Fifth Circuit Grants Triton Rehearing Before Full Court

The U.S. Court of Appeals for the Fifth Circuit granted Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC’s, request for the full court to re-hear Triton’s appeal of its marketing denial order (MDO), according to a court order handed down today.

Triton lost before a three-judge panel in July, but attorneys for Triton then filed a petition for a rehearing en banc by the entirety of the Fifth Circuit.

Most circuit court appeals are decided by a three-judge panel, however, the special circumstances surrounding the U.S. Food and Drug Administration’s denial of Triton’s premarket tobacco product applications (PMTAs) motivated the court to allow a majority of the active judges (an estimated 17 judges) to vote to rehear the case “en banc.”

The FDA rejected applications to market 55,000 flavored e-cigarettes in August 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval.

A Fifth Circuit panel in October then agreed with Triton’s claim that the new requirement for long-term studies differed from earlier FDA guidance and called the action a “surprise switcheroo” and the panel allowed Triton to keep selling its e-cigarettes until another panel could hear its appeal.

The court then denied Triton’s request for review of the agency’s MDOs in a 2-1 decision.

The Fifth Circuit will hear the en banc argument in Wages and White Lion Investments v. U.S. Food & Drug Administration in May.