Is Cannabidiol (CBD) a Drug or a Dietary Supplement?
Todd Subritzky, PhD
Great question, thank you, and with all the misinformation out there on the internet it is extremely difficult to find authoritative answers. For that reason, we take on the latest advice from the Food and Drug Administration (FDA). Following this, the short answer to your question is “yes” and “no” respectively, and there is really no room for ambiguity when you look at the latest statements on the FDA website.
“Based on available evidence, the FDA has concluded that THC and CBD products are excluded from the FD&C Act dietary supplement definition. Under that provision, if a substance (such as CBD) is an active ingredient in a drug product that has been approved under the FD&C Act, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.
There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, the FDA has concluded that this is not the case for CBD”. (US FDA, 2019)
From this statement, it would seem to be reasonably self-evident where the FDA stands on the matter. However, that doesn’t necessarily automatically transfer into compliance with the laws and there have been multiple reports of companies marketing food products infused with CBD. In particular, ‘artisanal wellness’ CBD products are being sold over the internet or in dispensaries to the extent that the Washington Post (2019, Apr. 7) recently reported that hemp cannabidiol (CBD) has become a nationwide health food craze.
For their part, the FDA has stated that they are aware that many firms are marketing CBD products and have issued several warnings. The FDA is concerned with the continued proliferation of CBD products being marketed for therapeutic purposes despite not having gained approval (US FDA, 2019). “Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law but also can put patients at risk, as these products have not been proven to be safe or effective” (US FDA, 2019).
Are there any compounds from the cannabis plant that can be marketed as a dietary supplement?
According once again to the FDA there are three hemp derived compounds that have been approved for marketing as dietary supplements including hulled hemp seed, hemp seed protein powder, and hemp seed oil. It is important to note that dietary supplements are also subject to numerous regulations including demonstrating the safety of the product and requirements as stipulated in the Current Good Manufacturing Practices (CGMPs).
US FDA. (2019). FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers. Retrieved 5/1/2019 from https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers.
Washington Post. (2019, Apr. 7). For CBD food craze, regulations and restrictions are all over the map. Retrieved 5/1/2019 from https://www.washingtonpost.com/national/health-science/for-cbd-food-craze-regulations-and-restrictions-are-all-over-the-map/2019/04/05/98ceec1c-5009-11e9-88a1-ed346f0ec94f_story.html?noredirect=on&utm_term=.1ebdb85fe8a2.[/vc_column_text][/vc_column][/vc_row]