The U.S. Food and Drug Administration (FDA) has decided that cannabidiol (CBD) products will not be regulated as a food or supplement, rather, a new approach will be developed for the increasingly popular substance. The agency has also denied three consumer petitions requesting that FDA allow the marketing of CBD products as dietary supplements, given the agency does not intend to regulate CBD as a supplement or food.
FDA came to the conclusion that a new regulatory pathway is required for CBD products after an extensive review by a high-level internal working group, chaired by FDA Principal Deputy Commissioner Janet Woodcock, M.D. The agency expresses that it is willing to work with U.S. Congress on the matter of forging a new framework for CBD oversight in food and supplements.
According to Dr. Woodcock, 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. FDA is also concerned about CBD exposure among certain vulnerable populations, such as children and those who are pregnant.
The working group examined studies related to the CBD-based drug Epidiolex, available scientific literature, information submitted to a public docket, and studies both conducted and commissioned by the agency. Given the available evidence, the working group was unable to define how CBD products could meet safety standards for dietary supplements or food additives. For example, FDA did not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, FDA does not intend to pursue rulemaking allowing the use of CBD in dietary supplements, conventional foods, or animal foods.
Earlier, in June 2022, the European Food Safety Authority (EFSA) also determined that it cannot establish the safety of CBD as a novel food, citing the need to address knowledge gaps about the substance to make an informed conclusion.