The action marks the first and only OTC topical drug with cannabidiol to receive certification for its listing in the National Drug Code Directory, according to its manufacturer.
EDITOR'S NOTE: This article was updated February 4, 2020 at 9:40 am with revised information from Honest Globe that clarifies the certification of the product listing.
Honest Globe’s over-the-counter (OTC) drug registration for cannabidiol (CBD)-infused pain relief products (Elixicure) has been certified by the FDA, according to the company. The action marks the first and only OTC topical drug with cannabidiol to receive certification for its listing.1
Product isting certification is not an indication of the FDA's approval, but rather that the product is included in the agency's National Drug Code Directory. In an email to Pharmacy Times, an FDA spokesperson said certification is an annual requirement for drug manufacturers, and it requires that a directory listing is up-to-date and accurate. "The company certifies the records, the FDA does not," the spokesperson said.2
The all-natural, pain relief cream is indicated to help reduce inflammation, swelling, aches, and pains. It contains CBD extract from the hemp plant that has medicinal qualities, according to a Honest Globe.1
Although the product is not FDA-approved, inclusion in the NCD Directory and the listing's certification mark a milestone, according to Yaniv Kotler, Chief of Business Development for the Elixicure brand. "This certification requires us to vet our processes, our equipment and systems, our vendors and suppliers, and conduct batch-by-batch testing to ensure quality," Kotler said, in a press release.1
In a prepared statement, Kotler said the product listing certification provides customers with an alternative to opioids for pain relief.1 However, drug products containing CBD cannot legally be marketed without an FDA-approved application, according to the agency spokesperson.
Currently, the only drug product containing CBD that has been approved by the FDA is Epidiolex (GW Research), an oral solution indicated to treat seizures associated with Lennox-Gastaut syndrome (LGS), and Dravet syndrome in patients aged 2 years and older. Approved by the FDA in 2018, Epidiolex is a prescription formulation of highly-purified, plant-derived CBD.2