The U.S. Food and Drug Administration has issued a Marketing Denial Order (MDO) for several menthol-flavored e-cigarette products sold by Logic Technology Development.

These products include Logic Pro Menthol e-liquid packaging and Logic Power Menthol e-liquid packaging. This is the first MDO issued by the FDA for a menthol product following scientific review.

The move appears to be in line with the regulator's goal of banning the use of menthol flavoring in tobacco products. The FDA is also not expected to approve any flavored vaping products other than tobacco.

In June, the National Institutes of Health and the FDA awarded the University of Louisville a $3.6 million grant to study the effects of flavorings such as mango and bubble gum used in vaping products. The research is still ongoing.

"Ensuring that new tobacco products undergo premarket evaluation is a critical part of FDA's efforts to reduce tobacco-related disease and deaths," Brian King, director of the FDA's Center for Tobacco Products (CTP), said in a release. "We remain committed to evaluating new tobacco products against public health standards that take into account the risks and benefits of tobacco products to the entire population."

Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told The Vapor Voice that the FDA's latest move to ban menthol e-cigarette flavors is reminiscent of the agency's fatally flawed review of the PMTA, which resulted in millions of denials. FDA uses the term fatal flaw to submit PMTAs without specific studies. The term has been at the center of nearly all litigation against the FDA over its handling of the PMTA process.

"The FDA's dysfunction is endless. For over a year, the FDA has put on hold an extended decision on menthol vaping products," Conley said. "Lest anyone think the FDA is trying to figure out a way to strike a balance, today they revealed that their grand plan for menthol vaping products is to follow the exact same 'fatal flaw' review process that has resulted in dozens of lawsuits being filed. against the agency."

The agency said that after reviewing the company's premarket tobacco product applications (PMTA), the FDA determined that the applications "lacked sufficient evidence that allowing the product to be marketed would be appropriate to protect public health (APPH)," the 2009 "Home Smoking" Applicable standards for legal requirements under the Prevention and Tobacco Control Act.

The FDA said the evidence presented in the PMTA, which Logic rejected, did not prove that menthol-flavored e-cigarettes were more effective than tobacco-flavored e-cigarettes in promoting "complete switching or significant reductions in cigarette use."

According to Tony Abboud, executive director of the Steam Technology Association, the announcement is concerning, especially since the CTP is undergoing an external review, with many industry stakeholders calling for a comprehensive PMTA review plan.

The FDA's action raises at least four major questions, he said.

“First, the announced rationale did not address the net public health benefit, raising the question of whether FDA addressed the necessary elements of the APPH test? Second, given the FDA’s inability to approve a less harmful menthol vaping product, the FDA approved What are the public health benefits of the 123 new menthol cigarette/cigar products?" asked Aboud. "Third, how the agency continues to rely on general (ie, non-logic-specific) menthol youth data to enforce higher logic-specific quit standards, especially given the [National Youth Tobacco Survey] NYTS youth use rate and no association with Logic products. Apparent connection?"

“Fourth, given FDA’s science that under the proposed standards, half of the expected quitters would have to switch to menthol e-cigarettes, none of which are authorized, is the agency undermining its proposed menthol cigarette rule?”

Logic must now decide whether to resubmit the application or submit a new application to address the deficiencies in products subject to these MDOs. However, the FDA noted that for non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, the available evidence indicates that there are significant known risks to youth attraction, absorption, and use.

"The FDA conducts rigorous, scientific review of submitted premarket tobacco product applications, evaluating data from each product to determine whether it meets public health standards," King said. "In this case, the applicant did not provide sufficient scientific evidence that the potential benefits to adult smokers outweighed the risks to adolescents."

A recently accepted manuscript for an upcoming article in Nicotine and Tobacco Research found that California's restrictions on flavored e-cigarettes and other tobacco sales did not affect youth e-cigarette use.

According to the agency, the MDO letter Logic received today was not limited to the two products mentioned above. Generally, FDA discloses only the names of the products that applicants are marketing to avoid potential disclosure of confidential business information.

Any MDO-bound product may not be sold or distributed in the United States or FDA may take enforcement action. These products cannot be legally introduced into U.S. interstate commerce without risking FDA enforcement. In March, the FDA approved several tobacco-flavored vaping products, including devices, under the company's Logic Vapeleaf, Logic Power and Logic Pro brands.

In addition to ensuring that Logic complies with the order, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA noted that all new tobacco products on the market without statutory premarket authorization are illegally marketed and their distribution or sale would be subject to enforcement action.

On behalf of the FDA, the U.S. Department of Justice recently filed a complaint in a federal district court against six e-cigarette makers for permanent injunctions. The cases are the first time the FDA has initiated injunctive proceedings to enforce the premarket review requirements of the Federal Food, Drug and Cosmetic (FD&C) Act for new tobacco products.

The following are important parts of the FDA statement:

After reviewing the company's premarket tobacco product applications (PMTA), the FDA determined that the applications lacked sufficient evidence that allowing the product to market would be appropriate to protect public health, the applicable standard required by the 2009 Family Law Smoking Prevention and Tobacco Control Act. The evidence presented in the application does not demonstrate that these menthol-flavored e-cigarettes are more effective than tobacco-flavored e-cigarettes in promoting complete switching or significantly reducing cigarette use among adult smokers. Companies may resubmit applications or submit new applications to address defects in products subject to these MDOs.

Before allowing products to be sold under the PMTA pathway, the agency reviews, among other things, the composition, ingredients, additives, ingredients, design, harmful and potentially harmful ingredients and health risks of tobacco products, as well as how the products are manufactured, packaged, and affixed with Label. Under the PMTA pathway, applicants must demonstrate to the agency that allowing the sale of a new tobacco product would be suitable to protect public health. When reviewing PMTAs for tobacco products, FDA assesses the risks and benefits of those tobacco products to the entire population, including users and non-users of tobacco products, and, among other things, considers the likelihood that those who do not do so. Tobacco products currently in use will start using those tobacco products.

For non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, available evidence points to known and significant risks in youth attraction, absorption, and use. The latest data from the 2022 National Youth Tobacco Survey found that the majority (84.9%) of youth who used e-cigarettes in the past 30 days used non-tobacco-flavored e-cigarettes, with 26.6% using menthol-flavored e-cigarettes. In addition, data suggest that tobacco-flavored e-cigarettes appeal to young people differently and therefore do not pose the same level of risk to young people.

The MDO letter Logic, LLC received today is not limited to the two products listed above; in general, FDA only discloses the products that applicants are selling to avoid potential disclosure of confidential business information. Any MDO-bound product may not be sold or distributed in the United States or FDA may take enforcement action. These products cannot be legally introduced into U.S. interstate commerce without risking FDA enforcement. In March, the FDA approved several tobacco-flavored vaping products, including devices, under the company's Logic Vapeleaf, Logic Power and Logic Pro brands.

In addition to ensuring that Logic complies with the order in the same way as unauthorized products in general, the FDA intends to ensure that distributors and retailers comply with the order. Specifically, the FDA noted that all new tobacco products on the market without statutory premarket authorization are illegally marketed and their distribution or sale is subject to enforcement action. Retailers should contact Logic with any questions about products in stock.

These MDOs released today are just one of many actions the FDA is taking to ensure that any tobacco product sold undergoes a science-based review and an FDA decision to sell. Of the nearly 6.7 million designated products submitted by the September 9, 2020 deadline, the agency has completed review and decision on more than 99 percent. To date, the FDA has authorized 23 tobacco-flavored vaping products and devices.

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