The makers of Hyde and Juno e-cigarettes are suing the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services, claiming the agencies violated the Administrative Procedure Act.

New York-based Magellan Technology accused the agencies of refusing to review the company's premarket tobacco product applications (PMTA) for 12 products, a process that cost the company $1 million. Under the law, Magellan claims the FDA rejected the applications arbitrarily and capriciously.

"At the time of issuing the RTA refusal to accept the order, Magellan had spent more than $1 million on PMTA and planned to spend more than $10 million on PMTA in total," the lawsuit states.

Texas retailer Vapor Train 2 LLC is also a plaintiff in the lawsuit. The companies are asking federal court in Texas to temporarily suspend the FDA's RTA order against Magellan, according to a lawsuit filed Thursday.

"The FDA acted arbitrarily, capriciously, and inconsistently with applicable law in issuing the denial order," the lawsuit states. "The agency invoked the provisions for premarket tobacco product application acceptance that did not apply to Magellan's applications, and did not consider timely amendments to include the required content of Magellan's correct submission."

According to the lawsuit, applications for Magellan's products were submitted to the FDA on May 12-13 by Guangdong Tante Testing Services Co., a third-party company based in China, ahead of the May 14 deadline.

However, before the deadline, the FDA made last-minute changes to the requirements in the application, the lawsuit said. Specifically, on April 14, the agency used emergency powers to amend a document, Form 4057, that Magellan needs to include in its application.

A revised version of the form has not been posted on the government website for nearly two weeks, and the FDA did not announce the changes until May 16, two days after the application deadline.

Magellan claims that when Skyte submitted the application, the government's website did not generate a submission tracking number. Magellan claims it didn't know the numbers until after the FDA released its RTA in October, the lawsuit said.

Without these numbers, Magellan would not be able to properly file amendments to its applications, particularly the new 4057 form. Skyte attempted to file updated filings on Aug. 18, explaining in a summary page that they should be included in its May filing, according to the lawsuit.

But the FDA later rejected the forms because they didn't include a filing tracking number, the lawsuit says. Specifically, the agency noted that despite submitting additional submissions that may be intended to amend your application, the submission did not specify the tracking number assigned to the original submission on FDA Form 4057.

Magellan claims the omission is not its fault.

The FDA did not "act in accordance with the law and did not consider the timely revisions submitted by Magellan on August 18, 2022, on the grounds that the revisions did not include or reference the assigned submission tracking number...when the FDA itself failed to assign the original number the bundled application corresponds to 's submission tracking number," the lawsuit states.

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