Magellan Sues FDA Over Vape Registration Petition Denials

Magellan Technology, Inc. and Vapor Train 2 LLC filed a complaint against the Food and Drug Administration (FDA) for unjustly denying Magellan’s twelve Premarket Tobacco Product Applications (PMTAs). They allege that the organization did not give Magellan the proper tracking numbers, so Magellan could not properly link their documentation.

In 2009, then president Obama signed into law the Family Smoking Prevention and Tobacco Control Act, which granted the FDA the authority to regulate tobacco products. At the time, tobacco products were only defined as those containing nicotine derived from tobacco and intended for human consumption. However, the complaint describes, many e-cigarettes and their associated accoutrement use nicotine synthesized without the use of tobacco leaves, so they escaped regulation. 

Ten years later, the FDA expressed an intent to update their Deeming Rule to redefine tobacco products as any product containing nicotine. This would require e-cigarette manufacturers to submit PMTAs prior to selling and marketing their products. The implementation of this rule was delayed due to political and bureaucratic turmoil until April 2022, yet the FDA stated they would use their discretionary enforcement powers to permit the ongoing sale of products whose PMTAs were pending resolution.

Magellan is one such manufacturer of e-cigarettes and associated products and Vapor Train is a retailer of said products. Magellan alleges they submitted the required forms in the correct way, however they say they were not given tracking numbers for each product submitted. This became an issue when they sought to add additional documentation as necessitated by new forms becoming available. Magellan states they included identifying information to tie the applications together, but when the FDA refused to accept Magellan’s permits, it appeared all the paperwork was not properly aggregated. Magellan further alleges the FDA incorrectly assumed their bi-language manufacturing documents were originally in Mandarin and then unverifiably translated into English. 

As such, the plaintiffs seek a stay on the agency’s Refuse to Accept rulings until the organization can properly review all the submitted documentation, as well as reasonable accommodation for legal fees. They brought the case in the Eastern District of Texas, where Vapor Train is located, and are represented by MT2 Law Group and Thompson Hine LLP.