Background. Cannabidiol (CBD), derived from cannabis (cannabis sativa L.), has been marketed for several years, but interest in CBD products – and the number of outlets selling such products – skyrocketed after Congress passed the Agriculture Improvement Act of 2018 (Farm Bill). The Farm Bill, among other things, established a new category of cannabis – hemp – defined as cannabis with 0.3 percent or less concentration of compound delta-9-tetrahydrocannabinol (THC). Products meeting the definition of hemp were removed from the purview of the federal Controlled Substances Act. Companies manufacturing CBD products interpreted this to mean that their CBD products were legal so long as they were derived from hemp. However, a statement from the federal Food and Drug Administration’s (FDA’s) recently departed commissioner Scott Gottlieb, MD, on April 2, 2019, emphasized that the Farm Bill “explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compound under the Federal Food, Drug and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.”

Import. Physicians will no doubt have patients listing CBD products in their medication/supplements list. They may even ask whether and how much they should be taking and whether it is effective for certain conditions. The answers to those questions lie within physicians’ medical judgment and review of the literature. However, it is important to be aware that some companies make unproven and “egregious” claims that could cause patients to forgo successful standard treatment. The FDA has issued warning letters against companies that have made claims that CBD:

 

  • Stops cancer cells in multiple cervical cancer varieties.
  • Decreases human glioma cell growth and invasion.
  • Slows the progression of Alzheimer’s.
  • Blocks mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other disorders.
  • Treats substance abuse disorders.
  • Reduces withdrawal symptoms from opioids.

 

The law. Epidiolex1 is the only FDA-approved drug containing CBD. (Marinol and Syndros are also FDA-approved, and they include as their active ingredient dronabinol, a synthetic form of THC.) Products sold for therapeutic or medical purposes are considered a “drug” subject to FDA approval. Therefore, the sale of any CBD-containing product expressly for medicinal or therapeutic purposes violates the FD&C Act. Further, the FDA holds the position that hemp-derived CBD products cannot be sold as “supplements” because CBD is an active ingredient in a drug product that has been FDA-approved. As such, it is statutorily excluded from the definition of “supplement” unless and until the FDA, in its discretion, issues a regulation establishing that the substance is lawful as a supplement. No such regulation has been issued. One reason for that is that the FDA does not want to disincentivize pharmaceutical companies from developing effective and safe drugs through clinical trials: If CBD were widely available legally in supplements, then there would be no incentive to incur the expense of clinical trials to demonstrate safety and efficacy. CBD also cannot be added to food for the same reason (that is, because CBD was a drug first). However, hulled hemp seed, hemp seed protein powder and hemp seed oil can be used in human food because they have been evaluated as green recognized as safe (GRAS) because hemp seeds do not naturally contain THC or CBD.

 

Conclusion. CBD products are, at this time, unregulated, and, according to the FDA, illegal to be sold as supplements or food. Physicians should be prepared to share this information with patients, as well as their personal clinical opinions regarding such products. The FDA has scheduled a public hearing for May 31, 2019, regarding CBD products and is accepting written public comments from all stakeholders. The evolving status of CBD products can be followed on the FDA website.2

 

DISCLAIMER: This article is for informational purposes only and does not constitute legal advice. You should contact your attorney to obtain advice with respect to your specific issue or problem.

References

 [1] Epidiolex was the subject of a previous article in the Bulletin: Williams, Anne, PharmD and Bonrzynski, Emily PharmD, BCPS, “Materia Medica: Epidiolex® (cannabidiol),” ACMS Bulletin (February 2019), pp. 52-54.

[1] Questions and answers can be found online at: https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm#legaltosell.