In the news – Cannabidiol (CBD) Regulations
Let’s look at CBD science and regulation to understand the FDA’s regulatory decision.
Cannabidiol (CBD) is the new rage, with oils, tonics, and tinctures popping up for sale online, in coffee shops, and at other, sometimes strange locations. It’s pitched as a miracle cure for everything from cancer to anxiety to chronic pain, and the CBD market continues to grow rapidly in the United States, in part, due to the passing of the 2018 United States farm bill, which legalized hemp plants in all forms.
However, that doesn’t mean it’s legal to consume in all states and in all forms. The laws are currently complicated and continuing to evolve. The U.S. Food and Drug Administration’s (FDA) recent announcement on CBD regulations puts a new onus on legislators. Let’s look at CBD science and regulation to understand the FDA’s decision better.
What is cannabidiol (CBD)?
Cannabidiol (CBD) is one of more than 113 different chemicals present in cannabis plants that have chemical structures similar to Δ⁹- tetrahydrocannabinol (THC). CBD in a purified form does not contain enough Δ⁹—tetrahydrocannabinol (THC) to cause psychotropic effects (e.g., get high). Without THC, people using pure CBD products do not experience a “high” when consumed.
What are the sources of CBD?
Manufacturers derive CBD from either hemp or marijuana plants. However, manufacturers making and selling legal CBD products in the United States derive their CBD from Sativa hemp plants using many different processes.
What is the difference between hemp and marijuana?
Hemp and marijuana plants are both members of the cannabis family; however, they are primarily distinguished by the amount of THC they contain.
Hemp contains less than 0.3% THC meaning it does not cause humans to feel high. Unless bred otherwise, marijuana plants contain THC at levels that cause users to feel high.
People consume the vast majority of marijuana plants because they produce THC and CBD, which can occur at varying levels depending on the plant.
In the United States, only CBD derived from hemp is federally legal and available for sale in some states. Other hybrid CBD/THC products are available in states with medicinal and/or recreational marijuana laws.
Is there truth to the health claims?
CBD health claims are an area where research opportunities abound (visit clinicaltrials.gov to view active CBD clinical trials). Current research is limited, but it suggests that CBD and some CBD/THC hybrid compounds may alleviate inflammation, spasticity, pain, anxiety, depression, and symptoms of epilepsy, as well as provide neuroprotection.
Research is still in its early stages concerning the ever-expanding list of benefits, but for the most part, unsubstantiated health claims.
Are there any government-approved CBD therapeutics on the market?
Yes, two drugs on the market contain CBD or CBD/THC hybrid compounds.
- Epidiolex® is a prescription medication used to treat two rare forms of childhood epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome. It contains purified CBD to alleviate symptoms.
- Nabiximols (Sativex)® is a prescription medication used for multiple sclerosis patients experiencing neuropathic pain, spasticity, overactive bladder, and other symptoms. It contains both THC and CBD to alleviate symptoms. It is awaiting FDA approval for use in the U.S.; however, it is available in many countries throughout Europe, Canada, and Australia.
What does the FDA say about regulating CBD?
The FDA released its decision announcing the currently established framework used for dietary supplements and additive food ingredients is inadequate to keep the public safe.
So, the FDA is asking congress to enable a new regulatory solution designed for an ingredient like CBD.
Why can’t the FDA use the current dietary supplement and additive food ingredient regulations for CBD?
There are a few reasons:
- For researchers to establish safety, they need key data, including purity, potency, dose, dose rate, exposure, and other variables that determine (1,2,3) safety for everyone, inducing vulnerable populations like children and pregnant people. Researchers do not have this data.
- Current research on CBD focuses heavily on the CBD-containing drug Epidiolex®. There is limited data available on CBD use in other populations and at other purity and dosage levels.
- The CBD-containing drug Epidiolex® established the regulatory pathway as a drug. Rules around pharmaceutical drug regulation include provisions that prohibit the commercial distribution of CBD (or any drug) as food or the addition of CBD (or any drug) to a food product (1).
To summarize, the current regulatory pathways require safety information and Current Good Manufacturing Practices that are currently unavailable. Additionally, the regulations do not have mechanisms (e.g., establishing a purchasing age) that may be required to maintain safety.
The good news.
The latest statement from the FDA establishes a need at the congressional level to create new frameworks that better reflect the needs associated with CBD. Hopefully, through collaboration with congress, regulators, and scientists, the US will establish a regulatory framework that works to keep the public safe.
Cannabidiol (CBD) research at CRIS.
CRIS has conducted research into the safety of the ingredient cannabidiol (CBD).
Our first publication is a consumer-focused collaborative white paper that thoroughly highlights our current science-based and regulation-based understanding of CBD.
Title: The current understanding of the benefits, safety, and regulation of cannabidiol in consumer products
Journal: Food and Chemical Toxicology
Read the paper now at https://pubmed.ncbi.nlm.nih.gov/34626752/.
We’ve conducted research to explore CBD’s potential anti-inflammatory activity.
Title: Cannabidiol selectively modulates interleukin (IL)-1β and IL-6 production in toll-like receptor-activated human peripheral blood monocytes
Read the paper now at https://pubmed.ncbi.nlm.nih.gov/34740670/
We’ve recently completed research on CBD and liver toxicity
Focus: Evaluation of the Potential Hepatotoxicity of CBD using a Human Hepatocyte Spheroid Model
Status: It’s currently under review at an academic journal, and we look forward to sharing results after it undergoes peer review.