Hemp, Cannabidiols and the FDA

image of cannabis leaf & cbd oilThe Agriculture Improvement Act of 2018 became Public Law 115-334 on 12/20/18.  Title XII Section 12619 of this act removed hemp and “tetrahydrocannabinols in hemp” from the Controlled Substances Act (CSA).  [Tetrahydrocannabinols (THC) are a cannabinoid subclass, as are Cannabidiols (CBD).]  Also on 12/20/18, Scott Gottlieb, the Food and Drug Administration (FDA) Commissioner, issued a Statement on the agency’s regulation of products containing cannabis and cannabis-derived compounds.  The 12/20/18 Statement acknowledges hemp’s removal from the CSA, but goes on to state “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds….  We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products….  The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.”  State lawmaker and public confusion on the legal status of CBD ensued.  On 1/15/19, Oregon Senators Ron Wyden and Jeffrey A. Merkley wrote Gottlieb asking the FDA “to immediately update federal regulations governing the use of certain hemp-derived ingredients in food, beverages or dietary supplements.”  On 2/19/19, Maine Congresswoman Chellie Pingree and 11 other Representatives wrote Gottlieb “to swiftly provide guidance on lawful pathways for food products containing hemp-derived CBD in interstate commerce.”  The FDA has not yet issued additional guidance, and Gottlieb recently announced his resignation effective 4/5/19.