FDA Approves CBD Treatment for Epilepsy

In 2018, the Food and Drug Administration (FDA) approved the cannabidiol (CBD) oral solution Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of pediatric epilepsy.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” said FDA Commissioner Scott Gottlieb, M.D.

This development has been long anticipated by the hemp industry. While the approval provides families necessary access to CBD, some feared the retail sale of hemp-derived CBD would be made illegal. Why? It was thought that an FDA-approved cannabidiol drug would prompt the Drug Enforcement Administration (DEA) to crack down on non-FDA-approved CBD products.

This has not been the case. The approval of Epidiolex has had no legal impact on the sale of hemp-derived CBD.

However, there are still some items of note.

As a hemp-derived CBD retailer, we must be cautious of the claims we make regarding our product. The FDA has, and will continue to, take action against the “proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.” This regulation protects consumers from unproven claims. Relief BeLeaf, LLC is dedicated to following hemp industry standards. The FDA Commissioner refers to “marijuana” and not the extracted CBD compound. As we are aware, the DEA does not differentiate between hemp and marijuana and consider the extracts of both to be controlled substances. However, hemp-derived CBD remains legal under the 2014 Farm Bill.

The approval of Epidiolex increases the visibility of CBD products. Our next action is for Congress to pass the Hemp Farming Act and establish hemp and hemp-derived products as “agricultural commodities”. Relief BeLeaf, LLC encourages our partners to reach out to their Congresspersons and urge them to support the Hemp Farming Act.