March 10, 2022
Congress To FDA: Regulate CBD Now
Some great news from Capitol Hill. Our champions in Congress, upon the advocacy of the U.S. Hemp Roundtable, were able to secure report language in the new omnibus spending bill that resolves it’s time to Regulate CBD Now.
Under Sec. 741 of Division A(p.120), the U.S. Senate Appropriations Committee directs the U.S. Federal Drug Administration (FDA) to allocate funds and resources toward the establishment of a regulatory framework for all cannabis derivatives, including cannabidiol (CBD).
Cannabis and Cannabis Derivatives.— The Committee notes that budget did not request additional resources for Cannabis and Cannabis Derivatives activities, and therefore directs the FDA to maintain funding levels to support regulatory activities, including developing policy, and for the FDA to continue to perform its existing regulatory responsibilities, including review of product applications, inspections, enforcement, and targeted research for cannabis-derived substances, such as cannabidiol [CBD]. Within 90 days of enactment of this Act, the 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 the FDA establishes a process for stakeholders to notify the FDA of use of CBD in products that include safety studies for intended use per product and makes a determination about such product. In addition, the FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigational New Drug application in the development of a regulatory pathway for CBD in products under the jurisdiction of the FDA and to ensure that any future regulatory activity does not discourage the development of new drugs. The Committee also encourages the FDA to partner with an academic institution to expand sampling studies of CBD products currently on the market.
The committee also encourages FDA to move forward with more clinical research and university studies on CBD. Other hemp-related language throughout the report shows that Congress recognizes other major issues impacting the industry and is trying to take action, including —
- Directing USDA to work with other federal agencies to determine a scientific basis for the current limit of .3 percent THC in hemp and suggest alternative levels if necessary, and establishing a dual designation for hemp as a specialty crop to ensure certain producers are not prevented from accessing USDA programs
- Development of hemp cultivars, germplasm, and production systems through a $2.5 million investment in special funding and research partnerships
- Continued rejection of domestic hemp production and other agricultural related proposals that administratively implement new user fees to cover the government’s cost for services, providing an additional $1.5 million in funding to the USDA Marketing and Regulatory Program for support
- Growing need for hemp and CBD related businesses to have access to capital, calling on federal agencies towork with the institutions under its jurisdiction to provide hemp producers with options for guaranteed loans
While this report language is non-binding, it sends a loud message to FDA and hemp producers, advocates and consumers that regulatory relief may be on the way as Congress now clearly recognizes its role in directing the agency “claiming stalemate” to provide it.
Now, more than ever, your advocacy is critical to ensuring Congress continues to take steps forward. Please visit the online action center at regulateCBDnow.com and fill out the customizable form asking your members of Congress to support passage of legislation or language that directs FDA to establish a regulatory framework for hemp-derived CBD products today!
Help US amplify the industry-wide call on Congress to #RegulateCBDNow by sharing on social media and encouraging your friends to fill out the form, too.