The FDA’s position as it pertains to marketing and selling CBD products as food items or dietary supplements is that a framework of regulations must be developed and uniform standards created before the lawful marketing of hemp-derived CBD products can exist. Kentucky Senator Mitch McConnell (R) is attempting to urge the FDA process along by inserting language in a congressional spending report that asks the FDA to issue a “policy of enforcement discretion” within 120 days with regarding to CBD products meeting the federal definition of hemp. McConnell’s proposal includes that such enforcement discretion shall be in effect “until FDA establishes a process for stakeholders to notify FDA for use of CBD in products that include safety studies for intended use per product, and makes a determination about such product.”
It is believed that McConnell’s proposal, if put into effect, would allow the industry to progress along its natural, upward trajectory while also providing for the necessary safety standards and regulations to be developed.
Here is the full report language from Senator McConnell to the FDA:
“As previously mentioned, the Committee provides $2,000,000 for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy, and appropriate regulatory activities with respect to products under the jurisdiction of the Food and Drug Administration which contain cannabidiol (CBD) and meet the definition of hemp, as set forth in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o). Within 90 days, FDA shall provide the Committee with a report regarding the Agency’s progress toward obtaining and analyzing data to help determine a policy of enforcement discretion, and the process in which CBD meeting the definition of hemp will be evaluated for use in products. Within 120 days, FDA shall issue a policy of enforcement discretion with regard to certain products containing CBD meeting the definition of hemp as defined by section 297A of the Agricultural Marketing Act of 1964 (7 U.S.C. 1639). Such enforcement discretion shall be in effect until FDA establishes a process for stakeholders to notify FDA for use of CBD in products that include safety studies for intended use per product, and makes a determination about such product. FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigation New Drug (IND) application in the development of a regulatory pathway for CBD in products under the jurisdiction of FDA and to ensure that any future regulatory activity does not discourage the development of new drugs.”
Last modified: September 20, 2019