On October 8, according to foreign reports, the FDA issued an announcement yesterday saying that it had sent MDO to Hyde, a disposable e-cigarette company, but Magellan Technology, the brand operating company, insisted that the FDA issued a statement to the contrary, But it has not received a Marketing Denial Order (MDO) from the Hyde brand.

Magellan Technology said it has not received a Marketing Denial Order (MDO). The U.S. Food and Drug Administration says it does. This isn't the first time regulators have made mistakes. The FDA seems to be getting into this habit lately.

Magellan claims the FDA made a glaring error by not receiving MDO for 32 products under the Hyde brand. Magellan CEO Jon Glauser said in an email that the FDA's statement was wrong for two reasons.

First, the regulator only issued a Rejection Acceptance (RTA) letter to the company, and second, the FDA failed to properly review the scientific evidence in the premarket tobacco product application (PMTA) review of its product.

"Contrary to the FDA's statement, the FDA is only issuing rejection letters for identified Magellan products, not MDOs," Glauser said. "The letter of refusal is simply a refusal based on a technical review of the content of the application, which in this case is a missing document, a sworn certificate relating to the translation of some part of the application. In other words, the refusal is a Based on bureaucratic technology.”

“This is not just a misnomer or a clerical error by the FDA, as the FDA detailed that it had conducted a scientific review and concluded that the PMTA lacked sufficient evidence. However, today’s FDA letter did not mention such a scientific review, There is no scientific basis for it.”

New FDA data from the 2022 National Youth Tobacco Survey (NYTS) shows that 2.5 million U.S. youth use e-cigarettes, according to findings published in the FDA's Morbidity and Mortality Weekly Report, published jointly with the Centers for Disease Control and Prevention. This is a slight increase from last year's figures.

Armed with this information, the FDA also issued a warning letter to Puff Bar (unrelated to the Magellan product) for the receipt and delivery of e-cigarettes in the United States without a Marketing Authorization Order. The FDA also asked for a response within 15 business days of receiving the letter detailing how the company intends to address the FDA's concerns.

This is at least the second letter the FDA has sent to Puff Bar without any follow-up. The FDA issued at least two warning letters for Puff Bar's non-tobacco nicotine single-use products.

At the Next Generation Nicotine conference in Miami, Puff Bar CEO Patrick Beltran said his single-use product is the end of the line for vaping products.

“In my opinion, this is the end of the vaping road. There is nothing more convenient for consumers than a single-use vaping device.”

Beltran then blamed the teenage problem on U.S. retailers and Chinese manufacturers.

"We're pioneering the single-use industry and the industry's single-use industry, and when I go to the store and see people and see these brands being marketed, it's very tough, and there's no enforcement," he explained. "I have to leave...I have to spend millions on PMTA."

During GTNF 2022, the nicotine industry conference in Washington, D.C., in September, Brian King, director of the FDA's Center for Tobacco Products, the division that oversees next-generation tobacco products, discussed the FDA's ability to enforce compliance with its regulations. So far, few companies have been told to pull their products from the market (including Puff Bar). King said the agency has multiple enforcement options to bring both manufacturers and retailers to their knees.

"We have a variety of tools at our disposal, including advisory operations," he said. “We also have regulatory enforcement actions, including voluntary recalls as well as various other requested recalls. We can also take administrative action, civil fines (in the case of a manufacturer, the fine for any single violation cannot exceed $15,000 or be related to a single conduct) of any number of violations must not exceed $1 million),” King explained. “In terms of judicial action, we can do seizures, injunctions and criminal prosecutions. I would say, in terms of enforcement and compliance, nothing is impossible.”

The FDA has not taken any serious action against any vaping company that violated its order. Although the company has received multiple warning letters from the FDA, Puff Bar products can still be found at retailers across the United States.

To date, Puff Bar has not received an MDO from the regulator.

However, after reviewing PMTAs for 32 Hyde e-cigarettes, the FDA issued an MDO for Magellan's submission (the company argues that they are in fact RTAs). During the scientific review, the FDA determined that the applications lacked sufficient evidence that the benefits to adult users of the products would be sufficient to outweigh the risks to adolescents.

Hyde products have not received a marketing authorization order from the FDA.

"To be sure, the FDA wrote expressly to Magellan that the absence of these required FDA forms hinders the FDA's uptake and processing of the application. In other words, the FDA cannot conduct any scientific review because it refuses to accept the application," Glauser wrote. road. "Our attorneys are asking the FDA not only to retract its press statement, but also to issue a correction statement, making it clear that the FDA has not issued an MDO to the company and has not conducted a scientific review of Magellan's products."

The FDA has a history of making mistakes during the PMTA process. It currently faces more than 20 lawsuits and has had to withdraw MDO from numerous companies including Juul Labs, Turning Point Brands and Kavial Brands.

Glauser wrote: Magellan Technology looks forward to addressing any administrative technical issues that exist so that the FDA can actually conduct a full scientific review of its products.