Category: News This Week

  • McKinney Regulatory Science’s New Website

    McKinney Regulatory Science’s New Website

    McKinney Regulatory Science Advisors has launch its new website that promises “a new era of innovation and transparency for their clients,” according to a press release.

    The new platform describes an array of advisory services to nicotine and cannabis clients, with an emphasis on providing McKinney clients with the best available regulatory services.

    Willie McKinney, CEO of McKinney, said the new website represents a significant milestone in journey to provide exceptional advisory services to our nicotine and cannabis clients.

    “The revamped platform reflects our dedication to innovation, transparency, and client satisfaction, making it easier for clients to explore our services and access valuable regulatory resources,” he said

    The new website offers a modern design that makes it easy for users to find the information they need quickly. It also features an intuitive navigation system that allows users to identify relevant services and access helpful resources rapidly, according to McKinney. Additionally, the site is optimized for mobile devices so that users can access the site from any device at any time.

    “McKinney RSA focuses on providing comprehensive solutions that meet complex regulatory requirements while also delivering superior customer service,” the release states. “With decades of industry experience under their belt, they are committed to helping their clients succeed by providing top-notch guidance every step of the way.”

  • 22nd Century Reports Second Quarter Results

    22nd Century Reports Second Quarter Results

    Photo: chechotkin

    22nd Century Group’ second quarter 2023 net revenues increased 62 percent to $23.4 million. Revenue from tobacco-related products was $8.1 million, reflecting the company’s transition away from low margin filtered cigar products to focus production and capacity on higher margin products, such as VLN and Pinnacle. Revenue from hemp/cannabis-related products was $15.4 million, as volumes continued to increase on share gains.

    Gross profit for the second quarter of 2023 was minus $2.3 million as compared to $0.9 million in the prior year period. Gross profit from tobacco-related products was minus $1 million, reflecting a lower margin product mix.

    Gross profit from hemp/cannabis-related products was minus $1.4 million, reflecting the final quarter of primarily ingredient trading activity due to a November 2022 plant fire. 22nd Century says it is restarting production of its ingredients at new facilities.

    Our focus remains transformation from a primary emphasis on R&D to a fully commercial enterprise providing innovative harm reduction and consumer health and wellness products.

    John Miller, interim CEO, 22nd Century

    “Our focus in 2023 remains 22nd Century’s transformation from a primary emphasis on research and development to a fully commercial enterprise providing innovative harm reduction and consumer health and wellness products to key end markets,” said interim CEO John Miller in a statement.”

    “We have now significantly advanced our commercialization plan for VLN sales across targeted states, 14 of which are now in place and two more states scheduled in September with a new drug store customer, a diversified hemp/cannabis ingredients and distribution business and a robust license and distribution business in both tobacco and hemp/cannabis.

    “Following an initial delay in our commercial plans earlier this year, which are common on retail launches, we have now substantially expanded the availability of our FDA-authorized, reduced nicotine- content cigarettes VLN—a tobacco harm reduction product unlike any other.

    “We are also implementing programs intended to reduce our operating costs by at least $15 million on an annualized basis.”

  • Warnings for Unauthorized Smokeless Products

    Warnings for Unauthorized Smokeless Products

    Image: calypso77

    The U.S. Food and Drug Administration sent a warning letter to Amarillo Snuff Co. on Aug. 11, 2023, for manufacturing, selling and/or distributing unauthorized smokeless nicotine products, including products that are made with corn husks instead of tobacco leaves, according to an FDA release.

    The unauthorized products contain nontobacco nicotine, which falls under the FDA’s regulation authority. 

    “Last year, Congress clarified FDA’s authority to regulate tobacco products containing nicotine from any source, which closed a loophole that several companies were using to try to evade regulation,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Our authority over these products is clear, and FDA is committed to holding those responsible for illegal products accountable for their actions.” 

    The cited products lack FDA marketing authorization. To date, the FDA has not authorized any nontobacco nicotine products.

    After receiving a warning letter, recipients have 15 working days to respond with steps they will take to correct and prevent future violations; failure to promptly correct violations can result in additional FDA actions such as injunction, seizure and/or civil money penalties.

    “A majority of firms that receive warning letters correct their violations, but if they fail to do so, the products are subject to enforcement,” said Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement. “FDA continues to bring enforcement actions, including injunctions and civil money penalties, as appropriate.”

    As of July 28, 2023, the FDA has issued about 600 warning letters to manufacturers of unauthorized tobacco products, with 100 of the letters being for unauthorized nontobacco nicotine products. As of June 30, 2023, the FDA has issued more than 2,800 warning letters and 825 civil money penalties for sales of e-cigarettes to underage purchasers, with over 1,000 warning letters and more than 140 civil money penalties relating to sales violations of nontobacco nicotine products to underage consumers.

  • Japan: Smoking Rates Continue to Decline

    Japan: Smoking Rates Continue to Decline

    Image: kapinon

    Smoking rates for men and women in Japan continued to decline in 2022, according to health ministry survey data, reports Kyodo News.

    The male smoking rate fell 3.4 percentage points compared to 2019 data, and the female smoking rate fell 1.1 percentage points.

    The survey classified smokers as respondents who said they either “smoke every day” or “sometimes have days where I smoke.” The rate of tobacco use was highest among men in their 40s (34.6 percent) followed by men in their 50s (32.6 percent) and men in their 30s (29.9 percent). The rate of tobacco use among women was highest for those in their 50s (12 percent) followed by those in their 40s (11.6 percent) and those in their 30s (9 percent). Almost all age groups showed a drop in usage from the 2019 data.

    In April 2020, the revised health promotion law came into effect in Japan, banning smoking indoors at many locations and requiring businesses that allow indoor smoking to install separate spaces for smokers.

  • Tobacco Used to for Cancer Antibodies

    Tobacco Used to for Cancer Antibodies

    Photo: Baiya Phytopharm

    Thailand researchers have successfully used tobacco plants to develop antibodies that have inhibitory effects on the growth of cancer cells in laboratory animals, according to News-Medical.

    “Our research team has developed the technology and system to produce plant proteins to make antibody drugs, with the hope to help reduce the cost of drug production so that cancer patients in the country can access drugs more easily and widely,” said Waranyoo Phoolcharoen, associate professor in the Department of Pharmacognosy and Pharmaceutical Botany, Faculty of Pharmaceutical Sciences at Chulalongkorn University, where the research is taking place.

    The potential of the research was recognized with a 2023 research award from the National Research Council of Thailand.

    The researchers are using an Australian species of Nicotiana benthamiana.

    “We use plants as factories to produce the proteins we need,” said Phoolcharoen. “We insert antibody-producing genes into tobacco plants in order for the tobacco plants to produce the antibodies (drugs) we need. The extracted protein (antibody) is then purified. We found that the antibodies produced by the plants can bind to proteins on the surface of immune cells.”

    “The antibodies that the research team produced from plants can inhibit the growth of cancer cells in laboratory animals,” Phoolcharoen said. “The size of the tumor cells in mice decreased. This ability to make cells shrink in size is comparable to that of the drugs used in the market.”

    The next steps in the research are testing for safety and toxicity and studying the structure of the drug.

    “If this research is successful, we will be able to produce our own medicines locally, reducing the cost of drug production and lowering medicinal expenses. More people will then have access to cancer medicines,” said Phoolcharoen.

    The technology used in this research could also be used to produce antibodies to develop drugs or vaccines for many other diseases.

    Phoolcharoen has also been involved in a venture to produce a Covid-19 vaccine using tobacco plants.

  • Tax Free World Association Director Steps Down

    Tax Free World Association Director Steps Down

    Image: Dmytro

    John Rimmer, managing director of the Tax Free World Association (TFWA), will step down from his position and leave the TFWA effective Oct. 30, 2023.

    Rimmer joined the TFWA in October 2012 as director of conferences and research. He was promoted to managing director in October 2017 following Alain Maingreaud’s retirement.

    “On behalf of the management committee, the board and the entire team at TFWA, I would like to thank John for his valuable contribution to the development and success of TFWA since he joined and wish him every success going forward,” said Erik Juul-Mortensen, president of the TFWA, in a statement.

    The search for a new managing director has been initiated, and an announcement will be made in due course, according to the TFWA.

  • Steve McGeough to Lead Übbs

    Steve McGeough to Lead Übbs

    Photo: Übbs

    Nicotine pouch manufacturer Übbs has appointed Steve McGeough as general manager.

    Previously head of retail at British American Tobacco, Steve brings considerable experience from within the nicotine space. During his time at BAT, McGeough transformed the retail and direct-to-consumer experience, boosting sales by 20 percent. In addition, McGeough led the launch of BAT’s Vuse and Velo brands across the U.K., underpinned by a global offline subscription proposition.

    Prior to BAT, McGeough was retail director for Tesco Mobile where he helped to achieve double-digit revenue growth and enhance customer satisfaction.

    As general manager for Übbs, Steve will drive distribution, accelerate the brand’s online presence, build awareness and focus on responsible growth.

    “With over 25 years’ experience across retail, start-ups and product-led businesses, including significant time in the nicotine industry, Steve brings an impressive blend of experience that means he is perfectly positioned to help propel Übbs forward,” says Nigel Hardy director of Übbs parent company, RV Kharma.

    “His experience at British American Tobacco working within the next generation products division where he achieved impressive sales growth and launched nicotine pouch products across the U.K. is a great grounding for what’s to come with Übbs.

    “Steve shares our unwavering commitment to excellence, sustainability and ethical practices. We look forward to him taking the reins as we continue to grow.”

    Founded in the U.K. in 2022, Übbs’ pouches are manufactured to global pharma standards in India.

  • KT&G Helps Harvest Tobacco

    KT&G Helps Harvest Tobacco

    Image: KT&G

    KT&G volunteers helped farmers in South Korea’s Chungnam Province harvest tobacco.

    The cultivation of leaf tobacco takes place in July and August. The work is mostly performed by hand, resulting in a high labor intensity due to the difficulty of mechanization. Tobacco farming communities struggle to secure labor due to continuous rural depopulation and aging issues.

    To help farmers struggling with labor shortages, KT&G has visited leaf tobacco farms every year since 2007. Earlier this year, KT&G volunteers assisted farmers with the transplanting of tobacco seedlings.

    Additionally, KT&G supports the welfare of domestic tobacco farmers. In June, the company provided over KRW520 million ($396,657) in financial aid to cover health checkup expenses, children’s education expenses and support for fuel-saving windbreak heaters.

    “KT&G remains committed to organizing yearly volunteering activities involving our executives and employees,” said Kim Jung-ho, the director of the headquarters of KT&G’s raw materials division, in a statement. “These efforts aim to uphold consistent and stable cultivation practices for leaf tobacco farmers confronting labor shortages. The support we offer to farmers to foster mutual growth continues to persist.”

  • Pyxus Revenues Jump Nearly 40 Percent

    Pyxus Revenues Jump Nearly 40 Percent

    Image: Monster Ztudio

    Pyxus International announced results for its fiscal quarter ended June 30, 2023.

    Sales and other operating revenues were $477.1 million, up 38.7 percent compared to 2022. Operating income increased $29.4 million to $36.4 million. Net income was $0.8 million, improving $15.5 million. Adjusted EBITDA increased $27.5 million to $43.5 million.

    For the full 2024 fiscal year, Pyxus continues to expect sales to be between $1.9 billion and $2.1 billion and adjusted EBITDA to be between $155 million and $180 million.

    “Fiscal 2024 is off to a strong start with higher tobacco prices, accelerated timing of shipments and a favorable shift in customer mix fueling a 39 percent increase in revenue and improved profitability compared to the prior year,” said Pyxus President and CEO Pieter Sikkel in a statement.

    “In the first quarter of fiscal 2024, we believe we reached the peak of our fiscal 2024 tobacco purchases as we significantly accelerated our buying, using our geographic footprint to acquire tobacco inventory from multiple markets to meet higher current crop supply requirements and customer demand for fiscal 2024. Customer shipments in fiscal 2024 will utilize a higher percentage of tobacco purchased during the current fiscal year to fulfill orders compared to the prior year given our uncommitted inventory continues to be historically low.

    “Our continued focus on aggressively managing our working capital provided sufficient liquidity through short-term borrowings under our foreign seasonal lines of credit, availability under the ABL Credit Facility, cash generated from operations and cash collections from our securitized receivables to purchase larger volumes of more expensive tobacco compared to the prior year. In the first quarter of fiscal 2024, we increased our purchases of inventory by more than $100 million compared to the prior year using $40 million of incremental foreign seasonal lines of credit and our improved cash conversion cycle.

    “We anticipate ongoing strong demand as undersupply conditions are expected to persist through fiscal 2024. We believe our positive first-quarter results position the company to achieve our previously announced fiscal 2024 guidance for sales between $1.9 billion and $2.1 billion and adjusted EBITDA between $155 million and $180 million. We are proud of the progress our global teams have made thus far and thank them for their unwavering commitment to our customers and their focus on achieving the company’s objectives so that together we can grow a better world.”

    The company held a conference call to report financial results for the period ended June 30, 2023, on Aug. 10, 2023, at 9:00 a.m. Eastern Time. For those who were unable to listen to the live event, a telephonic replay of the conference call will be available by dialing (647) 362-9199 or (800) 770-2030 and entering the access code 2624736.

  • Seed Sales Hint at Record Hectarage

    Seed Sales Hint at Record Hectarage

    Photo: Taco Tuinstra

    Zimbabwean seed sales suggest a record tobacco hectarage in the 2023-2024 growing season, reports The Herald.

    Statistics released by the Tobacco Research Board (TRB) reveal that, by August 8, farmers had procured 847.21 kg of tobacco seed with potential to cover 169,442 ha.

    The largest tobacco hectarage to date was recorded in 2019 when growers planted 146,000 ha. The final crop, livestock and fisheries assessment report shows that last year 131,656 ha were put under tobacco.

    Zimbabwean tobacco growers had sold 294 million kg of tobacco worth $891 million by day 100 of the ongoing 2023 marketing season.

    This is a 44 percent increase in volume and 43 percent rise in value compared to the same period last year.

    The average yield this season has risen to over 2 tons per hectare from 1.7 tons per hectare the previous season.

    As part of its Tobacco Value Chain Transformation Plan, Zimbabwe seeks to create a $5 billion tobacco industry by 2025 through localization of tobacco funding, increased production and productivity, value addition and beneficiation.