NJOY Sues FDA Over Flavored E-Cigarette Approval Delays
The ongoing standoff between the vaping industry and the U.S. Food and Drug Administration (FDA) escalated last week when NJOY LLC, a subsidiary of Altria Group, filed suit in federal court in Louisiana. The company accuses the FDA of unlawfully dragging its feet on reviewing applications to market flavored e-cigarettes—applications that NJOY says could help more adult smokers switch away from combustible tobacco.
The Backstory
The dispute dates back to December 2020, when the FDA denied NJOY’s flavored product applications. The denial rested on a single deficiency: that NJOY had not shown the flavored products “would increase the likelihood of complete switching among adult smokers” compared to NJOY’s already-authorized Rich Tobacco and Menthol devices.
But by March 2021, NJOY submitted data showing the opposite—flavored products produced 29% to 68% higher switching rates after six months of use compared to the authorized tobacco and menthol versions. Despite repeated attempts to move the process forward, NJOY says the FDA has remained silent.
What NJOY Discovered
In its lawsuit, NJOY points to documents obtained through a Freedom of Information Act (FOIA) request that raise even more questions about FDA’s inaction.
The FDA’s Office of Science epidemiology staff reportedly concluded that NJOY had adequately addressed the flavor-specific deficiency and that the flavored products were tied to higher cessation rates.
The FDA’s Office of Health Communication and Education also determined that NJOY’s proposed sales restrictions and reporting requirements could effectively mitigate youth-initiation concerns.
Despite these findings inside the agency, no final decision has been issued.
Why This Matters
The lawsuit highlights not only NJOY’s frustration but also broader concerns about the FDA’s handling of Premarket Tobacco Product Applications (PMTAs). The agency faces a massive backlog.
NJOY argues that the FDA’s delays:
- Burden legitimate businesses trying to comply with the law.
- Limit access to products that could help adult smokers switch from cigarettes.
- Distort the marketplace, leaving compliant companies sidelined.
A Sign of Growing Tensions
This lawsuit is just the latest sign of growing friction between the FDA and major industry players. For years, the FDA has struggled to balance the risk of youth use with the potential benefits for adult smokers, but critics argue the agency has leaned too heavily on prohibition and paralysis.
As the case unfolds, the outcome could shape how the FDA handles thousands of pending PMTAs—and determine whether adult consumers will ever have regulated, flavored vaping options on the U.S. market.
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