On July 16, the U.S. Food and Drug Administration’s (FDA)'s period of public comments on cannabidiol (CBD) products came to a close, with more than 4,000 comments submitted. Pressure has continued to mount for the FDA to provide a legal pathway for CBD, a naturally occurring compound found in cannabis and hemp that reportedly relieves stress and other ailments. Senate Majority Leader Mitch McConnell (R-Ky.) recently met with acting FDA Commissioner Ned Sharpless on the subject, and in July, FDA Principal Deputy Commissioner of Food and Drugs Amy Abernethy testified before the U.S. Senate Committee on Agriculture, Nutrition and Forestry.
Marijuana Moment reported Abernathy stated that the FDA “is committed to advancing hemp products through the agency’s existing regulatory pathways, and we are further exploring whether it would be appropriate to make additional regulatory pathways available to hemp products such as those containing CBD.”
She cited a number of challenges, including questions about the safety of CBD products, the safety of the manufacturing of CBD products, and ensuring products actually contain the ingredients and amounts of CBD advertised.
There are also issues around allowing CBD products into food and beverage and/or to be marketed as dietary supplements. Abernathy said the FDA would have to create exceptions for hemp and CBD under all of the agency’s regulations, as creating just one exception might create confusion in the marketplace. The agency will also need to consider whether allowing CBD to be marketed in foods or as a dietary supplement would deter companies from investing in clinical research of CBD’s therapeutic uses.
“Less research into the promise of cannabis-derived compounds and fewer drug approvals in this area would be a significant loss for American patients,” she said. “FDA will only consider creating legal pathways for CBD to be marketed as a dietary supplement or in food if the agency is confident that it can develop a framework that addresses safety concerns.”
Abernathy acknowledged that the FDA’s years-long rulemaking process “is a long time to wait for regulatory clarity, particularly given the significant public interest in hemp products and CBD in particular.” As such, the agency announced earlier in July that it is attempting to speed up the rulemaking process and will issue a status update this fall.
Many in the industry, however, expressed skepticism that the FDA’s fall announcement will provide any concrete information.
“We doubt that the FDA's update this fall will provide any regulatory certainty for CBD,” Vivien Azer, managing director and senior research analyst for Cowen & Co., New York, wrote in a collaborative research note. “In our view, the agency is more likely to issue a summary of the comments it received, outline the regulatory history of CBD and provide an initial definition of key baseline terms differentiating between hemp/CBD/ THC and what the Farm Bill said in layman terms.”
The agency might also make “a determination on whether a new regulatory framework that addresses safety concerns is even possible,” she added. “However, we believe that would likely be the start of the process and not the conclusion.”
Accordingly, Azer surmised “congressional intervention will likely be needed.”