In the well-lit back room of the Bean coffee shop in Germantown, owner Billy Seckman sifted through a container of chocolate-colored beans while more swirled behind him in an industrial-sized roaster.
After Seckman’s beans are ground and brewed, he might add one last ingredient to your espresso if you ask, one that he thinks is important: a $2 drop of CBD oil.
“Initially, I didn’t want to do CBD coffee, because of the way it would affect the taste, because I’m a roaster. I roast the coffee,” said Seckman, adding, however, that he believes CBD evens out his mood and reduces inflammation in his fingers. “I just believe in CBD, period. So, I was just trying to get it out to the public.”
CBD, or cannabidiol, is a compound from the cannabis plant that seems to be everywhere and in everything these days.
At Rainbow Blossom Natural Food Markets in Louisville, you can find it in ice cream and sparkling water. For Valentine’s Day, Laura’s Mercantile in Winchester, Kentucky, sold CBD candy packages for “your sweetheart.” And on Feb. 21, The Root in New Albany plans to host an evening of CBD bingo with bottles of oil as prizes. On its own, it’s found in gas stations, pharmacies and natural food stores. Prices depend on the ingredients, amount and product; roughly $45 for 250 milligrams for oil, $25 for 100 milligrams of gummies and $25 for salve.
CBD and its hemp-derived sister products amount to a multi-million dollar industry in Kentucky. CBD alone is projected to hit $22 billion nationally in 2020. Some users describe it as a miracle cure. They swear it will heal your pain, ease your mind and even calm ravaging diseases, such as Parkinson’s and multiple sclerosis, with no side effects. Others say it has not helped them at all.
Regardless, CBD hasn’t been proven in clinical trials to treat anything besides some types of childhood epilepsy. Early studies support claims of other medical benefits, but they are not conclusive — yet.
This, combined with CBD’s rapid boom, has left the U.S. Food and Drug Administration scrambling to figure out how to regulate it. Manufacturers and retailers are not allowed to market CBD with specific health claims and, under the Federal Food, Drug and Cosmetic Act, they’re not allowed to add it to food that’s transported across state lines, although many do. In December, the FDA announced plans for public meetings to make its rules “more predictable and efficient.”
For now, however, when it comes to making sure that the CBD you’re buying is legitimate and safe, the work is mostly up to you.
Throughout history, people have relentlessly sought the food or the drug that would change their lives. Sometimes, that’s worked out, as in the case of penicillin — a true miracle drug.
“Everything else has had some defect,” said Paul Freedman, a professor of history at Yale University who’s studied food. “You know, it’s had some problem. Either it makes you drunk, or it’s addictive, or it gives you cancer.”
Like cocaine. The drug was once regarded as a panacea for toothaches and painful operations… before patients started overdosing during surgery.
So, which one is CBD?
While the compound was described as safe by a 2018 World Health Organization Report, with no potential for abuse, that’s not a certainty. The same WHO report warned that not all potentially harmful effects of CBD have been studied yet.
“I don’t think in recent times, we’ve seen anything quite like this,” Freedman said about the compound.
Acolytes of CBD will tell you that there are reams of studies pitting it against a range of illnesses and showing positive effects.
The WHO report analyzed this research and determined that CBD presented properties that were anti-inflammatory, anti-asthmatic, anti-tumor, pain relieving, antipsychotic (for the management of such disorders as schizophrenia) and neuroprotective (to maintain the central nervous system). It also helped animals suffering from a lack of oxygen to the brain, and preliminary data shows that it could treat drug addiction.
But there’s a difference between promising and proven.
The amount of preliminary research regarding CBD is “significant,” said Pritesh Kumar, a Louisville-based pharmacologist who graduated from UofL with a doctorate earned by studying cannabis-derived compounds. But the studies are overwhelmingly in their infancy, he said. Most are animal experiments or those performed only on cells, which usually are not predicative of what works in humans, he said.
“That is the major concern of physicians here in the U.S. and abroad,” Kumar said.
To scientists, “proven” means supportive data and successful clinical trials, which are human studies approved by the FDA.
Epidiolex, the CBD drug that the FDA has approved to treat Lennox-Gastaut and Dravet syndromes, successfully completed rigorous Phase III clinical trials to receive its designation. In Canada, another drug, half made up of CBD and half consisting of THC (the compound in cannabis that produces a high), has been approved to treat patients with pain caused by multiple sclerosis.
CBD has failed to produce results in other studies. According to WHO, it did not reduce chronic kidney pain in transplant patients or symptoms of ulcerative colitis, and it had no effect on experimentally-induced anxiety.
The compound does have a good safety profile, said Kumar, but it could interact badly with other medications (which is why he suggests you consult a doctor before taking it).
CBD has known effects within the body, including on the endocannabinoid system, a function often cited by CBD advocates.
According to Kumar, CBD can increase or decrease the production of endocannabinoids in the body, including anandamide, “the bliss molecule” and 2-arachidonoylgylcerol, or 2-AG. Anandamide has some effects on illnesses, such as epilepsy and psychotic symptoms, while 2-AG is not as well studied. CBD also binds to serotonin and adenosine receptors, which have been connected to numerous bodily functions, from the regulation of mood to inflammation.
But without clinical studies, the potential health benefits of these interactions aren’t proven.
As long as this is the case, and as long as CBD isn’t FDA-approved to treat anything besides epilepsy, there will be limited regulations for those who extract it and sell it.
And, then, there is the pot question.
On its own, CBD is the same when it’s derived from marijuana as when it’s taken from hemp, said Kumar. There are arguments for “full-spectrum” CBD, products that include other compounds found within the cannabis plant. Some data suggests that these extras work with CBD to create a therapeutic effect, but no clinical data confirms it.
In 2017, the National Institutes of Health announced $140 million for the study of cannabis compounds, $15 million of which went to CBD. In general, though, clinical research on CBD is scant because of its legal ambiguity, according to Kumar. In the most recent farm bill, a provision pushed by U.S. Sen. Mitch McConnell legalized hemp, but CBD itself is still listed as a Schedule 1 controlled substance by the U.S. Drug Enforcement Administration, discouraging universities, which are often federally funded, from studying it.
BAD (AND GOOD) BUSINESS
Before CBD, John Taylor was suffering from seizures every two to three weeks. They seemingly came out of nowhere. He had no family history of seizures and yet, he had one. And then another.
Taylor went the traditional route at first: prescription medication. At the height of his illness, Taylor said, he was taking a “debilitating” cocktail of 28 pills a day, some of which had serious side effects such as osteoporosis and liver damage. They didn’t stop the seizures.
“My daughter was going to bury me,” said Taylor. “I had three near-fatal events, my life was spiraling out of control. I didn’t want to live like that.”
So, he decided to try CBD. Taylor started by making it himself in his kitchen.
The seizures stopped immediately, he said.
In 2014, with the creation of Kentucky’s industrial hemp pilot program, Taylor turned his home laboratory into Commonwealth Extracts. His company was one of the first to be registered in Kentucky, meaning that Taylor has had time to figure out what he considers to be the industry’s best practices. His warehouse, located in Pleasure Ridge Park, contains an industrial-size extractor, which uses carbon dioxide to separate CBD from the hemp plant, a method that Taylor selected for its financial benefits, but also for safety.
Manufacturers can use other substances to extract CBD, such as ethanol and butane, but carbon dioxide is generally regarded as safe, said Kumar. The other chemicals can be, too — if used correctly.
“If the evaporation is not complete [during extraction], then that product can be toxic when consumed,” Kumar said.
Across the room at Commonwealth Extracts, the company chemist oversees the testing of the company’s CBD. Later, the CBD is sent to an independent lab to be tested again. Not that Taylor expects to find anything untoward in its results — he said the four farms he contracts with for hemp have been thoroughly vetted. Some companies, he said, don’t bother with any of that, especially as more people jump into the industry to take advantage of CBD’s popularity.
“There’s great companies, and there’s poor companies, poorly managed companies, and then there’s the vast majority of people in the middle,” he said. “So, if you’re getting it from a great manufacturer who puts great care in producing valid products, verifiable by independent results, you know, that’s a great supplier — you’re doing good things. If you’re dealing with somebody who doesn’t have the budget, doesn’t have the knowledge or doesn’t care, that’s going to be at the other end of the spectrum.”
But each approach is legal, or at least easy to get away with.
Because CBD isn’t FDA approved for most uses, its regulated by the agency as if it were a food product or a dietary supplement. This means the regulations for CBD are minimal, and the ones that do exist, must be self-imposed by the producers. Key among them is that the contents must be the same as what is claimed on the label.
WHAT’S IN YOUR CBD?
Kumar is worried for CBD consumers who do not investigate what they’re buying.
“Most people in the medical community — scientists, physicians — are concerned about the purity of these compounds that patients are potentially taking,” he said.
A 2017 study in the Journal of the American Medical Association found that 25 percent of 84 CBD products found online contained less CBD than what was advertised.
From 2015 to 2017, the FDA found that “many” companies had advertised CBD levels that were incorrect.
Taylor warned that some products might not contain CBD at all.
Harmful substances might sneak into CBD as well. Along with left-over butane or ethanol, products could contain heavy metals or bacteria such as E. coli, according to Kumar. Illegal levels of THC also are a concern.
The FDA does test products on its own, although certainly not every bottle of CBD. If an inconsistency is found, it’ll send a warning letter that gives a certain amount of time for the offender to devise a plan to remedy the problem.
“They don’t come in with the police; they don’t force you to do a recall,” Taylor said. “It’s — they don’t have the manpower.”
The only other regulations facing Kentucky CBD manufacturers come from the state Department Of Agriculture. It tests every crop of hemp to ensure it contains less than 0.3 percent of THC.
HOW TO BUY CBD
If you can’t rely on the FDA to regulate your CBD — or a random company — then there’s only one person left.
Kumar’s advice is that every CBD user read the product label carefully, looking for questionable ingredients. If that information is not on the label, he said, ask for a Certificate Of Analysis, or COA, which contains test results from an independent laboratory.
But, even then, your work isn’t over.
Some laboratories aren’t trustworthy. Kumar believes in only buying from companies whose chosen lab meets ISO 17025 requirements, meaning that it abides by high scientific standards.
It’s also important to examine the COA closely to make sure the information is accurate.
Dee Dee Taylor, John Taylor’s wife and owner of the CBD store, 502 Hemp, has been given suspiciously familiar COAs from potential suppliers before.
“They’ve sent us our own results,” said John Taylor.
Rainbow Blossom has standards for its CBD products, said Andrea McGrath, the wellness category manager for the local chain. It looks for companies that use independent testing and carbon dioxide extraction (although they do carry at least one that uses butane). One requirement that isn’t scientific, but just as important to Rainbow Blossom, is a company with a mission: to heal people with its product.
“The vetting process has grown,” said McGrath. “Myself, and us as a company, we’ve learned alongside everyone.”
Once the CBD has been purchased, it’s time to take it. But how?
At Seeds and Greens, a market in New Albany, the CBD is held in a display case attached to the checkout desk, clearly seen from the shop’s entrance. It is not unusual to see customers head right to the CBD, ignoring the store’s shelves of essential oils and dietary supplements on their way. On one December evening at the shop, within 90 minutes, four people had visited the CBD, pointing to products and asking the cashier questions.
Stacey Freibert, the owner of Seeds and Greens, said she tries to make everything convenient for her customers, but one thing she cannot control is the inconsistency between the labels and in the doses of the CBD she carries.
“All these companies label it differently, and it makes it very confusing,” she said.
Just as with finding CBD with the right contents, the lack of FDA oversight makes taking the product tricky. There are no rules for how much CBD should be in each dose or how much customers should take.
Most physicians would recommend a gradual dosing schedule, called a self-titration model, according to Kumar. This means taking small amounts of CBD at first and slowly increasing the amount based on results.
There have been only a few studies on the effectiveness of different CBD doses. One, published in 2017 in Frontiers in Pharmacology, measured how much CBD was needed to ease the anxiety of someone giving a speech in public. Neither 100 milligrams of CBD, 900 milligrams nor the placebo had any effect on the speaker’s blood pressure or heart rate. The 300 milligram dose, however, did have a calming effect after the speech. (Klonopin, an anxiety drug, worked as well, both during the speech and after).
The study showed promise in treating anxiety, but 300 milligrams of CBD is a massive amount. Many bottles of CBD, meant to last a month or longer, contain that much.
Most studies examining CBD dosage used large amounts of the compound. One thought smaller: the clinical trial for Epidiolex.
Yet, the studies examining higher doses of CBD can’t be used to determine truths about the compound. That’s because they’re also preliminary, said Kumar.
“For example,” he said. “For pain, right? There isn’t enough data to say what milligrams or how many milligrams would be effective for pain.”
There is at least one thing about CBD that scientists can speak to (finally): The best form to take it in — from edibles to topical.
Based on known research, ingesting CBD oil and applying a cream are probably the best forms of dosing, according to Kumar. The oil starts working in the body quickly. Transdermal options, such as salves, steadily release the compound over time. Vaping, meanwhile, is quick to work, but your body will metabolize a significant amount of it, meaning only some of the CBD you take will have an effect. Edibles take a while to work.
IS IT A PLACEBO? DOES IT MATTER?
James Murphy is a man of science — a pain doctor based in New Albany. And, knowing everything he does about CBD, he feels perfectly comfortable suggesting it to his patients.
“It’s almost become to me a question of not whether I should recommend it, but whether I should not recommend it,” he said.
Murphy agrees that most of the studies surrounding CBD are not “high-quality” scientific evidence, but combined with what he knows about CBD’s effect on the endocannabinoid system — and the result he’s seen in his patients — Murphy believes that the compound helps.
Out of the 337 or so of his patients who have taken CBD, about two-thirds have seen some sort of benefit.
On a national level, 90 percent of Americans surveyed by Consumer Reports who tried CBD said that it helped reduce symptoms of a medical issue. The magazine interviewed a nationally representative number of 1,003 people, 13 percent of whom had tried CBD.
For Louisville resident Kenny Smith, it eased the pain in his shoulder to the point where he was able to sleep through the night again. It helped Ashlee Heath, a 30-year-old healthcare worker from Louisville, slumber, too, after years of suffering from insomnia. And Dino Pejkusic, 37, went from bedroom-confining depression and anxiety to working and hosting parties once again.
“I find it has been quite miraculous for me,” said Pejkusic.
If not a true result of CBD, their reaction could be caused by the placebo effect, an underrated but powerful phenomenon.
In a 2010 review of 202 drug trials, a placebo was able to ease patients’ pain, phobias, nausea and asthma, although there were inconsistent results for its effect on anxiety, depression, insomnia, dementia, obesity and hypertension.
And if CBD is a glorified placebo? In Kumar’s scientific opinion: Who cares?
“As a researcher and a scientist, you know, to me, even if there is a placebo effect — doesn’t really matter,” he said. “Because, it’s working, right?”
It’s the anecdotal evidence — of the Smiths, Heaths and Pejkusics of the world — that is driving more CBD research, too.
Freibert of Seeds and Greens encourages customers to adopt Kumar’s attitude.
“If you take something, and it works, why not just embrace it and be thankful that it works for you?” •