The US Food and Drug Administration (FDA) has said a new regulatory framework is needed for CBD and pledged to work with lawmakers to develop the scheme.
After an internal review, the agency concluded the existing regimes for food and supplements are not appropriate for CBD and that a new pathway is needed that “balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks”.
The FDA also denied three citizen petitions that asked it to set rules allowing the marketing of CBD products 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 said the FDA’s existing foods and dietary supplement authorities provide only limited tools for managing the risks associated with CBD products.
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.”
Meanwhile, Argentina has launched the first working group of a new national agency to regulate and promote the country’s cannabis industry.
Launching 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 legalised medicinal cannabis in 2017, allowing the federal government to grow for research and therapeutic purposes.
In 2020, it allowed people to grow at home for medicinal use, pharmacies to sell cannabis-derived products, and ordered insurers to cover cannabis-based medicine for patients with a prescription.