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Controlled Substances Food and Drug Administration (FDA)

Womble Bond Dickinson

FDA Rejects MDMA Treatment for PTSD; Setbacks and New Directions

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In a previous blog on the use of psychedelics to treat mental health disorders, we reported that the US Food and Drug Administration (FDA) granted breakthrough therapy designation to MDMA (a.k.a., ecstasy) in 2017 as part of...more

DLA Piper

HHS to DEA: Marijuana Should Be Schedule III – What This Means for The Cannabis Industry

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In a non-public letter sent earlier last week, the US Department of Health and Human Services (HHS) recommended to the US Drug Enforcement Administration (DEA) that marijuana be re-classified under the Controlled Substances...more

Bradley Arant Boult Cummings LLP

MDMA DOA at FDA Advisory Committee

Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

Sheppard Mullin Richter & Hampton LLP

Bridging the Gap: Cannabis Rescheduling to Align Policy with Research

In a much-anticipated move, sources recently reported that the Drug Enforcement Administration (“DEA”) will recommend rescheduling cannabis from a Schedule I substance to a Schedule III substance under the federal Controlled...more

Clark Hill PLC

Cannabis Reclassification: Litigation Impact

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In a historic move, the DEA accepted the US Department of Health and Human Services’ recommendation to reclassify marijuana from Schedule I to a Schedule III controlled substance, arguably the most significant change to...more

Clark Hill PLC

The Good, The Bad and The Ugly: DEA Rescheduling Marijuana to Schedule III

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On April 30, the U.S. Drug Enforcement Administration issued a proposed rule to move marijuana from the Schedule I class to Schedule III. If approved this will be the most significant change in federal marijuana law since...more

Hinshaw & Culbertson LLP

DEA's Decision to Reschedule Marijuana Represents a Massive Shift in U.S. Drug Policy, But Challenges for Cannabis Industry Remain

Earlier this week, we learned that the United States Drug Enforcement Administration (DEA) will likely reclassify marijuana under federal law from Schedule I to Schedule III of the Controlled Substances Act (CSA) based upon...more

Falcon Rappaport & Berkman LLP

Cannabis Rescheduling – A Look Towards the Future of the Industry

The Drug Enforcement Administration (DEA) will call for cannabis to be rescheduled according to a report by the Associated Press. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August...more

Woods Rogers

DEA’s Seismic Move to Reschedule Cannabis

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On Tuesday, April 30, the Associated Press reported that the Drug Enforcement Administration (DEA), will move to reclassify marijuana from a Schedule I drug to a Schedule III drug.  DEA’s move comes several months after the...more

Brownstein Hyatt Farber Schreck

Breaking: DEA Turns a New Leaf in Drug Policy, Moves Toward Rescheduling of Cannabis

In a groundbreaking development for the cannabis industry, sources within the U.S. Drug Enforcement Administration (DEA) are signaling the agency’s intention to reclassify marijuana from Schedule I to Schedule III under the...more

Bradley Arant Boult Cummings LLP

Legalizing LSD? FDA Says Mm-hmm to MM120

If you know either of us, you know neither of us would pass up a chance to say, “I told you so.” As we looked ahead to 2024 in January, we speculated that psychedelics could be legalized as a prescription medicine. Now, not...more

Console and Associates, P.C.

Parents Bring Kratom Lawsuits Following Overdose Deaths and Other Serious Injuries

Kratom, a natural substance derived from the leaves of the Mitragyna speciosa tree, has recently gained notoriety for its potential dangers. While proponents cite its therapeutic benefits, concerns have surged about its...more

Womble Bond Dickinson

An Update on Medical Research and Legal Battles for Psilocybin

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Scientists continue to research psilocybin as an alternative treatment for multiple neuropsychiatric disorders, including anxiety, depression, and PTSD. We previously highlighted this research in 2021. One area of research is...more

Nelson Hardiman, LLP

Too Much Of A Good Thing?

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F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more

McGuireWoods LLP

FDA Releases Its Scientific Support for Rescheduling Marijuana to Schedule III

McGuireWoods LLP on

On Jan. 12, 2024, the U.S. Department of Health and Human Services (HHS) officially released unredacted documents detailing the U.S. Food and Drug Administration’s (FDA) reasons for recommending that the Drug Enforcement...more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

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On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

The Rodman Law Group, LLC

DEA Rejects Psilocybin Rescheduling Petition

In December of 2023, Dr. Sunil Aggarwal of Advanced Integrative Medical Science Institute, filed a petition with the Ninth Circuit Court requesting a new order requiring the Drug Enforcement Administration (“DEA”) to refer...more

Bradley Arant Boult Cummings LLP

2023: A Good Trip Around the Sun for Psychedelics

2023 was a momentous year for psychedelics, and it’s not just because we at Budding Trends started writing about them. There were wins for the psychedelic industry at the local, state, and federal levels, as well as in the...more

Vicente LLP

A Potential Breakthrough for Psychedelic Treatments: Ninth Circuit Court Ruling on Psilocybin Rescheduling

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On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic...more

Husch Blackwell LLP

Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy

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Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the...more

Bradley Arant Boult Cummings LLP

Big Brother Cancels Trip, Court Says Not So Fast My Friend

A few weeks ago, the Ninth Circuit Court of Appeals in  Aggarwal v. U.S. DEA directed the U.S. Drug Enforcement Agency (DEA) to reconsider its decision not to transfer psilocybin from Schedule I to Schedule II....more

Troutman Pepper

Cannabis Plain Packaging Rules: Examples and Opportunities

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Much attention has recently been placed on hemp-derived products marketed in packaging that mimics popular snack foods. Originally published in Law360 - August 15, 2023....more

Alston & Bird

Health Care Week in Review: New House Speaker Elected; HRSA Issued a Notice on 340B Drug Pricing Program Requirements

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Neal, Gerber & Eisenberg LLP

Client Alert: HHS Recommends Rescheduling Marijuana to Schedule III: Implications and Uncertainties for the Industry

Marijuana has long been classified as a Schedule I controlled substance under the Controlled Substances Act of 1970 (the “CSA”), which is defined as a substance with no accepted medical use and a high potential for abuse,...more

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