FDA Says It Will Work With Congress On New CBD Regulations

The Food and Drug Administration

In an

“Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter,” Janet Woodcock, the principal deputy commissioner of the Food and Drug Administration, said in the announcement. 

The commissioner also warned that the agency is prepared to crack down against illicit CBD products.

“The FDA wiill 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,” she said.

Woodcock explained that the FDA will implement a cross-agency plan alongside Congress that intends to protect the safety and health of the public.

FDA Commissioner Cites CBD Safety Concerns

FDA Commissioner Woodcock also said that there are various safety concerns surrounding the long-term use of CBD raises various safety concerns, noting that 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 cross-agency strategy will implement safeguards and oversight of CBD products with the goal of reducing risks. “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,” Woodcock said.

There has been an explosion of CBD products in the United States’ market in recent years after the 2018 Farm Bill legalized the production of hemp. But a dearth of regulations has left many consumers wondering if the supplements they’re consuming are legit — or, for that matter, safe.

The trend has also led to a host of CBD-derived supplements for animals. Those also should not be trifled with, Woodcock said. 

“CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals,” Woodcock said in the statement on Thursday.

Woodcock said that the “FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products.”

“Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive,” Woodcock said. 

Woodcock said that she serves as the chair of a working group that “has closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both 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,” she said.