So is there anything out there that could potentially stand in our way of crossing the finish line in the upcoming economic stimulus bill?
In a perfect world, we would already have the liver function data from Validcare’s study, which involves 10 CBD companies administering their products to over 700 people
Because that study was scheduled to take place between March-June 2020
The novel coronavirus pandemic caused a delay in the start date and pushed it out to July
On the other hand, Mile High Labs and Canopy Growth have submitted safety data on Pure CBD to the FDA in 2020
Great Britain has already approved the consumption of up to 70 mg/day, which is what GW Pharma’s own internal research shows is safe from the standpoint of any CBD Isolate-associated liver issues
So the Validcare study seems far more important to prove the safety of broad spectrum and full spectrum CBD than it does for Pure CBD
The big difference between Pure CBD (CBD Isolate) and Broad/Full Spectrum CBD is that the former is CBD and the latter is CBD + 100-150 cannabinoids
CBD is homogenous
Pure CBD is CBD and nothing else
Assuming the same extraction process is utilized to create it, every batch is the same or virtually so
With Broad Spectrum and Full Spectrum, every batch is always going to be different, regardless of the consistency of the extraction process
CBD is a singular molecule, easy to standardize and measure
Broad Spectrum and Full Spectrum formulations aren’t CBD — they are whole plant extracts, resulting in a cannabinoid soup with CBD just happening to be the most predominant cannabinoid due to the innate composition of the hemp plant
But every hemp plant is different, and every batch of Broad and Full Spectrum CBD is different, with differing ratios of CBD, CBG, CBN, CBC, etc
So there is a wide variety of differing amounts of the various cannabinoids from one batch to the next
This brings up the possibility that certain cannabinoid ratios may be perfectly safe for the liver, while other cannabinoid ratios cause an elevation in liver enzymes
So if Charlotte’s Web and CV Sciences submitted liver safety data to the FDA for Full Spectrum CBD Oil, but they can’t produce that formulation on a repeated basis, is that really sufficient to prove safety for Whole Plant Hemp Extracts aka Full Spectrum CBD Oil?
Apparently not, according to the FDA
Which is why the Validcare study is far more important for Broad/Full Spectrum CBD — because even though neither formulation can ever really be standardized like Pure CBD, if a wide enough variety of different formulations with different cannabinoid ratios is tested, and the liver safety data looks good, then one can reasonably presume that whole plant hemp extracts are expected to be safe under a range of various cannabinoid concentrations and ratios
This is why I’ve always predicted that Pure CBD would be the first formulation to gain approval to be sold nationally
A more in-depth explanation of my rationale on the FDA’s thought process can be found here:
AN FDA-CENTRIC CANNABINOID-BASED PARADIGM FOR CBD PRODUCT REGULATION
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