Retail versus Pharmaceutical Hemp-Derived CBD and Inflammation

Posted on Behalf of  Heidi O'Neill, Neha Mandava, Elise De Gandiaga

In conjunction with the 2018 Farm Act’s legalization of hemp-derived cannabidiol (CBD), the FDA approved the use of a CBD product for childhood seizure disorders. CBD legalization also led to a plethora of over-the-counter retail products with added CBD, ranging from food and beverages to tinctures and oils. As with many cannabis products, health benefit claims surround many of these CBD products. These are claims that, unlike pharmaceutical grade CBD, lack clinical safety and efficacy studies.

Some clinical studies of efficacy in humans have occurred, with mixed results. Pure CBD was efficacious, for example, while extracts with other compounds appeared to be less so.

  • A single dose of 99% pure CBD (600 mg) significantly reduced inflammation-induced gastrointestinal permeability (Couch et al 2019).
  • Self-reported cannabis use in the 30 days preceding evaluation was associated with lower levels of systemic inflammation (Okafor et al 2020).
  • In contrast, a pilot study using 250 mg CBD-rich extract (which included cannabigerol, terpenoids, flavonoids, sterols, and 3.2-4.7% THC) did not have an impact on remission rates in ulcerative colitis patients (Irving et al 2018).

The Road Ahead: Clinical Trials to Evaluate Efficacy and Safety

Clinical trials using CBD are focused on CBD alone, as opposed to mixtures that contain other cannabinoids like THC or terpenoid compounds. One study currently in Phase 2 is evaluating CBD’s ability to prevent chemotherapy-induced peripheral neuropathy (Clinical Trials-Nielsen 2021). Multiple clinical trials are also investigating CBD efficacy on reducing the effects of acute respiratory distress syndrome (ARDS) in severe cases. A phase I clinical trial will be completed in November, 2021, measuring the ability of synthetic CBD to reduce inflammatory cytokine levels (Clinical Trials-Amital). Phase 2 and phase 3 clinical trials were completed in Brazil in December, 2020 to determine if a dose of 300 mg CBD for 14 days in people with mild to moderate COVID-19 would decrease viral load and modify inflammatory parameters, among other endpoints (Clinical Trials-De Souza Crippa, 2020). Finally, an interventional study seeking to determine if CBD treatment improves outcomes in severe and critical COVID-19 pulmonary infection by measuring changes in cytokine profiles is currently in Phase 1 testing (Clinical Trials, Yeshurun, 2021). Results are yet to be posted for most of these clinical trials, and studies are ongoing.

Overall, there is some indication that CBD may be beneficial in diseases in which inflammation plays an underlying role. Further research is needed to evaluate the safety and efficacy of hemp-derived CBD products, and caution should be used when comparing pharmaceutical grade CBD products to those purchased in a retail setting.

Cardno ChemRisk has a diverse team of scientists with expertise in the risk assessment and regulatory landscape of hemp-derived CBD. If you would like to learn more about our capabilities or have any questions specifically regarding cannabis or cannabis-related compounds, please contact Elise de Gandiaga or Heidi O’Neill.