- For Immediate Release:
On December 15, 2022, the U.S. Court of Appeals for the Third Circuit entered a stay pending review of the marketing denial order for Logic Technology Development LLC. All electronic nicotine delivery systems, including those made by Logic, are required by law to have FDA authorization to be legally marketed. The stay does not constitute authorization to market, sell or ship Logic products.
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). The currently marketed products include 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.
“Ensuring new tobacco products undergo premarket evaluation is a critical part of the FDA’s work to reduce tobacco-related disease and death,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We remain committed to evaluating new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
After reviewing the company’s premarket tobacco product applications (PMTAs), the 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, the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. 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 company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
Before permitting the marketing of a product under the PMTA pathway, among other things, the agency reviews a tobacco product’s components, ingredients, additives, constituents, design, harmful and potentially harmful constituents and health risks, as well as how the product is manufactured, packaged, and labeled. Under the PMTA pathway, applicants must demonstrate to the agency that permitting the marketing of a new tobacco product would be appropriate for the protection of the public health. In reviewing PMTAs for tobacco products, the FDA evaluates the risks and benefits of those tobacco products to the population as a whole, including users and nonusers of the tobacco product, and takes into account, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products.
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. Recent data from the 2022 National Youth Tobacco Survey found most (84.9%) 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. Additionally, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk of youth uptake. 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 conducts a rigorous, scientific review of submitted premarket tobacco product applications, evaluating the data for each product to determine if it meets the public health standard,” said Dr. King. “In this case, the applicant did not provide sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks to youth.”
The MDO 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. Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action. These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In March, the FDA authorized several tobacco-flavored e-cigarette products from the company under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.
In addition to ensuring that Logic complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and their distribution or sale is subject to enforcement action. Retailers should contact Logic with any questions about products in their inventory.
Today’s issuance of these MDOs is just one of the many actions the FDA has taken to ensure any tobacco products that are marketed undergo science-based review and receive marketing determinations by the FDA. The agency has completed the review of and made determinations 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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Abby Capobianco