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 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 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. Most of the time, THC-based products and use are being referred to. It is important to clarify which cannabinoid or part of the plant is being discussed.

• 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.

• 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.

• 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 the 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 almost 2 years, California only has 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 knowable. All of 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.

• Interestingly, no CBD product available today is legal from the Federal Government’s perspective, except Epidiolex.  That said, 40+ states have some form of medical 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 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 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.