In the latest sign that congressional pressure on the Food and Drug Administration (FDA) to expedite regulations on cannabidiol (CBD) products continues to intensify, Senate Majority Leader Mitch McConnell (R-KY) this week proposed language that would require the FDA to establish an enforcement policy on CBD within four months.
Specifically, this new language, which was inserted into the FY 20 funding bill for the FDA, would require the agency to submit a report to Congress detailing the FDA's progress on creating a policy targeting CBD companies for violating the Food, Drug, and Cosmetic Act (FDCA). Thirty days after this report is submitted, the FDA would be required to issue the enforcement policy and have it remain in effect as an interim guidance until a formal regulatory framework can be established.
This move by Senator McConnell to insert this language in a must-pass funding bill is significant, especially given that he was instrumental in incorporating the hemp provision into the 2018 farm bill. The language is being proposed subsequent to recent warning letters issued by the FDA and the Federal Trade Commission (FTC) to companies for making unsubstantiated claims on various CBD products.
Bipartisan House Letter to FDA Forthcoming
The House of Representatives also remains very active in monitoring the FDA's progress. According to a report by the U.S. Hemp Roundtable, a coalition of hemp companies, Reps. Chellie Pingree (D-ME) and James Comer (R-KY) sent a Dear Colleague letter requesting them to sign on to a letter to the FDA urging the agency to exercise enforcement discretion on companies selling CBD products responsibly. The Dear Colleague letter contends that the FDA's current approach on CBD is creating significant regulatory and legal uncertainty that is preventing economic opportunities in this quickly evolving industry to be realized.
The letter that eventually will be sent to the FDA urges the agency to issue an enforcement discretion policy that maintains the FDA's risk-based enforcement approach towards CBD products. The letter also requests the agency to consider issuing an interim final rule to allow a regulatory framework to be established. While the letter expresses appreciation for the way the FDA has pursued enforcement actions against the worst offenders, it argued that the agency can continue this practice while eliminating regulatory uncertainty for the industry.
FDA in Regulatory Quandary
While the FDA has professed that it is acting quickly to provide industry guidance, the announced next step the agency intends to take is to merely update their status in the fall. Congress clearly is not interpreting this action as an expedited process and is continuing to apply pressure on the FDA to facilitate action.
If the McConnell language is signed into law, which seems highly likely, the question becomes how the FDA will react to it. Timelines for issuing rules and implementing regulations are inserted into appropriations bills frequently and, quite often, agencies fail to meet these deadlines. However, agencies do this at their own peril because key Members of Congress, such as Senate Majority Leader McConnell, can respond by scrutinizing the agency in other ways.
Clearly, the FDA is uncomfortable expediting the process with the meager information they possess on the safety of CBD products. In recent congressional testimony, the FDA acknowledged that the agency continues to seek answers to questions not only about the intrinsic safety of CBD, but also about potentially unsafe manufacturing processes for products containing CBD; the FDA only will consider creating legal pathways for CBD products if it is confident that it can develop a framework that addresses safety concerns. Typically, a process like this at the FDA can take years before a regulatory framework can be established.
As a result of this conflict between congressional pressure to act and the absence of adequate safety data, the FDA is attempting to strike a careful balance between exercising its regulatory due diligence in ensuring CBD products are safe, while giving the perception that the agency is acting quickly to provide industry guidance. Ultimately, it is plausible that the FDA ends up moving forward quicker than they are comfortable with, but not as quickly as Congress would prefer.
Wilson Sonsini Goodrich & Rosati's FDA Regulatory, Healthcare, and Consumer Products Compliance practice group is actively following developments on regulatory activity impacting hemp and CBD.
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