Washington, DC: Regulators with the US Food and Drug Administration have announced that Congress, not the FDA, must take primary responsibility for creating a regulatory framework overseeing the commercial production and sale of hemp-derived CBD products.
The agency, which was tasked by Congress to establish regulations for hemp-derived products when federal lawmakers legalized them in 2018, said that the FDA’s existing rules governing foods and dietary supplements are inadequate for addressing hemp-derived CBD products.
“[A]fter careful review, the FDA has concluded that a new regulatory pathway for [hemp-derived] CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” the agency stated in a press release. “The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”
For years, NORML and other groups have urged the FDA to establish regulatory guidelines governing the production, testing, labeling, and marketing of hemp-derived CBD products. Analyses conducted by the FDA and others have consistently reported that many over-the-counter CBD products are of variable quality and potency, and that they may contain contaminants, adulterants, or elevated levels of heavy metals.
Survey data compiled by the National Consumers League reports that more than eight in ten US voters desire greater federal regulatory oversight over the labeling and marketing of commercially available CBD products.
The FDA’s press release made no mention of whether it intends to address the proliferation of novel intoxicating cannabinoid products, like THC-O and delta-8-THC, which are produced through a chemical synthesis of hemp-derived CBD. These unregulated products have grown widely in popularity in recent years, and the FDA has issued health warnings about them following consumer complaints. NORML has cautioned against the ingestion of these novel, unregulated products.
In 2018, the FDA approved the prescription use of plant-derived CBD in the drug Epidiolex. The medicine is authorized for the treatment of pediatric epilepsy, and it is classified by the DEA as a Schedule V controlled substance – the lowest restriction classification available under federal law.
In a 2020 report to Congress, the FDA acknowledged that regulating over-the-counter hemp-derived CBD products in a manner similar to dietary supplements could potentially disincentivize further clinical research into the compound’s development as a prescription drug to treat other medical conditions. The agency stated, “As FDA considers [regulating] additional non-drug products containing CBD, … we are committed to doing all we can to encourage the development of CBD drug products and additional cannabis-derived drug products through existing, legal pathways.”
They continued: “If the widespread availability of consumer CBD products were to significantly discourage clinical research, our knowledge of CBD’s potential medical uses could be stunted. … [W]e are mindful of the need to ensure that adequate incentives remain to encourage further clinical study.”
Additional information is available in the NORML Fact Sheet, ‘Guide to Delta-8 THC and Other Novel Cannabinoids.’