FDA Issues Denial Orders for myblu Menthol Vapor Product

SILVER SPRING, Md. — The Food and Drug Administration (FDA) issued a new marketing denial order (MDO) to a major vapor brand on July 10.

The MDO applies to myblu Menthol 2.4%, an e-cigarette product made by Fontem US LLC, which is barred from marketing or distributing the product within the United States, or it risks enforcement action by the agency.

The company may resubmit a new application to address the products deficiencies, according to the FDA.

"Thorough scientific review of tobacco applications is a key pillar under FDA's role to protect the public from the dangers of tobacco use," said Matthew Farrelly, Ph.D., director of the office of science within the FDA's Center for Tobacco Products. "This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweigh the known risks."

Greensboro, N.C.-based Fontem US, an affiliate of Imperial Brands, received multiple MDOs for myblu products in spring 2022, which are being appealed.

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The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the impact of the product on the population as a whole, including risks and benefits. After reviewing Fontem's PMTA, the agency determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Among other deficiencies, the application reportedly did not present sufficient scientific evidence to demonstrate that menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.

Tobacco products that receive a marketing denial order may not be offered for sale, distributed or marketed in the U.S. Additionally, such products may not be introduced or delivered for introduction into interstate commerce.

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S.