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

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 agency’s 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 days—although “not listed” (32.2 percent) and “not sure/don’t 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 agency’s 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.”

Second, after reviewing premarket tobacco applications for 32 Hyde e-cigarettes, FDA issued marketing denial orders (MDO) for these applications submitted by Magellan Technology Inc.

— FDA Tobacco (@FDATobacco) October 6, 2022

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

In a statement released soon after the FDA’s, Magellan said that the agency had issued a Refuse to Accept (RTA) letter for the Hyde PMTAs—an 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 FDA’s 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 FDA's 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 Magellan’s products.”

An update to my earlier story on NYTS. FDA has issued a warning letter to Puff and an MDO to Hyde. Will be very interesting to see if these are the first companies FDA throws the book at, or if the companies try to challenge FDA. https://t.co/HLJoUJhiog

— Nicholas Florko (@NicholasFlorko) October 6, 2022

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 month—until May 14—to 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 FDA’s marketing denials in court. Magellan Technology already has pending litigation against the agency—a petition for review in the Second Circuit Court of Appeals of an MDO issued last year for Magellan’s 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.