VDX Distro, Incorporated; Vapetastic, L.L.C v. United States Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services
VDX Distro, Incorporated; Vapetastic, L.L.C v. United States Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services
June 24, 2026·24-60537·Panel Decision·Cory T. Wilson·By Raj Patel
The Fifth Circuit denied a petition for review challenging the FDA's denial of marketing authorization for menthol-flavored e-cigarettes under the Family Smoking Prevention and Tobacco Control Act.
Congress granted the FDA authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act. The FDA deemed e-cigarettes to be tobacco products in 2016. The FDA denied VDX Distro’s application for menthol-flavored e-cigarettes because the company failed to demonstrate that the products offered adult smokers a benefit sufficient to outweigh the risks to youth, applying a comparative-efficacy standard.
The court’s reasoning
The court addressed four challenges raised by the petitioners. The court noted that the argument invoking the major questions doctrine was actually a nondelegation challenge, which was not properly raised or supported. The court proceeded to evaluate the FDA’s application of the appropriate for the protection of public health standard and the comparative-efficacy standard used to deny the marketing authorization.
What it means going forward
The denial of the petition upholds the FDA’s authority to deny marketing authorization for menthol-flavored e-cigarettes when the evidence does not show a sufficient public health benefit to outweigh youth risks.
