An earlier version of this article incorrectly stated that the Food and Drug Administration and Federal Trade Commission don't police whether marketing claims about marijuana products are true or false. In fact, both agencies have sent warning letters to firms making false claims about their products and how they can treat certain conditions.
“All this time we’ve been listening to the CDC, we should have been eating CBD,” Jimmy Kimmel joked on his show Wednesday night. The study is promising and the excitement understandable, but the reality is that we won’t know whether cannabinoids are a safe and effective treatment for covid-19 until they’re tested in human trials.
This seems straightforward enough, but human trials take years in normal times for normal compounds. Meanwhile, we’re in covid times, and we’re talking about marijuana. And the Food and Drug Administration has made studying products such as the cannabinoids identified in the study (which are already legal and available to consumers in 36 states for medical use and 18 for adult use) nearly impossible.
I know this from painful direct experience. I run a cannabis company in Colorado called Ripple, and the federal government has made it extraordinarily difficult and expensive for us to test our own products, even though part of the FDA’s mandate is protecting consumers. More testing and research benefits everyone.
The stated rationale for how complicated it is to conduct research on marijuana is that it’s not legal at the federal level and is still considered a Schedule I drug, with “no accepted medical value.” This of course makes no sense, given that cannabinoids are already FDA-approved to treat issues such as epilepsy and nausea from chemotherapy. (Federal restrictions on marijuana apply to the plant and its parts, not to the specific chemicals it contains.)
Nonetheless, any company that wishes to test marijuana products in humans for purposes of garnering FDA approval first has to get permission from the Drug Enforcement Administration. And then it can use only marijuana products supplied to the National Institute on Drug Abuse by the University of Mississippi, which offers freeze-dried joints that have been in storage for years and bear no resemblance to any actual cannabis products that people are using in 2022.
The FDA and the Biden administration have made some noise about expanding and liberalizing policy regarding cannabis research, but they still don’t allow research on state-legal products consumers are already buying and using — in large and growing numbers. As of May, the DEA plans to expand potential sources for marijuana research to a limited number of additional producers, but growers have to apply and meet the agency’s requirements, and this still does little to remedy the problem of not being able to test specific products that are being used by consumers. My company, for instance, makes dissolvable THC and CBD powders that are popular here in Colorado. How is studying the effects of a freeze-dried joint supposed to help consumers of our products make more-informed choices?
Fortunately, marijuana’s Schedule I status doesn’t make it impossible to conduct human trials — just ridiculously difficult and expensive. We know that because we did one. No one on our team wants to win by lying to consumers, so when we heard reports that our products “hit” people much faster (which would be huge if true, since the delayed effect associated with traditional edibles has caused more than a few problems for the uninitiated), we decided to run a clinical study to verify the claims. Last year, we funded a placebo-controlled human trial on our own products. Here are some of the wildly inefficient things and logistically absurd things we had to do to perform the research that the federal government claims to want to encourage.
First, we had to set up a testing center in our front office every weekend for two months. Not a medical center or lab — our office. Then university researchers (who were as interested in the findings as we were) had to pile their blood-testing equipment into a van every Saturday morning and drive it to Denver, where they would set up a mobile testing site in our warehouse. This was necessary because they weren’t allowed to use their state-of-the-art on-campus facilities to support the work, lest they risk losing federal funds for researching marijuana, which is still a Schedule I drug. Any organization we might potentially work with that gets federal funding runs this risk. Do you know many good public research centers that don’t rely on federal money? Neither do I.
The FDA should be pushing for more research to keep consumers safe, and instead companies such as mine have to do it on their own at great expense even though there are plenty of university scientists who would gladly put grant funding to work on the project. The federal government hasn’t gotten out of the way; it’s just become a more dissembling roadblock.
What’s worse, most companies don’t do this at all. When it comes to consumer marijuana products, when you see a claim on a THC or CBD product that says it’s “backed by research,” you might as well be listening to a carnival barker. (And yes, this goes for our claims, too.) The FDA sends warning letters to companies that make false claims, but without anyone to prevent consumer fraud, you really have no idea what kind of research a company is talking about, whether the research says what the company claims it does or whether the research exists at all. Our research benchmarked our products against one of the top brands in the space, whose “research-backed” functional claims about weight loss were perhaps part of why Canopy Growth, one of the sector’s largest companies, agreed to acquire it late last year for nearly $300 million. A couple of weeks ago, those claims were reported to be false. (The company and its research partner told the New York Times that a review board had approved the study that led it to make those claims.)
How does a consumer know the difference? They don’t, because the FDA is not allowing the kind of clinical research that needs to be done, and it’s not regulating the private research that those of us who are bothering to are conducting at our own expense.
If this new coronavirus study turns out to be valid, and human trials — whenever those are allowed — indicate that the cannabinoids CBGA and CBDA are effective and safe, it’ll be tragic that we didn’t learn this sooner. We might have if the FDA had facilitated this kind of research instead of making it all but impossible.
In the meantime, expect cannabis companies to start issuing coronavirus-related claims based on this study any minute now. The FDA will not stop them. I’ve already gotten emails from multiple ingredient companies trying to sell me the cannabinoids featured in the study for our products. The government’s policies create the opportunity and incentive for cannabis businesses to make false and unsubstantiated claims, because there are few or no consequences. The worst-case scenario for bad actors is often a warning letter with no real-world penalties. As always, willful ignorance does not make for great outcomes.
Unfortunately, much of the opposition to marijuana legalization at the federal level is voiced by elected officials who claim their reservations are predicated upon a lack of research. They continue to get away with this excuse for failing to act, because there actually is a lack of research — thanks to the FDA, the DEA, the Biden administration and its predecessors and a generation of lawmakers who can’t seem to leave the war on drugs in the past where it belongs.
The federal government’s position on marijuana is incoherent, offensive and, worst of all, irresponsible. It’s half a loaf of nonsense that tells Americans to ignore what’s in front of our noses. The public deserves a free and fair cannabinoid marketplace featuring robust consumer protections and public access to high-quality research funded by federal grants (not to mention expungement and all that goes with rectifying the harms of past policy). At a time when 68 percent of the American public supports legalization, anything less would be an insult.