News & Analysis as of

Comment Period Controlled Substances Act 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

Foley Hoag LLP

Big Four Health Committee Leaders Release Request for Information on Regulation of Cannabidiol

Foley Hoag LLP on

On July 27, 2023, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie...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The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more

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

White and Williams LLP

Cannabis and Cannabis-Derived Compounds: FDA Announces Public Hearing and TTB Issues Industry Circular

In late 2018, President Trump formally signed the Agricultural Improvement Act of 2018 (2018 Farm Bill) into law, and in turn declassified hemp as a Schedule 1 substance under the Controlled Substances Act (CSA). Hemp is...more

Latham & Watkins LLP

Legalization of Products Containing CBD? Not Quite Yet, Says FDA

Latham & Watkins LLP on

The Agency plays a significant role in the evolving legal landscape governing certain cannabis-derived products. Key Points: ..New law lifts or eases some, but not all, federal obstacles for certain cannabis-derived...more

Jackson Lewis P.C.

FDA Seeks Comments On Potential Marijuana Reclassification Under International Drug Control Treaty

Jackson Lewis P.C. on

The Food and Drug Administration requested comments in a notice published in the Federal Register on April 9, 2018 concerning the “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling...more

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