The congressional chorus calling on the Food and Drug Administration to finally regulate hemp-derived CBD continues to increase in volume.
On the heels of last week’s U.S. House vote that urged FDA to take immediate action, the U.S. Senate is on tap to issue its own directive to the agency. Specifically, report language that has been attached to a must-pass government spending bill that directs FDA to issue a formal enforcement discretion policy until its regulations are in place. Here’s the language:
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.
Of course, report language is not binding, and so far FDA has failed to respond to Congress’ repeated cries for action. That’s why it’s so critical to pass legislation – H.R. 841 in the House, S. 1698 in the Senate – that would legalize hemp extracts such as CBD and require FDA to regulate them as with other ingestible products.
Congress’ passion on this issue has been inflamed by YOUR advocacy. That’s why it is so critical for you TODAY to urge your Members of Congress to sign on to these important bills and regulate CBD now at www.regulateCBDnow.com
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