FDA calls on Congress to create CBD rules

The Food and Drug Administration said there are too many unknowns about CBD products to regulate them as foods or supplements under the agency’s current structure and called on Congress to create rules for the massive and growing market.

The marijuana-derived products have become increasingly popular in lotions, tinctures and foods, while their legal status has been murky in the U.S.

There’s not enough evidence about CBD to confirm that it’s safe for use in foods or as a dietary supplement, FDA Deputy Commissioner Dr. Janet Woodcock said in a statement Thursday.

“For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” she said.

The FDA has oversight of CBD because it is the active ingredient in an approved prescription drug, Epidiolex, used to treat two rare seizure disorders. Under FDA regulations, a drug can’t be added to food or sold as a dietary supplement if officials haven’t determined if it’s safe or effective for other conditions.

Questions remain about CBD’s effects on the liver, the male reproductive system and on pregnant women and children, the statement said.

New rules could include clear labels, regulations regarding contaminants and limits on CBD levels and requirements.

CBD often comes from a cannabis plant known as hemp, which is defined by the U.S. government as having less than 0.3% THC, the compound that causes marijuana’s mind-altering effect. CBD doesn’t cause that high, but fans of the products claim benefits including relief for pain and anxiety.

The FDA’s action comes after repeated calls from lawmakers, advocates and consumer groups for CBD to be allowed in foods and supplements.

The FDA will continue to take action against CBD and other cannabis products to protect the public, the statement said. The agency has sent warnings to some companies making health claims for CBD.