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Key Insights from InterTabac and TSRC
Nicotine
Oct 1, 2024 | Published by Phil Saunders
Nicotine, Events
The recent TSRC and InterTabac conferences have sparked important discussions surrounding the evolving landscape of tobacco products, regulatory standards, and harm reduction strategies.
FDA’s Focus on Toxicology and Constituent Identification
At TSRC, the FDA’s Matthew Farrelly emphasised a shift in focus towards toxicology, particularly around individual constituent identification and Excess Lifetime Cancer Risk (ELCR). While traditional in-vitro assays are still necessary, Farrelly highlighted the need for greater scrutiny of ingredients rather than just whole mixtures. Comparisons of ELCR to reference cigarettes and other products, were a key point of discussion.
Todd Cecil, FDA Director, added that applicants should focus on presenting robust, validated quantitative methods for assessing product analytes, with a strong emphasis on risk mitigation to discourage youth use and encourage adult switching. Flavours pose significant concerns, and manufacturers need substantial evidence of adult benefits to offset youth risks.
The Role of Flavours in Youth and Adult Preferences
The connection between youth and adult preferences for flavours was humorously highlighted by Jas Ahluwalia, suggesting that if kids prefer flavours, they likely carry these preferences into adulthood. This aligns with growing concerns about how flavours in e-cigarettes and other products could influence both youth initiation and adult switching.
Addressing Misconceptions and Perceptions
Chris Junker from RAI pointed out a troubling shift in public perception, with 80% of people now believing that ENDS (electronic nicotine delivery systems) are as harmful or more harmful than traditional cigarettes. This misconception extends even to healthcare providers, many of whom still incorrectly believe nicotine causes cancer. Junker stressed the importance of correcting these perceptions to maximise the public health impact of harm reduction strategies.
Innovation in Product Categories
At both conferences, nicotine pouches emerged as a hot topic. TSRC saw significant discussion around pouches, with presenters stressing that they occupy a vital step on the tobacco harm reduction continuum. They are perceived as less harmful and are gaining traction among adult users. However, high nicotine levels in some pouches (up to 150 mg) pose a potential risk to the category’s reputation.
There was also considerable discussion about the lack of defined FDA categories for pouches, with various types of nicotine sources (TDN, NTDN, OTDN) complicating the regulatory landscape. Coresta’s recommendation is to define pre-portioned nicotine pouches more clearly.
The Expanding Pouch Market and Harm Reduction Portfolio
At InterTabac, the rapid growth of the pouch market was echoed, with many vape brands launching their own pouch variants. This category is increasingly seen as a key player in the harm reduction space, alongside other heated tobacco products (HTP) and oral nicotine alternatives. Product stewardship remains a crucial factor in minimising health, safety, and environmental risks.
Legal and Regulatory Challenges
Global Health Expert, Derek Yach's TSRC presentation drew parallels between the tobacco industry and the food sector, suggesting that similar strategies could help abolish smoking. Meanwhile, Dr Brian Yagi focused on legal aspects, delving into cases like Wages & White Lions and questioning what Congress intended with current regulatory frameworks. The FDA’s stance on flavours remains a contentious issue, with industry leaders calling for clearer guidelines and more transparent communication from the agency.
Growing Interest in Alternative Nicotine Products
Both conferences highlighted the growing number of alternative nicotine products entering the market, particularly in the oral nicotine and botanical segments. Companies like JTI, Lucy, and Alchem are exploring these spaces, pushing innovation, and broadening the harm reduction portfolio. These developments are expected to shape future marketing strategies as manufacturers look to provide adult smokers with more options.
Conclusion
The TSRC and InterTabac conferences underscored the complex and evolving nature of the tobacco industry. With new product categories like nicotine pouches gaining momentum, and ongoing discussions about flavours, public perceptions, and regulatory challenges, the industry is at a critical juncture. The focus on harm reduction, alongside innovation and clearer regulatory guidance, will likely shape the future of tobacco and nicotine products in the coming years.
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