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Perkins Coie

Regulatory Update: FDA Takes Action on Concentrated Kratom-Derivative Products

Perkins Coie on

On July 29, 2025, the U.S. Food and Drug Administration (FDA) announced its recommendation to schedule 7-hydroxymitragynine (7-OH)—a concentrated byproduct of the kratom plant—under the Controlled Substances Act (CSA)....more

Troutman Pepper Locke

FDA Proposes Limiting Nicotine Levels in Cigarettes and Certain Other Combusted Tobacco Products

Troutman Pepper Locke on

On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products....more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

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