News & Analysis as of

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

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...

King & Spalding on

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

Mintz on

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

Latham & Watkins LLP

FDA Finalizes Quality Recommendations for Cannabis in Clinical Investigations

Latham & Watkins LLP on

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

Foley & Lardner LLP on

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

Butler Snow LLP on

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

Vicente LLP on

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

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

K&L Gates LLP on

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

King & Spalding

Selling CBD-Infused Products Might Be Riskier Than You Think

King & Spalding on

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

Womble Bond Dickinson on

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

Vicente LLP on

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

Vicente LLP on

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

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

MarkIt to Market® - July 2021

[co-author: Richa Patel, Summer Associate] The July 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fluid trademarks and the Cannabis Administration and Opportunity Act. Plus, check out the answer key...more

Vicente LLP

Minor Cannabinoids: Exploring the Science, Legality, & Opportunities

Vicente LLP on

While THC and CBD are the two most commonly known and sought-after “major” cannabinoids, several “minor” cannabinoids have been getting a lot of attention lately (we’re looking at you, Delta-8!). Despite the increasing buzz...more

Dorsey & Whitney LLP

TTAB Weighs in on Registrability of CBD Trademarks

Dorsey & Whitney LLP on

In a precedential decision earlier this year, the Trademark Trial and Appeal Board thinned some of the haze surrounding the registrability of trademarks for hemp-derived CBD products. In line with the U.S. Patent and...more

Rivkin Radler LLP

Cannabis Investors and Producers Face Need for Due Diligence

Rivkin Radler LLP on

The cannabis industry is growing in leaps and bounds, but entrepreneurs interested in developing cannabis companies – as well as business people interested in investing in them – must make certain that they know what they are...more

Rivkin Radler LLP

Cannabis Investments and Exit Strategies: A Case Study

Rivkin Radler LLP on

It is relatively easy for investors to make investments in cannabis companies. Given the risks, however, they would be well-advised to have an exit plan in the event their investment does not live up to their expectations....more

King & Spalding

FDA Releases Progress Report Regarding Enforcement Discretion Policy on Hemp-Derived Cannabidiol (CBD)

King & Spalding on

Last week, FDA submitted a report to Congress detailing the Agency’s progress on developing an enforcement discretion policy (i.e., a policy of not taking enforcement action) on hemp-derived cannabidiol (CBD). At the same...more

Haug Partners LLP

Global Developments and Considerations for Registering Cannabis and Cannabis-Related Trademarks

Haug Partners LLP on

This article discusses the global developments for the registration of cannabis and cannabis-related trademarks in the United States, Canada, Mexico, and the European Union....more

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