Reminiscent of the childhood game of Captain, May I?, every small step the federal government takes forward on the path toward legalization of cannabis seems to elicit a directive that takes it three giant steps back. Not so long ago, we wrote about President Biden’s pardoning of some federal cannabis offenses, which we stated as “indicating some progress on the policy front.”
But that potential step forward has been countered by FDA’s recent denial of three citizen petitions asking for rulemaking that would allow CBD products to be marketed as dietary supplements. Pushing it another step backward, FDA stated that its current authorities “provide only limited tools for managing many of the risks associated with CBD products,” so it would need Congressional intervention to develop “a new way forward” to federal legalization.
As FDA has stated several times in discussing its stance on cannabis in foods or dietary supplements, the agency again focused on the various safety concerns it has with CBD, especially with long-term use. The statement cited studies that have shown the potential for harm to the liver, interactions with certain medications, and possible harm to the male reproductive system, as well as concerns about vulnerable populations such as children and pregnant women.
It doesn’t help matters that a 2022 determination by the European Food Safety Authority (EFSA) held that more scientific information is needed to evaluate the safety of CBD. Having identified several hazards related to CBD intake and deficiencies in both the experimental animal and human data, the panel ruled that “the data gaps and uncertainties identified in this statement need to be addressed by the applicants to provide the basis for the safety assessment of CBD as a NF (novel food).” Its concluding statement that “the safety of CBD as a NF cannot currently be established” in all likelihood serves as an indicator of another step backward on the U.S. path toward CBD use in food or dietary supplements.
With all this, FDA has essentially passed the buck to a new “captain,” concluding that the regulatory pathway needed to balance consumer access to CBD products with regulatory oversight is a matter for Congress to handle. Though the agency “looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products,” it seems that any further citizen petitions requesting even a small step forward should now be sent directly to Congress.
Meanwhile, FDA will continue to take action against CBD and other cannabis-derived products and remain diligent in monitoring the marketplace, identifying products that pose risks, and acting within its authorities.