News & Analysis as of

Comment Period FDA Warning Letters

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

Brownstein Hyatt Farber Schreck

FDA Cracks Down on Companies Selling CBD Products

The past year has seen a veritable tidal wave of consumer product marketing claiming that cannabidiol (CBD) infused or derived products cure or treat cancer, epilepsy, anxiety, inflammation, diabetes, Alzheimer’s disease,...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

Dorsey & Whitney LLP

FDA Conducts First Public Hearings Regarding CBD

Dorsey & Whitney LLP on

On Friday, May 31, 2019, the Food and Drug Administration (“FDA”) conducted its first public hearing to create a regulatory framework for the legal marketing and sale of cannabidiol (“CBD”) products. The FDA asked the...more

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