The ARAC, an American behavioral institute, CORESTAC 2024 conference presented the latest research conducted under the FDA-regulated PMTA framework, showing that nicotine bags are less attractive to non-smokers regardless of taste, further supporting oral nicotine’s feasibility. Discusses how these findings affect the future of the industry in the current nicotine bag market disruption, including competition between compliant tobacco companies and vape players, as well as the emergence of grey markets and counterfeit products, which promote the need for higher compliance.
Introduction
In the rapidly evolving market for new tobacco products, oral nicotine packs are considered a promising solution to reduce health risks. According to the latest insights from the Industry, the global oral nicotine bag market is expected to soar to $5.5 billion in 2023 by 2033. Major tobacco companies including Philip Morris International (PMI), including Altria, dominate this rapidly expanding market. At the same time, the supply chain of Chinese vape companies, in particular, is rapidly entering the field of nicotine bags, trying to seize this growth opportunity and increase the competitiveness of the field.
Currently, the United States is the largest market for nicotine bags and a barometer of the global market. While the public increasingly values the potential of nicotine packs in terms of reducing health risks and convenience, they are increasingly concerned about the appeal of no n-cigarette customers, especially teenagers. Under the regulations of the FDACTP (Cigarette Commodity Center), businesses are required to apply for a new Cigarette Commodity (PMTA) to conduct a Cigarette Commodity Perception and Intent in Link (TPPI) study.
At the CORESTA 2024 conference. ARAC presented a key TPPI study on public perception of the Oral Nicotine White Bag Project (ONWP). Studies have shown that non-customers have a lower intention to try or use ONWP compared to smokers.
Three key findings from the study: Support the argument for oral nicotine white bags
1. Compare the intentions of customers and non-customers:
A key conclusion of the study is that ONWP attempts to compare intentions between users and non-users. Non-customers were significantly less likely to try flavored and tobacco-flavored ONWP than customers. An important aspect of the research also discusses whether taste or tobacco taste is more appealing to non-customers. The findings showed that for non-users, the intention to try or use ONWP was similar between flavorings and tobacco-flavored products.
2. Relative risk perception:
Both customers and non-customers perceived similar health risks across the nicotine bag category, including flavored ONWP and tobacco-flavored ONWP. Most participants believed that the perceived health risks of ONWP were lower than those of tobacco; Others considered the risks of using ONWP to be comparable to smoking. This indicates that ONWP is rated more positively in terms of risk perception.
3. Reasons for using ONWP:
According to the survey, its main appeal is that it is less harmful than the perceived harm of smoking. Both user and non-user groups recognize that “using ONWP is less harmful to me than smoking” as the main reason for using ONWP. While the top reasons for using ONWP vary across populations, this shared perception of harm reduction always occupies a central position.
How to perform ARAC Tobacco Tar Bag TPIPI in FDA compliance?
The study was conducted from October to November 2023 and involved 1,423 U.S. adults, including 432 smokers and 991 non-smokers. Participants were recruited through an online selection process to ensure they met specific inclusion criteria. The study focused on adults aged 21 to 65.
The study tested three oral nicotine white packs (ONWP): the regular version, the flavored version, and the tobacco-flavored version. After viewing the product stimulus, participants were asked about their intention to try, their intention to use, or the probability of switching to the product, as well as their perception of the associated risks.
The study design explored two key levels:
- Cigarette customers versus Non-customers: Study how cigarette users and non-customers view ONWP products, focusing on their intentions to try and use the product and their perception of risk.
- Intentions and risk attitudes: Study and assess participants’ behavioral intentions (whether they would try or use ONWP normally) and their attitudes toward perceived risks associated with using these products.
Research impact: Analyze misconceptions, inform FDA policy and guide industry innovation
ARAC’s TPPI study shows that the appeal of nicotine packs to non-smokers is a key moment. By addressing longstanding misconceptions, the study provides a clearer picture of the role of such products in harm reduction and public health.
This study provides a key insight into controlling decision-making, showing that ONWP can significantly reduce health risks for smokers and minimize risks for non-smokers. This finding meets the FDA’s “Suitability to Protect Public Health” (APPH) criteria, suggesting that ONWP may meet the criteria for PMTA approval.
The study also showed that the nicotine bags met FDA standards, suggesting that the compliance process could be expedited. This will reduce the grey market and counterfeit products and create a more transparent and regulated market. Businesses committed to compliance will benefit. In addition, research has shown that flavored nicotine packs are less attractive to non-smokers than tobacco flavors, which could spur innovation in flavoring development, but only if scientifically validated and in compliance with regulatory standards.
Study limitations: Lack of data on adolescents
A limitation of the study is that it focused only on adult participants and ignored a key group: teenagers. The smell of cigarette products is often thought to appeal to younger users. However, the study’s argument – which suggests that taste is less attractive to non-smokers – is based only on adult data. This is a significant gap because teens who are influenced by social and developmental factors may respond differently to condiments.
Introduction to ARAC
ARAC is the nation’s leading behavioral science research firm, providing design, implementation, and scientific, normative, and customized research to support manufacturers, regulators, and industry consultants. Their expertise includes consumer-focused research services related to product development and innovation and regulatory science supporting market authorization applications, with success in U.S. product authorization and applications.
ARAC 5 and 6 MODULE studies include label/claim development and understanding of randomized trial verticals, and practical applications. TPPI and post-market monitoring systems, usability testing, and clinical/behavioral studies.
ARAC is the recipient of the Gold Leaf Award for “Best Service in the Industry 2024.” It has full-time in-house psychologists, behavioral scientists, statisticians, survey methodologists, and medical monitors, and offers customized research solutions with unparalleled integrity and an exceptional user experience. (Credit: ARAC)
