On Monday, the U.S. Food and Drug Administration (FDA) approved Epidiolex,
a drug containing Cannabidiol (CBD). CBD is one of the 80 active chemicals
found in the marijuana plant, but unlike the more commonly known cannabinoid
chemical Tetrahydrocannabinol (THC), CBD does not produce a “high”.
Justin Gover, chief executive officer of GW Pharmaceuticals, the UK-based
biopharmaceutical company that makes Epidiolex, stated the FDA assessed
Epidiolex as having a low to negative potential for abuse.
The FDA approved Epidiolex as a prescription drug to be used to treat two
severe epileptic conditions, Lennox-Gastaut syndrome and Dravet syndrome.
Epidiolex is the first drug the FDA has approved that contains a substance
derived from marijuana, and it is also the first drug approved by the
FDA to be used to treat patients with Dravet syndrome.
The FDA’s approval of the drug is just one step toward getting Epidiolex
on the market and available to doctors to prescribe as a treatment option.
Moreover, the ball is in the Drug Enforcement Agency’s (DEA) court.
As the Controlled Substances Act (CSA) currently stands, CBD is still
a Schedule I substance, which classifies CBD as having no medicinal uses.
The FDA can make recommendations to the DEA about substances subjected
to scheduling under the CSA, but the DEA is the entity with the power
to reschedule CBD.
In the recent case
Hemp Industries Associations v. U.S. DEA, the DEA expressed in their brief that they do not wish to control cannabinoids,
but rather only those cannabinoids derived from the flowers and resins
of a cannabis plant above .3% THC. Further, the DEA issued a directive
to federal agencies this past May clarifying that the presence of cannabinoids
alone, in any product or derivative, does not automatically qualify the
substance as controlled under the CSA. The problem that arises is trying
to determine where the CBD was derived from after the CBD has already
been derived and processed, which is an arguably impossible task.
So for now, we wait in anticipation for the DEA to commence proceedings
to determine how to amend the scheduling of CBD under the CSA in a way
that will allow for Epidiolex to be prescribed by health care providers
and dispensed by pharmaceutical companies appropriately and legally.
Even though the use of CBD for medicine has the support of the FDA, the
methods of extracting CBD and the marketing of CBD products will likely
become the subjects of high scrutiny. FDA Commissioner Scott Gottlieb stated:
“We’ll continue to support rigorous scientific research on
the potential medical uses of marijuana-derived products and work with
product developers who are interested in bringing patients safe and effective,
high quality products. But, at the same time, we are prepared to take
action when we see the illegal marketing of CBD-containing products with
serious, unproven medical claims. Marketing unapproved products, with
uncertain dosages and formulations can keep patients from accessing appropriate,
recognized therapies to treat serious and even fatal diseases”.
As CBD gains recognition as a medicine, the producers and manufacturers
will be subject to strict regulatory policies, and noncompliance will
not be tolerated. CBD will increasingly become even more heavily regulated
on both the state and federal levels. Attorney Charles Feldmann has worked
extensively with a variety of state agencies focused on enforcement, licensing,
federal risk mitigation, and compliance. For five years Mr. Feldmann worked
under the United States Drug Enforcement Division. Using his unique and
rare expertise, Mr. Feldmann assists his clients in establishing strict
regulatory compliance protocols at both the state and federal levels.
Mr. Feldmann is a trusted advisor for marijuana businesses. If you are
in need of an attorney who can help you successfully navigate both the
federal and state CBD rules and regulations, contact Feldmann Nagel Cantafio PLLC today.