CBD is billed as the panacea du jour.
CBD, short for cannabidiol, is a non-intoxicating chemical component of cannabis, touted as a treatment for just about everything — anxiety, acne, insomnia, digestive problems, arthritis, epilepsy, nausea, pain, depression, headaches and tremors — and for overcoming addiction’s persistent urges. You name it.
My college-age daughter and friends use CBD sublingual (under the tongue) tinctures for anxiety flare-ups, from overwhelming academic demands and a too busy university life. My adult son eats CBD gummies for insomnia. A neighbor gives CBD to his arthritic Labrador retriever who, before CBD dosing, could not even stand up. Now she walks a mile a day, a slight hitch kicking her tail into a whirligig.
It is a half-billion dollar industry, projected to soon hit $22 billion, according to Brightfield Group, a Chicago-based market research company focused on cannabis. And that figure was calculated before the U.S. Congress legalized industrial hemp as a crop when it passed the 2018 Farm Bill last month. Growing hemp is already legal in California, and CBD is nearly everywhere — in Pasadena-area health food stores, foodie eateries, CBD-only storefronts, artisanal coffee houses and boutique hotels. You will find elegantly packaged CBD gummies in minibars, CBD-infused foods and smoothies, CBD tinctures, CBD-infused waters and CBD gel pills. There are also topical treatments like CBD-infused salves, lotions and body oils. I can walk to a health food store and have a dropper of CBD added to a juice tonic for $4. Pet food stores sell a range of CBD tinctures for beloved animals, lined up behind the cashier, beckoning as you buy premium-grade chow.
But there is trouble in CBD-land.
All ingestible CBD products derived from industrial hemp are being sold unlawfully, according to the California Bureau of Cannabis Control. CBD or CBD oil can be derived from both industrial hemp and cannabis. The distinction is this: Hemp or industrial hemp is a variety of the Cannabis sativa L. plant species, which has no more than .3 percent of THC (the psychoactive component). The only lawful places to buy ingestible CBD — as long as the CBD is derived from cannabis plants (which have 5 to 35 percent THC), not of the industrial hemp variety — are marijuana businesses that are state-licensed and locally permitted to sell marijuana products.
The prohibition on selling hemp-derived CBD ingestible products elsewhere is fairly recent. In July, the California Department of Public Health’s Food and Drug Branch stated that CBD is a prohibited food additive and that cannabis cannot be sold in any retail food operation such as restaurants, coffeehouses or grocery stores. CBD oil or CBD ingestible products derived from cannabis — that is, the non-hemp variety — can be sold only in state-licensed cannabis retail stores and businesses, according to the CDPC. The prohibition is based, in part, on the grounds that CBD derived from both hemp and cannabis is a federally regulated controlled substance. Cannabis and CBD is listed as a Schedule I Drug, along with LSD, heroin and cocaine. A Schedule I Drug is defined as a substance with no known medical use and a high potential for abuse under the Controlled Substances Act of 1970, according to the federal Department of Drug Enforcement (DEA).
“Until the FDA rules that industrial-hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive or dietary supplement,” the CDPH website states.
Ingestible CBD products derived from non-hemp cannabis plant species are legally sold in licensed cannabis retail stores and businesses, which are required by state regulations to lab test all products. Strictly regulated and licensed cannabis businesses protect consumers from mislabeling and contaminants like mold or pesticides, the state says. There is no regulatory agency that has oversight of CBD-oil production from industrial hemp, the CDPH website states.
None of the ingestible CBD derived from industrial hemp is being sold legally in brick-and-mortar stores or online. But you can probably still buy it over the counter at your local health food store, get a café latte with a shot of CBD in it, purchase tinctures online or cruise Ocean Front Walk in Venice, where there are two freestanding CBD-only stores in operation.
As for Pasadena, the city bans all sales of cannabis, including CBD from cannabis or hemp, said Lisa Derderian, Pasadena public information officer. “Cannabis operations have been prohibited from operating since 2005 and in [October], we shut down two of them and the city attorney charged them with operating without a license and operating illegally,” said Derderian. “All of it, including CBD that is derived from cannabis or industrial-hemp CBD, is illegal.”
But that will change this year. Pasadena voters passed measures CC and DD in 2018, a move that allows the city to permit limited legal cannabis businesses within the municipal district. Pasadena will be permitting six cannabis retailers, four testing labs and four cannabis cultivators in 2019, Derderian said. A November workshop attracted 250 cannabis business interests, some from as far away as Canada, she added.
Confusion over regulating a market that has exploded well in advance of laws, permits and licenses needed to govern it, is normal for all things cannabis. But there is a multipronged effort in the works to push the state to address the lapse in regulation specifically addressing industrial-hemp-derived CBD ingestible products. “There is a very broad coalition of cannabis industry associations, individuals and legislators working to tackle hemp-derived CBD regulations,” said Josh Drayton, communications outreach director for the California Cannabis Industry Assn. (CCIA), a trade group based in Sacramento. “There has been hesitancy at the state Bureau of Cannabis Control to deal with this because they weren’t specifically tasked to do this. Everyone is so careful of the language used, because we don’t want to overtax, overregulate or overburden hemp and hemp-derived CBD the way cannabis has been.”
Refining the language in a proposal to write regulations for hemp CBD is one of CCIA’s top priorities for 2019. There is a new state legislature with many new members, along with a new governor, Drayton added, so many of the people the coalition had worked with have moved on and fresh connections must be forged to move proposed regulation forward.
Quality control and labeling accuracy is a reasonable concern. A November 2017 Journal of American Medical Association (JAMA) study found that nearly 70 percent of all cannabidiol products sold online contained either higher or lower concentrations of CBD or THC than indicated on the label. What that means is these mislabeled products are ineffective or potentially harmful. Pure CBD should be THC-free, the study’s lead author Marcel Bonn-Miller, an adjunct professor of psychology in psychiatry at the University of Pennsylvania, wrote in JAMA. Underlabeling was less concerning because CBD appears to have no serious harmful consequences at high doses, but “the THC content observed may be sufficient to produce intoxication or impairment, especially among children,” Bonn-Miller wrote. He called for manufacturing and testing standards and oversight of online medicinal cannabis. (Bonn-Miller and co-researcher Ryan Vandrey reported receiving personal fees from cannabis industry groups, nonprofits and pharmaceutical companies.)
The regulations simply have not caught up with the public enthusiasm for CBD and its potential to alleviate a raft of health issues without devastating side effects. One FDA-approved drug based on CBD is Epidiolex, made by GW Pharmaceuticals, a British company. The drug, approved by the FDA in June, is the first prescription cannabis-derived medicine available in the U.S. It is used to treat two forms of epilepsy, Lennox-Gaustaut syndrome and Dravet syndrome. Both are among the most difficult types of epilepsy to treat, according to the FDA. Lennox-Gastaut syndrome usually appears between the ages of 3 to 5 years old, and Dravet syndrome starts in the first year of life. Both are lifelong conditions that can be catastrophic. An estimated 30,000 children and adults have Lennox-Gastaut syndrome; fewer have Dravet syndrome.
Epidiolex was approved by the FDA after GW Pharma submitted beneficial results from three randomized, double-blind, placebo-controlled trials conducted on patients with both forms of epilepsy. The medication is now available at local pharmacies like Walgreens and CVS. The DEA had to classify Epidiolex’s precise CBD formula as a Schedule V, indicating a low risk for abuse; this is the first time the DEA has listed a cannabis product as anything other than a Schedule 1 substance (i.e., the most dangerous) under the Controlled Substances Act of 1970.
Epidiolex is proof of CBD’s promise. CBD, whether drawn from cannabis or industrial hemp, is being investigated for a wildly diverse array of physical and psychiatric maladies. Studies are ongoing, but it’s a slow laborious process getting a cannabis-based drug through research trials to final FDA approval. The time frame depends in part on delays in getting all of the federal regulatory approvals for the research and then gaining access to product. It could be four years before there are published results from a given cannabis study, according to J. Hampton Atkinson, a psychiatrist and co-director of UCSD’s Center for Medicinal Cannabis Research (CMCR). U.S. and international clinical trials either completed or in the process of recruiting participants number 167, said Atkinson.
The studies are focused on various conditions, including CBD treatment for cannabis withdrawal and cannabis abuse, heart failure, bipolar disorder, acute schizophrenia, alcohol and cocaine abuse, Crohn’s disease, infantile spasms, various types of childhood epilepsy, Tourette’s Syndrome, anxiety disorders and post-traumatic-stress disorder. At CMCR, Atkinson said, researchers plan to study CBD’s efficacy in treating early psychosis (in addition to conventional antipsychotic drugs); anorexia nervosa anxiety; low-movement tremor; and childhood autism-spectrum disorders. In childhood autism, for example, CBD has been shown to reduce anger and repetitive behaviors, like turning in circles and head banging, thereby improving a child’s social skills and ability to attend school.
“The published evidence lags way behind the enthusiasm,” Atkinson said in an email. “There is some evidence from two human trials that CBD may help reduce anxiety and negative self-talk in people with social phobia. There is some evidence that it may help with certain kinds of insomnia and conflicting evidence on whether it is effective in psychosis.”
Some physicians are already using cannabis medicine to treat patients. Sherry Yafai, an emergency medicine physician who is founder and director of Releaf Institute, a medical marijuana clinic in Santa Monica, treats patients for cancer, pain, insomnia, tremors, Parkinson’s disease, anxiety and multiple sclerosis. “My big gripe about this industry is we are allowing people who don’t have the expertise like I do or my colleagues do to advise people,” said Yafai, who credits licensed cannabis shops with at least lab-testing their products and following regulations that protect consumers. “The question about dosing is going to take into consideration, what else are you taking? I am going to ask you 50 questions. You know, it really is a challenge because we have people who don’t know any better.”
So for now, when it comes to grabbing hemp-derived CBD ingestible products off the shelf at a health food store or ordering them online, it is buyer beware. Bonn-Miller advises consumers to buy from reputable sources or have the products tested yourself in an independent lab, adding cost. To be sure, a great many hemp-derived tinctures are from locally based companies with compelling inception stories rooted in a desire to help an epileptic child, grandmother or cancer-stricken mother, and to avoid sometimes horrific side effects of pharmaceutical medications.
These admirable product narratives are compelling, moving and relatable. Still, consumers should be mindful that for now, when buying hemp-derived CBD tinctures, gel pills and salves, they are accepting product labeling at face value. Proceed with caution. Or head to a licensed cannabis store for tested and vetted CBD products.