FDA Declines to Approve CBD for Foods and Supplements Citing Health Concerns

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore CBD products. On Jan. 26, the FDA announced that it discovered “various safety concerns” with CBD and, rather than give its seal of approval. asked for the creation of a new regulatory pathway for CBD, punting the issue to Congress and seeking “a new way forward” and the creation of regulatory oversight needed to manage risks it sees.

“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,” the agency writes. “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. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”

The  new “regulatory pathway” the agency envisions includes providing safeguards and risk management tools could include improved labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, the FDA is seeking oversight for certain CBD-containing products for animals.

The agency’s reluctance to green-light CBD comes as a tremendous blow to the industry, ignoring calls from lawmakers, cannabis advocates and companies to allow CBD in health products and foods. Frustration grew among CBD marketers, with the FDA announcing the same day it was also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.