On October 6, the day the Centers for Disease Control and Prevention (CDC) released new data showing a modest uptick in youth vaping amid a longer-term decline, the Food and Drug Administration (FDA) made an announcement of its own. The agency said it had issued marketing denial orders (MDOs) for 32 disposable vaping products through its premarket tobacco product application (PMTA) processall of them manufactured by Magellan Technology, Inc. and sold under the popular Hyde brand.

Many tobacco harm reduction proponents interpreted this as a fairly transparent move by the FDA to appear to be doing something, assuming the new data would be sure toset off the prohibitionist camp. A messy dispute over the FDAs communication has now seen the agency accused of abandoning clarity in a rush to score public relations points.

These days, middle school and high school students who vape overwhelmingly prefer disposables to other vapes, like the once-favored pod devices. The CDC reported that of youth who were current usersmeaning they said theyd vaped at least once in the past 30 daysand listed a brand, Hyde was the sixth most commonly reported, at 7.3 percent.

Puff Bar, Vuse, Juul, Smok and NJOY all outranked Hyde by varying margins. But asJim McDonald noted in Vaping360, not listed (32.2 percent) and not sure/dont know (28.3 percent) were the only responses that ranked closed to Puff Bars 29.7 percent.

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 agencys press release read about the 32 Hyde vaping products. Therefore, the FDA has determined that permitting the marketing of these products would not be appropriate for the protection of the public health. The company must stop selling and distributing these products, and those currently on the market must be removed or risk enforcement action. (Hyde, like all other vapor companies, had to submit PMTAs by a September 2020 deadline, demonstrating that its products would be more likely to help adults switch from cigarettes than introduce a new generation to nicotine.)

Confusion immediately ensued.

Magellan insisted that the FDA not only retract the press statement it made but also issue a corrective statement.

By the end of the day, Magellan had put out a press statement of its own. It claimed that the company had not received any MDOs, but instead just a letter stating that the FDA had refused to accept the PMTAs for some of its products.

Anyone unfortunate enough to be versed in the bureaucratic jargon of the FDAs Center for Tobacco Products (CTP) will know that the distinction is crucial. An MDO would imply that the agency completed a scientific review of the products and then rejected them. A refusal to accept applications, on the other hand, could indicate that the FDA essentially rejected them without a robust examination, based on something like a clerical technicality.

Magellan insisted that the 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 Magellans products.

A few days later, on October 11, an FDA spokesperson told Filter that the agency had issued marketing denial orders (MDOs) for these applications submitted by Magellan Technology, Inc. on October 6, but that as acknowledged by Magellan Technology, Inc. in their statement, FDA also issued a Refuse to Accept (RTA) Letter for other Hyde e-cigarette products.

Two days later, on October 13, Magellan put out yet another press statement, saying that the FDA had failed to inform the company of the MDOs and had only originally alerted it to the RTA Letter.

The refusal to accept was based, in the end, on a host of seemingly minor technicalities which Magellan believes were not even mistakes.

Jon Glauser, who has been running the company for over a decade from Buffalo, New York, explained to Filter that the RTA Letter noted two of the Magellans bundled PMTAs did not contain a signed declaration from a Chinese translatorcertification, he maintains, that was not needed because the documents were initially in both English and Chinese, as the companys manufacturer keeps them in both languages. That mix-up could have been handled in a phone call, Glauser said.

Nine of the other bundled applications were apparently missing a certification statement, a required amendment that Magellan contends it included. But the FDA, according to the company, could not figure out which applications the amendments were supposed to be applied to.

The RTA Letter applied to synthetic nicotine Hyde products, whereas the MDOs were for tobacco-derived nicotine productsproducts, Glauser said, that are not even sold any longer. Its a non-issue, basically, he said. (Congress recently granted the FDA the authority to regulate synthetic nicotine; it previously only had the power to oversee tobacco-derived nicotine, and the agency set manufacturers what was largely considered an unmeetable deadline of a couple months to complete expensive and onerous PMTAs.)

We can only surmise that [this] was caused by an apparent rush to include the MDO action with the FDAs press release on the National Youth Tobacco Survey data.

Our press release was accurate from my perspective at first, but it was factually incorrect because the FDA did not give us the information we needed to put [out] a factually correct statement, Glauser said.

Because the affected PMTAs had been pending with the agency for over two years, we can only surmise that [what] the FDA deemed an inadvertent error in failing to inform the company was caused by an apparent rush to include the MDO action with the agencys press release on the National Youth Tobacco Survey data, which shows youth vaping down 50 percent since 2019, Magellans second press release read, echoing the the chorus of tobacco harm reduction critics.

Glauser and Magellan have requested a petition to stay with the FDAwhich would, at least temporarily, allow them to keep selling their products. But he thinks it is more likely that the company will have to file a legal appeal in court by the end of the week. Typically, it is the only way the agency comes to the table.

I want to work with the FDA, Glauser told Filter. I want to get this application done in a way that proves these products are appropriate for the protection of public health. Thats my goal. If the FDA is willing to work with me, and I hope they are, I definitely want to go down that path with them. Thats good for our company, of course, but I also think its good for public health.

Photograph by Felton Davis viaFlickr

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Hyde Rejections: The FDA's Rush to Capitalize on New Youth Vaping Data - Filter