Feeling stressed out in the morning? Why not drink some CBD with your coffee?
What if your dog is too hyper? There’s a hemp-derived treat for Fido.
Don’t want to take CBD orally? How about putting it on your eyelashes as mascara, or dropping it in the tub as a bath bomb?
These are just a handful of ways companies are promoting cannabinoids, the marijuana and hemp-derived chemical that could become a $20 billion market by 2024, according to one analysis. But in the Green Rush to get a slice of that business, medical and legal experts are concerned that the industry is leapfrogging regulation, which could harm CBD’s image and potentially put deficient products on the market.
What we know about CBD
Clinical studies are long and arduous for any company looking to put a drug on the market, with rounds of pre-clinical research and three phases of trials to make sure drugs are safe and effective.
It’s even harder to do that research when your drug may or may not be a federally controlled substance.
Maureen Leehey, a neurologist and medical researcher at the University of Colorado School of Medicine, is running a pilot study to see if CBD can reduce tremors in Parkinson’s Disease patients.
In order to get clinical-grade organic CBD, researchers first have to get a Schedule I license from the U.S. Drug Enforcement Agency, then get the substance from the University of Mississippi, which is the only entity that the U.S. allows to grow marijuana for research purposes. All of that comes before even beginning to ask the U.S. Food and Drug Administration for permission to start investigating a new drug.
Leehey said those strict rules mean the medical community doesn’t know exactly how CBD can be used as a drug and how it is best delivered into the human body, and it is decades behind in building a body of scientific evidence.
“With the current laws, [it would take] 10 to 20 years,” she said. “If we didn’t have these very restrictive laws on cannabis products, it would be much closer to five to 10 years.”
Extracted from green, but in a legal gray area
The FDA considers putting CBD into food and drinks to be illegal, meaning your favorite CBD gummies, seltzer waters, jams and breakfast cereals are technically contraband.
David Wunderlich, a cannabis lawyer with Denver-based McAllister Garfield P.C., said the agency doesn’t have the resources to fully enforce its rule, so it mainly issues cease and desist letters against the most egregious claims, like saying CBD has anti-cancer effects.
Most CBD products have escaped federal scrutiny by calling themselves dietary supplements, which takes far less regulatory scrutiny than drugs or food. Under federal law, the makers of the supplements are responsible for making sure their products are safe and labelled correctly before going to market.
In other words, dietary supplements are safe until proven not.
That means CBD manufacturers have to walk a fine, yet ill-defined line as to what they say on labels based on how much risk they’re willing to take. Wunderlich said some advertising has gotten around this problem by leaning on the public imagination of what CBD is and what it does (such as “promoting a healthy spirit,” for example,) rather than making precise claims.
But the public’s perception of cannabinoids isn’t the same as getting a doctor’s opinion, and Wunderlich said companies can use search engine optimization and other marketing tricks to promote their websites and bury unbiased studies and sources.
“There’s so much misinformation about CBD on the internet right now that it’s almost impossible to get a good source regarding CBD,” he said. “… You can google ‘is CBD legal in Oklahoma,’ for example, and the first 20 results are going to be people trying to sell you CBD and saying of course it’s legal.”
For the record, hemp-derived CBD is legal for possession and sale in the Sooner State. In Colorado, CBD from hemp is legal if it’s grown by a producer licensed by state health and agriculture agencies.
Placebo and hype
Almost all of the evidence about CBD’s effectiveness is anecdotal, or from a non-clinical study. Earlier this year, four researchers in the state published a case review of 103 patients of a Fort Collins mental health clinic who were given CBD for sleep and anxiety issues.
Shannon Hughes, a professor of social work at Colorado State University and at the Colorado School of Public Health, was a co-author of the report. She said the review didn’t have the controls and rigor needed in a medical study to weed out the placebo effect and other factors that can affect patient outcomes.
Hughes said positive stories combined with the current marketing around CBD can create a collective placebo effect, making patients feel better not because the CBD is necessarily working, but because they’ve heard other people say it works.
That effect could be so strong that the psychological effects of CBD could manifest when taking low-quality CBD, or products with barely any CBD at all.
“I think that’s part of the problem, that we don’t have a system of testing and monitoring at this point,” she said. “So unless you have some way to test the CBD quantity of something you’re buying, it’s sort of a buyer’s beware market.”
“If it’s a cure-all for everything… then it’s not believable”
Leehey compared CBD’s marketing to diet fads like cutting out sugar, cutting out carbohydrates or eating high amounts of protein: the overpromotion could cause a backlash from disappointed consumers.
“If it’s a cure-all for everything, then obviously, it’s not believable,” she said. “…The pendulum will swing to the point where the opposite people will say, ‘I tried it and it didn’t work, and it was a big fluke.’ So as much as it’s loved right now, it’ll probably be hated in the future.”
Cannabis has the potential to be a painkiller alternative to narcotics, Leehey said, and her own gut feeling is that CBD is helpful for pain. However, her early research showed higher liver activity in patients, something she has to look into as a possible side effect.
It’s unclear at this point how the 2018 Farm Bill’s legalization of hemp and the FDA approving a CBD drug for epilepsy will affect the regulatory landscape in the future.
Today, it’s a wait-and-see game until the medical community can say with a degree of certainty how CBD plays into the arsenal of drugs doctors use to help patients.
“I counsel people to stick with what we know,” she said. “…If you want to go get some CBD, I’m not recommending it because we don’t know if it’s helpful or not, and we don’t know about what dangers there might be. We do know that it’s going to affect your pocketbook.”