TPE 2024 and recent news - February 5, 2024

Issue # 02

I had the opportunity to attend the Total Product Expo 2024 in Las Vegas last week. Chemular hosted an educational event at TPE titled Fortify Your Future. This event brought together many manufacturing, scientific, regulatory and legal experts in the field of nicotine, tobacco and harm reduction. The event provided a comprehensive overview of the current state of the industry as well as strategies to minimize the damage being inflicted by illicit product distribution and incoherent regulatory decisions. Thoughtful consideration was provided by knowledgeable stakeholders to where the industry might be headed in the next several years. I saw many former colleagues and friends for the first time after probably the most devastating 18 months for business closures and job losses in the industry. The future does, in fact, belong to those who show up and it was refreshing to see so much enthusiasm even after so much setback. Here is a rundown of my high-level takeaways from several of the presentations.

• Industry Outlook:

  • Regulatory, business, and operating environment insights were provided by Chris Greer from TMA.

  • Discussion on flavors, menthol bans, and the impact of political changes on regulations (pendulums swing both ways).

• Four Pillars of PMTA Strategy by Lillian Ortega:

  • Legal considerations, scientific foundations, manufacturing processes, and marketing strategies discussed.

  • Emphasis on abuse liability, brand reputation, and engaging in the PMTA process.

  • Compliance is slow but over 300 warning letters issued in 2023 which is higher than previous years.

• Application Pitfalls by Stacy Ehrlich:

  • Detailed stages of FDA application failure, from refuse to file, refuse accept to deficiency letters.

  • Emphasis on the importance of switching studies in PMTAs now.

• Essential Values of Good Suppliers by Bonnie Coffa and Mike Bond:

  • Criteria for lab selection and the consequences of wrong testing.

  • Changing suppliers considerations and transition planning to new suppliers is important.

• Panel Discussion:

  • Pain points for clients include vague communication with FDA CTP, compliance for new regulations introduced after submissions and incentives being backwards. The cost/benefit ratio is out of order.

  • Tech stack at FDA CTP is improving to include more listening sessions and industry being considered as stakeholders rather than victims of the process.

• Marketing and Product Intelligence by Tim Phillips:

  • Overview of disposable vape market trends.

  • Insights into intoxicating hemp-derived cannabanoids (IHDC) and THC caps in hemp products.

• Making the Switch by Brad Seipel:

  • Overview of innovation in the nicotine market.

  • Survey-based research insights and considerations for different consumer demographics.

  • The last 10-15 years have been an explosion of innovation after years of stagnation in the industry.

• Creating Great Products in an Increasingly Regulated Market by Henry Sicignano:

  • Success story of creating Spree Bar using Metatine, a non-nicotine alkaloid.

  • Emphasis on rechargeable and reusable technology.

• The Growth of Nicotine Pouches and other Innovative Products by David O’Neill:

  • First-mover advantage is a thing in the nicotine pouch category.

  • Comparison of mature vs nascent markets in the US versus EU.

  • The impact of AI on product development of flavor combinations in the market.

• FDA Challenges and Practical Implications by Bryan Burd:

  • Overview of the various stakeholders at play in the market, including FDA, lawmakers, industry, and illicit market participants.

  • Strategies for navigating PMTA, NTN, and new applications include submitting minimum viable product PMTAs with rolling amendments and keeping FDA CTP informed of ongoing studies and open lines of communication with RHPMs.

UBS released a report titled - Global Tobacco - Tobacco’s Transformation likely to slow. The key takeaway is that next-generation products (NGP) contribution revenue in industry, currently around 20% of total revenue per year, is likely to slow over the next 5 years. This report is an equities analysis of worldwide nicotine and tobacco industry trends. Very dense with information and highlights the evolution of NGPs over different geographies. I found this chart to be extremely helpful when keeping track of who’s manufacturing what in the NGP space.

PMTA

FDA Seeks $20K+ Fines Against Retailers Selling Unauthorized Youth-Appealing E-Cigarettes (January 30 2024)

FDA has issued complaints for civil money penalties (CMPs) against 21 brick and mortar retailers for the sale of unauthorized Esco Bars e-cigarettes, a popular youth-appealing brand.

Takeaway: Enforcement efforts continue to accelerate with 22 warning letters issued so far in 2024.

Policy

Opinion

Altria: The Great Race (February 4, 2024) - Devin Lasarre

Recent Publications of Interest

ENDS PMTA Marketing Denial Order Litigation Appeals Tracker (non-exhaustive)

This is an ever-evolving list of appeals in the various U.S. Circuit Court of Appeals, with the most recent (as of this publishing) being the Shenzhen IVPS Technology Co., Ltd., (SMOK brand) appeal in the 5th Circuit Court of Appeals on January 19, 2024.

Select Dates for Acceptance/Filing Review for Various PMTAs as of January 23, 2024

Covered PMTA Timelines

Average time from submission to decision is 2.5 years.

Resource Links