For immediate release:

Today, the U.S. Food and Drug Administration has issued marketing denial orders (MDOs) for several e-cigarette products currently being marketed by Logic Technology Development LLC (Logic). Currently marketed products include Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. Consequently, the company must not market or distribute these products in the United States or risk law enforcement by the FDA. These are the first menthol e-cigarette products to receive a marketing decision based on a full scientific review by the FDA.

“Ensuring that new tobacco products undergo pre-marketing evaluation is a critical part of the FDA’s work to reduce tobacco-related diseases and deaths,” said Brian King, Ph.D., MPH, director of the Center. for Tobacco Products from the FDA. “We remain committed to evaluating new tobacco products against 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 pre-marketing tobacco product (PMTA) applications, the FDA determined that the applications did not have sufficient evidence to demonstrate that allowing the products to be commercialized would be appropriate for public health protection, the standard legally enforceable required by the family 2009 Smoking Prevention and Tobacco Control Act. The evidence provided in the application does not demonstrate that these menthol-flavored e-cigarettes are more effective in promoting complete switching or a significant reduction in cigarette use than e-cigarettes to tobacco among adult smokers. The company may resubmit applications or submit new applications to address shortages of products subject to these MDOs.

Before allowing the commercialization of a product under the PMTA path, among other things, the agency examines the components, ingredients, additives, components of a tobacco product, design, harmful and potentially harmful components and health risks, as well as the way the product is manufactured, packaged and labeled. As part of the PMTA route, applicants must demonstrate to the agency that allowing the marketing of a new tobacco product would be appropriate for public health protection. In reviewing PMTAs for tobacco products, the FDA evaluates the risks and benefits of those tobacco products to the population as a whole, including consumers and non-users of the tobacco product, and takes into account, among other things, of 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, the existing evidence demonstrates a known and substantial risk with regard to attractiveness, spread and use by young people. Recent data from the National Youth Tobacco Survey of 2022 found that most (84.9%) of young people who have used e-cigarettes in the past 30 days have used non-tobacco-flavored e-cigarettes and, of them, 26.6% used menthol-flavored e-cigarettes. Furthermore, the data indicate that tobacco-flavored e-cigarettes do not have the same appeal to young people and therefore do not present the same degree of risk of adoption by young people. Given these existing differences in risk to young people, applicants must provide solid evidence to demonstrate that the use of their menthol-flavored e-cigarette products can promote complete switching or is likely to significantly reduce cigarette use in adult smokers. in addition to that facilitated by flavored tobacco products for electronic cigarettes.

“The FDA conducts a rigorous scientific review of applications submitted for tobacco products prior to marketing, evaluating the data for each product to determine if it meets public health standards,” said Dr. King. “In this case, the applicant has not provided sufficient scientific evidence to show that the potential benefit for adult smokers outweighs the risks for young people.”

The MDO letter that Logic, LLC received today is not limited to the two products mentioned above; in general, the FDA publicly names only the products the applicant is marketing to avoid the potential disclosure of confidential business information. All 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 legally be introduced into interstate commerce in the United States without risking FDA enforcement. In March, the FDA cleared several of the company’s tobacco e-cigarette products under the Logic Vapeleaf, Logic Power, and Logic Pro brands, including devices.

In addition to ensuring that Logic complies with this order, as in general for unauthorized products, the FDA intends to ensure compliance by distributors and resellers. In particular, the FDA notes that all new tobacco products on the market without the pre-marketing authorization required by law are illegally marketed and their distribution or sale is subject to enforcement. Resellers should contact Logic with any questions about the products in their inventory.

Today’s issuance of these MDOs is just one of many actions the FDA has taken to ensure that all tobacco products marketed undergo scientific review and receive marketing determinations from the FDA. The agency has completed the review and made decisions on more than 99% of the nearly 6.7 million products considered for which applications were submitted by the September 9, 2020 deadline. To date, the FDA has cleared 23 products and tobacco flavored electronic cigarette devices.

Related information

###

Water heater

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and protection of drugs, vaccines, and other biological products for human use and human medical devices and veterinarians. The agency is also responsible for our nation’s food safety and supply, cosmetics, dietary supplements, products that emit electronic radiation, and for regulating tobacco products.