FDA Approves Additional ENDS Products for Marketing

Logic Technology Development received approval for certain products, but multiple other Logic ENDS products were denied.

March 28, 2022

A Person Vaping

ALEXANDRIA, Va.—The U.S. Food and Drug Administration has approved several tobacco-flavored vape products made by Japan Tobacco’s brand Logic Technology Development under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices, according to a statement.

This is the second round of electronic nicotine delivery system (ENDS) approvals since the FDA authorized the marketing of R.J. Reynolds’ Vuse vape product, which included the Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods (Vuse Replacement Cartridge Original 4.8% G1 and Vuse Replacement Cartridge Original 4.8% G2).

Data submitted to the FDA by Japan Tobacco showed that current tobacco users who used these tobacco-flavored products were more likely to significantly decrease their use of combustible cigarettes and that those who don’t smoke are unlikely to start using these products. Most study subjects decreased the number of combustible cigarettes they smoked each day by greater than 80%. The data also showed that the products produce fewer or lower levels of some toxins than combustible cigarettes, and the products’ abuse liability, or their ability to encourage continued tobacco use, addiction or dependence, was lower than combustible cigarettes.

The agency also issued marketing denial orders to Logic for multiple other ENDS products.

According to the FDA, the agency has taken action on about 99% of the nearly 6.7 million ENDS products submitted for premarket authorization, including issuing marketing denial orders for more than one million ENDS products. The agency says it is close to making additional decisions on applications for popular ENDS products that account for a large part of the market.

“Ensuring new tobacco products undergo premarket evaluation by the FDA is a critical part of our work to reduce tobacco-related disease and death,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “For the authorized products, the manufacturer demonstrated that possible benefits to adult smokers outweigh the risk of youth possibly initiating. We are making progress in our review of flavored ENDS, and we will continue to deny marketing of products where the applicant hasn’t provided enough evidence to show that the potential benefit to adult smokers outweighs the considerable risk to youth.”

In January, the FDA formally responded to a request from NACS and other groups that asked the agency to publish the names of vapor products for which it has taken action in their premarket tobacco application review. In their letters to FDA, the associations expressed the critical nature of this list for their retail members who need to know which products are legal to sell and which are not.

In its letter response to the associations, the FDA states that it understands the retail groups’ request for specific names of deemed products and that the agency is working to update the list with final actions taken on individual products, including those that received MDOs.

“Given the large number of products involved, sharing this information requires additional time and resources so that the agency does not disclose confidential commercial information (CCI) about products that are not yet marketed,” FDA stated.

FDA’s response explains that the agency does not have the authority to disclose CCI of products that are not on the market or whose marketing status is unclear. However, FDA’s website does disclose the names of companies that have received marketing denial orders. Until the list is updated, FDA encourages retailers to contact manufacturers and/or suppliers with any questions about specific products.

NACS will notify members when FDA updates the PMTA product list with actions taken.