GREENSPOON MARDER CLIENT ALERT: Epidiolex: The Federal Government Acknowledges Cannabis for Medical Use

Oct 1, 2018

By: Rachel Gillette and Nabil Rodriguez

In June of 2018, the United States Food and Drug Administration (“FDA”) approved of Epidiolex CBD Oral Solution – the first cannabis-derived drug to be accepted for medical use and treatment in the United States.

Epidiolex survived rigorous FDA testing and was ultimately approved for the treatment of seizures associated with two severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.

Published September 28, 2018, the Federal Drug Enforcement Agency (“DEA”) and Federal Department of Justice (“DOJ”) released Final Order billing code 4410-09-P “Schedules of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol; Corresponding Change to Permit Requirements.” Under this Final Order, a product approved by the FDA which contains CBD derived from cannabis and “no more than 0.1 percent” [one tenth of one percent] THC automatically becomes a Schedule V controlled substance.

By definition under the Controlled Substances Act (“CSA”), a Schedule I controlled substance “has no currently accepted medical use in treatment in the United States.” However, for the first time in U.S. history, the Federal Government has acknowledged cannabis – a Schedule I drug – as having medical use. In essence, the FDA’s approval of Epidiolex evidences a cannabis-derived product with accepted and proven medical benefits. However, in general, cannabis-derived CBD extracts, derivatives and products that do not have FDA approval remain Schedule I controlled substances under the CSA.

In light of Epidiolex’s approval, a persistent wave of confusion and misinformation has flooded both the cannabis and hemp industries. At this time, it is critical for cannabis and hemp industry operators to remain mindful and aware of rapidly changing laws. Greenspoon Marder’s expanding Cannabis Law Practice Group is committed to remaining active and alert for legislative adjustments at both the federal and state levels in order to best advise our clients.

Should you have any questions regarding the current legal status of CBD, hemp or other cannabis derived products, please reach out to your Greenspoon Marder attorney. The Final Order was published here on September 28, 2018.

About Greenspoon Marder

Greenspoon Marder LLP is a full-service law firm with over 225 attorneys and more than 20 office locations across the United States. With operations from Miami to New York and from Denver to Los Angeles, our firm attracts some of the nation’s top talent in key markets and innovation hubs. Our core practice areas include Real Estate, Litigation, and Transactional Services, complemented by the capabilities of a full-service firm. Greenspoon Marder has maintained a spot on The American Lawyer’s Am Law 200 as one of the top law firms in the U.S. since 2015, and our goal is to provide exceptional client service by developing a thorough understanding of each client’s business needs and objectives in order to provide strategic, cost-effective solutions.

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This Greenspoon Marder LLP Client Alert is issued for informational purposes only and is not intended to be construed or used as general legal advice nor a solicitation of any type. Please contact the author(s) or your Greenspoon Marder LLP contact if you have any questions regarding the currency of this information. The hiring of a lawyer is an important decision. Before you decide, ask for written information about the lawyer’s legal qualifications and experience.

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GREENSPOON MARDER CLIENT ALERT: Epidiolex: The Federal Government Acknowledges Cannabis for Medical Use

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