Epidiolex for Seizures
Last week, 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.
How Does Epidiolex Impact the Hemp-Derived CBD Industry?
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. US Hemp Wholesale is dedicated to following hemp industry standards and encourages our partners to do the same.
- 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 2018 Farm Bill.
The approval of Epidiolex increases the visibility of CBD products. Our next action is waiting on the FDA to make their statement on how they will regulate hemp-derived CBD. They have held open sessions where everyday citizens, as well as multiple experts, we’re able to have their opinions heard in regards to cannabidiol. We at US Hemp Wholesale are anxiously awaiting their official statements.
For more information on this and other hemp industry news, subscribe to our newsletter.