News & Analysis as of

Controlled Substances Act Federal Food Drug and Cosmetic Act (FFDCA)

ArentFox Schiff

Investigations Newsletter: DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to...

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DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing - On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...more

Harris Beach PLLC

Does Rescheduling Cannabis Make it Eligible for Interstate Commerce?

Harris Beach PLLC on

Even with the expected rescheduling of cannabis from a Schedule I drug to a Schedule III drug, it will take more for it to be eligible for interstate commerce. Marijuana would remain subject to provisions of the Food,...more

King & Spalding

DEA's Proposed Rule to Reschedule Marijuana Could Reduce Obstacles to Medical Research but Public Input Is Needed to Fill in...

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On May 16, 2024, the U.S. Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to reclassify marijuana from Schedule I to Schedule III under the federal Controlled Substances Act (“CSA”) and...more

Akin Gump Strauss Hauer & Feld LLP

High Stakes: HHS Shakes Things Up on Marijuana Scheduling and DEA Abides

On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more

Mintz

Rescheduling Madness: Key Takeaways from the Proposed Rule to Reschedule Marijuana under the CSA

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Moving marijuana under the Controlled Substances Act (“CSA”) from Schedule I to Schedule III will bring celebrated changes to the beleaguered state-sanctioned cannabis industries currently operating in 37 states, but will...more

Holland & Knight LLP

U.S. Drug Enforcement Administration Proposes Reclassification of Marijuana

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The U.S. Drug Enforcement Administration (DEA) on May 16, 2024, issued a proposed rule to move marijuana from its current classification as a Schedule I drug to a Schedule III drug, thereby loosening federal DEA restrictions....more

Husch Blackwell LLP

Schedule 3 Marijuana Alert: DEA Publishes NPRM

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On May 16, the Drug Enforcement Administration (“DEA“) published its 92-page notice of proposed rulemaking (“NPRM“) to move marijuana from schedule 1 on the Controlled Substances Act (“CSA”) to schedule 3 (ironically, the...more

Troutman Pepper

High Stakes: Eight Tips (and One Bonus) for Cannabis Professionals on the Budding World of Trademarks

Troutman Pepper on

Apologies for the cannabis puns in the title, but they are required by law. Okay, you are correct. That is not true. But it is true that trademark protection is important for individuals in the cannabis industry. Earlier this...more

Vicente LLP

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

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On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more

Latham & Watkins LLP

FDA Finalizes Quality Recommendations for Cannabis in Clinical Investigations

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FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act. Key Points: ..The Food and Drug...more

Eversheds Sutherland (US) LLP

FDA says “no” to CBD: Now what?

The FDA’s recent decision not to regulate CBD like a food or dietary supplement leaves a multi-billion-dollar industry in a lurch. What’s next, and what should companies do now?...more

Foley & Lardner LLP

Psychedelic Drugs – Easing the Regulatory Hurdles for Development

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Congress recently introduced a bill that could expand access to therapeutic psychedelics that are designated as Breakthrough Therapies. These products are potentially useful in treating addiction, depression, post-traumatic...more

Butler Snow LLP

Half-Baked: An Overview of Current Cannabinoid Laws & Regulations

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Over 50 years ago President Nixon declared a “War on Drugs,” leaving housewives over the country proclaiming marijuana to be the devil’s lettuce and urging sweet Billy to steer clear of the gateway drug...more

Vicente LLP

President Biden's Cannabis Scheduling Directive Is a Game Changer

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Most commentary I’ve seen on President Biden’s recently announced “three steps to end [the federal government’s] failed approach” to cannabis focuses primarily (often nearly entirely) on his decision to pardon all federal...more

Mintz - Health Care Viewpoints

FDA Expresses Displeasure with Consumer Products Containing Trendy Cannabis Ingredient Delta-8 THC

On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more

Lippes Mathias LLP

The Blunt Reality of Trademark Registration for Cannabis Marks

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With the list of states that have legalized adult-use cannabis continuing to grow, businesses are entering the industry at a rapid pace. However, one of the biggest questions facing these businesses is how to develop and...more

Vicente LLP

Financing Adaptogenic Mushroom Companies: Seven Basic Regulatory Points to Understand

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Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more

K&L Gates LLP

In the Weeds: The States Reform Act of 2021, the Latest Comprehensive Cannabis Reform Bill

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On 15 November 2021, Representative Nancy Mace (R-SC) introduced a comprehensive cannabis reform bill: the “States Reform Act” (SRA). As discussed in further detail below, the SRA would deschedule cannabis from the Controlled...more

Ward and Smith, P.A.

Delta-8 THC: More Risk than Reward

Ward and Smith, P.A. on

Hemp product producers and sellers must consider a large number of legal and regulatory compliance risks each day.  Are their inputs and plant material coming from legally compliant sources?  Are their products,...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - September 2021

The September 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses a recent non-precedential Trademark Trial and Appeal Board decision regarding intent-to-use applications covering CBD products currently...more

King & Spalding

Selling CBD-Infused Products Might Be Riskier Than You Think

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The global cannabidiol (CBD) market size is expected to reach USD 13.4 billion by 2028. And yet a large part of that market—CBD-infused food, beverages, and dietary supplements—consists of unlawful sales. This article...more

Womble Bond Dickinson

Six Things You Need to Know About CBD and Other Hemp-containing Pet Products

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The trend toward state-level legalization of cannabis has led to a surge in cannabis-derived products and a continually evolving market with many types of cannabis products for people as well as their pets. Analysts predict...more

Vicente LLP

Psychedelics As Medicine: Right To Try Case Versus DEA

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In what could be a groundbreaking case for psychedelic medicine, VS counsel Shane Pennington is part of a team working on an exciting and very important Ninth Circuit challenge to the U.S. Drug Enforcement Administration’s...more

Vicente LLP

Cannabis Administration And Opportunity Act: What The Proposed Federal Cannabis Laws Would Mean For Hemp

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On July 14, 2021, Senators Chuck Schumer (D-NY), Ron Wyden (D-OR), and Cory Booker (D-NJ) released the discussion draft of historic federal cannabis legalization legislation, the Cannabis Administration and Opportunity Act...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - July 2021: Budding Legislation – The Cannabis Administration and Opportunity Act

On July 14, 2021, Senate Majority Leader Chuck Schumer, together with Senate Finance Committee Chair Ron Wyden and Senator Cory Booker, released a discussion draft of the Cannabis Administration and Opportunity Act (the...more

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