The U.S. Food and Drug Administration (FDA) has issued marketing denial orders for menthol-flavored e-cigarettes developed and marketed by Logic Technology Development LLC. These orders came after the FDA determined that the products posed a threat to public health, according to the agency's Oct. 26 announcement.
This action is in line with the agency’s findings on all flavored tobacco products, citing their ease of access for new smokers.
The FDA had been reviewing several products by Logic, including the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. However, after the review of Logic’s premarket tobacco product application (PMTA), the agency determined that the applications lacked sufficient evidence to demonstrate that the marketing of Logic’s products would be appropriate to protect public health, according to the standards set in the 2009 Family Smoking Prevention and Tobacco Control Act. According to the FDA, these are the first menthol e-cigarette products to receive a marketing decision based on a “full scientific review.”
According to the FDA, the agency considers many factors to determine if a PMTA should be approved, including:
- Ingredients
- Additives
- Constituents
- Design
- Harmful or potentially harmful constituents
- Health risks
- How the product is manufactured
- Packaging
- Labeling
Additionally, a PMTA must demonstrate that the approval of this device is not contrary to the public health of the nation. According to the FDA, Logic did not provide evidence demonstrating that their menthol-flavored e-cigarettes are more effective in promoting switching or significant cigarette use reduction when compared to tobacco-flavored e-cigarettes among adult smokers.
When considering PMTAs, the FDA evaluates not only the risks and benefits of tobacco products on the smoking population but also the likelihood that people who do not use tobacco products will use them. The evidence shows that flavored tobacco products are “a known and substantial risk” to approve. According to the FDA and the 2022 National Youth Tobacco Survey, 84.9% of underage e-cigarette users use flavored e-cigarettes, with 26.6% using menthol e-cigarettes.
With the increased likelihood of youth use, the FDA issued marketing denial orders in the name of public health. Logic now faces injunction, fines and penalties if they continue to manufacture and market their products in the U.S.