Rod Selected to Speak at FDA Hearing on CBD

Rod was selected to speak at FDA’s Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds Public Hearing on Friday, May 31, 2019. Of the nearly 400 requests to present and/or provide oral remarks the FDA selected 65.

The hearing starts at 8:00am. You can watch it by clicking here. If you are a stakeholder in the hemp/CBD industry, then we strongly encourage you to submit comments to the public docket FDA-2019-N-1482 by July 2, 2019. The Regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 2, 2019.

You may recall our post from April regarding this public hearing, which is an initial step by the FDA to consider how to regulate CBD and hemp products. As we’ve previously discussed, the FDA currently holds the position that CBD cannot be used as a food ingredient, marketed as a dietary supplement, and that no medical/disease claims can be made about it. This is based on the FDA’s approval last summer of Epidiolex, a CBD medication for the treatment of a handful of severe seizure disorders. Both chambers of Congress have urged the FDA to modify its position and industry stakeholders across the board have requested clarity.

We have argued that, at a minimum, the FDA should acknowledge in writing the distinction between CBD and hemp extract pursuant to the 10th Circuit Court of Appeals ruling in FDA v. Pharmanex regarding red yeast rice and lovastatin. (If you’re unfamiliar with this important case, which has direct implications for the hemp/CBD industry, then you can read about it here.) Additionally, given the findings in two recent reports by the World Health Organization that CBD is non-toxic, non-addictive, non-psychoactive, and has significant potential as a health aid, the FDA should create a regulatory framework to allow it as an ingredient and/or a dietary supplement.

If you will be in Washington, DC and would like to meet with Rod, please send a message through our portal.

May 28, 2019

Rod Kight is an attorney who represents lawful cannabis businesses. He speaks at cannabis conferences across the country, drafts and presents cannabis legislation to foreign governments, is regularly quoted on cannabis matters in the media, and maintains the Kight on Cannabis legal blog, where he discusses legal issues affecting the cannabis industry. You can contact him here.