Update: The FDA issued an administrative stay on Logic's marketing denial order (MDO) on Oct. 28, a Logic spokesperson told CSP. The FDA could not immediately be reached for comment.
SILVER SPRING, Md. — The U.S. Food and Drug Administration denied several menthol-flavored e-cigarette products from Logic Technology Development LLC—the first menthol vape products to receive a marketing decision based on full scientific review from the FDA, it said.
The currently marketed products by Logic include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. Following the marketing denial order (MDO), the company must not market or distribute these products in the United States, or risk enforcement action by the FDA, the agency said.
The brand still has other electronic nicotine delivery system (ENDS) products that are legal to sell, though.
In March, the FDA authorized several e-cigarettes from the Teaneck, N.J.-based company under the Logic Vapeleaf, Logic Power and Logic Pro brands. At the time, it said Logic’s menthol products remained under review. The FDA delayed decisions on menthol products for several other companies, as well.
On Oct. 26, the FDA said after reviewing Logic’s premarket tobacco product applications (PMTAs) for the menthol products, the agency determined the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.
“The evidence provided within the application does not demonstrate that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers,” the FDA said.
For non-tobacco flavored e-cigarettes, including menthol e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use, the agency said.
The 2022 National Youth Tobacco Survey found most youth who used e-cigarettes in the past 30 days used non-tobacco flavored e-cigarettes, and of them, 26.6% used menthol-flavored e-cigarettes. The data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and do not pose the same degree of risk to youth, the FDA said.
“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 complete switching or are likely to significantly reduce cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products,” the FDA said.
The MDO is not limited to the two products named above. The FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information. Retailers should contact Logic with any questions about products in their inventory, the FDA said.
Corrado Mautone, Logic's president, said the applications submitted to the FDA for its menthol e-liquids contained comprehensive data, which was as robust as its tobacco-flavored submissions.
“Therefore, we will exercise our right to appeal the denial orders through all applicable administrative and legal pathways,” Mautone said. “We have always taken the way our menthol e-liquids are marketed and sold extremely seriously, and believe the robust evidence submitted to FDA demonstrates that these e-liquid capsules, like our tobacco capsule submissions which were authorized, are appropriate for the protection of public health.”
So far, the agency has completed the review of and made terminations on more than 99% of the nearly 6.7 million deemed products for which applications were submitted by the Sept. 9, 2020, deadline. To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.