9/7/2023 0 Comments Ciro mentholThe company announced today that it “intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products.”ĭozens of smaller vaping manufacturers have appealed FDA denial orders in federal courts across the country, with mixed results. Reynolds will likewise seek relief in the courts. The company quickly appealed the MDO, and received a temporary stay of the order from a federal appeals court. However, last October, the FDA issued denial orders for menthol refills sold by Logic for those devices. Like Reynolds, vape manufacturer Logic received FDA authorization last spring for its Pro and Power devices, along with tobacco-flavored refills. Manufacturers submitted millions of products for review through the FDA’s premarket tobacco application (PMTA) pathway. The FDA has not yet authorized any vaping products in flavors other than tobacco, and has not authorized any bottled e-liquid or open-system (refillable) products in any flavor, including tobacco. (The FDA has taken no action on Reynolds’ very popular Vuse Alto device or its refills.) Neither Vuse device has a significant share of the convenience store/gas station vaping market segment. At that time, the agency said the menthol refills were still under review. “Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol flavored e-cigarette products are likely to promote a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes products.”īoth the Vibe and Ciro devices, and tobacco-flavored refills for both, were authorized by the CTP last May to be sold. “Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” the FDA said in a press release. The CTP action marks the second time the agency has issued a marketing denial order (MDO) for menthol vaping products based solely on the flavor itself. Reynolds for menthol refills used in its Vuse Vibe and Vuse Ciro vape devices. The FDA Center for Tobacco Products today denied marketing applications from R.J.
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