What is CBD?
/The FDA & CBD
Fall 2021 update - We applaud Charlotte’s Web for actually submitting clinical trials to the FDA to validate its CBD products and claims made about the product. To date, all others in the marijuana industry have refused to behave like all other companies that sell products in America who submit FDA applications to prove product safety and legitimacy of claims made about products.
Unfortunately however, the FDA was not able to approve Charlotte’s Web CBD product as a dietary supplement. CBD is not under the definition of a dietary supplement and "none of the clinical and pre-clinical studies provided adequately addressed certain reported toxicity endpoints of CBD such as hepatoxicity* and reproductive toxicity." This means CBD is still not "reasonably expected to be safe," which is required for dietary supplement status. Click on the image below to see the entire FDA letter.
*Hepatoxicity is liver damage. Reproductive toxicity is a hazard associated with some chemical substances, which interfere in some way with normal human reproduction.
July 21, 2020 - after over a year of deliberation, conversation, research and discernment, the FDA is recommitting to the drug approval process that currently insures the public can rely on drug efficacy and safety …
”It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis. The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds [like CBD], are available to patients in need of appropriate medical therapy.”
See the full report/statement here.
Since spring of 2019, the FDA has been actively trying to determine how to identify, manage and regulate CBD in particular, and marijuana-derived elements and products in general (THC, terpenes, hemp, etc..). The FDA moved to address this in response to the wide array of CBD-based products currently in the market place, but also because of the 2018 Farm Bill 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.
The FDA held a day-long discussion May 31, 2019 about CBD and cannabis-derived compounds. It included an unprecedented 105 speakers from all facets of this topic. Following the discussion, the FDA dedicated a page to it, entitled: ”What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.”
Well-researched Article - Concerns About CBD by Dave Evans March 19, 2020
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.
Also, cannabinoids like CBD (and THC) are neurotransmitters, with specific roles in the brain. It is not clear whether this is a positive or negative feature of CBD. The brain needs cannabinoids at specific levels to function properly. They are derived inside the body at the exact levels the brain requires - these are endogenous cannabinoids like Anadamide. Neurotransmitters not derived naturally, but that come from outside the body can change brain function over time and rewire the brain to require greater quantities to achieve baseline function.
Addiction vs dependency - CBD is not considered addictive, however we have no evidence that use will not result in dependence. One common example of physical dependency can occur with laxatives. Some people who over use laxatives become dependent on them - their bodies lose the ability to function normally/without the laxative. Dependency can usually be reversed but can be difficult.
When a person refers to “Medical Marijuana” sometimes they are referring to CBD. Most of the time, the use of THC-based products is what’s being referred to. It is important to clarify which cannabinoid or part of the plant is being discussed when talking about medical marijuana.
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 required by the FDA (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). Epidiolex was effective for 33% of users vs placebo. Unfortunately, Epidiolex did not work for more common forms of pediatric seizures or pain.
Epidiolex listed side-effects are: Liver Injury, Somnolence/Sedation, Suicidal Behavior and Ideation and negative interaction with other anti-epileptic drugs, as well as common cholesterol and blood pressure medicines 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 product or substance’s efficacy (value or potential to make a difference or achieve a desired result) and the potential side-effects. We make this mental calculation all the time and need data to support this discernment.
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 or reliable state oversight on manufacturing of these products). Tests revealed i) significant contaminants – pesticides, herbicides, molds, ii) massive mislabeling (68% of products tested) and iii) 22% of products tested contained THC. So, there are serious concerns about CBD product quality, plus a user may just be getting high from THC.
The marijuana supply in our country has generally been grown with significant amounts of pesticides, herbicides and rodenticides. The regulation in RecLegal states has promised to address this and some state codes do. The problem is that none of the RecLegal states are funding law enforcement to the degree necessary to enforce very much of their regulatory code, if any. Additionally and for example, in over 2 years since its regulatory framework has been established, California finds only 15% of its existing cultivators/growers operating under state required licenses. If the remaining 85% outside the legal framework have begun to operate under the state’s pesticide and chemical guidelines, is not known. This puts the CBD supply at risk for contamination.
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.
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 components. 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 stop working when additional 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 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.
There are no state-level agencies that function like the FDA, so nothing is controlling or monitoring quality relative to THC or CBD products. Consumers are on their own relative to product safety where CBD products are available.
“Synthetic” CBD (cannabidiol) has been seen in the marketplace and has caused hospitalization for altered mental status, seizures, confusion, loss of consciousness, and hallucinations.
