October 10, 2022
On October 6, the FDA announced the release of preliminary results from the 2022 National Youth Smoking Survey (NYTS) through a press release. Much of this document was devoted to highlighting the agency’s approach to disposable vapes, and specifically highlighted new actions taken against Puff Bar importers and disposables maker Hyde. .
According to the authors of the CDC report released last week, Hyde was named the sixth most popular vaping brand (7.3%) among middle and high school students who listed a brand in their NYTS responses. Only Puff Bar, Vuse, JUUL, SMOK, and NJOY were cited more often by students who had vaped in the past 30 days, although “not listed” (32.2%) and “not sure/don’t know” (28.3%) were the only answers that rivaled Puff Bar (29.7%) for the best answer.
The FDA said in its press release that the agency’s Center for Tobacco Products (CTP) has issued marketing denial orders (MDOs) for 32 Hyde-branded products for which PMTAs were 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 sufficient to outweigh the risks to youth. Therefore, the FDA has determined that allowing these products to be marketed would not be appropriate for the protection of public health. The company should stop selling and distributing these products, and those currently on the market should be withdrawn under penalty of coercive measures.
Second, after reviewing premarket tobacco applications for 32 Hyde e-cigarettes, the FDA issued marketing denial orders (MDOs) for these applications submitted by Magellan Technology Inc.
— FDA Tobacco (@FDATobacco) October 6, 2022
But, according to Magellan, the FDA has not issued MDOs for any Hyde products.
In a statement released shortly after the FDA’s, Magellan said the agency issued a denial of acceptance letter (RTA) for Hyde’s PMTAs, an entirely different response from the FDA than an MDO. An RTA letter is a notice that certain basic technical requirements for a successful PMTA submission have not been met. When an RTA decision is made, the application cannot be subject to scientific review.
According to the company, the FDA’s communication to Magellan made it clear that the agency had not conducted the scientific review on which it claims to have based the alleged marketing denial orders. In fact, Magellan claims that the refusal to accept determination was based on a single missing document: “a sworn certification related to the translation of certain elements of the application.”
Magellan calls the FDA’s claim to have issued an MDO a “flagrant error.” But if Magellan is correct in its assertion that no MDO was issued, the FDA’s statement goes far beyond error. This is either evidence of supreme incompetence or an outright lie intended to mislead the public and the many journalists who have published articles claiming that Hyde products were given MDOs and ordered off the market.
Magellan says his attorney has “demanded that the FDA not only retract the press release it made, but also issue a corrective statement making it clear that the FDA did not issue an MDO to Magellan and that it did not has not yet performed a scientific review of Magellan’s products”.
An update to my previous NYTS story. The FDA issued a warning letter to Puff and an MDO to Hyde. It will be very interesting to see if these are the first companies the FDA throws the book at, or if the companies try to challenge the FDA. https://t.co/HLJoUJhiog
— Nicolas Florko (@NicholasFlorko) October 6, 2022
The FDA was granted regulatory authority over synthetic nicotine products by Congress in March. The law went into effect in April and manufacturers had one month – until May 14 – to submit premarket tobacco applications (PMTAs) and an additional two months to continue selling products with pending PMTAs. When the grace period ended on July 13, all synthetic nicotine products were brought under FDA enforcement, although the agency apparently had not yet taken action against the products for which PMTAs are still pending.
We reported over two months ago that the FDA changed some forms required for PMTA acceptance just before the submission deadline for synthetic nicotine vaping products. This may have been done deliberately to allow the agency to easily weed out thousands of applications by making RTA decisions, rather than having to go through the full PMTA review process. In fact, CTP Director Brian King bragged in August that “in the past three weeks alone, the FDA has issued Denial of Acceptance Letters (RTAs) for more than 88,000 products in applications that do not meet the acceptance criteria”.
Dozens of smaller vape makers have challenged the FDA’s marketing denials in court. Magellan Technology already has litigation pending against the agency — a petition for review in the Second Circuit Court of Appeals from an MDO issued last year for Magellan’s pod-based Juno vaping products.
Vaping360 has asked the FDA to confirm that it has issued MDOs for the Hyde products in question, but press officials are away today (for the Federal holiday). We’ll update the story when the agency responds.