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Comment Period DEA Food and Drug Administration (FDA)

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

McGlinchey Stafford

Rescheduling Marijuana FAQs: How Do I Submit Comments on DEA’s Proposed Rules?

McGlinchey Stafford on

On May 16, 2024, the U.S. Drug Enforcement Administration (DEA) released the proposed rule (Proposed Rule) to reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA). The Office of Legal...more

Holland & Knight LLP

FDA Issues First Guidance on Clinical Trials for Psychedelic Drugs

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more

Foley & Lardner LLP

Key Takeaways from USDA’s Interim Hemp Production Rule

Foley & Lardner LLP on

On October 31, 2019 the U.S. Department of Agriculture (USDA) published an Interim Final Rule (84 FR 58522) establishing the U.S. Domestic Hemp Production Program and outlining a regulatory framework for monitoring hemp...more

King & Spalding

USDA Issues Interim Final Rule to Establish Domestic Hemp Production Program and Approve State and Tribal Oversight Plans

King & Spalding on

Effective upon Publication, USDA’s Interim Final Rule Sets Forth One Important Part of the Regime for Marketing Hemp Products in the United States - This week, the U.S. Department of Agriculture (USDA) issued an interim...more

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