WASHINGTON —Congressman James Comer (R-Ky.) is investigating the Food and Drug Administration’s (FDA) failure to regulate cannabidiols (CBD) products as dietary supplements. In a letter to the Commissioner of Food and Drugs at the FDA, Dr. Robert M. Califf, Congressman Comer raises concern that the agency’s failure to regulate CBD products could allow dangerous products to come to market and is requesting documents and information to enable oversight of the FDA’s failure to provide Americans with regulatory guidance.
“The Committee on Oversight and Accountability is investigating the Food and Drug Administration’s (FDA) recent announcement regarding its authority to regulate CBD products as dietary supplements. The announcement states that the FDA does not believe its current regulatory framework allows for regulation of cannabidiols (CBD). The mission of the FDA is to advance[e] the public health by helping to ‘speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.’ We seek documents and information to enable oversight of the FDA’s actions related to this announcement,” wrote Congressman Comer.
A recent World Health Organization (WHO) report regarding the safety and efficacy of CBD states that “across a number of controlled and open label trials of the potential therapeutic effects of CBD it is generally well tolerated, with a good safety profile.” The lack of regulation of non-intoxicating CBD products have allowed for potentially dangerous products to enter the market, leading to increasing concern that some products contain potentially dangerous ingredients due to the lack of regulation.
“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. 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. It is imperative that the FDA engages in this regulation quickly, safely, and efficiently to provide proper guidance to the American people about the safety of CBD products,” continued Congressman Comer.
Read the letter to the FDA here.