Triton Files Brief in Opposition to FDA’s Supreme Court Petition to Review PMTA Reversal

As previously posted, a federal appeals court (Fifth Circuit Court of Appeals) overturned the Marketing Denial Orders (MDOs) handed down by the U.S. Food and Drug Administration to Triton Distribution and Vapetasia.

In March the FDA filed a petition for writ of certiorari requesting the Supreme Court review the Fifth Circuit opinion and reverse it.

This month (May) Triton filed its response, a brief in opposition to FDA’s petition for certiorari regarding the denial of its marketing application for flavored electronic nicotine delivery systems (ENDS) by the FDA.

The lengthy response, nearly 42 pages, provides reasons for denying the petition and argues that the decision by the en banc Fifth Circuit was correct. ​ It argues that the FDA changed its position on the authorization requirements for ENDS without giving fair notice to the applicants and without considering their reliance interests. ​ The response further argues that the FDA committed prejudicial errors by ignoring the marketing and sales access restriction plans proposed by the applicants. ​ It concludes by stating that there are other cases in which the Circuit splits on these issues can be resolved (Lotus Vaping Techs., LLC v. FDA, petition for cert. pending, No. 23871 (filed Feb. 9, 2024); Magellan Tech, Inc. v. FDA, petition for cert. pending, No. 23-799 (filed Jan. 22, 2024)). It’s possible all three cases could be consolidated.​

The brief persuasively argues FDA’s denial of the Triton marketing application for flavored ENDS was justified and should not be overturned. It will now be up tp the Supreme Court to decide whether it should hear the case.

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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