The U.S. Food & Drug Administration’s (FDA) failure to regulate CBD leaves the door open for nefarious business operators, and threatens consumers’ health, the chairman of a key congressional committee has warned the agency.
In a letter last week, Rep. James Comer, a Kentucky Republican who is Chairman of the House Committee on Oversight and Accountability, criticized the FDA’s announcement earlier this year that declared federal safety standards are insufficient to manage the CBD industry. The agency said not enough is known about CBD products to regulate them as foods or supplements under the FDA’s current structure, and called on Congress to set a legislative framework for regulations.
“FDA’s claim of a lack of a regulatory pathway is not only an insufficient rationale for inaction, but it is directly affecting the welfare of the American public,” Comer said in the letter, which was addressed to Robert Califf, FDA’s Commissioner of Food and Drugs
“The lack of regulation of non-intoxicating CBD products have allowed for potentially dangerous products to enter the market in the form of delta-8 and other hemp-derived intoxicants, leading to increasing concern that some products contain potentially dangerous ingredients due to the lack of regulation,” Comer said in the letter.
“Proper regulation from the FDA would not only prevent bad faith actors from entering the market but will increase the amount of good faith manufacturers’ contributions of a useful product for the American public,” Comer wrote.
Comer’s committee is investigating the FDA’s failure to regulate hemp-derived CBD products as dietary supplements, and its failure to reign in synthetic delta-8 THC, a psychoactive compound made from CBD. Delta-8 products have massively proliferated across the U.S. over the past three years, raising health concerns.
“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,” Comer said.
As part of his committee’s investigation, Comer requested the FDA provide “all scientific data, reports, and research in the possession of the FDA relating to the safety of CBD products for consumption,” as well as internal FDA communications related to its regulatory review of the compound.
Safe or not?
In calling for Congress to act, the agency said its existing foods and dietary supplement authorities are not able to manage many of the risks associated with CBD under rules for dietary supplements and food additives. FDA has said not enough is known about CBD’s effects on the liver and male reproductive system, and that little is known about how it interacts with drugs, and its effects on children and pregnant women.
“Given the available evidence, it is not apparent how CBD products could meet safety standards” for such products, FDA said in January.
But Comer, citing a recent World Health Organization (WHO) report which concluded that CBD is generally well tolerated by humans, and has a good safety profile, suggested “science is catching up regarding the safety of CBD usage”