Mitch McConnell's Stance On The FDA and CBD Regulations

Jan 29th 2020

Mitch McConnell's Stance On The FDA and CBD Regulations

Legalizing CBD is not enough, Mitch McConnell (Kentucky senator) believes a directive should be given to the FDA to formulate laws that will allow for the increased lawful marketing of hemp-derived products. Even after legalizing CBD for medical and recreational use through the provisions of the 2018 Farm Bill, Mitch McConnell believes there is need to get CBD products more funding to educate consumers and utilize the benefits in items or dietary supplements.

In response to the submission of the senator, the FDA made it clear that creating such a law which allows CBD to be sold as a dietary supplement or food item would require the formulation of alternative regulations which may take several years to achieve if no congressional action was issued. To fast forward the entire process, the senator will be asking the FDA to complete the entire process within 120 days. This will not only affect the way consumers see these products but also clarify rules to stakeholders. Here is a full report of the senator’s submission for consideration;

"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 USC 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 USC 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."

In response to this move, CBD experts like Jenelle Kim (founder and chief formulator of JBK Wellness Labs) and John Huemoeller (CEO of AXIM Biotechnologies) believe this move will create more awareness on the benefits of the cannabis plant. It will also increase the level of trust customers have in CBD products.

The proposal is still in motion, and with the right response from the concerned authorities, it is clear that CBD may experience a big push in 2020 and receive its due recognition.