FDA to Seek New Regulatory Path for CBD

Agency says it does not intend to pursue rulemaking to allow use of cannabidiol in dietary supplements, conventional foods
CBD oil
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The Food and Drug Administration will work with Congress to determine a new regulatory path for CBD that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks; however, the agency said it does not intend to pursue rulemaking to allow the use of CBD in dietary supplements or conventional foods.

“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” Janet Woodcock, FDA principal deputy commissioner, said in a statement on Jan. 26. “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 decision was made given the growing CBD, or cannabidiol, products market and following a review from a high-level internal working group convened by the FDA to explore regulatory pathways for CBD products.

Use of CBD raises various safety concerns, according to the FDA, especially with long-term use. Studies have shown potential for harm to the liver, interactions with medications and possible harm to the male reproductive system.

The FDA’s existing foods and dietary supplement authorities provide limited tools for managing many of the risks associated with CBD, Woodcock said. Under the law, any substance must meet specific safety standard to be lawfully marketed as a dietary supplement or food additive.

The working group, which Woodcock leads, closes examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket and studies commissioned and conducted by the agency.

“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” Woodcock said. “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.”

CBD also poses risks to animals, and people could be unknowingly exposed to it through meat, milk and eggs form animals fed CBD. The FDA said it also does not intend to pursue rulemaking allowing the use of CBD in animal food, but a new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.

“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,” Woodcock said. “We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”

The FDA also denied three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.

The 2018 Farm Bill removed hemp from the Controlled Substances Act, but products that add CBD to a food or label CBD as a dietary supplement are illegal under federal law. Some states have come up with their own regulations for CBD products.

While both come from cannabis plants, CBD differs from tetrahydrocannabinol (THC), a compound that produces the “high” from marijuana.

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