Pointing to a lack of scientific research, the FDA said on Thursday that it would not consider rulemaking for the use of cannabidiol products as dietary or food supplements or in animal feed. Instead, said principal deputy commissioner Janet Woodcock, the FDA wants to work with Congress on “a new regulatory pathway” for CBD, derived from hemp.
At present, CBD products are sold in a regulatory gray market that has inhibited the growth of industrial hemp as an agricultural crop. Hemp also is marketed as a fiber and seed. CBD contains little or none of the psychoactive element found in marijuana. The 2018 farm policy law legalized industrial hemp.
“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,” said Woodcock. “The agency is prepared to work with Congress on this matter.”
Some studies have shown potential harm from the use of CBD, especially with long-term use, said Woodcock, who chaired an FDA working group that explored potential regulatory pathways. To be approved as a dietary supplement or food additive, substances must meet specific safety standards, which she said CBD cannot do with the evidence now at hand.
“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,” she said. “We also do not intend to pursue rulemaking allowing the use of CBD in animal food,” she added.
A new regulatory pathway, said Woodcock, “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.”