By: Nabil Rodriguez, Esq., Associate For a recap of Day One, click here…
On August 16, 2019, the afternoon panels of the
American Herbal Production Association Hemp-CBD Supplement Congress offered unique perspectives on the regulatory landscapes and hurdles still in the path of CBD product legality. Panels in the afternoon session included USDA and FDA representatives discussing the challenges with drafting hemp cultivation and CBD regulations, a panel focused on the current regulatory enforcement of the FDA, and a final panel aimed at discussing hemp-derived CBD supplements from the perspective of retailers.
Although each panel provided critical information for companies attempting to navigate the intricate field of hemp and CBD laws, the elephant in the room was definitively the FDA. As a quick review: immediately following the passage of the 2018 Farm Bill, the FDA published a press release on December 20, 2018, with the position that it was illegal to introduce food products containing CBD or THC into interstate commerce, including dietary supplements. In addition, the FDA indicated its intention of taking enforcement actions against companies marketing CBD products with therapeutic claims.
With such a notable position, when those in the hemp-CBD industry were given the opportunity to inquire as to when the FDA might promulgate regulations to provide a legal pathway for CBD, the crowd was eager to get some answers.
Cara Welch, Acting Special Assistant to the Deputy Commissioner for Policy Legislation & International Affairs, held steadfast in the FDA’s need for more information on CBD. Asking questions such as: “how much is too much?… What are the long-term effects of regular consumption?” helped the audience to understand the challenge the FDA is currently facing with creating a legal market for CBD. Although public interest is growing, there is missing data that the FDA needs to consider in order to protect and promote the public health.
As a response to one of her initial direct questions, Welch highlighted the stark contrast between CBD in Epidiolex for children with severe seizure conditions and CBD in everyday foods and products. For Epidiolex to be approved, it was studied thoroughly for a specific indication in a specific population that is under close medical supervision. The main concern of the FDA is not knowing the effects of extended exposure when foods and dietary supplements are not under the same level of scrutiny as a prescribed medication. Welch, on behalf of the FDA, encourages those with any additional research available to come forward and assist with collecting information regarding the safety of CBD.
An assembly of the stature at this AHPA meeting is hard to come by, but by doing so, the path to progression of hemp and CBD continues to move in the right direction. In the meantime, should you have any specific questions regarding your hemp or CBD business, or questions regarding this specific conference, or how attending these conferences could advance your business, please contact Greenspoon Marder LLP today.