July 10, 2023
Today, the U.S. Food and Drug Administration (FDA) issued a marketing denial order (MDO) for myblu Menthol 2.4%, an e-cigarette product made by Fontem US, LLC (myblu). As a result, the company must not market or distribute this product in the United States, or they risk enforcement action by FDA. The company may resubmit a new application to address the deficiencies for the product subject to this MDO.
“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 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.”
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 benefits (i.e., complete transitioning to the product or significant reduction in combustible cigarette use among adults who smoke) and risks (e.g., initiation among youth). After reviewing the company’s PMTA, FDA 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. For example, among other deficiencies, the application did not present sufficient scientific evidence to show the 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, and if the product is already on the market, the product must be removed from the market – or risk FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, FDA intends to ensure compliance by distributors and retailers.
Today’s actions are just one of many FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. To date, the agency has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.
“FDA has made considerable progress on the unprecedented volume of applications received,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products. “We’re committed to making determinations on the remaining applications as expeditiously as possible, while ensuring the decisions are scientifically accurate, legally defensible, and aligned with the authorities granted by Congress.”
To date, 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 United States. Last year, FDA issued MDOs to Fontem US for several other myblu products, which are the subject of ongoing litigation. Decisions on additional Fontem US e-cigarette products are pending. Retailers should contact Fontem US, LLC with any questions about products in their inventory.