Mitch McConnell Urges FDA To Ease CBD Regulations 'Within 120 Days'
The Kentucky Senator drafted a proposal that would clear a path for the lawful marketing of hemp-derived CBD products.
Kentucky Senator Mitch McConnell (R), a chief proponent of a hemp legalization provision in the 2018 Farm Bill, has put the pressure on the Food and Drug Administration (FDA) to expedite the path for lawful marketing of hemp-derived CBD products. It's the latest push by the Senator to get CBD products more funding to educate consumers and to utilize the benefits in food items or dietary supplements.
Prior to today's movement from McConnell, the FDA has said that allowing CBD to be sold as food items or dietary supplements would require it to develop alternative regulations that could take years to complete if no congressional action was used.
McConnell's plan is to insert language into a congressional spending report that is asking the FDA to "issue a policy of enforcement discretion with regard to certain products containing CBD" within 120 days — something that will help stakeholders clarify rules, which, in effect, could make banks become more willing to service CBD companies.
Here's a look at the full report language from Mitch 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."
CBD industry response
In general, the CBD industry has been receptive to McConnell's proposal to the FDA. Here's what both John Huemoeller, CEO of AXIM Biotechnologies, Inc., and Jenelle Kim, Founder and Chief Formulator of JBK Wellness Labs, had to say.
Huemoeller: "Last year, hemp and CBD were legalized through the 2018 Farm Bill. A few months ago, the DEA requested an increase in the amount of cannabis grown in the U.S. for research. Now it's time for the FDA to recognize that cannabis and CBD products aren't just a fad, but, because of their many wellness benefits, they are here to stay. We look forward to understanding how these new regulations may help the industry grow by setting needed safety standards and provide consumers with an overall improved level of trust in CBD and other cannabis products."
Kim: "Mitch McConnell's move to call on the FDA is certainly a progressive and important move, which will help to open the doors for more people to reap the incredible benefits of CBD. It is vital to remember that hemp is one of the 50 Fundamental Herbs in Chinese Medicine and its healing properties date back 4000 years. For a medicinal herb that has been used responsibly for thousands of years as a treatment for pain and fatigue, among other conditions, to be given a larger opportunity is certainly a winning situation for all involved."
In order to hit McConnell's target of 120 days, there's some work still left to be completed.
On Tuesday, the Senate Appropriations Subcommittee on Agriculture will mark up the provision of the spending report. Next, the Appropriations Committee will receive it two days later. Finally, The FDA would need to submit a report to the committee within 90 days, which opens up the possibility of a new policy. Lastly, if the new enforcement guidelines are established, they would continue to be implemented until the regulatory process is finalized by the FDA.
In support of Mitch McConnell's proposal, Oregon Senator Jeff Merkley praised the bill during the subcommittee meeting last Thursday, with Merkley specifically mentioning the revenue that hemp will bring to his state alone. "You might note that this year in Oregon, the hemp industry may well be a billion-dollar crop, and that is an incredible addition to income for our agricultural community," he said.
Only time will tell where McConnell's proposal and timeline goes, but it is a big day for the CBD industry as a whole to have such support.