FDA denies marketing of two menthol e-cigarette replacement cartridges
The FDA has issued marketing denial orders to R.J. Reynolds Vapor Company for two popular menthol e-cigarette replacement cartridges, stating that the company cannot distribute or market these replacement cartridges in the United States.
The products are the Vuse Replacement Cartridge Menthol 4.8% G1 and G2, which is the second-most common brand typically used among youth e-cigarette users found in the 2022 National Youth Tobacco Survey, according to a press release from the agency.
This FDA decision comes after its marketing denial of two other menthol e-cigarette products from R.J. Reynolds in late January: the Vuse Vibe Tank Menthol 3% and the Vuse Ciro Cartridge Menthol 1.5%.
Similar to the denial in January, the FDA deemed that the premarket tobacco product applications (PMTAs) filled out by R.J. Reynolds Vapor Company did not meet its standards for protecting the public health. In PMTAs, the FDA looks at additives, product components, constituents, design, harmful and potentially harmful constituents and health risks, ingredients and more, according to the January press release from the FDA.
Importantly, the FDA said in the release that the applicant did not provide the agency with evidence that “its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.”
According to the release, e-cigarettes that are nontobacco-flavored are known to be more appealing to youth than tobacco-flavored products, heightening the risk for uptake and use. Due to this, the FDA is looking for strong evidence from e-cigarette companies that shows use of “their menthol-flavored e-cigarette products are likely to promote complete switching or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes.”
This marketing denial order is among recent efforts the FDA has taken against e-cigarette companies. In February, the agency fined four e-cigarette manufacturers for illegally selling products, and last June, the FDA denied marketing authorization to Juul Labs.
“The FDA is a data-driven agency and science remains the cornerstone of our tobacco product regulatory activities,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in the release. “The science has guided — and will always guide — the FDA’s decision-making on premarket tobacco product applications, including today’s marketing denial orders.”
Reference:
- FDA denies marketing of two Vuse menthol e-cigarette products following determination they do not meet public health standard. https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-two-vuse-menthol-e-cigarette-products-following-determination-they-do-not-meet?utm_medium=email&utm_source=govdelivery. Published Jan. 24, 2023. Accessed March 17, 2023.