The U.S. Food and Drug Administration (FDA) announced Jan. 26 that a new regulatory pathway for CBD is needed and is calling for Congress to establish one.
The agency announced that after careful review, the regulatory pathway for CBD is needed to manage risks and safety concerns, but it does not plan to pursue rulemaking allowing for the use of CBD in dietary supplements, conventional foods, or animal products.
“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 agency wrote.
The FDA noted that it has carefully reviewed and examined several published studies related to Epidiolex (CBD) and that within the available data and findings, “it is not apparent how CBD products could meet safety standards for dietary supplements or food additives.”
Due to inadequate evidence, the FDA said it does not “intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”
The agency also added that it does not plan to establish a regulatory framework for the use of CBD in animal feed due to there not being enough study-based findings on the effects of CBD in animal feed and on individuals who consume it through meat, milk and eggs from animals fed CBD.
Cannabis law firm Vicente Sederberg released a statement, stating that they do not anticipate the FDA to shift their enforcement priorities and that the “state hemp regulatory patchwork will continue until/if a congressional framework is established.”
Industry associations also voiced their concerns over the FDA’s announcement.
Aaron Smith, CEO and co-founder of the National Cannabis Industry Association, said that the FDA’s announcement “underscores the urgent need for Congress and the Administration to take swift action to modernize federal cannabis policy and regulate CBD and other products appropriately and in harmony with the vast majority of states that have already legalized cannabis in some form.”
Jonathan Miller, president of the U.S. Hemp Roundtable (USHR), said that the USHR is highly disappointed in the FDA’s announcement.
“When it comes to the safety of CBD, the FDA gets it wrong,” Miller said. “Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues. The roundtable recently met with the FDA and shared a broad range of safety studies showing that standard CBD serving sizes are safe, while the FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail.
“We, therefore, see no need for [the] FDA to go through the lengthy, burdensome exercise of establishing a new regulatory pathway for CBD or other hemp-derived cannabinoids. This action would be unprecedented and is unnecessary given the existing dietary supplement and food pathways provided under the Federal Food, Drug, & Cosmetic Act, which include[s] robust, comprehensive requirements aimed at ensuring the safety and quality of products, in addition to extensive FDA regulations covering the manufacturing, labeling, and marketing of products.”