Archives: Agenda

Moderator: Melis Coraggio, Consultant, King & Spalding LLP

• How can tobacco companies work with regulators and combat the illicit market
• Law enforcement initiatives
• The US Customs and Border Protection (CBP) – latest developments

Moderator: John F.O’Brien, Counsel

• Recap of Successful State Tobacco Tax Refunds & Savings
• Common State Tax Audit Pitfalls
• Future Vape & Tobacco Refund Opportunities
• State Licensing Issues

Interviewee: Gerald J Donnini II, Esq., President, Moffa, Sutton, & Donnini, P.A.

Interviewer: TBC

• Status of PMTA review/high-level metrics
• Efforts to improve the review process (across acceptance, filing, and substantive scientific review)
• Scientific considerations
• Complementary efforts (including MRTP pathway and public education)

• Overview of FDA’s new enforcement-priorities framework: what the guidance does—and does not—change for unauthorized ENDS and nicotine pouch products
• Key eligibility thresholds for lower enforcement priority: accepted-and-filed PMTAs submitted under the post-November 2021 framework, qualifying sPMTAs, and why timely submission under prior deadlines is no longer enough
• Special issues for flavored ENDS: FDA’s additional data-sufficiency requirement, APPH considerations, and the relationship to FDA’s broader flavored-ENDS evidentiary framework
• Practical market implications: FDA’s forthcoming public list, import and illicit-product enforcement, retailer/distributor diligence, and potential conflicts with state PMTA directory laws

• Traces the history of the U.S. oral tobacco category, from traditional smokeless rituals to the modern segment.
• Highlights of emerging trends and new developments are currently shaping the industry.
• Showcases how Black Buffalo honors tobacco traditions while offering “no-compromise” products for the modern consumer.