The US Food and Drug Administration (FDA) has determined that CBD requires a dedicated regulatory framework and committed to collaborating with Congress to build one.
Following an internal review, the agency found that existing rules governing food and dietary supplements do not adequately cover CBD, and that a new pathway is required — one that "balances individuals' desire for access to CBD products with the regulatory oversight needed to manage risks."
The FDA also rejected three citizen petitions requesting that it establish rules permitting CBD products to be marketed as dietary supplements.
FDA principal deputy commissioner Janet Woodcock said: "The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system.
"CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.
"A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimise risks related to CBD products.
"Some risk-management tools could include clear labels, prevention of contaminants, CBD content limits, and measures such as minimum purchase age, to mitigate the risk of ingestion by children.
"In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals."
Woodcock noted that the FDA's current authority over foods and dietary supplements offers only limited tools for addressing the risks that CBD products present.
She added: "The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency.
"Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives.
"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."
Separately, Argentina has established the first working group under a new national agency tasked with regulating and advancing the country's cannabis sector.
At the launch of national hemp and cannabis agency ARICCAME, economy minister Sergio Massa said: "This opens the door for Argentina to start a new path in terms of industrial exports, on the basis of huge global demand."
Argentina decriminalised medicinal cannabis in 2017, giving the federal government authority to cultivate it for research and therapeutic purposes.
Three years later, the country extended those permissions to allow home cultivation for medicinal use, authorised pharmacies to stock cannabis-derived products, and required insurers to cover cannabis-based medicines for patients holding a prescription.
