Archives: Agenda

1)         Recent Actions

• Review Actions (MGO,MDO, Deficiency Letters, RTA, RTF, Flavored ENDS, Etc.)

2)         Additional resources/ Transparency

• Memo posting
• Searchable Products Database
• Public meeting
• Further discussion of APPH

3)         Questions FDA would like some feedback on

• What do you need to hear from us?
• What scientific guidance do you need the most?
• How do you want to engage with us?

• The TCA was a landmark event that for the first time, established a comprehensive regulatory system with the goal of reducing tobacco-related death and disease as the proper framework for regulation
• As we approach the 15th anniversary of the TCA’s enactment—and the inception of FDA’s Center for Tobacco Products—it’s time to reflect on what’s working well at the Center and where there are potential opportunities for improvement
• Regulations and Guidance: Do stakeholders have clarity on the Center’s current thinking, expectations, and requirements?
• Timely, Clear, and Consistent Application Review: Is the current application process fostering innovation and promoting tobacco harm reduction?
• Compliance and Enforcement: Has the Center established a coherent compliance framework for responsible industry members that has resulted in a well-regulated marketplace?
• Communication and Education: Has the Center provided clear, science-based, and relevant communications to public health and adult smokers on the continuum of risk and the misperceptions of nicotine?

• PMTA applications update
• Update on the ban on menthol
• Upcoming rulemaking: flavored vapes, flavored disposable vapes, very low nicotine cigarettes (VLNCs), salt nicotine pouches
• Are any of the products currently on the market likely to get banned in the near future?
• How the FDA is responding to serious youth-vaping concerns

• Understanding the importance of identity and age verification
• What is involved in using an age-verification app
• Unlocking devices using a Bluetooth connection
• Ensuring compliance with FDA rules and regulations

Speaker Hosted Roundtables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Each roundtable session lasts for 40 minutes, and delegates may attend up to 2 roundtables.

ROUNDTABLE 1: Opportunities for Stronger, More Effective, and Streamlined Enforcement

Stronger Enforcement

• How can CTP leverage its existing enforcement toolkit to strengthen its enforcement?
• What’s the role of Civil Money Penalties, and should they be enhanced?
• How can CTP improve enforcement up the supply chain, including at the ports?

More Effective Enforcement

• How can CTP implement more effective enforcement?
• Are there learnings from other Centers, e.g., infant formula, heparin, that CTP could leverage?
• Can AI play a role in post inspections to effectively verify products entering the ports?

Streamlined Enforcement

• How can CTP streamline its enforcement activities to be more agile?
• Is direct seizure authority possible for CBP?
• Are there other improvements that would allow CTP to minimize the time between warning letter and enforcement or judicial action, e.g., seizures, injunctions, or civil monetary penalties?

Hosted by: Angela Ho-Chen, Managing Counsel – Regulatory, Reynolds American

ROUNDTABLE 2: Non-Internet Connected Youth Access Prevention Technology to Nicotine Products

Youth Access Prevention Technologies are critical for nicotine products to mitigate risks to minors and assist transitioning adult smokers. While many suitable technologies assist, industry proposals have focused on Bluetooth LE solutions. Yet critics have pointed out issues related to data privacy of user information and usability issues for adult smokers. This round table reviews the current public discourse around youth access and discusses alternative solutions to Bluetooth.

• Sources of youth access and adult smoker demographics
• Technological solutions to solve the problem of youth access while not overburdening smokers
• Unique challenges to Bluetooth and internet-connected solutions in the nicotine industry
• Apple store ban on nicotine apps causes usability issues for adult smokers and barrier to trial
• Data privacy concerns for collected user data on company apps
• Propensity of adult smokers to adopt technology may dramatically impact switching rates to ENDS
• Access prevention technologies tailored to continuum of product appeal (tobacco vs flavors)
• Emerging field of youth access solutions to disposable ENDS and oral nicotine products

HOSTS:

Martin Steinbauer, Co-founder, SMOOD