Researchers presented initial results from a study to the FDA in March suggesting there is no evidence of liver disease from the use of hemp-derived CBD products.
The study, conducted by a team from clinical research company Validcare, aims to help the FDA to determine how to appropriately regulate CBD products.
CBD, short for cannabidiol, comes from the cannabis plant. It is one of two most commonly known compounds of cannabis (marijuana), the other being delta-9-tetrahydrocannabinol (THC). It’s the THC that is associated with a “high,” not CBD.
The CBD industry has grown since the legalization of hemp, but many questions remain. Many people who ingest CBD products — such as oil or gummies — say it helps ease anxiety and certain pains.
So far the FDA has approved only one CBD product: A prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older.
The FDA has been researching to learn more about CBD, including specifically whether or not it can cause harm to a person’s liver. The Validcare researchers say their new study’s preliminary findings “show no evidence of liver disease in the 839 participants and no increase in the prevalence of elevated liver function tests when compared to a population with a similar incidence of medical conditions.”
“Our primary endpoint in this study is to observe potential liver effects in adults ingesting oral forms of hemp derived CBD for a minimum of 60 days,” said co- investigator Jeff Lombardo PharmD, BCOP. “What we observed to date is no clinical evidence of liver disease in any participants. We observed slight, clinically insignificant elevations of liver function tests in less than ten percent of consumers irrespective of age, product composition and form and the amount consumed. Three of the 839 participants had 3x normal levels of the liver enzyme ALT. These three consumers are taking prescription medications that are known to elevate liver enzymes, and we are investigating whether prescribed medications or other factors contribute to these outliers.”
Furthermore, this research is aiming to answer another FDA question about CBD: Can it affect how other drugs you are taking work, potentially causing serious side effects? Validcare’s researchers say they were surprised to find almost 70% of study participants reported having a medical condition and taking medications for those conditions, without an increase in reporting of adverse events.
“This unexpected, positive finding makes the data even more compelling and provides significant data to consider secondary safety measurements in the general population,” said Keith Aqua, MD, co-principal investigator of this IRB-approved study.
The study of 839 people was completed between August 2020 and February 2021.
“Congressional leadership asked ValidCare almost 18 months ago to engage industry help collect safety data for FDA. We understand the significance, importance and immediate need for CBD safety research for the FDA, industry and the US consumer. This first of its kind, industry led, multi-branded study required trust, collaboration, operational excellence, innovation, and resilience. It demonstrates the incredible potential for decentralized clinical research to increase participant access and accelerate results – even during the most challenging times” said Patrick McCarthy, CEO of Validcare. “We are excited for our principal investigators to continue, expand and report out on this foundational work in the next few months. Once completed, safety results of this study will be shared with participating brands and FDA. The investigators also plan to publish in a peer reviewed journal.”
Related: Aug. 5, 2019 — CBD 101: What is it? Why is it showing up everywhere?
Michigan’s guidance on CBD and industrial hemp
In March 2019, the Michigan Marijuana Regulatory Agency (MRA) and the Michigan Department of Agriculture and Rural Development (MDARD) issued joint guidance for CBD and industrial hemp:
From the Marijuana Regulatory Agency:
CBD products produced from marijuana will not be regulated as marijuana if the THC content is below 0.3%.
Edible marijuana products containing CBD made by licensed processors may only be produced using CBD obtained from regulated sources. Currently, these regulated sources include state of Michigan licensed growers or processors under the MMFLA.
MRA is in the process of writing administrative rules under the MMFLA and MRTMA to determine the methods for industrial hemp grown under the Industrial Hemp Research and Development Act to be transferred to licensed marijuana facilities. Until the administrative rules are written, there is no authorized method for licensed facilities to obtain industrial hemp.
Only facilities licensed by the Marijuana Regulatory Agency (MRA) under the MMFLA can commercially grow, process, and sell marijuana and marijuana products.
MRA does not regulate marijuana or marijuana products grown or produced by registered qualifying patients or designated primary caregivers under the MMMA or individuals over 21 for personal use under the MRTMA.
From the Michigan Department of Agriculture and Rural Development:
Any product derived from industrial hemp with a THC concentration above 0.3% is classified as marijuana and regulated under the laws that apply to those products through the Michigan Department of Licensing and Regulatory Affairs.
Products derived from industrial hemp, including CBD oil, fall under several different categories. Any substances that will be added to food or drink or marketed as dietary supplements must first be approved by the U.S. Food and Drug Administration for that intended use. At this time, the FDA has not approved CBD for use in food or drink or as a dietary supplement. Therefore, it’s currently illegal to add CBD into food products or drinks or sell it as dietary supplements.
GRAS (Generally Regarded As Safe) is a list of substances that the FDA considers safe to add to food. Hulled hemp seeds, hemp seed protein and hemp seed oil are considered GRAS, as of 12/20/18. CBD is currently not considered GRAS, as of 3/29/19. In Michigan, any food production falls under the Michigan Food Law and the licensing requirements within the law.
Growing industrial hemp will require a license from the Michigan Department of Agriculture and Rural Development (MDARD). MDARD is in the process of developing a licensing program for growers to meet the requirements of both state and federal laws to allow interstate commerce of the plants.
Marihuana (legal term) or Marijuana (common term): the plant Cannabis sativa L. with delta-9-THC concentrations above 0.3%. Includes products made from the marijuana plant, but excludes stalks, products made from the stalks, and some products made from seeds.
Industrial Hemp: the plant Cannabis sativa L. with delta-9-THC concentrations below 0.3%. Includes products made from the industrial hemp plant.
CBD (Cannabidiol): a substance derived from cannabis plants that does not have psychoactive effects.
Read: Michigan cannabis jobs doubled in 2020, report details
More: Michigan Marijuana news