FDA Says Foods & Supplements Regulations Not Appropriate For CBD, Will Work With Congress To Change Them

In view of the growing CBD products market, the Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. 

“Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks,” per an FDA press release. “The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.” 

The FDA has long warned against the long-term use of CBD generally citing studies showing the potential harm it can cause to internal organs, the male reproductive system and interactions with certain medications. 

As such, a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products, the FDA said.

“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. 

“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,” said FDA’s Janet Woodcock, principal deputy commissioner in the press release. 

“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.”

Woodcock went on to reiterate other controversial warnings that CBD poses risks to animals and that people could therefore be unknowingly exposed to it. She confirmed that the FDA will essentially maintain its current policy regarding CBD which includes taking action against CBD and other cannabis-derived products.