Senate Leader Mitch McConnell (R-KY) inserted “report language” into an appropriations bill being considered by the Senate Agriculture Appropriations Subcommittee that demands FDA take significant actions with respect to products containing cannabidiol (CBD). The language introduced by McConnell sets milestones for FDA actions related to CBD.
The language states the following: “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.”
While the bill’s language falls short of changing federal regulations for CBD outright to allow its automatic inclusion in foods and dietary supplements, it does pressure FDA to exercise enforcement discretion and places the agency on a timeline. The latest draft of the appropriations bill also 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. 1639).”
In response to the latest draft of the appropriations bill, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), said in a press release: “When a marketer puts a Supplement Facts Label on a product, it is a very real promise to obey the rigorous rules policing supplement manufacturers. That means, among other things, that it is adhering to good manufacturing practices, registering its facilities with FDA, giving consumers a manner to report any adverse events, accurately listing all ingredients on the label, and refraining from making illegal drug-like claims. The instant FDA creates a legal CBD supplement market, there is a well-developed body of law and regulations governing dietary supplements that can and should be enforced. While CRN is always seeking additional resources for the FDA, it won’t take much for the FDA to have a big impact. Several high-profile enforcement actions would change the calculation of risk by companies who may be skirting the requirements of the law and can immediately change behavior.”