201810.12
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Jay Manfre Provides CBD Update: FDA-Approved CBD Drugs No Longer a Schedule I Controlled Substance

Timely Article Addresses New DEA Action on FDA-Approved CBD Drugs

CGMB associate Jay Manfre is currently featured on the popular supplement website PricePlow.com, as the author of a new article on the site’s blog addressing the timely topic of the laws surrounding CBD – and discussing the recent announcement that the Drug Enforcement Administration (DEA) is now placing certain FDA-approved drugs that contain cannabidiol (CBD) in schedule V of the Controlled Substances Act. Prior to this announcement by the DEA on September 28th, CBD was a schedule I substance – defined as drugs with no currently accepted medical use in treatment in the U.S.

Jay’s article, “CBD Law 2018 Update: CBD No Longer a Schedule I Controlled Substance”, is accompanied by a video summary of this timely topic by PricePlow founder and CEO Mike Roberto. The article addresses the specific details, and implications, of the DEA’s recent action – which was in response to FDA’s approval of Epidiolex, the first FDA-approved drug that contains a purified drug substance derived from cannabis. As Jay notes in his article, the DEA’s action moving CBD drugs from schedule I to schedule V is only for certain FDA-approved CBD drugs with no more than 0.1 percent THC – with any non-FDA approved CBD extract that falls with the CSA definition remaining as schedule I.

Within the article, Jay discusses the significance of this CBD rescheduling – both for those people who will now be able to legally be prescribed Epidiolex for seizures, as well as the fact that this now opens the door for potential new applications for CBD in treating other types of medical conditions. Jay also provides a great deal of important legal insight on the impact of this rescheduling within the dietary supplement industry – addressing the important fact that the rescheduling does not change the regulatory status of CBD as a dietary supplement. In the blog, Jay notes that upon approving Epidiolex, the FDA specifically addressed dietary supplements containing CBD and that “ …the FDA has taken recent actions against companies distributing unapproved CBD products” – and continuing its opinion that CBD is not a dietary ingredient/supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The rescheduling of FDA-approved CBD from schedule I to schedule V is important and timely news for so many people – including those of us in the dietary supplement industry. As Jay addresses in his blog, this recent DEA action does not change the regulatory status of CBD as a dietary supplement – and this important article addresses the complex issues surrounding this recent development … and what those in the dietary supplement industry today need to know about the legal and regulatory considerations surrounding CBD.

To read Jay’s blog on PricePlow.com and to view the video, click here. For more information about CBD and the law, or for any questions surrounding the latest legal and regulatory guidelines surrounding dietary supplements, call us at 516-294-0300, or email us at info@supplementcounsel.com