Monica Groat

2 weeks ago | jdsupra.com | Monica Groat |Ben Haas |Trevor Thompson

On April 2, 2025, the Supreme Court unanimously held that the US Food and Drug Administration (FDA) lawfully denied marketing authorization for certain flavored e-liquids used in electronic nicotine delivery systems (ENDS), otherwise known as e-cigarettes or “vapes.” The Court vacated and remanded the Fifth Circuit’s decision that FDA had acted arbitrarily and capriciously under the Administrative Procedure Act (APA) by issuing marketing denial orders (MDOs) to the respondents for their...

Sep 10, 2024 | jdsupra.com | Monica Groat |Ben Haas |Evan Miller

FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its opening brief in the Supreme Court proceedings for FDA v.