Adam Jackson
The House Committee on Oversight and Accountability said on Tuesday that it will be investigating the Food and Drug Administration’s inaction in regulating cannabidiol (CBD) products.
Despite the legalization of cannabis containing less than 0.3% THC by the 2018 farm bill, the FDA has yet to issue regulations for CBD products. For years, hemp companies and trade groups have urged the FDA to regulate CBD as a dietary supplement, a proposal the agency declined earlier this year.
GOP chair of the committee, Rep. James Comer of Kentucky — a state that has become a hub for the struggling industry — criticized the FDA’s lack of regulatory action. Comer said the agency’s claim of an absence of a regulatory pathway was “an insufficient rationale for inaction” and that it was “directly affecting the welfare of the American public.”
In a letter to FDA Commissioner Robert M. Califf, Comer requested documents and information to oversee the FDA’s inability to provide regulatory guidance on CBD products. He expressed concern that the absence of regulation for nonintoxicating CBD products has permitted potentially harmful items to infiltrate the market.
“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 said.
The U.S. Drug Enforcement Administration quietly issued a letter in February that synthetic cannabinoids, such as delta-8-THCO and delta-9-THCO, are still illegal controlled substances, even if they are derived from hemp.
The DEA’s Drug & Chemical Evaluation Section Chief Terrence Boos wrote to North Carolina attorney Rod Kight that these two specific cannabinoids “do not occur naturally in the cannabis plant and can only be obtained synthetically, and therefore do not fall under the definition of hemp.”
Legal experts at the time saw the news as somewhat difficult to interpret, but there appears to be a clear process by which stakeholders can ask the DEA if particular cannabinoids are federally legal or not.
However, until the DEA makes its stance more public and clear, some have predicted that a lot of the hemp market will be “regulation by letter.”
A recent World Health Organization report on the safety and efficacy of CBD indicated that it is generally well-tolerated and has a positive safety profile. Comer said he is investigating the FDA’s failure to regulate CBD products as dietary supplements and is advocating for urgent, well-rounded regulation to offer clear guidance on CBD product safety.
