AUTHORS

Cynthia Sheppard Solomon, BSPharm, RPh, FASCP, CTTS, NCTTP, Clinical Assistant Professor, Department of Internal Medicine
and Neurology, Wright State University Boonshoft School of Medicine, Dayton, OH

Glen D. Solomon, MD, MACP, CTTS, NCTTP, Professor and Chair, Department of Internal Medicine and Neurology, Wright State University Boonshoft School of Medicine, Dayton, OH

PEER REVIEWER

William Elliott, MD, FACP, Assistant Clinical Professor of Medicine, University of California, San Francisco


Cannabidiol (CBD) is not just one entity. There are three distinct variations that differ by source of origin and strength.

When marijuana is the source:

  • CBD is a significant ingredient of marijuana, found in a mixture of more than 400 constituents. Delta-9-tetrahydrocannabinol (THC) and CBD are the major compounds responsible for marijuana’s effects. The CBD concentration may vary by batch in strength and potency, depending on the THC:CBD ratio, growing conditions, and genetics. Medical marijuana or recreational marijuana is federally categorized as a Schedule I illegal drug, although states approve individually whether medical marijuana or recreational marijuana is available for sale.
  • CBD, with a THC content of 0.1% or less, is the Food and Drug Administration (FDA)-approved drug Epidiolex, a pharmaceutical-grade, reproducible oral solution (100 mg/mL) classified as a Schedule V controlled substance for the treatment of seizures associated with two rare, severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older. Epidiolex is the first FDA-approved drug containing a purified drug substance derived from marijuana. Epidiolex, as an add-on therapy, is effective in reducing the frequency of seizures. It was compared with placebo in three randomized, double-blind, placebo-controlled trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome.1

When the origin is the hemp plant:

  • CBD is found as the primary compound in hemp, and legally must contain 0.3% or less of THC. The hemp plant is a cousin of marijuana, although both originate with Cannabis sativa L.2 Products marketed as “hemp-derived CBD” are not always what they seem to be. Currently, these CBD-containing products fall into a neverland not consistent with or considered reproducible entities. CBD derived from hemp continues to be considered a Schedule I illegal drug. Currently, hemp is not a controlled substance, but CBD derived from it continues to be under the jurisdiction of the FDA and is illegal. State laws vary regarding the legality of CBD products. Manufacturers and distributors of products labeled as CBD often make a variety of claims without having to prove efficacy. The FDA does not consider them dietary supplements and, in fact, considers CBD in food or CBD products marketed to be ingested as illegal. Cosmetic CBD products manufactured and marketed locally from hemp-derived CBD may be legal as long as they are not transported in interstate commerce. Therapeutic claims made for hemp-derived CBD-containing products are not allowed. In a recent study of 84 products evaluated for CBD labeling accuracy, only one-third (30%) were labeled accurately, while the rest were over-labeled, under-labeled, or did not contain CBD at all.3

REFERENCES

  1. Food and Drug Administration. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. Published June 25, 2018. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms
  2. Food and Drug Administration. FDA regulation of cannabis and cannabis-derived products including cannabidiol (CBD). March 11, 2020. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
  3. Bonn-Miller MO, Loflin MJE, Thomas BF, et al. Labeling accuracy of cannabidiol extracts sold online. JAMA 2017;318:1708-1709.