Four Takeaways From TPE 2024
LAS VEGAS — Total Product Expo (TPE) 2024 returned to Las Vegas in late January, bringing together hundreds of manufacturers, distributors and independent retailers for the largest TPE in the event's history.
In addition to a two-day expo, which spanned two floors at the South Hall at the Las Vegas Convention Center, this year's show saw the return of education sessions. The 12 sessions and two Q&A panels covered topics ranging from the ever-changing legislative and regulatory environment to harm reduction, the future of flavors in the tobacco and nicotine space, and successfully working with the U.S. Food and Drug Administration (FDA).
Here, Convenience Store News highlights a few top takeaways from the event:
1. On Solid Footing
As more manufacturers explore innovation to move away from a combustible tobacco product future to one focused on harm reduction, filings of premarket tobacco product applications (PMTAs) with the FDA will only increase. As noted by Lillian Ortega, regulatory consultant with Chemular, there are a lot of negative feelings around the PMTA process currently. Turning the negative experience into a positive one starts with a sound PMTA strategy, she said.
Important to keep in mind, according to Ortega, is that a robust PMTA strategy is not only about a company's current products, but also about how the strategy will evolve to meet ever-changing regulations.
Ortega explained that there are four pillars of a sound strategy:
- Legal considerations: Start with knowing what is required; don't give the FDA the opportunity to not move the application to scientific review.
- Scientific foundation: There are two pieces: nonclinical testing and clinical testing. Show the FDA the potential health risks not only to users, but also non-users.
- Manufacturing process: Be prepared for inspection and any questions the agency may have.
- Marketing: A marketing plan is not set in stone; it should be fluid and address the labeling, advertising and media a company plans to use.
Importantly, Ortega noted, these pillars are not developed in silos. "Having a fluid and adaptable strategy enables you to pivot if the regulatory environment shifts," she said.
[Read more: Multiple Factors Are Driving an Uncertain Future for Tobacco]
2. Pain Points
The PMTA process draws a lot of feelings to the surface and, as already noted, some of those feelings are not good. Sitting on a question-and-answer panel with other speakers at TPE, Ortega cited changing FDA regulations and the delayed review process as being among the pain points of the PMTA process.
Stacy Ehrlich, an attorney with Kleinfeld Kaplan & Becker LP, added that the statutory standard for an application approval — the protection of public health — is very vague. Additionally, there is a lack of effective enforcement, which has lead to an uneven playing field. "If you are trying to do the right thing, there is no incentive," she said.
Adding to the pain points from industry circles, Tobacco Manufacturers' Association President and CEO Chris Greer explained that uncertainty is driving a lot of the decisions to do something and also not do something.
Along those same lines, Labstat International President Mike Bond said many companies are weighing the cost vs. the payoff. Spending money to create and submit a PMTA does not guarantee a positive outcome, the panelists agreed.
3. Trending Now: New Nicotine Products
Despite the largely negative view of the regulatory environment in the United States, new nicotine products are posting impressive growth in the market, according to Tim Phillips, CEO and president of Tamarind Intelligence, a market research firm.
In 2023, the novel nicotine market in the U.S. was valued at $60 billion and counted more than 100 million users. This market is mostly focused on vapor products, but nicotine pouches are growing, he said, pointing out that nicotine pouches are seen as a crossover product with vapor product users.
On the global level, the novel nicotine category is not experiencing much growth in Latin America, but there is "a massive amount of potential" considering the high number of cigarette smokers there, Phillips explained.
Elsewhere, Europe and Asia are both large heated-tobacco markets. These products first took off in Japan and though many were skeptical that the products would do well in other markets, the latest numbers are proving otherwise, he said.
Whether it's vapor products, nicotine pouches or heated tobacco, there is massive headroom, Phillips said. "When you are bogged down by the PMTA process, remember this sector is really lively," he advised.
4. Filling the FDA Gap
Just as some states and municipalities have given up waiting for the FDA to take federal action on flavored tobacco products, a small — but possibly growing — number of states are also taking matters into their own hands when it comes to communicating which products retailers can legally sell.
The Reagan-Udall Foundation recently conducted a review of the FDA's Center for Tobacco Products (CTP) and among its findings, the report recommended the CTP use public communication to do a better job to provide greater transparency about its approach to compliance and enforcement, including posting and disseminating a list of legally marketed products, according to David Spross, executive director of the National Association of Tobacco Outlets.
In the meantime, four states have passed legislation calling for a vapor directory. These directories, Spross explained, are lists of products that retailers in each state are legally allowed to sell. If a product is not on the list, a retailer cannot sell it. The vapor directories bring clarity in the absence of information from the FDA.
Today, the states with vapor directory legislation on the books are Alabama, Louisiana, Oklahoma and, most recently, Wisconsin. In Alabama, the state directory also includes alternative tobacco products.
The state directory in Louisiana is currently on hold following a legal challenge, and the Wisconsin directory is in the early stages of development with an expected go-live date of mid-2025, Spross said.
More states are mulling vapor directories this year.
TPE 2024 took place from Jan. 31-Feb. 2 at the Las Vegas Convention Center. Chemular sponsored the education sessions.
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