Author: Taco Tuinstra

  • Smoore Flattered by FDA Marketing Orders

    Smoore Flattered by FDA Marketing Orders

    Photo: Timothy S. Donahue

    When the U.S. Food and Drug Administration authorized the NJOY Ace vaporizer and its tobacco-flavored e-liquid pods on April 26, the Ace became the first e-cigarette authorized by the FDA equipped with a ceramic coil. That coil is manufactured by FEELM, Smoore International’s flagship atomization tech brand.

    The Ace marketing orders mark the first approval by the FDA of a pod vaping product. It is also the first approval of any vaping product manufactured by a company that is independent of the tobacco industry.

    Smoore products have a good record of securing FDA authorizations. The first brand to receive marketing orders through the premarket tobacco product application (PMTA) pathway, Vuse Solo, is a strategic partner of Smoore, a Smoore representative told Tobacco Reporter’s sister publication, Vapor Voice. The second set of approved electronic nicotine-delivery system (ENDS) products, produced by Logic, are also manufactured by Smoore.

    “NJOY has partnered with Smoore since 2009. The NJOY Ace was launched in 2018 and is powered by FEELM inside, the world’s first black ceramic atomization coil with metallic film. As the first ceramic coil e-cigarette and pod vape authorized by the FDA, NJOY Ace’s approval for sale fully showcases the harm reduction potential of FEELM ceramic coil,” the representative said.

    “According to the FDA, NJOY Ace is authorized for sale because ‘chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.’”

    Based on PMTA requirements, Smoore established a comprehensive analytical testing and safety assessment system, including the vaping industry’s first corporate toxicology laboratory, which explores the health impacts of exposure to e-cigarette vapor by means of cytotoxicity test, evaluating the reaction of living cells to different components of e-cigarette vapor, according to Smoore.

    The company has also developed the third generation of in-house safety standards—Smoore 3.0—that covers all of the PMTA tests, including harmful and potentially harmful constituents (HPHCs) listed by the FDA.

    “The principle of PMTA is to scientifically and systematically substantiate harm reduction performance of the vaping product and show it is appropriate for the protection of the public health (APPH),” said Long, director of the Smoore Analytical Testing and Safety Assessment Center. “The manufacturer must demonstrate the product’s potential to switch adult smokers while preventing youth and non-smokers from nicotine addiction.”

    Long said this could explain why all the FDA-authorized vaping products so far have been for tobacco flavors, and popular flavored products the agency has said promote youth use have been issued marketing denial orders. It is also an indication that vaping manufacturers should focus on “tobacco flavor reproduction and improve harm reduction performance” in order to be approved under the PMTA pathway.

    According to Nielsen, for the two weeks ended April 9, 2022, Vuse has now surpassed Juul and become No.1 in U.S. e-cigarette sales with a market share of 35 percent. Its flagship product Vuse Alto is also equipped with FEELM ceramic coils.

    As the No. 3 player in the U.S., NJOY accounts for approximately 3.1 percent market share. Moreover, a federal judge has required the FDA to provide progress reports on PMTAs submitted by major vaping brands and the first reports are due on April 29.

    The FDA also found that the risk to youth initiation with NJOY’s Ace was outweighed by the benefit to adult smokers, warning that NJOY must comply with strict post-marketing requirements.

  • Match Sets Dividend and Elects Directors

    Match Sets Dividend and Elects Directors

    Photo: Swedish Match

    Participants in Swedish Match’s annual general meeting on April 27 resolved to pay a dividend of SEK1.86 ($0.19) per share distributed to the shareholders in two equal payments of SEK0.93 per share, the company announced in a press note.

    The record date for the right to receive a cash dividend for the first payment is April 29, 2022, and payment through Euroclear Sweden is expected to be made on May 4, 2022. The record date for the second payment is Nov. 14, 2022, and payment through Euroclear Sweden is expected to be made on Nov. 17, 2022.

    The board of directors and the CEO were granted discharge for the financial year 2021.

    Charles A. Blixt, Jacqueline Hoogerbrugge, Conny Karlsson, Alexander Lacik, Pauline Lindwall and Joakim Westh were reelected as members of Swedish Match’s board of directors. Sanna Suvanto-Harsaae was elected as a new member of the board of directors. Conny Karlsson was reelected as chairman of the board.

    The annual general meeting elected Deloitte as auditor until the end of the annual general meeting 2024.

    The board of directors’ remuneration report for 2021 was adopted. Furthermore, the annual general meeting approved the board of directors’ proposal that it be authorized to resolve on acquisition of the company’s own shares, on one or several occasions prior to the next annual general meeting, provided the company’s holding does not at any time exceed 10 percent of all shares in the company. The shares shall be acquired on Nasdaq Stockholm at a price within the price interval registered at any given time, i.e., the interval between the highest bid price and the lowest selling price. Swedish Match owns 59,285,810 treasury shares as per April 27, 2022.

    In addition, the company’s share capital was reduced by SEK13,559,080.98 by means of withdrawal of 55,000,000 previously repurchased shares held in treasury, with a simultaneous bonus issue, without issuing any new shares, of a corresponding amount to restore the share capital. The shareholders further approved the proposal that the reduction will be allocated to a fund for use pursuant to a resolution adopted by the annual general meeting.

    The annual general meeting approved all other proposals made by the board of directors and the nominating committee. The proposals are outlined in the published notice of the annual general meeting.

  • Bank Policies Threaten Egypt’s Leaf Imports

    Bank Policies Threaten Egypt’s Leaf Imports

    Photo: Taco Tuinstra

    The reluctance of banks to open the documentary credits required to import leaf tobacco is endangering the operations of Egypt’s tobacco factories, reports Egypt Independent, citing the Tobacco Division of the Federation of Egyptian Industries ((FEI).

    FEI Division Head Ibrahim al-Embabi warned that more than 23 factories will close following the Eid al-Fitr holiday, after which they will have used their entire stock of raw tobacco. Due to a ban on tobacco cultivation in Egypt, the country’s tobacco industry is entirely dependent on leaf imports.

    Earlier this year, Egypt’s Central Bank of Egypt stopped collecting documents upon import, requiring importers to cover the entire value of the shipment before importing. The decisions forced many factories, including tobacco manufacturing plants, to suspend their imports of raw materials.

    Al-Embabi said that stopping the import of raw materials and the consequent disruption of production will lead to the displacement of nearly 30,000 direct workers in the sector, and threaten the state’s intake of taxes and fees paid by cigarette and tobacco companies, which exceed EGP79 billion ($4.27 billion) annually.

    Tobacco factories import raw materials worth about $500 million each year while exports reach $120 million annually.

    The remaining percentage is used to satisfy the needs of the local market. Despite its high consumption of imported raw materials, the tobacco sector is the state treasury’s most important source of revenue, according to al-Embabi.

  • TPB’s Quarter ‘In Line With Expectations’

    TPB’s Quarter ‘In Line With Expectations’

    Yavor Efremov (Photo: TPB)

    Turning Point Brands announced financial results for the first quarter ended March 31, 2022.

    Net sales for the first quarter of 2022 decreased 6.3 percent to $100.9 million compared to the previous year. Net sales for Zig-Zag and Stoker’s Products increased 10.1 percent over 2021. Gross profit decreased 2.8 percent to $51.8 million while net income decreased 6.7 percent to $11 million.

    “Our first- quarter results were in line with our expectations as we continued to grow our market share for both Zig-Zag and Stoker’s while navigating a difficult consumer and regulatory environment to drive profitability in each of our segments, including NewGen. Sales decreased 6 percent from the previous year driven by a 37 percent decline in NewGen sales but showed double-digit growth excluding NewGen,” said Yavor Efremov, president and CEO of Turning Point Brands, in a statement.

    “Zig-Zag delivered another strong growth quarter led by our U.S. papers business, which built on its market-leading share during the quarter. At the same time, Stoker’s maintained its growth trajectory driven by double-digit growth in the moist snuff tobacco business, which benefited from consumer trade-down as a leading value brand. Despite the expected sales decline, NewGen maintained positive profitability during the quarter while improving the distribution reach for its regulated products.”

    “We continue to monitor FDA developments. While added regulation may cause short-term disruption, this is a necessary step to fully regulate the industry, create a level playing field and provide consumers with additional reduced-risk alternatives to cigarettes,” continued Efremov.

    “We maintain a strong balance sheet that is allowing us to deploy a substantial amount of our free cash flow toward share repurchases, which continued during the quarter. While inflationary pressures, including a spike in gas prices, are impacting the consumer wallet, we remain favorably positioned as we continue to execute and outpace the overall industry. In addition to solid execution on the business side, we have completed both the ERP and CRM scopes we discussed on our last earnings call. I am particularly proud of the fact that the organization undertook a detailed review of the business with heavy involvement from every level of the company while delivering a solid quarter.”

     

  • FDA Authorizes Several NJOY Products

    FDA Authorizes Several NJOY Products

    Photo: NJOY

    The U.S. Food and Drug Administration on April 26 authorized four NJOY products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods—NJOY Ace Pod Classic Tobacco 2.4 percent, NJOY Ace Pod Classic Tobacco 5 percent and NJOY Ace Pod Rich Tobacco 5 percent.

    The decision is significant because, unlike previous marketing orders—the FDA earlier authorized varieties of BAT’s Vuse Solo brand and Japan Tobacco International’s Logic e-cigarette—this one covers a product with a decent market share. While Vuse overall is a bestseller, the variety that received marketing approval in October 2021 is based on outdated technology and used by only a few people.

    According to Nielsen and analyst reports, which measure financial data typically from convenience stores (and not vape shops), NJOY is the third-largest vape manufacturer in the United States, holding a little more than 3 percent of the market.

    The most recent authorization is also the first for a brand not owned by a major tobacco firm.

    “Looking at the situation with rose-colored glasses, an independent pioneer like NJOY getting two nicotine vaping products through the convoluted FDA authorization process is something to celebrate,” Greg Conley, the president of the American Vaping Association, told Filter. “Unlike the only two other companies with authorizations, NJOY could not subsidize their applications with cigarette sales, so they were at a disadvantage from the start.”

    While authorizing NJOY Ace tobacco-flavored pods, the FDA rejected other Ace e-cigarette products. Applications for two menthol-flavored Ace e-liquid pods remain under FDA review.

    No flavored product has yet received FDA authorization, even though tobacco harm reduction advocates insist flavors are necessary to lure smokers away from combustible cigarettes. “The FDA’s current policy of denying all flavors and deferring action on menthol applications is evidence of just how broken the agency is,” Conley told Filter. “The FDA still has not accepted that millions of adult vapers will not be switching to tobacco flavors anytime in the future.”

    Under the PMTA pathway, the applicant must demonstrate to the FDA that marketing of the new tobacco product would be appropriate for the protection of the public health, the FDA explained in a statement. According to the agency, the authorized NJOY products were found to meet this standard because chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.

    “Further, data provided by the applicant demonstrated that participants who had used only the authorized NJOY Ace products had lower levels of exposure to HPHCs compared to the dual users of the new products and combusted cigarettes,” the FDA wrote. “Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.”

  • Activist: Minister Won’t Stop Legalization

    Activist: Minister Won’t Stop Legalization

    Asa Saligupta

    Tobacco harm reduction advocates remain optimistic that Thailand will legalize e-cigarettes, despite vocal opposition from the country’s health minister.

    On April 26, Public Health Minister Anutin Charnvirakul said he opposes legalization of vapor products in the country, citing concern about underage consumption and the plight of tobacco farmers.

    Asa Saligupta, director of ENDS Cigarette Smoke Thailand (ECST), suggested Charnvirakul was playing politics. “After his abysmal handling of the pandemic, among other things, he could easily lose his seat at Thailand’s upcoming general election. He’s simply panicking but has completely underestimated the wide support for legalizing and regulating vaping,” said Saligupta.

    With draft legislation to legalize e-cigarettes currently before a sub-committee, the ECST director remains confident that the vaping bill will be passed by Thailand’s parliament this year.

    “The Thai government can and will regulate safer nicotine products regardless of what one minister says,” said Saligupta. “Let’s not forget that Digital Economy and Society Minister Chaiwut Thanakamanusorn, government officials and public health experts have all been key to finally confronting Thailand’s failed tobacco control policies,” he says.

    According to Saligupta, Thailand’s harsh ban and penalties on vape imports and sales have failed.

    “Smoking continues to kill about 50,000 Thai people each and every year. Too many smokers have been stuck with cigarettes or are forced onto the black market for vapes where there’s no control over the purchase age or product safety standards. An effective public health minister would not accept this dire situation, let alone support it,” he says.

    ECST believes it’s no surprise the minister made his anti-vaping statement to ThaiHealth board members. Its senior adviser, Prakit Vathesatogkit, recently received the Dr Lee Jong-wook Memorial Prize by the World Health Organization for his work against tobacco. He has also been a high-profile voice against legalizing vaping.

    “ThaiHealth along with some local conservative health voices continue to publicly scaremonger, conveniently ignoring the growing tobacco harm reduction success globally,” said Saligupta. “By joining the minority, Thailand’s Public Health Minister is now among an increasingly isolated crowd who continue to follow the WHO’s discredited anti-vape agenda,” he says.

    According to Saligupta, nearly 70 countries have now adopted regulatory frameworks on safer nicotine products despite the WHO position, leading to dramatic declines in their overall smoking rates. The Philippines and Malaysia are also set to legalize vaping.  

    “Thankfully the Thai government remains on the right side of the debate,” he said. “Regulating will give consumers better protection, encourage more smokes to quit deadly cigarettes, and ensure we have much better control over youth vaping with a strict purchase age,” he says.

  • Russian Tobacco Mogul Faces Scrutiny

    Russian Tobacco Mogul Faces Scrutiny

    Photo: GAlexS

    Metro published a profile of Russian tobacco mogul Igor Kesaev, who has been sanctioned by the EU and the U.K. for aiding Russia’s invasion of Ukraine.

    Listed by Forbes as Russia’s 35th-richest person last year, Kesaev’s holdings have included a major stake in the V.A. Degtyarev factory, which makes machine guns, anti-tank and anti-aircraft weapons, some of which have been used in Ukraine, according to sources.

    Until recently, Kesaev was also the board chairman of Russia’s leading tobacco distributor, TC Megapolis. Kesaev resigned from the board on April 11, 2022, according to a Russian-language press release, which stressed that Megapolis was not subject to EU sanctions and Kesaev did not influence the company’s business.

    Kesaev’s involvement in tobacco dates to the early 1990s. As the Soviet Union broke up into its constituent republics, he started an importing business that worked with international tobacco companies eager to get their products into the Russian market, according to a 2014 profile of the magnate published on Forbes’ Russian website.

    Russia was—and continues to be—an attractive market for international tobacco companies, with its large population of around 145 million people and one of the highest smoking rates in the world. More than 40 percent of men there light up, according to the World Health Organization.

    According to the Forbes profile, Kesaev graduated from Russia’s prestigious Moscow State Institute of International Relations. In the 1990s, he lived in Switzerland, where he developed personal connections with executives at Philip Morris International’s regional headquarters in Lausanne.

    Over time, Kesaev built the largest tobacco distributor in Russia through acquisitions of regional competitors, according to Forbes’ Russian website. Today, Megapolis delivers to 160,000 retailers across the country, according to the firm’s website. In 2013, PMI and Japan Tobacco International both purchased 20 percent stakes in Megapolis’ holding company for $750 million each.

    Kesaev has also been involved with the tobacco business in Ukraine. Following the toppling of Ukraine’s pro-Russian president, Viktor Yanukovych, in 2014 and Russia’s subsequent annexation of Crimea, Ukrainian officials began scrutinizing the role of Russian companies in various sectors of its economy.

    At the time, Trading Company Megapolis-Ukraine controlled 99 percent of Ukraine’s tobacco distribution market, according to research from the Anti-Monopoly Committee of Ukraine.

    Kyiv sanctioned Kesaev in 2016 for unspecified actions that it said threatened Ukraine’s national security. A top Ukrainian prosecutor later accused Kesaev of supporting “terrorist organizations” by supplying arms to Russian-backed separatist groups that have been fighting for nearly a decade to carve out two independent states—Donetsk and Luhansk—in eastern Ukraine.

  • NY May Verify Legal Age With Facial Recognition

    NY May Verify Legal Age With Facial Recognition

    Photo: zapp2photo

    The New York State Senate is moving forward with proposed legislation that would allow bars and restaurants to use facial recognition or fingerprint scanners to verify customers’ ages before allowing them to buy alcohol, tobacco or electronic cigarettes, according to the New York Post.

    “This is the new frontier of age verification,” said state Senator James Skoufis, who is sponsoring the biometrics bill. “It does advance the interests of convenience.”

    Skoufis envisions that bars and restaurants could scan fingerprints, faces or retinas of customers who want to be spared the trouble of showing an ID when they return to an establishment in the future. The proposed legislation requires all data to be encrypted and prohibits businesses from selling biometric data to third parties.

    “No one’s forced into engaging with this technology, but they would have the choice,” Skoufis said. “There’s no Big Brother involved.”

    Age verification based on facial recognition technology is widespread in China, but has yet to catch on in Western countries, where critics have voiced concerns about consumer privacy.

  • China Drafts Guidelines for E-Cig Production

    China Drafts Guidelines for E-Cig Production

    Photo: Taco Tuinstra

    China’s tobacco regulator on Jan. 25 released draft rules for e-cigarette production, according to Reuters.

    The State Tobacco Monopoly Administration said it would “reasonably” control manufacturing to prevent overcapacity.

    The regulator said it would ban foreign investment in domestic e-cigarette retail operations while reviewing foreign involvement in production, requiring vapor companies that want to list in China or abroad to obtain pre-approval.

    China has in recent months been tightening its scrutiny of e-cigarettes, and last year amended its tobacco monopoly law to include vaping products. Since then, it instructed e-cigarette and vaping companies to sell their products only through authorized channels, and barred vendors from selling e-cigarette flavors other than tobacco.

    Earlier this month, China unveiled technical standards for e-cigarettes and vaping products.

    China’s cigarette industry operates under a state-run monopoly directly controlled by the STMA, which dictates pricing and distribution for brands and generates tax income for the government.

  • Egypt Legalizes E-Cigs

    Egypt Legalizes E-Cigs

    Photo: Dzmitry

    The vapor industry has welcomed Egypt’s decision to allow the import and commercialization of e-cigarette product.

    “The lifting of the ban highlights the Egyptian authorities’ progressive approach to e-cigarettes and sets the stage for the creation of a regulated market rich with business opportunities, through serving the demand for easily accessible, quality products by legal age (adult) consumers across the country,” wrote RELX International, a leading player in the segment, in a statement dated April 24.

    With its recent decision, Egypt joins global and regional markets, such as Kuwait, Saudi Arabia and the United Arab Emirates, which have legalized and commercialized the consumption of e-cigarettes. As regulators around the world become more accepting of e-cigarettes, the market is expected to continue its steady growth in the coming years.

    As of March 2022 global e-cigarette market revenues were $22.95 billion, and the market is expected to expand annually at a compound annual growth rate of 4.19 percent until 2027, according to Statista.

    “The decision by Egyptian authorities reflects its commitment to support legal businesses in the country while cracking down on the illicit trade of those products, in line with what we are seeing in an increasing number of markets around the globe,” said Robert Naouss, REXL International’s external affairs director for the Middle East, Northern Africa and Europe

    “The business and investment environment in the country will significantly benefit from this decision, as will adult consumers who can now conveniently, and legally, purchase better alternatives to combustible cigarettes. We look forward to working with our partners to grow and protect their income via our portfolio of quality products”

    By lifting the ban on e-cigarette products, Egyptian authorities have opened the door to a plethora of business and investment options, according to RELX International. “Authorized e-cigarette products are traditionally retailed by small- and medium-sized businesses, so the move will bolster existing businesses that sell such products, and will attract entrepreneurs wishing to set up new retail points across the country. It will likewise draw investment into the country from e-cigarette brands who wish to set up shop in the country and address the market,” the company wrote in its statement.  

    “Adult consumers stand to benefit from the move, as they now have legal access to e-cigarettes whether they wish to switch to a better alternative to traditional cigarettes. Several health authorities and regulators including the U.K.’s NHS and the Ministry of Health of New Zealand have positively clarified their position on vaping as a way for people to move away from smoking combustible cigarettes.

    “In addition, the decision will contribute to the country’s economic recovery post-pandemic via the collection of tax revenues from legally imported products. Simultaneously, it will allow Egyptian authorities to clamp down on tax evasion issues associated with illegal market players. In a similar vein, the move and balanced regulation of the market offers authorities and e-cigarette vendors a path to stem the spread of inferior and dangerous black-market products that do not meet the standards and regulations outlined by Egyptian and international authorities. In doing so, adult consumers can rest assured the products they do find on sale are indeed a reliable alternative to traditional cigarettes.”