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  • FDA Releases Environmental Review for Oral Nicotine Products

    FDA Releases Environmental Review for Oral Nicotine Products

    Today (May 21), the U.S. Food and Drug Administration published a programmatic environmental assessment covering nicotine pouches and other oral nicotine products reviewed through the premarket tobacco product application (PMTA) process. The assessment applies to products categorized as “other,” including nicotine pouches, lozenges, tablets, gums, discs, dissolvable tobacco products, and nicotine-infused products, while excluding traditional smokeless tobacco products such as snus, dip, and chewing tobacco.

    The FDA concluded that the environmental impact of these products is generally minimal, citing the absence of airborne emissions during use and relatively limited environmental contamination from product waste. According to the agency, these products reduce or eliminate secondhand and thirdhand exposure risks compared with combustible products, while the waste generated contains comparatively fewer harmful chemicals that persist or bioaccumulate in the environment.

    The agency said the assessment is intended to support transparency and may be referenced by FDA reviewers evaluating individual product applications. However, the FDA emphasized that authorization decisions will continue to be made on a case-by-case basis based on the specific scientific evidence submitted for each product.

  • NYT Report Draws Attention to RJR Donation and FDA Policy Shift

    NYT Report Draws Attention to RJR Donation and FDA Policy Shift

    Reynolds American is under scrutiny following a The New York Times report linking a $5 million donation to a pro-Donald Trump super PAC with recent shifts in U.S. Food and Drug Administration policy on flavored vaping products. The report said Reynolds executives met with Trump shortly before the FDA issued guidance that could ease market access for certain flavored vape and nicotine pouch products, potentially benefiting major tobacco companies in the growing U.S. e-cigarette market.

    The White House denied any connection between the donations and policy decisions, stating that FDA actions are based on scientific evidence and public health considerations.

  • EU Requests Feedback on New Tobacco Control Rules

    EU Requests Feedback on New Tobacco Control Rules

    The European Commission launched a public consultation on plans to update the EU’s tobacco control framework, reflecting changing market dynamics, evolving consumption trends, and the growing role of digital marketing in nicotine product promotion. The proposed directive aims to strengthen public health protections, improve the functioning of the EU internal market, and support implementation of the World Health Organization Framework Convention on Tobacco Control in line with Europe’s Beating Cancer Plan. The feedback period for the initiative runs from May 18 to June 15, and is expected to inform future regulatory changes affecting traditional tobacco products as well as emerging nicotine categories.

  • ITC Posts 32% Increase in Cigarette Revenue

    ITC Posts 32% Increase in Cigarette Revenue

    ITC Limited reported a marginal rise in quarterly adjusted profit as pricing gains in its cigarette business helped offset the impact of higher excise duties and rising input costs. Profit before exceptional items and tax increased 4.3% year-on-year to 66.9 billion rupees ($669.2 million), while total revenue rose 17% to 217 billion rupees ($2.2 billion). Cigarette revenue, which remains the company’s primary earnings driver, climbed about 32% to 110.66 billion rupees ($1.1 billion), supported by price increases across key brands and a shift in product mix.

    The company said profitability was pressured by India’s excise duty hike on cigarettes and higher raw material costs, including edible oil, soap noodles, and packaging inputs, which rose due to supply chain disruptions and geopolitical tensions linked to the Middle East. Analysts noted that price hikes of 20%–40% across major cigarette brands were not sufficient to fully offset the tax increase, suggesting continued near-term margin pressure despite resilient demand.

    Performance across other segments was mixed, with the consumer goods division posting 15% revenue growth and an improvement in EBITDA margin to 11%, while the agri-business segment declined about 16% amid global trade disruptions affecting commodities such as rice, coffee, and leaf tobacco.

  • Japan Review Raises Questions Over HTP Risks

    Japan Review Raises Questions Over HTP Risks

    Health officials in Japan are reviewing whether to tighten regulations on heated tobacco products (HTPs) after a government panel claimed that some devices may produce higher levels of certain carcinogenic substances than conventional cigarettes. The review, which was led by Takeo Nakayama, an epidemiologist at Kyoto University, examined global scientific studies published between 2010 and 2025, and concluded that HTPs are strongly associated with nicotine dependence and cardiovascular disease, while evidence on risks related to cancer, respiratory illness, pregnancy complications, and secondhand exposure remains limited or inconclusive. Researchers also identified potentially harmful chemicals, including furfural and mercury, in some products.

    The findings are expected to inform a broader policy proposal on passive smoking measures later this year as regulators debate whether existing exemptions for heated tobacco products under Japan’s indoor smoking laws should be reconsidered. Japan remains one of the world’s largest markets for heat-not-burn tobacco products, with HTP users estimated to account for roughly 40% of all nicotine consumers.

  • EU Tobacco Scale Doesn’t Always Add Up

    EU Tobacco Scale Doesn’t Always Add Up

    The latest European Tobacco Control Scale released by public health researchers, ranked Ireland, the United Kingdom, the Netherlands, and France at the top, based on criteria such as taxation policies, broad smoking restrictions, comprehensive advertising bans, and greater investment in cessation and prevention programs. Mid-ranked countries such as Germany and Austria were docked for partial policy coverage across key tobacco control measures, while Switzerland and Bosnia and Herzegovina were at the bottom, criticized for less strict regulations, tobacco industry influence, and not fully investing in World Health Organization best practices.

    However, the ranking does not always correspond directly with smoking prevalence outcomes across Europe. While the U.K. and the Netherlands earned their lofty rankings with smoking rates of 10.6% and 11% respectively, top-ranked Ireland has a smoking rate of 17%, with France checking in at 18.2%, both higher than last-ranked Bosnia and Herzegovina with an estimated smoking rate as low as 15.5% according to the Tobacco Atlas 2025 estimate. Switzerland’s smoking rate is 20%, Austria’s is as high as 21%, while Germany’s is as high as 24%.

  • South Australia Reports Record-Low Smoking, Rising Illicit Concerns

    South Australia Reports Record-Low Smoking, Rising Illicit Concerns

    South Australia reported record-low smoking rates as part of its Tobacco Strategy 2023–2027, with daily smoking falling to 7.5% in 2025 from 10.6% in 2020, according to the latest government progress report. Declines were also recorded among younger adults, middle-aged populations, and people living with mental illness, while the average age of smoking initiation increased to 17 years. State officials credited legislative reforms, public health campaigns, and expanded enforcement efforts for progress, while emphasizing ongoing investment in anti-vaping initiatives and illicit tobacco crackdowns.

    However, the report also highlights significant ongoing challenges for the tobacco and nicotine sector. Rising youth vaping rates remain a concern despite stricter regulations, and authorities estimate illicit tobacco and e-cigarette products now account for roughly 55% of Australia’s total market, underscoring the scale of illegal trade and enforcement difficulties. The government signaled that additional reforms targeting illicit supply chains and organized crime are under consideration, suggesting further regulatory pressure ahead for both legal tobacco and alternative nicotine product markets.

  • Malawi Tobacco Farmers Facing 91% Rejection Rate

    Malawi Tobacco Farmers Facing 91% Rejection Rate

    Malawi tobacco farmers are raising renewed concerns over extremely high rejection rates for auction burley tobacco during the 2026 marketing season, with some growers reporting rejection levels as high as 91% at the Lilongwe Auction Floors. Farmers claim the system unfairly favors contract tobacco, which moves more smoothly through sales channels, while independent growers face repeated rejections, mounting transport and accommodation costs, and shrinking profitability.

    Parliamentary Agriculture Committee Chairperson Antony Kamoto acknowledged the challenges and called for contract reforms and greater competition among tobacco buyers, while Tobacco Commission Chairperson Reverend Daniel Gunya said authorities are engaging stakeholders to address the issue. Despite the tensions, Malawi has sold about 19.3 million kg of tobacco worth approximately $40.8 million in the first four weeks of the season, with average prices at $2.12 per kg.

  • A New Direction for ENDS

    A New Direction for ENDS

    ~ What FDA approvals mean for ENDS flavoured tobacco products ~

    The FDA’s decision to authorise flavoured Electronic Nicotine Delivery System (ENDS) products marks one of the most significant regulatory developments the sector has seen in recent years. While tobacco and menthol authorisations had already signalled a gradual shift in regulatory thinking, the approval of mango and blueberry flavoured products suggests the agency is increasingly willing to assess reduced-risk nicotine products through a broader public health lens. Here, Chris Allen, CEO of nicotine testing and regulatory consultancy Broughton, explains the significance of this decision and why it reflects a growing emphasis on evidence-based harm reduction, behavioural science and product safeguards.

    Central to the FDA’s assessment process is its “Appropriate for the Protection of Public Health” (APPH) standard, which requires regulators to weigh the potential benefits for adult smokers against the possible risks associated with youth uptake. Emerging evidence suggests that flavoured alternatives may help some adult smokers move away from combustible cigarettes, particularly those who do not successfully transition using tobacco-flavoured products alone.

    One longitudinal study published via the National Library of Medicine found that adult users of sweet or fruit-flavoured nicotine vaping products were more likely to transition away from cigarette smoking than those using tobacco-flavoured alternatives.

    In draft guidance published in early 2026, the FDA acknowledged that non-tobacco flavoured ENDS products may, “in certain circumstances”, support adult smokers in switching away from combustible cigarettes or increasing quit attempts. However, ENDS products continue to face heightened scrutiny due to historic concerns surrounding youth access, abuse liability and the toxicological considerations associated with inhaled products.

    Importantly, the latest authorisations should not be interpreted as a relaxation of regulatory expectations. If anything, they reinforce the extent to which manufacturers are now expected to integrate public health and compliance considerations into product development at an early stage. For ENDS products in particular, this means fully characterising products from a toxicological perspective, understanding behavioural risk factors and demonstrating that appropriate controls are built into the product itself.

    The FDA’s continued scrutiny of inhaled nicotine products – particularly flavoured variants – means manufacturers must increasingly show not only that products can support adult smokers in moving away from combustible cigarettes, but also that meaningful steps have been taken to restrict youth access and minimise unintended use. This will likely place greater emphasis on access-control technologies and submission-ready behavioural data as regulators continue to refine their expectations around next-generation nicotine products. For developers, regulatory strategy can no longer be treated as a final-stage compliance exercise; they must be incorporated into product design from the outset.

    The latest authorisations may also have implications beyond the US market. While regulatory approaches continue to vary globally, the FDA’s decision reflects a broader shift towards more nuanced, evidence-led discussions around harm reduction and the role alternative nicotine products may play in supporting smoke-free ambitions. Increasingly, the debate is moving away from whether reduced-risk products should exist at all, and towards how they can be appropriately regulated to maximise public health benefits while minimising unintended consequences.

    Ultimately, the significance of these authorisations extends far beyond the approval of two flavoured products. They signal that regulators are willing to consider the full public health picture – including adult switching potential, behavioural evidence and technological safeguards – when assessing alternative nicotine products. For manufacturers that raises the bar for scientific substantiation, product stewardship and regulatory preparedness. However, it also demonstrates that innovation supported by robust evidence and responsible product design can still find a pathway through even the most rigorous regulatory environments.

    As the regulatory environment for nicotine products continues to evolve, manufacturers face growing pressure to navigate increasingly complex submission requirements across multiple international markets. Broughton supports businesses through the product lifecycle, combining scientific expertise with regulatory insight across ENDS, nicotine pouches and other alternative nicotine products. To find out how Broughton can help support your submission, visit its website.

  • PMI Announces Andolina as Next CFO

    PMI Announces Andolina as Next CFO

    Philip Morris International appointed Massimo Andolina as its new Group Chief Financial Officer, effective August 1, succeeding Emmanuel Babeau, who will remain with the company as Strategic Advisor to CEO Jacek Olczak until March 2027 to support the transition. Andolina, currently president of PMI’s Europe Region, has been credited with driving strong smoke-free growth and financial performance across the company’s largest region, while previously leading global operations and transformation initiatives that improved efficiency and supply-chain resilience.

    Olczak described Andolina as a respected leader with deep company knowledge and a strong record in innovation and growth. PMI also praised Babeau’s six-year tenure, during which the company strengthened its smoke-free business, completed the acquisition of Swedish Match in 2022, and increased smoke-free products’ share of net revenues to 43% in Q1 2026.