Recent Regulatory Intelligence Recap

TRADE PRESS SUMMARY:

Key Developments:

1. Regulatory & Policy:

• Multiple countries (UK, Gibraltar, Jersey) announcing plans to ban disposable vapes

• New tax measures being implemented on vaping products in UK, Poland, and Italy

• France announcing plans to ban nicotine pouches

• FDA updating import alerts and warning against "smart" e-cigarettes

2. Market Performance:

• Altria Q3 revenue slightly down (-0.4%) to $6.3B, with NJOY gaining market share

• Japan Tobacco (JT) reporting Q3 net profit down 11.5% YoY to $900M

• BAT Malaysia showing positive results with 14% profit increase driven by Vuse sales

• Turning Point Brands reports increased sales and profits.

• Haypp Group experiences a 25% rise in sales.

3. Illicit Trade:

• Multiple reports of illegal vape seizures across countries

• Growing concerns about black market following flavor bans

• The Philippine Finance Department estimates a $900 million annual impact from tobacco and e-cigarette smuggling, with recent seizures valued at $14 million.

PUBLICATIONS SUMMARY:

Key Research Themes:

1. Health Impact Studies:

• New research on vaping's effects on cardiovascular health

• Studies on nicotine's impact on brain development

• Research on e-cigarette use in specific populations (older adults, youth)

2. Behavioral Research:

• Multiple studies on quitting behaviors and cessation effectiveness

• Research on social media's influence on vaping behavior

• Studies on stress, anxiety, and depression related to e-cigarette use

CLINICAL TRIALS:

Active Focus Areas:

• Youth vaping prevention

• Smoking cessation programs

• Nicotine delivery systems evaluation

• Behavioral interventions for quitting

Swedish Match General Snus Modified Risk Application Renewal Authorized

The Modified Risk Claim:

The FDA granted an 8-year authorization renewal (versus original 5-year) based on:

• Well-established health risk evidence

• Continued low youth initiation risk

• Demonstrated appropriate consumer understanding

• Fulfilled post-market requirements

• Need for longer assessment period of switching behavior

Consumer Comprehension (from the Patterns of Use Study):

1. Understanding of Risk Reduction:

• 69.8% of baseline participants correctly understood the basic risk reduction message

• Understanding remained high (72.5% to 77.8%) across all study waves

• Comprehension levels aligned with or exceeded those seen in peer-reviewed literature

2. Understanding of Continued Health Risks:

• Consumers understood General Snus still carries health risks

• For mouth cancer risk perception:

  • 34.9% perceived low risk

  • 34.6% perceived moderate risk

  • 13.1% perceived very low risk

• For heart disease risk perception:

  • 39.1% perceived low risk

  • 34.1% perceived moderate risk

  • 18.1% perceived very low risk

3. Understanding of Exclusive Use Requirement:

• Among those who understood the basic claim (69.8% of participants):

  • 80.3% correctly understood they must use "zero cigarettes" to reduce risk

  • This understanding remained stable across study waves

  • Participants perceived dual use (cigarettes + snus) as more harmful than exclusive snus use

4. Study Limitations:

• All participants were General Snus users at baseline

• Significant study attrition occurred

• Participants weren't shown the claim during the study to avoid biasing the sample

• Demographics differed somewhat from general population of cigarette smokers

The FDA concluded that the evidence shows:

• Most users understand the relative risk reduction compared to smoking

• Users understand the products still pose health risks

• Users comprehend the need for exclusive use to achieve risk reduction

• The claim continues to be "understood by consumers in the context of total health and in a manner that could reduce individual risk and benefit population health"

Timeline to Authorization

July 17, 2023

• Swedish Match U.S.A., Inc. submitted MRTP renewal application

December 1, 2023

• FDA made MRTPA renewal available for public comment

June 2024

• TPSAC meeting held to discuss renewal application

• Committee discussed health effects, marketing strategy, and recommendations for future post-market surveillance

August 14, 2024

• Public comment period closed

• FDA received 11 unique submissions:

  • 10 contained relevant comments

  • 1 was not relevant

  • Comments focused on legal issues, consumer understanding, study methods, and marketing concerns

November 6, 2024

• Environmental assessment and FONSI (Finding of No Significant Impact) completed

November 7, 2024

• FDA issued Modified Risk Granted Order (MRGO)

• 8-year authorization granted

Notable timing elements:

• Total review time: approximately 16 months

• Public comment period: approximately 8.5 months

• TPSAC meeting held about 6 months after submission

• Authorization granted about 3 months after public comment period closed

Tobacco Online Policy Seminar - November 1, 2024

The seminar led by Dr. Benjamin Toll, titled “E-cigarettes in the US: Use by Physicians, Prevalence, Intentions to Quit, and Findings from Several Trials Investigating Methods for Quitting,” provided a comprehensive look at e-cigarette use, especially among young adults, and presented research on cessation methods. Here’s an overview:

1. Speaker Background:

   • Dr. Toll, a prominent figure in tobacco treatment, shared his extensive experience working in public health and advocacy, particularly in treating tobacco dependence.

2. Healthcare Considerations for E-Cigarettes:

   • Dr. Toll discussed the importance of behavioral counseling and FDA-approved medications as first-line treatments for tobacco cessation. He noted that for individuals unable to quit smoking through these methods, e-cigarettes might serve as an alternative to reduce exposure to harmful chemicals.

3. Focus on Young Adults:

   • The seminar emphasized the significance of e-cigarette use among 18-24-year-olds, a demographic the tobacco industry targets due to its potential for long-term brand loyalty.

4. Studies on Cessation Intentions and Efforts:

   • Data from the PATH study (a large, nationally representative survey) was reviewed to illustrate patterns in e-cigarette use and intentions to quit. Findings indicated a substantial interest in quitting, though success rates varied across user types (e.g., dual users versus e-cigarette-only users).

5. Pilot Studies on Cessation Aids:

   • Dr. Toll shared results from two pilot studies:

     • Nicotine Replacement Therapy (NRT): A trial using NRT (patches and lozenges) showed modest success in helping e-cigarette users quit.

     • Varenicline vs. Placebo: This study, conducted at two sites, indicated that varenicline could be effective for e-cigarette cessation, with significant quit rates observed at the 8- and 12-week marks.

6. Dual Users:

   • Findings suggested that dual users (those who smoke both cigarettes and e-cigarettes) had more difficulty quitting and might require higher NRT doses. This highlighted the need for more robust cessation interventions for this group.

7. Future Directions:

   • Upcoming studies plan to expand on the varenicline trial with a larger sample size and include biological markers of oncogenesis. These trials aim to refine and validate effective cessation strategies for those dependent on e-cigarettes.

8. Summary Points:

   • Dr. Toll concluded with key takeaways: FDA-approved methods remain the primary recommendation, but e-cigarettes could serve as harm reduction for persistent smokers. The urgency for quality research in e-cigarette cessation was underscored, as the popularity of e-cigarettes continues to rise in the U.S.

The seminar emphasized both the potential role of e-cigarettes in harm reduction and the critical need for effective cessation support, particularly for young adults and dual users​