The U.S. Food and Drug Administration issued marketing denial orders for menthol e-cigarette products manufactured by the R.J. Reynolds Vapor Company. The Jan. 24 announcement targeted the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%, the second most common product type that surveyed youths report regularly using.
When the FDA reviews a premarket tobacco product application, it evaluates a number of factors, including:
- Tobacco product components
- Ingredients
- Additives
- Constituents
- Design
- Harmful or potentially-harmful components
- Health risks
- Manufacturing practice
- Labeling
- Packaging
According to the agency, R.J. Reynolds’ Vuse products “lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of public health.” With the issuance of the marketing denial orders, R.J. Reynolds is now forbidden from marketing or distributing their Vuse products in the U.S. or it will face enforcement actions.
The agency chose to deny the Vuse menthol products based on existing evidence that shows that non-tobacco-flavored e-cigarette products “have a known and substantial risk with regard to youth appeal, uptake, and use.” The FDA notes that for tobacco-flavored products, this enhanced risk is not present. Because Vuse’s menthol products pose a more significant risk of youth use and addiction, the FDA stated that R.J. Reynolds must provide “robust evidence” showing that there is likely to be a significant decrease in the use of traditional cigarettes in adult smokers compared to tobacco-flavored e-cigarettes.
Many e-cigarette companies have faced legal consequences after multiple states and territories filed suit against manufacturers such as Juul Labs. These lawsuits have claimed that e-cigarette manufacturers intentionally appealed to minors through the use of younger models and flavors that appeal to minors, including birthday cake and bubblegum. The FDA has also taken action against e-cigarette manufacturers by restricting the marketing of non-tobacco-flavored e-cigarette products.