On June 21, 2024 the FDA granted marketing authorization for four menthol-flavored NJOY vaping products. These products include the NJOY ACE menthol pods in 2.4% and 5% nicotine strengths, and the NJOY DAILY Menthol (4.5%) and NJOY DAILY EXTRA Menthol (6%). This decision marks the first instance in over two years that the FDA has authorized any vaping products, and notably, these are the first non-tobacco flavored vapes to receive such approval. 

 A Long-Awaited Authorization 

The journey to this authorization has been lengthy and fraught with challenges. NJOY submitted their marketing applications before the September 2020 deadline, resulting in a four-year review process. In contrast, millions of flavored vaping products from smaller manufacturers were swiftly denied review or received marketing denial orders (MDOs) after what many describe as inadequate and cursory evaluations by the FDA. 

Regulatory and Legal Implications 

Brian King, the Director of the FDA’s Center for Tobacco Products (CTP), emphasized the rigorous evidence required to obtain marketing authorization. "This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it," King stated. However, this decision raises questions about the evidence NJOY provided that other manufacturers did not, especially considering previous MDOs issued for similar menthol products from other brands like R.J. Reynolds’ Vuse and Logic. 

These MDOs have led to numerous legal challenges, with cases being heard in federal courts. Notably, the Third Circuit Court of Appeals upheld an MDO for Logic, prompting a petition to the Supreme Court. The FDA’s decision on NJOY’s menthol products came just a day after the Supreme Court held a conference to discuss several petitions challenging the FDA’s regulation of the vaping market, indicating the ongoing complexity and contention in this regulatory landscape. 

Financial Windfall for Former NJOY Owners 

In a twist, the authorization of the NJOY ACE menthol pod in 5% strength triggered a $250 million payout to NJOY’s former owners. This contingency was part of the sale agreement when NJOY was acquired by Altria Group, the manufacturer of Marlboro, for $2.75 billion in March 2023. This bonus highlights the high stakes and financial implications tied to FDA authorizations in the vaping industry. 

The FDA’s Growing “Authorized List” 

The addition of the four NJOY products expands the FDA’s list of authorized e-cigarettes. However, this list has been criticized for its deceptive inclusions, such as heated tobacco products and duplicate entries. Currently, all authorized products are manufactured by companies owned by major tobacco corporations, including Logic (Japan Tobacco), NJOY (Altria), and Vuse (R.J. Reynolds). 

As of now, the FDA has not authorized any products in flavors other than tobacco or menthol, nor has it approved any open-system (refillable) products or bottled e-liquids. This lack of diversity in authorized products has driven numerous small American manufacturers to challenge the FDA’s denial orders in federal court. 

The Future of Vaping Regulation 

The FDA’s recent authorization of NJOY’s menthol products signifies a pivotal moment in the regulation of vaping products. While it demonstrates that obtaining marketing permission is possible with adequate scientific evidence, it also underscores the disparities and challenges faced by smaller manufacturers. As legal battles continue and regulatory frameworks evolve, the vaping industry awaits further clarity and fairness in the FDA’s decision-making processes. 

For consumers and industry stakeholders, these developments highlight the importance of staying informed about regulatory changes and the ongoing legal landscape that shapes the availability and variety of vaping products in the market.