U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
The Ninth Circuit upheld the FDA's denial of MH Global's flavored vape applications, ruling the agency's comparative-efficacy framework is consistent with public health standards.Summary
The U.S. Court of Appeals for the Ninth Circuit has upheld the Food and Drug Administration's (FDA) denial of marketing applications submitted by MH Global LLC for flavored electronic nicotine delivery systems (ENDS). The court ruled that FDA's requirement for applicants to demonstrate that flavored products provide greater cessation or switching benefits than tobacco-flavored alternatives is consistent with the Tobacco Control Act's (TCA) "appropriate for the protection of the public health" (APPH) standard. The decision confirms that FDA may require product-specific evidence showing flavored products offer additional public health benefits compared with tobacco-flavored alternatives. The court also rejected MH Global's argument that FDA should have established the comparative-efficacy framework through notice-and-comment rulemaking, finding that agencies generally may develop regulatory standards through either rulemaking or individual adjudications. This ruling reinforces the evidentiary standards facing flavored ENDS products seeking PMTA authorization.
(Source：2Firsts)
