Today, FDA issued marketing denial orders for several e-cigarette products currently marketed by Logic Technology Development LLC, including the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. As a result, the company must not market or distribute these products in the United States or risk enforcement action by the FDA. These are the first menthol e-cigarette products to receive a marketing decision based on a full scientific review from the FDA. The marketing denial order letter that Logic, LLC received today is not limited to the two products named above; in general, the FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information.Under the PMTA pathway, applicants must demonstrate to FDA, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health. For non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use. Additionally, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth. Applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products is likely to promote complete switching or are likely to significantly reduce cigarette use in adult smokers beyond that of tobacco-flavored e-cigarette products. After reviewing the company’s applications, FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.
FDA has completed the review & made determinations on more than 99% of the nearly 6.7 million deemed products for which apps were submitted by Sept. 9, 2020. FDA is committed to ensuring tobacco products undergo science-based review & receive marketing determinations by FDA. https://www.fda.gov/…/fda-denies-marketing-logics…
