In a statement released Oct. 13, Magellan Technology admitted the FDA had issued marketing denial orders (MDOs) for 32 Hyde disposable vaping products on Oct. 6, but said the agency issued its press release announcing the action before notifying Magellan. The company had previously questioned whether the FDA had issued MDOs at all.
“It wasn’t until that evening that the Agency acknowledged in writing that it had erred in failing to inform the company and actually sent notice of the MDOs to Magellan,” the company said in its statement. The FDA blamed the lack of notification on an “inadvertent error.”
More interesting is the fact that the products in question were all made with tobacco-derived nicotine, and the premarket tobacco applications (PMTAs) for those products were submitted by Magellan before the Sept. 9, 2020 PMTA submission deadline. The agency waited two years to take action on them.
Did the FDA use a different review method for the Hyde PMTAs than the so-called “fatal flaw” standard that allowed it to issue thousands of denial orders with the stroke of a pen, based on the lack of certain kinds of studies? If the agency used a “fatal flaw” review, the MDO could have been issued as early as last year, since it required no actual effort to complete. And if the FDA actually conducted a thorough scientific review, how did agency scientists manage to complete their work at exactly this very opportune moment for FDA leadership?
Jim McDonald – Vaping360.com – 2022-10-17.
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