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Archive for June 25th, 2019


FDA Holds Public Hearing & Opens Public Docket on Cannabis-Derived Compounds

graphic of CBD oilThe U.S. Food and Drug Administration (FDA) recently held a public hearing on cannabis-derived compounds, including cannabinoids, such as cannabidiol (CBD).  The hearing was prompted by industry confusion since the passage of the Agriculture Improvement Act of 2018 (AIA; Pub. L. No. 115-334).  The AIA excluded hemp from the statutory definition of marijuana (a controlled substance), and expanded the definition of hemp to “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 of not more than 0.3 percent on a dry weight basis.” [See The 2018 Farm Bill (P.L. 115-334): Summary and Side-by-Side Comparison, Congressional Research Service R45525, updated 2/22/19.]  The FDA continues to classify cannabis-derived compounds as “unsafe,” but the FDA has taken little action to remove such products from the marketplace.  The recent FDA public hearing provided a forum for “stakeholders to share their experiences and challenges with products containing cannabis and cannabis-derived compounds, including information and views related to the safety of such products, as well as to solicit input relevant to the agency’s regulatory strategy related to existing products.”  The FDA has also opened a public docket on regulations.gov, and the docket will be open until 7/16/19.  For additional information see the FDA Regulation of Cannabis and Cannabis-Derived Products page.