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FDA submits CBD guidance to White House


FDA Headquarters in Washington, D.C. Source: Wikimedia Commons

Earlier this week, we looked at the U.S. Food and Drug Administration and its role in cooling off the CBD market. Now, the agency’s inaction seems to have come to an end.


This week, the FDA submitted CBD enforcement guidance to the White House’s Office of Management and Budget for review. The move represents the culmination of months CBD fans and entrepreneurs have spent waiting for the agency to clear up the murky marketplace, plagued by the FDA’s own safety warnings and confusion that may be hurting growth.


Details about the new FDA guidance are still sparse, but it could be an important milestone in the development of an industry many projections have valued in the billions.


According to Marijuana Moment, we do know that the draft guidance is titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.”

“We recognize that there is substantial public interest in marketing and accessing CBD for a variety of products. We are working toward a goal of providing additional guidance, and have made substantial progress,” the FDA said in a statement.

“There are many questions to explore regarding the science, safety, effectiveness and quality of products containing CBD, and we need to do our due diligence.”

Meanwhile, RollCall.com reports that the hemp industry itself has a definite preference that the FDA guidance include provision that re-define CBD as a dietary supplement to maximize the potential for industry growth.

According to Roll Call, Mitch McConnell, one of the senators who led the legalization of industrial hemp in 2018, has had much to say on the inactivity of the FDA during the months since the substance has become licit.


"One of the biggest lessons of the past year is the need for regulatory clarity from the FDA,” McConnell said in a statement. “Without these federal guidelines, Kentucky growers, processors and manufacturers lack the certainty needed to take full advantage of the opportunities hemp offers.”


Still, hope that CBD fans and entrepreneurs can determine their own destiny still exists.


According to Marijuana Moment, the FDA has also opened a public comment period which will continue indefinitely while the White House reflects on its new guidance drafts.


“To provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available, we are reopening the comment period and extending it indefinitely to allow interested parties to continue to comment,” FDA said in a statement.


Sources


[1] https://www.nothingbuthemp.net/post/is-the-fda-the-reason-hemp-hasn-t-flourished-as-it-might-have


[2] https://www.bostonglobe.com/2020/06/04/marijuana/white-house-is-reviewing-cbd-marijuana-research-guidance-fda/


[3] https://www.rollcall.com/2020/06/04/hemp-industry-asks-congress-to-help-on-fda-guidance/

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