On April 2, 2025, the U.S. Supreme Court issued its decision in the Wages and White Lion Investments d/b/a Triton Distribution (hereafter “Triton”) Premarket Tobacco Product Application (PMTA) Marketing Denial Order (MDO) challenge. In a 9-0 unanimous ruling, the Supreme Court held that FDA did not act arbitrarily and capriciously when it denied the PMTA for Triton’s flavored electronic nicotine delivery systems (ENDS) (open-system e-liquid products) under the “fatal flaw” review standard. Food & Drug Admin. v. Wages & White Lion Invs., L.L.C., 604 U.S. ___ (2025). While the decision reaffirmed the deference owed to FDA under the Administrative Procedure Act (APA), at least with respect to t... [Read more]