FDA refuses, Logic menthol e-cigarette products for sale, after she discovered, that they do not meet public health standards

Today the U.S. Food and Drug Administration issued an order (FDA) a marketing refusal order (Marketing Denial Order, MDO) for multiple e-cigarette products, currently owned by Logic Technology Development LLC (Logic) be marketed. Products currently listed include the Logic Pro Menthol Vape Kit and the Logic Power Menthol Vape Kit. As a result, the company is prohibited from doing so, sell or distribute these products in the United States, otherwise it will face enforcement action by the FDA. These are the first to contain menthol E-cigarettes Products, for which a marketing decision was made based on a comprehensive scientific review by the FDA.

“The security, that new tobacco products are tested before they are put on the market, is a critical part of the FDA's efforts, reduce tobacco-related illnesses and deaths”, said Brian King, PhD, MPH, Director of the FDA Center for Tobacco Products. “We will continue to advocate for this, that new tobacco products are assessed against a public health standard, which takes into account the risks and benefits of tobacco products for the entire population”.

After reviewing the company's applications for pre-market approval of tobacco products (PMTA) the FDA concluded, that the applications did not contain sufficient evidence to support this, that allowing the sale of the products would be appropriate to protect public health, as required by the Family Law Smoking Prevention and Tobacco Control Act 2009 prescribes. There was no evidence in the applications, that these E-cigarettes Menthol flavored e-cigarettes are more effective than tobacco flavored e-cigarettes, when it comes to, to promote complete switching or to significantly reduce cigarette consumption among adult smokers. Companies can reapply or submit a new application, to correct the defects of the products, that fall under these MDOs.

Before a product is allowed to be sold under the PMTA path, the authority checks the composition, the ingredients, the additives, the ingredients, the design, the harmful and potentially harmful ingredients and health risks of the tobacco product and the manner in which it is used, how the product is manufactured, is packaged and labeled. As part of the PMTA process, the applicant must provide evidence to the authority, that allowing the sale of a new tobacco product serves to protect public health. When reviewing the PMTA for tobacco products, the FDA evaluates the risks and benefits of these tobacco products for the general population, including users and non-users of tobacco products, and takes into account, among other things, that those, who do not currently use tobacco products, will start consuming these tobacco products.

For e-cigarettes without tobacco flavor, including menthol flavored e-cigarettes, the available data suggests this, that the attractiveness, intake and consumption among young people are known to be associated with significant risks. The most recent data from the National Youth Tobacco Study from 2019 2022 show, that the majority (84,9 %) of the young people, the ones in the last few 30 days E-cigarettes have consumed, E-cigarettes used without tobacco flavor, where 26,6 % Have used menthol flavored e-cigarettes. Furthermore, the data suggests so, that tobacco-flavored e-cigarettes affect young people differently and therefore do not pose the same risk to young people, to smoke. Given these existing differences in youth risk, the

“The FDA maintains a strict, carries out scientific review of submitted applications for tobacco products before market launch and evaluates the data for each product, to realize, whether it meets public health standards”, said Dr. King. “In this case, the applicant has not provided sufficient scientific evidence to support this, that the potential benefits for adult smokers outweigh the risks for adolescents.

The MDO letter, das Logic, LLC received today, is not limited to the two products mentioned above; generally, the FDA only discloses the name of the product, which is marketed by the applicant, to avoid possible disclosure of confidential business information. Every product, which is subject to an MDO, may not be sold or distributed in the United States, without the FDA being able to take coercive measures. Without the risk of FDA enforcement, these products cannot legally enter U.S. interstate commerce. In March of this year, the FDA granted the company approval, under the brands Logic Vapeleaf, Logic Power and Logic Pro a range of tobacco flavored e-cigarette products, including devices, to produce.

As with unapproved products in general, the FDA doesn't just want to make sure, that Logic complies with this order, but also, that distributors and retailers do this. In particular, the FDA points this out, that all new tobacco products brought onto the market, which do not have the legally required approval before being placed on the market, are illegal and their distribution or sale will be subject to enforcement action. Retailers should contact Logic if they have any questions about the products they stock.

Today's publication of these MDOs is just one of many measures, that the FDA is taking, to ensure, that every tobacco product sold has undergone a scientifically based review and received a marketing decision from the FDA. Of the almost 6,7 Millions of products, which by the deadline 9. September 2020 were submitted, the agency has completed its audit and more than 99 Percent identified. So far the FDA has 23 E-cigarette products and tobacco-flavored devices approved.