What is CBD?
May 2019 - Read a detailed response to the FDA.
The FDA is actively trying to determine how to identify, manage and regulate CBD in particular, but it is requiring a response to all elements of marijuana (THC, terpenes, hemp, etc..). The FDA has moved on this in response to the wide array of CBD-based products currently in the market place. but also because of the 2018 Farm Bill that makes growing hemp legal (cannabis strains with no/low THC content) and which allows any CBD product (derived from hemp) to contain 0.3% of THC based on dry weight. Although it sounds small, this is a massive amount of THC and as such the Farm Bill further confuses the marijuana theater and potentially endangers consumers.
CBD – Cannabidiol is one of the many cannabinoids found in the marijuana plant. THC – Delta9-Tetrahydrocannabinol is the cannabinoid in marijuana that makes a user “high” or intoxicated.
CBD is considered non-psychoactive, meaning it does not make you “high.”
However, CBD is still fat soluble, meaning it accumulates in the body over time. It is not clear whether this is a protective or cautionary feature.
When a person refers to “Medical Marijuana” sometimes they are referring to CBD.
CBD is being touted as a cure-all for everything, however almost all claims of efficacy are based on anecdotal evidence; very little scientific research (beyond the next point) has been completed.
The first FDA-approved CBD-based product became available summer 2018 – Epidiolex by GW Pharmaceuticals. It treats 2 rare forms of pediatric seizures (Lennox-Gastaut and Dravet syndrome). Epiliolex was effective for 33% of users vs placebo. Unfortunately, Epiliolex did not work for more common forms of pediatric seizures.
Epidiolex listed side-effects are: Liver Injury, Somnolence/Sedation, Suicidal Behavior and Ideation and negative interaction with other anti-epileptic drugs, to name a few.
This tells us CBD is not benign. When using any medicine or substance in pursuit of a medicinal affect, the user must weigh the trade-offs between the potential side-effects and the product or substance’s efficacy (value or potential to make a difference/achieve a desired result). We make this mental calculation all the time.
From time-to-time the FDA tests samples of artisanal-grade CBD products (all products other than Epidiolex are considered artisanal-grade because there is no federal regulation or oversight on manufacturing of these products). Recently, tests revealed i) significant contaminants – pesticides, herbicides, molds, ii) massive mislabeling (68% of products tested) and iii) 22% of products tested contained THC. So, with CBD products, a user may just be getting high.
It’s also been discovered that when CBD is digested (taken in some kind of oral/edible form vs a form that goes directly into the blood stream, i.e. vaporized or topical solution) CBD breaks down into many components and they can include THC. It may happen as often as 40% of the time. So, again a user (young or old) of oral CBD may just be getting high.
Interestingly, no CBD product available today is legal from the Federal Government’s perspective, except Epidiolex. That said, 40+ states have some form of marijuana law, under which they allow THC and CBD products. Unfortunately, there are almost no state regulations in place today that control or monitor quality relative to these products. Consumers are on their own relative to product safety where CBD products are available.
Dedi Meiri – noted Israeli CBD researcher - explains that some plants contain more CBD than others, but CBD can be extracted from every known varietal of marijuana plant (there are 100s) including hemp. The difficulty is that CBD is made up of many molecular compounds. Those components can vary widely even within the same strain or plant. This makes product lots difficult to standardize. He finds solutions that seem to work initially, but not after more product is sourced - possibly because of this component variation.
Scientific research that supports product claims is legally required in the United States. In lieu of this, all CBD claims of efficacy in the US today are unsubstantiated - except for Epidiolex. From time-to-time, the FDA sends letters to CBD manufacturers directing them to cease making false claims in their advertising/promotion. However, the velocity with which CBD product are coming on the market seems to be stifling the FDA’s ability to respond.
“Synthetic” CBD (cannabidiol) has been seen in the marketplace and has caused hospitalization for altered mental status, seizures, confusion, loss of consciousness, and hallucinations.