WHAT IS CBD?
CBD is a molecule found in cannabis and has become an increasingly popular ingredient in therapeutic oils and alternative medicines.
CBD, short for cannabidiol, is a trending ingredient the natural products industry and is the focus of a new area of cannabis research. CBD is one of many cannabinoids, or molecules produced uniquely by the cannabis family. Unlike tetrahydrocannabinol (THC, the primary psychoactive element in marijuana), CBD is non-psychoactive, meaning it doesn't have a strong effect on cognitive brain activity and doesn't cause the "high" associated with marijuana.
Every variety of the cannabis family produces cannabinoids, including hemp. While CBD and THC are the most well-known cannabinoids, there are many different types, and only recently have significant resources been poured into their study. Our brains have specific receptors designed to accept cannabinoids, known as CB1 and CB2. These receptors are responsible for the assimilation of cannabinoid molecules into your system, resulting in the psychoactive and immune responses correlated with cannabis consumption.
In the last few years, there have been many advances in cannabis processing and consumption methods. Concentrated products such as oil and rosin (a sap-like product extracted via heat and pressure) have allowed for cleaner ingestion methods, such as vaporization, to become more widespread. These new technologies have brought more consistent, identifiable dosages to patients and enthusiasts alike, while potentially enabling safer methods of consumption. Finally, more accurate and detailed studies of cannabis effects and usage are underway, as prohibition continues to be challenged.
According to nonscientific anecdotal evidence, CBD is good for treating discomfort and illness of all kinds. Sufferers of everything from anxiety and aches to epilepsy and cancer are evangelizing for the CBD molecule. But the largely prohibited status of cannabis has prevented many long-term, academically rigorous studies on most cannabinoids in isolation, leaving these anecdotal claims mostly uninvestigated until recently.
Research on CBD
"There is a great deal of interest in the possible therapeutic effects of CBD, but there is very little evidence of efficacy," said Dr. J Hampton Atkinson, co-director of the Center for Medical Cannabis Research (CMCR) at the University of California, San Diego. CBD may have health benefits, but the lack of research in this area means there just aren't enough data points to support most of the anecdotal claims. Along that same line, the lack of research also means the potential health risks of consuming CBD are unclear.
However, now that cannabis is enjoying a research renaissance by way of legalization efforts, medical science is gaining a much more detailed perspective on this popular and fascinating plant. According to ClinicalTrials.gov, a federal database of accredited clinical trials worldwide, there are about 150 trials in progress that are testing CBD as a treatment for a wide variety of health conditions, including autism, alcoholism, skin conditions and schizophrenia. For their part, the CMCR is conducting rigorous studies of CBD for its potential to treat schizophrenia and autism.
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Some research suggests that CBD may reduce anxiety and self-deprecating thoughts, and there's evidence that CBD has antipsychotic effects in people with schizophrenia. But other studies show no significant benefit of CBD over a placebo.
A 2017 clinical trial published in The New England Journal of Medicine found that CBD was highly effective in reducing seizures in people with Dravet syndrome, a rare form of epilepsy. The FDA subsequently approved an oral CBD solution, called Epidiolex, for treating the rare disease.
Within the CMCR, there is also "much interest in the possible anti-inflammatory effects of CBD, for use in arthritis of various types, including knees and hands," Atkinson said. Recent in vitro research with human cell lines afflicted with rheumatoid arthritis has suggested that CBD treatment may help reduce inflammation.
Atkinson emphasized that "CBD, like many other substances, probably should be avoided in pregnancy." Additionally, since the commercial cannabis market is mostly unregulated, there is no good way to know that what you buy is actually what you get in terms of dosage or content of product. "In studies done by the state of California it appears that a good deal of product labeling is incorrect — the dose or percentage of CBD or THC is usually overstated," he said.
Scientific observation takes time, and the research community has only just begun to pursue scientific inquiry into the discrete effects of various cannabinoids. That said, many researchers believe the potential carried by CBD is promising.
IS CBD LEGAL?
With President Trump signing off on the Agricultural Improvement Act of 2018 (aka the 2018 Farm Bill) last month, the federal government now fully recognizes hemp as a legal agricultural product. But while many reports are claiming that this means that cannabidiol (CBD) is also legal, that’s not quite correct. With a lot of misinformation flying around, and contradictions between state and federal laws, things are admittedly somewhat confusing. Let’s try to sort things out by answering some questions about hemp, CBD, and what has recently changed in federal law.
What's legal and what's not?
Here’s where things can get confusing. With the increasing legalization of cannabis and cannabinoids, more and more states have legalized cannabis and its constituents including THC and CBD for either medical or recreational use (several states have specifically legalized CBD products, but not THC or cannabis in general). But the federal government has held firm, keeping marijuana illegal as a Schedule I drug (defined as having no accepted medical use in the US, a lack of accepted safety for use under medical supervision, and a high potential for abuse) per the Drug Enforcement Agency’s classification of controlled substances.
Since marijuana is illegal on a federal level, but legal on a state-by-state basis, growers and cannabis businesses cannot legally transport cannabis products across state lines. Some companies that make CBD products — usually supplied in the form of lotion, oils, and pills — have done so anyway, based on the claim that CBD derived from hemp can be classified as a botanical extract and a dietary supplement. But over the past few years, the FDA has issued numerous “cease and desist” letters to companies that produce cannabis products warning them not to make health-related CBD claims and making clear that it does not consider CBD a dietary supplement.
The FDA’s refusal to allow companies to market CBD as a dietary supplement is based on the fact that federal classification as a dietary supplement requires that a substance has not been authorized for investigation as a new drug or medicine. Since Epidiolex has been studied in clinical trials by GW Pharmaceuticals going back several years now and was granted orphan drug status by the FDA in 2013, CBD cannot therefore be classified as a dietary supplement. Or so the FDA says. However, cannabis companies are arguing that they started marketing CBD as a dietary supplement before there were any drug trials involving CBD, such that they should still be allowed to claim dietary supplement status for their products. Thus far, however, the FDA isn’t budging on this issue.
In 2016, the Drug Enforcement Agency (DEA) created a new coding category to classify “marihuana extracts” like CBD, but in doing so made clear that CBD was still classified as a Schedule I drug and therefore still illegal. Although the 2018 FDA approval of Epidiolex meant that the DEA removed this specific CBD drug from Schedule I classification, all other non-FDA approved forms for CBD remained classified as Schedule I drugs.
Now, with the passing of the new 2018 Farm Bill, hemp and hemp-derived products have been officially removed from the purview of the Controlled Substances Act, such that they are no longer subject to Schedule I status. Meaning that so long as CBD is extracted from hemp and completely pure (without any THC — something the DEA doubts is possible) and grown by licensed farmers in accordance with state and federal regulations, it is legal as a hemp product.
But in response to the 2018 Farm Bill, the FDA issued a statement noting that the new legislation preserves the FDA’s authority to regulate cannabis and cannabis-derived compounds like CBD, regardless of its source. It also voiced specific concerns about unsubstantiated health-related CBD claims and iterated the unlawfulness of marketing CBD as a dietary supplement or adding it into food products (read the full FDA statement here). So while hemp cultivation and the extraction of CBD from it may now be legal, what the federal government will allow to be done with CBD products from that point on remains to be seen.
Note that the original federal distinction between hemp and marijuana in the Controlled Substances Act of 1970 was intended to separate useful industrial applications of hemp from the potentially hazardous smoking or other consumption of marijuana and its constituents for recreational purposes. In the fine print of the Controlled Substances Act however, exemption of hemp from the definition of marijuana did not include the resin extracted from the mature stalks of plants which might be expected to contain concentrated cannabinoids. While the 2018 Farm Bill passed by a Republican majority US Senate and House of Representatives in order to provide relief to farmers so that they can now grow hemp for industrial applications and apply for grants and insurance to do so, it may not have been intended to provide a new pathway to extract and purify CBD from hemp plants with the intent of large-scale human consumption as a food additive, dietary supplement, or medication. But make no mistake — cannabis companies are excited about and are intending to negotiate just this possibility. We’ll have to see how the FDA and DEA, and in turn federal judges and legislators, respond.