What is the Current Situation Regarding FDA Regulations and Cannabidiol (CBD)?
Todd Subritzky, PhD
Great question and thanks for giving me the chance to try and bring some clarity around the issue – it really is a can of worms. Currently in the US cannabis is legally available for medicinal reasons in around 50% of states while approximately 20 more states allow high cannabidiol (CBD), low tetrahydrocannabinol (THC) products (Mead, 2017). This has resulted in ‘artisanal wellness’ CBD products 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. This despite not having gained Food and Drug Administration (FDA) approval to market these products.
However, there is a lot of misinformation out there and the internet is not much help in identifying authoritative and up to date information. The recent FARM Bill that legalized hemp has further muddied the waters. At the heart of the matter is the conflict between federal & state laws on CBD, which has led to a lot of confusion for health care providers, caregivers, and patients (Mead, 2017), and the debate around whether the CBD was sourced from cannabis or hemp.
We have taken our information as provided from the FDA so we believe it is sound, but the landscape is quickly changing.
FDA Regulations and CBD
As noted by the US FDA (2019) “the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. The FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.”
In June 2018 the FDA approved Epidiolex, the first cannabis-derived treatment for 2 epilepsy syndromes, Lennox-Gastaut (LGS) and Dravet (DS). It contains a purified form of cannabidiol (CBD) for the treatment of seizures. “While other drugs containing synthetic versions of tetrahydrocannabinol found in the cannabis plant have been previously approved by the FDA, Epidiolex is the first plant extract that will be available in the United States” (Yang, Szaflarski, & Szaflarski, 2018, p.135).
Just as a small aside, the three FDA approved medications with synthetic versions of THC include Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone).
Beyond Epidiolex, there are currently no FDA-approved drug products containing CBD. However, the FDA has stated that they are aware that many firms are marketing CBD products and have issued several warnings. The FDA are 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).
Is it legal to sell CBD products? According to the FDA, it depends on how the product will be used and is labeled. “Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act.” (US FDA, 2019).
Mead, A. (2017). The legal status of cannabis (marijuana) and cannabidiol (CBD) under U.S. law. Epilepsy & Behavior, 70(Pt B), 288-291. doi:10.1016/j.yebeh.2016.11.021
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.
Yang, Y., Szaflarski, T., & Szaflarski, J. (2018). The US Food and Drug Administration’s Authorization of the First Cannabis-Derived Pharmaceutical: Are We Out of the Haze?. Retrieved 5/1/2019 from JAMA Neurology 11/19/2018. Web.[/vc_column_text][/vc_column][/vc_row]