Oct. 17 updateIn 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 wasnt 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?

The FDA announced the denials the same day and in the same press release as its comments on the 2022 National Youth Tobacco Survey, which for the first time showed that Hyde was a popular brand among school-age vapers. The agency used the occasion to trumpet the Hyde MDOs, obviously intended to please tobacco control groups that have criticized the agency for weak enforcement action on disposables.

In conducting its scientific review, wrote the agency in the Oct. 6 press release, 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. 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.

It would be an amazing coincidence for FDA scientists to just happen to complete a two-year scientific review of the Hyde PMTA submissions on the very same day that preliminary NYTS numbers were released, and the agency needed a recognizable disposable vape manufacturer to publicly chastise.

Because the affected PMTAs had been pending with the Agency for over two years, said Magellan, 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% since 2019.

Regarding the other Hyde products for which Magellan received Refuse to Accept (RTA) letters (but not MDOs), the company explained that technical SNAFUs with the applications were to blame, and said it had asked the FDA to reconsider its initial determination so that Magellans application review can progress forward. Magellan said it would seek a stay in federal court if the FDA refuses to reconsider the RTA.

Oct. 10, 2022

On Oct. 6, the FDA marked the release of preliminary 2022 National Youth Tobacco Survey (NYTS) results with a press release. A large part of that document was dedicated to playing up the agencys get-tough approach to disposable vapes, and specifically highlighted new actions taken against Puff Bar importers and the manufacturer of Hyde disposables.

Hyde was named as the sixth most popular vape brand (7.3 percent) among vaping middle and high school students who listed a brand in their NYTS responses, according to the authors of the CDC report released last week. Only Puff Bar, Vuse, JUUL, SMOK and NJOY were listed more often by students who had vaped in the previous 30 daysalthough not listed (32.2 percent) and not sure/dont know.(28.3 percent) were the only answers that vied with Puff Bar (29.7 percent) for the top response.

The FDA said in its press release that the agencys Center for Tobacco Products (CTP) had issued marketing denial orders (MDOs) for 32 Hyde-branded products for which PMTAs had been submitted by Magellan Technology, Inc., a well-known manufacturer and distributor based in Buffalo, New York.

In conducting its scientific review, the agency wrote, 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. 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.

But, according to Magellan, the FDA has not issued an MDO for any Hyde products.

In a statement released soon after the FDAs, Magellan said that the agency had issued a Refuse to Accept (RTA) letter for the Hyde PMTAsan entirely different FDA response than an MDO. An RTA letter is a notice that some basic technical requirement for successful PMTA submission has not been met. When an RTA determination is made, the application is unable to proceed to scientific review.

According to the company, the FDAs communication to Magellan made clear that the agency did not conduct the scientific review on which it claims to have based the alleged marketing denial orders. In fact, Magellan says the Refuse to Accept determination was based on a single missing document: a sworn certification related to the translation of certain components of the application.

Magellan calls the FDA claim it issued an MDO a glaring error. But if Magellan is correct in its assertion that no MDO has been issued, the FDAs statement goes far beyond an error. It is either evidence of supreme incompetence, or an outright lie intended to deceive the public and the many reporters that published stories claiming that Hyde products had received MDOs and had been ordered off the market.

Magellan says its attorney 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 Magellans products.

The FDA was granted regulatory authority over synthetic nicotine products by Congress in March. The law took effect in April, and manufacturers were given a monthuntil May 14to submit premarket tobacco applications (PMTAs), and two additional months to continue selling products with pending PMTAs. When the grace period ended July 13, all synthetic nicotine-based products became subject to FDA enforcement, although the agency has apparently not yet taken action against products for which PMTAs are still pending.

We reported more than two months ago that the FDA had changed some forms required for PMTA acceptance just before the submission deadline for vape products made with synthetic nicotine. This may have been done deliberately to allow the agency to easily eliminate thousands of applications by making RTA determinations, rather than have to slog through the full PMTA review process. In fact, CTP Director Brian King bragged in August that In the past three weeks alone, FDA has issued refuse-to-accept (RTA) letters for more than 88,000 products in applications that do not meet the criteria for acceptance.

Dozens of small vaping manufacturers have challenged FDAs marketing denials in court. Magellan Technology already has pending litigation against the agencya petition for review in the Second Circuit Court of Appeals of an MDO issued last year for Magellans pod-based Juno vaping products.

Vaping360 has asked the FDA for confirmation that it issued MDOs for the Hyde products in question, but press officials are off today (for the federal holiday). We will update the story when the agency responds.

Link:

FDA Conveniently Denied Hyde PMTAs Just in Time for NYTS Press Release - Vaping360 News