In January 2023, the US Federal Drug Administration announced it will not regulate CBD as dietary supplements, citing insufficient evidence regarding its safety, despite its current market presence as such. The agency has urged Congress to establish not just regulations but a new regulatory framework for the burgeoning CBD industry, according to USA Today.
FDA Deputy Commissioner Dr. Janet Woodcock expressed concerns over CBD’s safety, particularly with prolonged use. “There are risks, including liver damage, interactions with other drugs, and potential effects on male fertility, as well as concerns for vulnerable groups like children and pregnant women,” Woodcock stated.
The narrative that concerns for children seem dismissive overlooks the foundational role of pediatric needs in the cannabis and CBD movements. The case of Charlotte Figi, who significantly benefited from CBD for her severe epilepsy, highlights the potential positive impact of CBD on children’s lives, challenging the notion that CBD exposure is universally harmful to this demographic.
However, the FDA feels its current regulatory powers are insufficient to address the complexities of CBD risks. “Our existing authority over foods and supplements provides limited mechanisms for managing CBD product risks,” explained Woodcock. Without clear evidence on safe consumption levels and duration, the FDA has decided against initiating rule-making for CBD in foods or supplements.
Despite CBD’s generally mild profile compared to traditional pharmaceuticals, concerns about its interaction with other medications persist due to its action on specific body receptors.
The future of CBD regulation, particularly in the supplements industry, remains uncertain. The FDA has previously cautioned companies against making unverified health claims about CBD and intends to continue enforcement.
Prospective regulations could involve specific labeling requirements, contamination controls, CBD concentration limits, and age restrictions for purchase. The exact nature of these potential regulations remains to be determined.
The FDA’s stance has been met with disappointment from various stakeholders. Calls for allowing CBD in foods and supplements have come from lawmakers, advocacy groups, and consumers. Aaron Smith, CEO of the National Cannabis Industry Association, highlighted the necessity for prompt action by Congress and the Administration to align federal cannabis policies with state laws and regulate CBD products effectively. “A well-regulated industry already exists, offering cannabinoid products and medicines to millions of Americans, with widespread voter support. Advancing bipartisan federal cannabis reform this year would benefit public health and political strategy,” Smith emphasized.