The Food and Drug Administration (FDA) on Thursday called for new regulations for the cannabidiol (CBD) market, saying the agency needs to provide additional oversight to manage the risks involved in using those products.
Janet Woodcock, the principal deputy commissioner of the FDA, said in a release that the agency conducted a review and determined that a new “regulatory pathway” is needed to balance the public’s desire to use CBD with the necessary oversight. She said the FDA is prepared to work with Congress to enact the regulations.
The agency said CBD use has raised some safety concerns especially for long-term users, and studies have shown that it can lead to liver damage, interactions with certain medicines and harm to the male reproductive system. Exposure to CBD can be especially “concerning” to children and those who are pregnant.
Woodcock said some regulations to help manage the risk include adding clear labels, preventing contaminants, limiting CBD content and instituting minimum ages to purchase these products.
She said the existing regulations for food and dietary supplements only provide “limited tools” for managing the risks of CBD use. She said the working group she chairs has examined studies related to a CBD-based drug and published scientific literature and studies but has not found sufficient evidence to determine how much CBD can be consumed without harm being caused to a person.
Woodcock said the FDA does not plan to pursue regulations that permit CBD use in dietary supplements or conventional foods as a result.
She said CBD can also pose a danger to animals who are fed it, and people could be exposed to CBD without realizing through the animals’ meat, eggs and milk.
“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,” she said. “We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities.”
The 2018 Farm Bill federally legalized hemp and derivatives like CBD.