Esco Bar manufacturer Pastel Cartel has filed a federal lawsuit challenging the FDA’s refuse-to-accept (RTA) determination for over 100 products included in multiple premarket tobacco applications (PMTAs) filed by the company. The products include disposable Esco Bar devices and bottled e-liquids.
The lawsuit, filed Aug. 25 in the U.S. District Court for the Western District of Texas, alleges the FDA acted arbitrarily and capriciously when it refused to accept the PMTAs for review on technical grounds.
The company is seeking:
RTA is the first step of the PMTA process—a quick check that the application meets statutory and regulatory requirements for filing. Once a PMTA is accepted and filed, the actual scientific review begins.
If the FDA refuses to accept a PMTA, the manufacturer has no choice but to submit a new PMTA. However, because PMTAs submitted after the deadline (in this case, after the May 14, 2022 deadline for synthetic nicotine PMTA submissions) must receive an FDA marketing granted order (MGO) before the product can be sold, the manufacturer would be forced to stop selling the product while waiting for authorization to begin selling it again. However, products for which PMTAs were submitted before the deadline (and the PMTAs accepted for review) appear to be protected from enforcement by the FDA while the applications are still being considered.
Additionally, legal challenges to a refuse-to-accept decision—unlike challenges to marketing denial orders (MDOs)—do not automatically advance to a federal appeals court. The company must, as Pastel Cartel has done here, first file a lawsuit in a federal district court.
Pastel Cartel’s PMTAs were not accepted for review, in large part, because of supposed irregularities in the company’s submissions. The FDA claimed in its RTA letters that Pastel Cartel did not provide authorization to access certain tobacco product master files (TPMFs) referenced in the applications. (TPMFs are usually scientific breakdowns of third-party-provided ingredients used to make the products being submitted for review. In this case, one of the TPMFs in question was a scientific review prepared by a consultant for a coalition of manufacturers.) The agency also said the company failed to use required forms in its PMTAs.
According to the company’s court filing, Pastel Cartel’s PMTAs did include documentation of its right to access the relevant master files. Further, even if the TPMF authorizations had been missing from the PMTAs, internal FDA policy is to first contact the applicant before refusing to accept the application. The agency did not do that, according to Pastel Cartel.
The FDA also claimed that amended form 4057b was not included in Pastel Cartel’s applications, which were filed on May 14, 2022—the deadline for submission of PMTAs for synthetic nicotine products. However, the amended version of this form—which was used as a pretext for issuing RTA letters to many applicants—was not published in the Federal Register until two days after the submission deadline, and was not available on the FDA’s website until just two weeks before the deadline.
Amanda Wheeler, then president of the American Vapor Manufacturers Association (AVM), told Vaping360 last fall she believed the FDA changed the forms just before the submission deadline “apparently as a means to disqualify wide swaths of already-filed applications.” She described the form switcheroo as “another outrageous example of how FDA has been underhandedly rigging the approval process.”
The most interesting Pastel Cartel allegation may not be legally relevant, but is certainly an illustration of the FDA’s lack of seriousness regarding synthetic nicotine PMTA submissions. According to the court filing, the FDA Regulatory Health Project Manager assigned to Pastel Cartel’s applications had quit working at the agency months before the RTA letters were sent. Seriously.
“This slipshod treatment,” write Pastel Cartel’s lawyers, “strongly implies that the RTAs were not much more than cookie-cutter templates and raises serious questions regarding FDA’s conduct in this matter.”
Esco Bar has received perhaps the most attention from the FDA in its “war on disposables.” In mid-May, the FDA issued import alerts ordering FDA inspectors to detain shipments of Esco Bar products. A week later, the agency sent warning letters to the manufacturers of Esco Bar disposables, ordering products removed from the market.
In June, the FDA issued warning letters to 189 retailers for selling “unauthorized” Esco Bar products. A month later, the agency warned additional online retailers for selling Esco Bar products.
While it’s possible other companies have sued the FDA after receiving RTA determinations for submitted PMTAs, we only know of one for certain.
Last November, New York-based Magellan Technology and Texas-based retailer Vapor Train filed a lawsuit in the U.S. District Court for Eastern Texas, alleging similar administrative malfeasance by the FDA regarding Magellan’s PMTAs for some of its Juno and Hyde vapes. As in the Pastel Cartel case, the products in question contained synthetic nicotine and the PMTAs were filed just before the May 14 deadline.
Nearly a year after the filing of the lawsuit, which asked for a temporary restraining order and preliminary injunction staying the RTAs, the court has taken no action and set no schedule for hearings. Meanwhile, Magellan, like Esco Bar, has become a regular target for government legal attacks.
Some of Magellan’s RTA issues are described in this 2022 article about MDOs issued to the company as part of an FDA publicity stunt. In May of this year, the FDA warned several retailers to stop selling Hyde disposables. A month later, the Second Circuit Court of Appeals denied Magellan’s petition for review of 12 Juno MDOs. In July, New York City sued Magellan and other vape distributors, alleging racketeering, among other crimes.