Robert Califf, FDA’a commissioner, reiterated the agency’s year-old appeal to Congress for a framework enabling the sale of cannabidiol (CBD) as a dietary supplement and as a food ingredient. Currently, FDA believes it lacks the authority to pursue this course of action within its existing structure.
Califf addressed a U.S. House of Representatives oversight committee earlier this month and noted that FDA deemed hemp-derived CBD not sufficiently safe for lawful sale as a dietary supplement. He urged Congress to establish a pathway for regulating the substance.
Based on a recent report from the World Health Organization (WHO), CBD shows promising therapeutic potential in various trials, both controlled and open label, demonstrating good tolerance and a favorable safety profile.
The regulation of hemp derivatives, including CBD, has been a matter of concern since the legalization of its cultivation in the 2018 Farm Bill, predominantly crafted by USDA and ratified by Congress. Since then, the product has become widespread as a supplement and has also found its way into certain food and beverage items, despite FDA never officially declaring it safe as a food ingredient. “It’s Congress’s decision to make, so we would really look forward to work with you all as quickly as possible to come up with a regulatory pathway that you think is reasonable and enables us to take action,” Califf said during his address.
James Comer, chairman of the House Committee on Oversight and Accountability, sent a letter to Califf on Wednesday in reply, stating it is imperative that FDA engages in this regulation quickly, safely, and efficiently to provide proper guidance to consumers about the safety of CBD products. “Without allowing for therapeutic CBD products to be regulated as dietary supplements such as melatonin or fish oils, the good faith actors in the industry are unable to enter the market and provide people with helpful products because they are currently not distinguished under the FDA from the intoxicating products containing Delta-8,” he wrote, asking FDA for documents and information to enable oversight of the agency’s actions.
Another issue gaining steam revolves around the national legalization of tetrahydrocannabinol (THC), the intoxicating component of marijuana, and its potential integration into food and beverage items. While some states where the drug is already legalized have incorporated it into food products, interstate transportation of such products remains prohibited.
Califf has gone on record declaring there is no justification for the Drug Enforcement Administration (DEA) to prolong its decision regarding the rescheduling of marijuana from a Schedule I to a Schedule III substance, thereby aligning it with medications such as acetaminophen and ketamine, rather than with substances like heroin and LSD.
“This is an area where I believe we would be better off if we had guidance from Congress about how to proceed,” Califf said.
Leave a Reply