FDA calls for authority to regulate CBD products

Citing safety risks, FDA said that products containing cannabidiol (CBD) call for greater supervision than the agency can now offer, and FDA will request new authorities to do so from Congress.

FDA also said products derived from legal cannabis should not be regulated as they currently are (i.e., as dietary supplements or food additives) in light of the products’ risk to human and animal health, in particular to children and pregnant people.

FDA’s expanded authority could include mandating clear labels, prohibiting contaminants, restricting doses, and establishing a minimum purchase age, according to the agency.

“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplement or food additives,” said FDA Principal Deputy Commissioner Janet Woodcock in a press statement.

She also said studies suggest that long-term use of CBD products could have safety issues, such as potential damage to the liver, drug interactions, and possible harm to the male reproductive system.

When Congress legalized hemp and related products in 2018, it left their regulation to FDA. As a result, makers of CBD products have operated in the absence of specific federal rules over their marketing or manufacturing. Some states have established their own sets of rules. A report from FDA in 2021 estimated that the $4.6 billion market would quadruple by 2026.