In a significant development for the next-generation nicotine industry, the U.S. Food and Drug Administration (FDA) has recently issued marketing orders (MOs) for four menthol-flavored e-cigarette products. This is a pivotal moment as it marks the first time the FDA has approved nontobacco-flavored products through the premarket tobacco product application (PMTA) pathway. Chris Allen, CEO of PMTA specialist Broughton, provides insights from the documentation and highlights key learnings from the technical project lead (TPL) review.
Introducing the New Menthol Products
The products that received MOs include Altria’s Njoy Ace Pod Menthol at 2.4 percent and 5 percent nicotine levels, as well as the Njoy Daily Menthol at 4.5 percent and the Njoy Daily Extra Menthol at 6 percent. The Ace products feature sealed pod-based systems, while the Daily products are disposable e-cigarettes with a prefilled, nonrefillable e-liquid reservoir. Presently, Njoy Ace stands as the only pod-based e-cigarette with such an MO.
A Big Step for Tobacco Harm Reduction
The FDA’s decision to grant MOs for menthol e-cigarettes opens new possibilities for tobacco harm reduction, offering millions of adult smokers in the U.S. regulated alternatives to smoking. This approval could lead smokers to choose these safer options over illicit products. It’s crucial to note, however, that these products have been on the market for eight years, highlighting the need for the FDA to expedite the PMTA process to keep up with evolving consumer behaviors.
The PMTA Process
The PMTA process is comprehensive, requiring manufacturers to demonstrate that their product is “appropriate for the protection of public health” (APPH) as mandated by the Tobacco Control Act. To date, 27 products and devices have received marketing orders, with a full list available here. The approval of these menthol products shows that meeting the PMTA standards is possible with high-quality data and products.
What Can We Learn from These Products?
Each PMTA is evaluated individually, and the MO granted to these Njoy products is specific to them. This approval provides valuable lessons for the industry, particularly highlighting the FDA’s recognition of the additional benefits of menthol flavor in helping adult smokers transition away from combustible cigarettes (CCs). This benefit was deemed to outweigh the potential increased risk of youth usage.
Reducing the Risk of Youth Use
The approval process included significant considerations about minimizing youth appeal. The FDA emphasized the importance of stringent marketing and access restrictions to mitigate the risks associated with flavored ENDS. For these menthol products, the agency noted the necessity of robust evidence showing their benefit to adult smokers, including cessation or significant reduction in CC use.
Comparisons from Adult Smokers
Data from a longitudinal cohort study highlighted that the menthol Njoy Daily products had higher rates of complete switching from CCs compared to their tobacco-flavored counterparts. These findings underscore the potential public health benefits of these menthol products in aiding smoking cessation.
Conclusion
The FDA’s authorization of these menthol ENDS underlines the potential for nontobacco flavors to play a role in reducing smoking rates among adults while managing risks to youth. This landmark approval could pave the way for future approvals of flavored electronic nicotine-delivery systems.
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