Hyde Disposables is now the latest company to have been issued marketing denial orders (MDOs) by the Food & Drug Administration.
The agency denied 32 Hyde e-cigarettes in accordance with its October 6, 2022 press release statement.
Although the FDA has cited underage vaping as a reason for previous MDOs, this round of denials appears to be even more strongly related to this issue given the 2022 National Youth Tobacco Survey (NYTS).
Interestingly, the MDOs cover only tobacco-derived nicotine products from Hyde Disposables. This means that their products with synthetic nicotine are still under review.
It was later brought to light by Magellan Technology CEO, Jon Glauser, that the FDA had notified the public first of this bout of marketing orders being issued. This sparked a conflict between Magellan and the FDA.
The Back and Forth
Upon the news of the MDO, Magellan was quick to make claims that the FDA had failed to notify the company of its decision, learning of the decision through public sources.
Glauser went on to state in an email that his company had received only a Refuse to Accept (RTA) letter. He also claimed that the agency did not properly review the evidence in favor of Magellan’s case, resulting in the MDOs being issued for the 32 Hyde brand products.
“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 statement said.
The agency later responded, claiming the lack of notification to be merely an “inadvertent error.”
It appears that the RTA was issued to products that were outside of the 32 MDOs. These products are likely only the synthetic nicotine offerings from Hyde.
Magellan later admitted that they had in fact received the 32 MDOs. The company’s reasoning for denying the issued MDOs is yet to be determined. However, the fact that Magellan was able to get the FDA to admit they made an “inadvertent error” when no such error was made is commendable.
The Looming National Youth Tobacco Survey
Hyde Vapes is one of the most popular disposable vapes on the US market, according to the Oct. 6 release statement by the FDA.
In the very same statement for the MDOs, the FDA clearly targets Hyde as a key culprit in the underage youth “epidemic.”
“In conducting its scientific review, the FDA determined that the applications lacked sufficient evidence demonstrating that these flavored e-cigarettes would provide a benefit to adult users that would be adequate to outweigh the risks to youth,” the statement reads. “Therefore, the FDA has determined that permitting the marketing of these products would not be appropriate for the protection of public health. The company must stop selling and distributing these products, and those currently on the market must be removed or risk enforcement action.”
In addition to this, the FDA statement boldly claims that they are working hard to act against underage vaping, citing Puff Bar and Hyde as “two of the most popular brands with youth.”
This is followed by the agency’s plans to reign in these brands, which is likely an attempt to show favor among the public in light of the upcoming National Youth Tobacco Survey by targeting such important culprits in the underage vaping narrative.
What makes this situation even more interesting is the timeline. Glauser mentioned that every product subject to the recent MDOs are based on tobacco-derived nicotine, rather than synthetic nicotine.
This has led to speculation from many that the FDA simply waited until the results of the upcoming 2022 National Youth Tobacco Survey, even though they had likely come to their decision over Magellan’s evidence portfolio however long ago.
The bottom line
Hyde vapes were recently issued 32 marketing denial orders by the Food & Drug Administration. This immediately sparked conflict between the two groups after claims were made that the agency did not inform the vape company of these marketing orders.
It appears neither party was playing straight, though. Magellan later admitted to receiving the MDO notification, while the FDA suspiciously remained silent on the marketing orders seemingly to make a point in their favor for the upcoming National Youth Tobacco Survey results.
At this point, it is unclear whether the FDA willfully attempted to use this move against Hyde Disposables as a means to save face with anti-vape groups.