Retailers must remove the myblu Menthol 2.4% e-cigarette from shelves following the Food and Drug Administration’s issuance of a marketing denial order (MDO). The product, from Fontem U.S. LLC, risks FDA enforcement action if it is distributed or marketed in the U.S., the agency said.
“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, 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.”
The FDA evaluates premarket tobacco product applications (PMTAs) based on public health standards that consider the effect of the product on the population, including benefits like transitioning from combustible cigarettes to risks like youth initiation.
The application for myblu Menthol 2.4% 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, the FDA said.
The product must be removed from the market, or it risks FDA enforcement. In addition to ensuring the manufacturer complies, the FDA said it intends to ensure compliance by distributors and retailers. The agency recently sent warning letters to 189 retailers who were selling unauthorized Elf Bar and Esco Bars disposable e-cigarettes.
In April 2022, the FDA also denied the myblu Device Kit, myblu Intense Tobacco Chill 2.5%, myblu Intense Tobacco Chill 4.0%, myblu Intense Tobacco 2.4%, myblu Intense Tobacco 3.6%, myblu Gold Leaf 1.2% and myblu Gold Leaf 2.4%. These products are the subject of ongoing litigation. Retailers should contact Fontem U.S. LLC with any questions about products in their inventory, the FDA said.
“On April 8, 2022, the U.S. Food and Drug Administration issued marketing denial orders for a number of ITG Brands’ myblu pod-based vapor products, our challenge to which is currently under review by the Fifth Circuit U.S. Court of Appeals,” ITG Brands, Greensboro, North Carolina, said in a statement to CSP Daily News. “On July 10, 2023, the FDA issued a marketing denial order for the myblu menthol 2.4% e-liquid cartridge. ITG Brands disagrees with the scientific evaluation and conclusion reached by the FDA and plans to appeal the marketing denial order for the menthol cartridge.”
ITG Brands is the U.S. affiliate of Fontem U.S., which sells blu e-cigarettes.
To date, the FDA has received applications for more than 26 million deemed tobacco products and has made determinations on 99% of these applications. It has authorized 23 tobacco-flavored e-cigarette products and devices.
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