Magellan Technology insists it did not receive a marketing denial order (MDO) for its Hyde Brand, despite a U.S. Food and Drug Administration announcement to the contrary.
In an email to Tobacco Reporter’s sister publication, Vapor Voice, Magellan CEO Jon Glauser said his company had received a “refuse to accept” (RTA) letter. An RTA is not a judgment on the product’s appropriateness for the protection of public health. It is merely a determination that the premarket tobacco product application doesn’t conform to the FDA’s standards, and it leaves the applicant the option to refile.
“A refuse to accept letter is a refusal based on nothing more than a technical review of the applications’ contents, which, in this case, was a missing document, i.e., a sworn certification related to the translation of certain components of the application,” wrote Gauser. “In other words, the refusal to accept was based on bureaucratic technicalities.”
In its letter to Magellan, the FDA wrote that the absence of the forms prevented the agency from accepting and processing the applications. “In other words, FDA could not have conducted any scientific review because it refused to accept the application,” wrote Glauser. “Our counsel has demanded that FDA not only retract the press statement it made but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.”
Magellan is not the first company to take issue with the FDA’s handling of the PMTA process. The agency is currently facing more than 20 lawsuits and has had to backtrack on MDOs issued to companies such as Juul Labs, Turning Point Brands and Kavial Brands.