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Category: News This Week

  • Enorama Sues FDA for Disparate Pouch PMTAs

    Enorama Sues FDA for Disparate Pouch PMTAs

    Enorama Pharma Inc. filed a lawsuit against the U.S. Food and Drug Administration in federal court in Washington, D.C., alleging the agency unlawfully imposed costly premarket tobacco application (PMTA) requirements on its nicotine oral pouches. In a complaint filed Feb. 17, the company argues the FDA violated the Regulatory Flexibility Act and Administrative Procedure Act by subjecting pouches to the same regulatory framework as combustible tobacco without properly assessing the impact on small businesses. Enorama contends that although the FDA previously suggested publicly available data could support applications, it now requires product-specific scientific studies, dramatically increasing costs.

    According to the filing, the FDA estimated bundled application costs between $181,686 and $2 million, but Enorama claims actual expenses range from $3 million to more than $15 million — forcing some manufacturers to exit the market. The company also alleges unequal treatment, asserting that larger competitors such as Philip Morris International and Altria Group have been allowed to market similar nicotine pouch products despite pending applications, while Enorama received a refusal-to-file letter. Attorney Eric N. Heyer of Thompson Hine LLP said the company plans to seek a preliminary injunction to halt the FDA’s action.

  • CDP Recognizes Pyxus for Work in Climate Change, Forestry

    CDP Recognizes Pyxus for Work in Climate Change, Forestry

    Pyxus International, Inc. was recognized as a global leader in environmental performance and transparency by CDP, earning “Leadership” status with improved A- ratings in both climate change and forestry. The company also maintained a “Management” level B rating in water security, reflecting its efforts to reduce greenhouse gas emissions, strengthen water stewardship, and mitigate deforestation across its global operations. CEO Pieter Sikkel said the recognition highlights Pyxus’ disciplined execution, transparent reporting, and collaboration throughout its value chain.

    CDP’s 2025 evaluation assessed more than 23,100 entities worldwide, with scores ranging from A to D-. Pyxus has reported greenhouse gas emissions to CDP since 2009, added water security disclosures in 2014, and began reporting forestry data in 2020.

  • Indonesian Health Groups Push to Regulate Vape Packaging

    Indonesian Health Groups Push to Regulate Vape Packaging

    Indonesian health groups are pressing the Ministry of Health to immediately mandate pictorial health warnings and standardized packaging for e-cigarettes, citing rising youth use and regulatory gaps. The Indonesian Health Policy Room, TCSC–IAKMI, and CISDI warned that colorful vape packaging and weak oversight increase the risk of nicotine addiction and exposure to illicit substances among adolescents, and called for stronger enforcement and a ban on e-cigarette advertising on social media.

    Citing national data showing high smoking rates among teens, the groups urged swift regulatory action to curb youth uptake and close oversight gaps.

  • Jordan Leverages Ramadan to Fight Smoking

    Jordan Leverages Ramadan to Fight Smoking

    Jordan’s Coalition of Health Associations launched its first nationwide awareness campaign, “Ramadan Without Smoking,” at an event held at the National Library of Jordan, bringing together health professionals, medical students and community members. Announced on February 18, the initiative seeks to leverage the holy month of Ramadan as a catalyst for smoking cessation, highlighting the health, social and economic harms of tobacco and e-cigarette use. The coalition called for stronger institutional partnerships and expanded community outreach to reduce tobacco use, particularly among youth, and said further awareness and prevention programs will be rolled out in the coming months.

  • Turning Point to Host Q4, FY25 Financial Call March 2

    Turning Point to Host Q4, FY25 Financial Call March 2

    Turning Point Brands, Inc. announced it will host a conference call on March 2, at 9 a.m. ET to review its fourth quarter and full-year 2025 results. Those interested can join via toll-free 800-715-9871 or international 646-307-1963 using Event ID 6640134, with participants asked to dial in at least 10 minutes early. The call will also be webcast live in listen-only mode through the investor relations section of the company’s website, with a replay available approximately two hours after the event.

  • Altria Moving Forward with Smoke-Free Products

    Altria Moving Forward with Smoke-Free Products

    Altria Group, Inc. reaffirmed its 2026 full-year guidance at the Consumer Analyst Group of New York Conference on February 18, projecting adjusted diluted EPS of $5.56 to $5.72, representing growth of 2.5% to 5.5% from a 2025 base of $5.42. CEO Billy Gifford and CFO Sal Mancuso told investors earnings growth is expected to be weighted toward the second half of the year, driven by a progressive increase in cigarette import and export activity, continued pricing power in the combustibles segment, and capital allocation including share repurchases. The company also emphasized its strategic pivot toward smoke-free products, including its on! nicotine pouch portfolio, positioning reduced-risk categories as a key long-term growth driver as cigarette volumes continue to decline.

    “Long term, it’s important to compete in e-vapor with flavored products that meet evolving consumer preferences,” Gifford said. “We are working on a pipeline of products to drive to that future. The proliferation of illicit disposable products, slow pace of FDA authorizations, and the intellectual property landscape remain significant headwinds. We intend to maintain a measured approach to our investments in e-vapor, until the regulatory framework is functioning as intended and enforcement actions meaningfully address the illicit market.”

  • La Aurora Joins CAA

    La Aurora Joins CAA

    The Cigar Association of America announced that La Aurora USA has joined the national trade body. La Aurora USA is the U.S. distribution arm of La Aurora, the Dominican Republic’s oldest cigar factory, founded in 1903, and manages sales and marketing of brands including La Aurora 1903, Preferidos 1903, ADN Dominicano, 107 and León Jimenes. CAA President Scott Pearce welcomed the company’s membership, citing its role in strengthening the association’s advocacy and industry data programs, while La Aurora USA CEO Ed McKenna said joining CAA will support collaboration across both premium and mass-market cigar segments.

  • BAT Reaffirms FY26 Guidance at Low End of Target

    BAT Reaffirms FY26 Guidance at Low End of Target

    British American Tobacco reaffirmed its full-year 2026 guidance with its presentation at the Consumer Analyst Group of New York Conference today (Feb. 18), signaling results will land at the lower end of its previously issued targets. BAT CEO Tadeu Marroco and Reynolds American President David Waterfieldhe said the group expects constant-currency revenue growth of 3–5%, adjusted profit from operations growth of 4–6% (adjusted for Canada and weighted toward the second half) and adjusted diluted EPS growth of 5–8%. BAT said its smokeless portfolio — including Vuse, glo and Velo — reached more than 31 million adult consumers globally by the end of 2025, contributing 18.2% of its £25.6 billion annual revenue. The company is targeting 50 million smokeless consumers by 2030 and aims for these products to generate half of group revenue by 2035, as it continues its transition toward reduced-risk categories.

    “We are committed to actively encouraging adult smokers, who would otherwise choose to continue to smoke, to make a full switch to smokeless alternatives,” Marroco said. “Regulation is not homogeneous globally. This affects not only which products are legally available for consumers, but also communication freedoms and excise levels.

    “BAT has taken a consumer-led, multi-category approach from the outset.  While initially more complex and costly to execute, it has proven to be the right strategy. Together with leveraging our brand building expertise, and global distribution reach, this enables us to maximize our opportunity – to switch smokers who would otherwise choose to continue to smoke, drive harm reduction, and create value.”

  • PMI Talks Smoke-Free Progress at CAGNY

    PMI Talks Smoke-Free Progress at CAGNY

    Today (Feb. 18), Philip Morris International outlined its long-term strategy at the Consumer Analyst Group of New York Conference, emphasizing its accelerated shift toward smoke-free products. CEO Jacek Olczak and CFO Emmanuel Babeau said more than 40% of current net revenues now come from smoke-free alternatives and reiterated its goal of reaching two-thirds of total revenue from these products by 2030. For 2026–2028, PMI projects 6%–8% organic revenue growth, 8%–10% operating income growth and 9%–11% adjusted EPS growth, driven by high single-digit to low-teen smoke-free volume increases, strong pricing power and margin expansion. Smoke-free products generated $17 billion in revenue and 180 billion units in volume, delivering more than double the revenue and gross profit per unit compared with combustibles, while operating cash flow is expected to reach about $45 billion over the period.

    “Somebody very recently interested in this category of smoke-free products, told me, ‘Jacek, your problem is not that there is too little science about this product. Your problem is that there is too much politics about these products,’” Olczak said. “Because the science is very indisputable what these products offer versus a cigarette. It just takes a while until it really starts penetrating and open the last, if I may say, closed minds in the world.”

    Operationally, PMI has smoke-free products available in 106 markets, exceeding the company’s 2025 target, with three of four regions deriving over half of their revenue from smoke-free categories. PMI highlighted early success in Taiwan, where IQOS captured a 6% share in Taipei within three months of launch, and said growth in smoke-free volumes is expected to offset combustible declines. The company is also engaging regulators to expand market access and address illicit trade in the e-vapor segment, while targeting a net debt-to-EBITDA ratio near 2x by end-2026 and increasing dividend growth toward a 75% payout ratio of net profit.

  • NCV Sparks Agricultural Transformation in Zimbabwe

    NCV Sparks Agricultural Transformation in Zimbabwe

    Naturally cured Virginia (NCV) tobacco is driving what officials describe as an agricultural breakthrough in Zimbabwe’s Matabeleland North and South provinces, with 325 growers planting 370 hectares this season — up from 122 growers and 84 hectares last year. Backed by contracts with Atlas Agri and supported by the Tobacco Industry and Marketing Board, the crop’s rapid expansion marks a shift beyond the country’s traditional tobacco regions in Mashonaland and Manicaland.

    Introduced as a 10-hectare pilot just three seasons ago, NCV is gaining traction as a climate-smart alternative that requires no firewood for curing, lowering costs and environmental impact while offering smallholder farmers in drier regions a viable new income stream. With growing global demand for sustainably produced tobacco and the establishment of a local sales floor to ease market access, stakeholders say NCV is helping to decentralize production and unlock fresh economic potential in previously underrepresented farming communities.

    “As global markets increasingly demand sustainably produced tobacco, buyers are paying premiums for crops with low environmental footprints,” Rhyne Chikuni wrote for News Day. “NCV tobacco answers this global call, positioning Zimbabwe as a responsible and forward-looking producer. This is sustainability paired with economic viability.”