Democratic Senators Ron Wyden and Jeff Merkley are urging FDA Commissioner Scott Gottlieb to update regulations for food, beverage, and dietary supplement products that contain hemp-derived CBD.
Democratic Senators Ron Wyden and Jeff Merkley have sent a letter to the U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, urging him to update federal regulations governing the use of hemp-derived cannabidiol (CBD) in food, beverage, and dietary supplements. A provision of the Agriculture Improvement Act of 2018, otherwise known as the 2018 Farm Bill, removed hemp from Schedule I of the Controlled Substances Act and legalized the cultivation of hemp as well as the production and sale of hemp and hemp derivatives.
However, FDA holds the opinion that CBD may not be used in food, beverages, and dietary supplements because of an investigational new drug (IND) clause prohibiting an ingredient’s use in supplement products once it has been studied as a potential drug. In this case, CBD was investigated as a drug by GW Pharmaceuticals (Cambridge, UK) as a treatment for epilepsy and was later approved for sale as GW's drug Epidiolex. Despite this, foods, beverages, cosmetics, and wellness products that contain hemp-derived CBD and other cannabinoids have taken off, and consumer awareness and market interest in CBD is very high.
“Current, outdated regulations limit producers from taking full advantage of the industrial hemp market by, for example, prohibiting food products containing CBD from being sold across state lines. In recent years, the public has developed a widespread interest in the production and use of CBD, one of the primary non-psychoactive compounds in Cannabis sativa L.,” write the Senators. “We therefore request the FDA immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and give U.S. producers more flexibility in the production, consumption, and sale of hemp products.”
CBD is the dominant naturally occurring active cannabinoid in hemp, and while it was isolated for use in a pharmaceutical, hemp products like tinctures will inevitably contain CBD and other actives called cannabinoids. It is therefore significant that Senators Wyden and Merkley say “hemp-derived CBD and other hemp-derived cannabinoids” because it may force FDA to acknowledge the presence of these actives in hemp products and make a decision on how to update regulations under the newfound context of the 2018 Farm Bill’s hemp-farming provision.