CBD companies have not had an easy row to hoe. While the CBD industry is finally somewhat mainstream, The FDA remains the largest barrier to legitimacy of the industry. That will hopefully change soon.
A history of inaction
According to this FDA statement from 2018, their largest concern is the marketing of CBD with specific medical claims. These claims often rest on anecdotal evidence and still await scientific substantiation. For this very reason, reputable CBD companies make no medical claims about their products. Even so, all CBD companies suffer the consequences resulting from bad actors in the industry.
In another FDA statement, they comment on their approval of Epidiolex, the only FDA-approved drug containing CBD. They state,
“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. […] 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.”
In the past year and one half, actually longer, they have yet to approve a single other CBD product.
It seems that the FDA created a very narrow channel through which only Epidiolex has passed. Stanley Jutkowitz expands on this in his blog, The Blunt Truth. He states,
“‘FDA ‘places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinol in Schedule V.’’ DEA Final Order, Docket No. DEA-486 […] So, really what this order does is allow doctors in the US legally to prescribe the recently approved epilepsy drug, Epidiolex, and allows pharmacies, rather than marijuana dispensaries, to legally sell the drug.”
Logically, this would lead to the de-scheduling of cannabis on a broader scale. In actuality though, this specific FDA “approval” has thus far been reserved for Epidiolex alone.
Those of us at 4 Corners Cannabis would like to see the FDA take some action: to see the FDA set appropriate standards for quality CBD products. Many customers and other companies share our stance as well. The sooner the FDA decides the scrutiny that CBD companies need to undergo to get their products approved, the sooner all of the questionable CBD companies and charlatans out there will be outcompeted and fade away.
Many people speculate as to why no other products have been approved. Is the FDA stalling to allow larger companies to do adequate research, swoop in, and monopolize the industry? Are they concerned that approving good companies would allow some smaller, but honest, businesses to profit? Or do they just have a very prohibitive bureaucratic process like other government agencies?
One thing is certain. They have yet to establish a legitimate screening process in which quality CBD products might pass and be approved.
The Winds of Change
Surprisingly though, Author Hank Schultz’ recent article reveals the new and potentially improved attitude within the FDA. He shares that FDA Commissioner Stephen Hahn, MD, thinks shutting down the CBD industry is a “fool’s game” at this point.
The floodgates have opened, and the current of CBD continues to gain force and momentum. Commissioner Hahn goes on, saying the FDA needs to consider the possibility that CBD products likely have some merit. In Hahn’s opinion, the FDA’s duty at this point is to bridge informational gaps. He wants them to help customers make the most informed decisions possible.
While this tone isn’t necessarily positive rhetoric (it has more of an “if you can’t beat ‘em, join ‘em” sentiment), it’s a big step. The FDA has been citing a “lack of data” as their reason for not taking action on the CBD front for a couple of years now. It now sounds as though they intend to start using the available data to inform some kind of substantive policy.Alongside other quality brands, 4 Corners Cannabis has been tasked (out of necessity) with devising our own measures of quality and reliability in lieu of FDA protocols. It looks like some actions on the part of the FDA are right around the corner. We hope they ultimately do a decent job of rewarding quality CBD brands and systematically barring bad players from participating in the industry.