Regulation of Cannabidiol (CBD) Proposed Amendment for VMS Council, Sunday, Nov. 3, 2019

WHEREAS, safety concerns exist for prescribed federally-regulated cannabidiol (Epidiolex) including: hepatocellular injury and necrosis,  hepatic toxicity and histologic evidence of necrosis, suicidal behavior and ideation, somnolence and sedation,  hypersensitivity, drug interactions, and possible risk of DNA damage and chromosomal aberrations; and 

WHEREAS, more severe safety concerns exist for non-prescribed, non-federally regulated cannabidiol (CBD) as currently available and consumed by the public, and a number of side effects are documented including anxiety, confusion, nausea, vomiting, fatigue, somnolence, gastrointestinal symptoms and seizures, 

WHEREAS, non-prescribed CBD consumer products may contain dangerous heavy metals, pesticides, rodenticides, molds; and 

WHEREAS, CBD and THC (tetrahydrocannabinol) content in commercially available CBD products varies and is not easily determined by consumers: a 2017 analysis showed that only 31% of CBD-containing products were accurately labeled for CBD content, 42% were under-labeled and 26% were over-labeled, and moreover THC was detected in 21%; and 

WHEREAS, non-prescribed CBD consumer products sold can contain up to 24 mg of THC, more than that of a typical cannabis joint, which contains up to 17 mg of THC, putting the consumer at risk for intoxication, unintended cannabis addiction relapse, and unintended mental health harm; and   

WHEREAS, the THC content of CBD products sold in Vermont is not routinely tested by the State so the public cannot reliably know the true content of THC or CBD of the non-prescription CBD products for sale in the state, though the Vermont Hemp Program is in the process of finalizing rules for the Vermont Hemp Program, which would include testing by certified labs for THC concentration as well as pesticides, heavy metals, mycotoxins and bacterial and fungal contaminants ; 

WHEREAS, the public is subjected to pervasive false medical claims regarding non-prescribed CBD both online and in other media; and 

WHEREAS, non-prescribed CBD is found in food for human consumption in Vermont, contrary to FDA regulations and law and there is confusion in Vermont as to the advisability and legality of placing CBD and/or hemp in animal feed destined for human consumption; and 

WHEREAS, the FDA has concluded that THC and CBD products are excluded from the dietary supplement definition and therefore may not be added to foods; and

WHEREAS, the Secretary of Health and Human Services and the Commissioner of the U.S. Food and Drug Administration (FDA) have authority to regulate hemp and hemp products under applicable FDA laws in order to protect patients and the public health, foster innovation for safe and appropriate products, and promote consumer confidence; and 

WHEREAS, the FDA has stated: “We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses, and we have issued several warning letters to such firms….Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective….;”  therefore be it 

RESOLVED, that VMS support the distribution of evidence-based information to the public and clinicians regarding cannabidiol (CBD), including potential health risks of its use such as increased hepatoxicity, and drug interactions; and be it further 

RESOLVED, that VMS oppose and work to increase enforcement against the false advertising of non-FDA approved CBD for therapeutic or medical purposes, and be it further

RESOLVED, the VMS support the availability of CBD only as an FDA-approved drug; and be it further 

RESOLVED, that VMS support regulation of the manufacture of CBD that protects human health including requirements that it be free of contaminants such as mold, heavy metals and pesticides; has reliable active drug concentration of cannabidiol; that it contain no more than trace amounts (0.3 %) of tetrahydrocannabinol (THC); that it not be added to food, especially that attractive or appealing to children; and that it not be fed to livestock.