WASHINGTON—The U.S. Food and Drug Administration (FDA) has decided that a new regulatory pathway for CBD is necessary, and the agency says it’s prepared to work with Congress on the updated process.
The FDA believes the CBD regulatory pathway needs to balance consumer access to CBD products and regulatory oversight to manage risks. The agency is also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.
“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” said FDA Principal Deputy Commissioner Janet Woodcock in a statement.
According to the FDA, risk management tools included within the new regulatory process could include clear labels, prevention of contaminants, and CBD content limits, as well as measures such as minimum purchase age to mitigate the risk of ingestion by children.
Prior to the decision, the FDA held a working group to closely examine studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies conducted and commissioned by the agency.
“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,” said Woodcock.
The agency also states that CBD poses risks to animals, and that consumers could be unknowingly exposed to CBD through meat, milk and eggs from animals that are fed CBD. The FDA does not intend to pursue rulemaking allowing the use of CBD in animal food because it is not apparent how CBD products could meet the safety standard for substances in such food. However, a new regulatory pathway could provide access and oversight for certain CBD-containing products for animals, according to the FDA.
“The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities,” said Woodcock.
In May, the FDA issued warning letters to five companies for selling products labeled as containing delta-8 THC in ways that violate the Federal Food, Drug and Cosmetic Act. This was the first time FDA had issued warning letters for products containing delta-8 THC.
“Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products,” wrote the FDA in the release.
Visit the NACS CBD and Cannabis topics page for news and legal information on the sale of CBD and CBD-related products. In addition, the NACS Sales of CBD and Related Products resource is designed to help retailers navigate the gray areas around the sale of these products.