FDA decision on CBD could arrive in coming months

In a huge win for advocates, the U.S. Food and Drug Administration (FDA) says it will be reviewing hemp-derived CBD regulations within the next few months. If all goes well, consumers will soon be able to purchase federally-approved over-the-counter CBD-infused foods and supplements.

Cannabidiol (CBD) is a non-psychoactive chemical found in cannabis. Since the 2018 Farm Bill legalized “hemp”—defined as cannabis containing less than 0.3 percent THC by dry weight—hemp-derived CBD was also believed to have been legalized.

However that belief was quickly shattered by the FDA, which pointed out that while hemp is legal, CBD is used as the active ingredient in Epidiolex, a pharmaceutical drug used to treat rare forms of epilepsy in children. Federal law prohibits the inclusion of any active drug ingredient in over-the-counter consumables, meaning hemp-derived CBD was still illegal.

Facing public backlash and pressure from lawmakers, the FDA agreed to allow companies to continue selling CBD products as long as they didn’t print any medical claims about them. Meanwhile, the agency said it would research the drug and fast track its approval for general consumption if it was proven to be relatively safe.

Last month FDA Principal Deputy Commissioner Janet Woodcock told The Wall Street Journal that the department is moving forward on that process. “Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” FDA Principal Deputy Commissioner Janet Woodcock told reporters.

Dr. Patrick Cournoye, the head of FDA’s Cannabis Product Committee, said the agency is looking particularly close at the effects of long-term CBD use and use during pregnancy.

The agency is reportedly weighing how best to regulate the drug and will be considering whether to draft new rules or press Congress for new legislation regarding the issue.

National Institutes of Health says CBD research is still in its early stages but there is evidence that it can be harmful to some consumers.

The introduction of hemp-derived Delta-8 THC products into the market—which are psychotropic and are technically legal at the federal level, although many states have banned their sale—has reportedly complicated matters for regulators.

“Over the last year and a half, we have seen a whole host and cadre of intoxicating hemp derived cannabinoids come up,” said Norman Birenbaum, a senior advisor to the agency. “There are very, very different regulatory considerations for products that are going to intoxicate you.”

The agency said it is focusing on keeping intoxicating compounds like Delta-8 THC out of the hands of children.

Shares of some U.S.-listed cannabis companies were down following the FDA’s announcement.