its IPO.