The FDA has denied authorization for two menthol-flavored Vuse e-cigarette products from R.J. Reynolds, citing insufficient evidence they benefit public health. The decision signals tighter regulation of menthol vaping amid youth addiction worries.
On Tuesday, the U.S. Food and Drug Administration (FDA) issued marketing denial orders for two menthol electronic cigarettes made by R.J. Reynolds Vapor Company. The agency ruled the applications failed to demonstrate the potential public health benefits outweigh risks.
Specifically, the FDA rejected the Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5% products. However, other Reynolds menthol e-cigs remain unaffected. This article examines the FDA’s reasoning and potential implications.
Concerns Around Youth Appeal
The FDA based its ruling on a lack of adequate scientific evidence that adult smoker transition benefits justify menthol vaping’s risk for youth. Menthol’s flavor helps mask harshness and enhances palatability. This raises the product’s appeal among adolescents and likelihood of addiction according to regulators.
Nearly 18% of high school students reported current e-cigarette use in 2022. Among middle and high school e-cigarette users in 2021, over 28% opted for menthol flavored varieties. Preventing underage adoption remains a top FDA priority.
Reynolds can resubmit applications addressing issues identified by the agency. For now, the company said it will seek an immediate stay of enforcement while pursuing options to keep offering the menthol products to adults. Reynolds believes they play a critical role in migrating smokers away from riskier combustible cigarettes.
Review Process and Standards
The FDA announcement comes amid the agency’s ongoing review of over 6 million deemed new tobacco product applications submitted by a September 2020 deadline. This includes e-cigarette devices and flavored vape liquids first hitting the market after 2016.
To secure regulatory clearance, companies must provide scientific data showing the product:
- Is appropriate for public health protection
- Will significantly reduce harm and tobacco-related disease
- Will not cause or increase youth initiation
The FDA closely examines ingredients, health risks, manufacturing practices, labeling, and more. Just 23 tobacco flavored vapes have been authorized so far, with most denials citing insufficient youth protection measures.
Menthol Regulation Outlook
Some advocacy groups praised the rejection of Reynolds’ menthol applications as confirming menthol’s dangers for youth. They urge similar denials for all flavored tobacco varieties to reduce initiation risk.
In April 2022, the FDA proposed banning menthol cigarettes nationwide to curb youth smoking rates. A finalized rule has not emerged yet. But the agency seems poised to aggressively regulate menthol in all combustible and electronic nicotine products given the well-documented risk factors.
Reynolds called the menthol vape denials detrimental to public health progress. But the FDA concluded benefits for adult smokers cannot outweigh potential youth impacts without more convincing clinical data.
Stricter oversight aims to avoid regressing after curbing underage nicotine addiction in recent years. However, the vaping market continues evolving rapidly, challenging regulators.
Conclusion
The FDA’s denial of two R.J. Reynolds menthol e-cigarette products underscores increased scrutiny of menthol’s appeal to youth. While marketed as aiding adult smoker switching, unproven benefits failed to outweigh addiction concerns.
As the FDA works through a giant backlog of new tobacco product applications, denials will likely continue absent compelling behavioral research. The agency maintains a high bar for regulatory authorization.
For vaping companies, more menthol restrictions seem imminent without strong scientific counterarguments. The FDA is also exploring a potential menthol cigarette prohibition. Reduced initiation may come at the cost of adult choice.
R.J. Reynolds Menthol Vape Denial Highlights:
- FDA rejects marketing applications for 2 products
- Cites lack of evidence for net public health benefit
- Menthol flavor raises youth addiction worries
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