Photo Credit: Marcia O'Connor (Flickr CC)
CBD dispensaries and cafes have opened all over town, and new ones seem to be popping up frequently. The website of the Wisconsin Department of Financial Institutions lists more than 150 corporations with the words “hemp,” “cannabis” or “CBD” in their names. Most of them organized or registered as corporations in the past year or so.
In case you’re wondering, CBD is short for cannabidiol, the chemical compound in cannabis plants known as “industrial hemp,” that have had the THC (tetrahydrocannabinol) bred out of them. THC, CBD’s more famous cousin (at least until recently) is the active compound found in marijuana and is responsible for producing a high when it connects with cannabidiol receptors in the body. CBD does not produce euphoria but is coveted as a medicine for a wide range of conditions.
In 2017, when growing hemp was legalized in Wisconsin, growers and CBD oil product producers and retailers enthusiastically embraced cannabis sativa L (industrial hemp). Consumers have shared their enthusiasm. CBD-producing hemp must have a THC concentration of less than .3% after drying to be legal under the 2014 federal Farm Bill and under Wisconsin’s Act 100. Since that time, CBD has grown in popularity with the public. People are seeking it out as a panacea. Some enthusiasts tout relief from an extensive range of diseases and afflictions, including acne, opioid addiction, Alzheimer’s, diabetes, kidney disease, arthritis, Parkinson’s, epilepsy, anxiety, stress and schizophrenia. Though it has been studied in laboratories for more than 50 years for possible pharmacological applications, it has gained popularity in recent years largely by word of mouth.
Hemp Industry Grows Overnight
One of the many hemp farmers and entrepreneurs in Wisconsin, Will Allen, the force behind the former Growing Power, is now in the hemp and CBD business. His niche is hemp grown in organic soil with organic seed in a greenhouse. His product is U.S. Department of Agriculture (USDA)-certified organic. Marketed under the name Will Allen’s Beyond Organic (WABO), his CBD product line includes oil, lotion, soap and dog treats. “It’s all about the soil,” Allen says.
“Soil is particularly important when growing hemp, because hemp is a phytoremediation plant—a plant that draws toxins from the soil. If you grow it in toxic soils, there will be toxins in the plant. It’s really important for people to seek out products that are USDA organically certified products like ours.” He adds that WABO CBD oil is cold-pressed without additives. “You should know your farmer and know that they are growing it in clean soil,” he cautions.
Allen says his sales have built rapidly through word of mouth and through the various CBD workshops he holds to bring together growers, producers and consumers. WABO sells through its website. Allen partners with a Washington state company which presses the dried hemp and extracts the oil needed to make WABO CBD products. He says he is anticipating opening a pressing operation in Milwaukee soon in partnership with the Washington-based company. This would make the pressing process more efficient, Allen says, and would provide other Wisconsin growers with local pressing services.
Allen is one of many hemp farmers in Wisconsin. According to the Wisconsin Department of Agriculture, Trade and Consumer Protection, 183 growers planted hemp on 1,850 acres in 2018. Across the country, CBD has turned into the next big thing almost overnight. A report from the Brightfield Group, a CBD market research firm, projects that the Hemp-CBD market will rapidly expand from about $591 million this year to $22 billion by 2022. The 2018 Farm Bill passed by the U.S. Congress excluded hemp and all of its derivatives from the Controlled Substances Act (CSA).
Medical Researchers Hamstrung by Antiquated Regulations
While CBD products are becoming increasingly popular among the general public, CBD remains a “Schedule One” drug for the Drug Enforcement Administration (DEA). Such a classification inhibits pharmaceutical research, since Schedule One drugs are considered to have no known medical benefits. More than 500 clinical studies involving CBD are listed in The National Institutes of Health database, with many of them being conducted in Europe or Israel. In June 2018, the federal Food and Drug Administration (FDA) approved the first CBD-derived medication called Epidiolex for the treatment of epilepsy.
Cecilia Hillard, director of the Medical College of Wisconsin’s Neuroscience Research Center, has been studying cannabis for more than 40 years. She says that, while researchers in the U.S. are able to use CBD in animal and other laboratory studies, they must rely on the FDA-approved formulation of Epidiolex if they want to use CBD in clinical trials with humans. If they don’t use Epidiolex, researchers risk losing federal research funding. Human trials are a necessary step in drug research once promising laboratory studies have been completed.
Epidiolex “costs a fortune. It costs thousands of dollars,” Hillard says, adding that the expense of using that patented formulation is slowing down research in the U.S. There is a movement to de-schedule CBD, which would lower costs for CBD researchers, but it has not happened yet. “I think this logjam is going to go away pretty soon, but it is still not gone,” Hillard says. “The DEA is a conservative organization, and they take their time. CBD should not be scheduled at all. It has no dependence liability.”
She says research on CBD could go fairly quickly if CBD were de-scheduled, because a lot of the laboratory work has been done already. “We’re not starting from zero,” Hillard says. “We’re 10 or 15 years into the progress in research. I think we have a lot to be grateful for to GW Pharmaceuticals [which did the Epidiolex research] for doing the clinical trials in seizures, because they’ve laid the groundwork for safety studies that will really help physicians be confident that it’s safe. What we’re missing right now are the studies showing that it’s effective for certain things. Those are ongoing.”
MMJ International Holdings, a medical cannabis research company, recently applied for fast-track designation approval from the FDA for clinical trials of CBD medications for multiple sclerosis and Huntington’s disease. Hillard, who has been doing cannabis research since the 1970s, says that while CBD can seem like snake oil in the booming popular marketplace, she believes it has real promise as a pharmaceutical. “There are a few things I think it is good for,” she says. “I think it’s a good anti-inflammatory. It might be good for anxiety. There’s some evidence that it might have some profound effects in reducing craving among people who are opioid addicts, which to me is the most exciting data out there. The data that’s out there is that one single dose of CBD stopped people from craving for a whole week. If that all holds up, this is going to be the most exciting thing that comes out of it.”
With a little help from the DEA in de-scheduling CBD, research could progress quite quickly because of all the research that has already been done. “We already know a lot about this drug,” Hillard says.” I think in two or three years we will have a lot of answers, depending on where we go with regulation; that’s the key right now. I think as more and more of these clinical trials come out, the FDA and the DEA will say this looks pretty safe, and we can de-schedule it.”
‘It’s the ‘Wild, Wild West’
Hillard views the popular appetite for CBD somewhat cautiously. “I don’t know what people are selling out there,” she says. “It’s the wild, wild west. It’s a plant that’s being grown under who knows what circumstances. There was a paper that came out recently that found that more than three-quarters of the cannabis products sold in Washington State were contaminated with pesticides. There are no requirements that people do testing. You don’t know how much THC or other contaminants might be in there. There’s a lot of ‘buyer beware.’”
She says that the CBD in food products cannot be absorbed by the blood stream. “We have to continue to educate people and help them to not spend a lot of money. As an example, putting it into beer or into food or baking it into macaroons is not going to do any good. It isn’t very available if you eat it. Everything that goes through our stomach goes to the liver. There are enzymes in the liver that act on it and inactivate it. Less than 10% of what you take in orally gets absorbed.” She says that CBD is best absorbed through the skin or under the tongue.
While antiquated regulations are stalling pharmaceutical research, the legalization of hemp and the rapid popularization of CBD products is drawing attention to the medical potential of the compound. Perhaps the popular craze will help shine a light on the regulations that are impeding promising pharmaceutical research and medical progress and, perhaps one day soon, the pharmaceutical research will yield scientific evidence for the safety and efficacy of marketplace CBD products.
