Existing Regulatory Framework for Foods & Supplements Not Appropriate for CBD: FDA

The US Food and Drug Administration (FDA) has concluded that a new regulatory pathway for CBD, and according to FDA Principal Deputy Commissioner Janet Woodcock, M.D., the agency is prepared to work with Congress on the matter.

Woodcock’s statement was released on Jan. 26.

The agency has also denied three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements. 

According to FDA, a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize 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.

The FDA's existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.

FDA’s internal working group created to explore the matter 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. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods,” said Woodcock in a statement.

The FDA said it will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate.

“We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. 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,” said Woodcock.