By now I’m sure you have heard of Cannabis, but how much do you know about the regulatory policy and available science-based health benefits that surround this green plant?
Generally accepted as originating in Asia,[vi] Cannabis has been around for thousands of years, and it has long been used to produce hemp products and for medicinal and recreational purposes. But during the early 20th century Cannabis endured increased restrictions in the United States, being officially outlawed for any use (including medical), along with several other drugs, with the passage of the 1970 Controlled Substance Act (CSA).[vii]
Thereafter, individual states began to liberalize cannabis laws through decriminalization, beginning with Oregon in 1973. In 1996, California became the first state to legalize medical Cannabis.[viii] In 2012, Colorado and Washington became the first states to legalize Cannabis for recreational, adult use.[ix] [x]
Now, 47 states and the District of Columbia have passed laws broadly legalizing Cannabis in one way or another – through decriminalization or total legalization of the plant or its cannabinoids for recreational or medical use – but it remains a Schedule I drug under federal law. [xi] [xii] This is where it gets murky.
The Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill) is a federal mandate that included provisions to legalize hemp, removing it from the Schedule I controlled substance list and making it an ordinary agricultural commodity.[xiii] The 2018 Farm Bill (Section 10113) defines hemp as, “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration [THC] of not more than 0.3 percent on a dry weight basis.”[xiii]
But what about CBD? Because the 2018 Farm Bill’s definition for hemp included cannabinoids (e.g., CBD), there was an insurgence of CBD products in the marketplace, in particular, promoting their health benefits. But the Farm Bill also preserved the FDA authority to regulate products containing cannabis/cannabis-derived compounds (e.g., CBD).[xi] [xiv] [xv]
If a product is marketed as a pharmaceutical, it is illegal to market it as a dietary supplement, add it to foods or sell it without FDA approval. At least one CBD-containing drug, Epidiolex, is approved by the FDA which subsequently classifies CBD as a pharmaceutical, rendering it illegal to add to foods or market as a supplement.[xvi]
For the time being, FDA does not intend to approve CBD, or THC, for use in foods, as a therapeutic or as a dietary supplement. But other cannabis-derivatives are making their way onto grocery shelves. Three hemp seed ingredients have been classified as generally recognized as safe (GRAS) for use.[xvii]
As Dr. Norman E. Sharpless, MD, National Cancer Institute, poignantly noted at a recent FDA public hearing, “this is a very complex issue and there are important reasons to generally prohibit putting drugs in the food supply, as well as other consumer products, like cosmetics.”[xviii] As with any drug, there are recommended dosages and potential side effects to be determined and outlined, and with CBD being added to a variety of consumer products, another layer of concern exists.
There is robust research on the effectiveness of CBD in treating childhood epilepsy. Studies have shown CBD to be helpful at reducing severe seizures, leading to the development of the FDA-approved drug, Epidiolex. Comparatively, evidence to support the effectiveness of CBD in reducing pain, anxiety, insomnia, post-traumatic stress disorder and other neurological conditions is still fairly new. While the emerging evidence is promising, there have been few human studies and further research is necessary to support health-related claims or outcomes.
The FDA is well aware of companies marketing CBD products to treat diseases or for other therapeutic uses and the agency has issued several warning letters to such companies to remove their products from the market. Also, the agency keeps an active webpage on Cannabis products, research and regulation, including topics such as safety and efficacy of the cannabinoid’s use for pregnant and lactating women, children and pets.
The agency will continue to oversee research regarding the safety of CBD and interested researchers should submit Investigational New Drug applications on botanical drug products for FDA review. The FDA mentions on the webpage referenced above that removing hemp from the Controlled Substances Act “may streamline the process for research to study Cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.”[xvii]
If companies are eager to jump on the CBD bandwagon, we recommend consulting an agency that is well-versed in the food regulatory landscape that can help you navigate the various regulations that need to be met, as it is going to be a long and arduous process to achieve CBD to get approval for use as a dietary supplement, a therapeutic or an ingredient in food. So, contact FoodMinds today!
Laura Campbell, RD is a senior account executive at FoodMinds, a division of Padilla. She is based in Chicago.
[v] El-Alfy AT, Ivey K, Robinson K, et al. Antidepressant-like effect of Δ9-tetrahydrocannabinol and other cannabinoids isolated from Cannabis sativa L. Pharmacology Biochemistry and Behavior. 2010; 95(4): 434-442. doi:10.1016/j.pbb.2010.03.004.
[vii] Title 21 United States Code (USC) Controlled Substances Act. Title 21 United States Code (USC) Controlled Substances Act – Section 801-971. 2019. Accessed at: https://www.deadiversion.usdoj.gov/21cfr/21usc/index.html.
[x] Washington Marijuana Legalization and Regulation, Initiative 502 (2012). Ballotpedia. 2012. Accessed at: https://ballotpedia.org/Washington_Marijuana_Legalization_and_Regulation,_Initiative_502_(2012).
[xi] State By State Policies: National Cannabis Industry Association. The National Cannabis Industry Association. 2019. Accessed at: https://thecannabisindustry.org/ncia-news-resources/state-by-state-policies/.
[xvi] FDA Regulation of Cannabis and Cannabis-Derived Products. U.S. Food and Drug Administration. 2019. Accessed at: https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.
[xvii] Three GRAS Notices for Hemp Seed-Derived Ingredients for Food. U.S. Food and Drug Administration. 2018. Accessed at: https://www.fda.gov/food/cfsan-constituent-updates/fda-responds-three-gras-notices-hemp-seed-derived-ingredients-use-human-food.
[xviii] Sharpless NE. FDA Public Hearing on Products Containing Cannabis or CBD compounds. U.S. Food and Drug Administration. 2019. Accessed at: https://www.fda.gov/news-events/speeches-fda-officials/remarks-dr-sharpless-fda-public-hearing-scientific-data-and-information-about-products-containing.