Editor’s Note: This is the final installment of a three-part series on the future of CBD. Read the previous installment here.
When the U.S. Food and Drug Administration approved CBD as an ingredient in Epidiolex, a prescription drug used to treat severe epilepsy, the molecule’s path for over-the-counter products was sealed.
Hemp industry members say that drug approval has been the major holdup in the FDA’s willingness to regulate CBD as a dietary supplement or ingredient, and impacted the agency’s most recent decision to reject two new dietary ingredient applications.
Minor cannabinoids, however, may not experience the same struggles as CBD, because they haven’t yet been approved as prescription drugs.
But FDA’s approach to both minor and major cannabinoids could change, depending on legislation that could lead to eventual federal cannabis legalization.
Hemp Industry Daily asked product manufacturers and other hemp leaders for their thoughts on how minor cannabinoids such as CBG, CBN, CBC and others could be impacted by the FDA’s inaction on CBD, and what happens if cannabis becomes federally legal.
Mike Lewis
How will FDA’s inaction on CBD and denial of CBD NDIs affect its approach to other cannabinoids?
Mike Lewis, Kentucky organic farmer, president of Hemp Industries Association: The rejections were based on the fact that cannabidiol is the active ingredient in the FDA-approved drug Epidiolex, which means that most hemp cannabinoids should not be subject to the (Federal Food, Drug and Cosmetic Act’s) preclusion provision in the same manner.
Klee Irwin
Lack of research data will continue to be an obstacle for new hemp cannabinoids, but clear regulation will bring big players to the industry. And big players bring a lot of resources, including research capabilities.
Klee Irwin, founder, Irwin Naturals, Los Angeles: It actually should not have a carryover effect on other cannabinoids. FDA’s analysis that CBD and CBD-containing products are preempted is based on a specific situation where they are treating the active ingredient in the approved drug Epidiolex, an isolated CBD molecule, as the equivalent to the CBD found in nutraceutical products. …
We are not aware of clinical trials for other cannabinoids instituted before the sale of such cannabinoids in the U.S., so the same set of factors should not be at play.
Priyanka Sharma
Priyanka Sharma, co-founder, Kazmira, Denver: I don’t think it will affect this approach – I think that they’re going to look at everything on a case-by-case basis. Where (hemp entrepreneurs) need to be very educated before approaching the agency with other cannabinoids is, understanding how they’re produced, how they’re purifying them and then again how they’re looking at them from a safety perspective.
A lot of the cannabinoids beyond CBD that are produced on the market today are mostly produced in synthetic production processes, and I think it does require a lot of feedback from different groups regulatory safety toxicology to understand how that could be presented to the agency.
Kelly Shea
Kelly Shea, SVP of government affairs and corporate communications, Charlotte’s Web: The cannabis industry, when federally legal, will face the same situation with THC, which has been approved as a drug. Other cannabinoids could be in the NDI phase (investigational new drug application). This is why HR 841 is the preferred piece of legislation. It addresses the drug preclusion with all part of the hemp plant, not just CBD.
Patrick McCarthy, CEO, ValidCare, Denver: If anyone goes to the FDA and asks their opinion, they’re going to be instructive and tell folks to go down the NDI process for any (cannabinoid). They said ultimately in those letters that if you’re controlling for a cannabinoid in your (hemp-derived) product, then what you’re actually doing is selling that cannabinoid and therefore it becomes a drug, so that’s how I expect them to act.
Patrick McCarthy
I think it would be really smart for industry (members), if they’re going to sell a high CBD concentration within a hemp oil, for them to (invest in) safety science and to make certain that they know what’s in there, what it does, what it doesn’t do and at what thresholds things could happen that might be considered a side effect. And be ready, because if it goes down a drug route, they’re going to need it.
If ultimately, FDA says based on whatever it takes for them to acknowledge things as a supplement, you’re still going to need that information.
…
I think if folks want to look at solving a problem, right there is the problem that needs to be solved for everything hemp, as well as for supplements going forward.
Consumers like you and me really deserve to understand what truly is the safety profile of all these products, what are the upper limits, what do they do, what don’t they do, and can they truly help with health issues or not, instead of ambiguous claims that have been made forever. I think there’s an opportunity to clarify things and elevate the entire industry.
How could full legalization of cannabis impact FDA’s approach to CBD and other cannabinoids?
Sharma: There’s a section in the Cannabis Opportunity and Administration Act… about treating CBD as a dietary supplement, as well, so in the cannabis (efforts), people are thinking about CBD and other cannabinoids still in the same way that HR 841 is thinking about it. And what it what I think it would do is redirect cannabinoids coming from both cannabis and industrial hemp to the FDA’s purview.
So I think it would maybe go the same way … under certain safety data that you can produce around the other cannabinoids. And can those be at certain levels and products, it probably would make them think about it the same way they’re thinking about CBD.
Lewis: While federal descheduling of cannabis would undoubtedly represent a significant net gain for American farmers, businesses, individual liberty, criminal justice, logic, and sanity, much would depend on the form it took and how it was implemented.
What we do know is this: The cannabis plant offers tremendous potential as a remarkably versatile agricultural commodity. The hemp industry just wants to see that potential realized, which can only happen once there is a clear, logical, and consistent federal regulatory framework in place.
Irwin: One of the significant roadblocks to getting federal regulators to see CBD and other cannabinoids the same as any other botanical ingredient is the stigma put on it because it comes from the cannabis plant.
As you know, the regulated term for cannabis with less than 0.3% of THC is hemp. If cannabis is fully legalized in all its forms, we think that could go a long way in destigmatizing the plant and put it in a different light to the public and regulators, which would allow for more common sense discussions around applying existing regulations to its uses.
Laura Drotleff can be reached at [email protected]
