The head of the Food and Drug Administration on Thursday acknowledged that the FDA has done little to regulate CBD products since hemp was legalized in 2018, reports Marijuana Moment.
“It looks pretty much the same in terms of where we are now,” FDA Commissioner Dr. Robert M. Califf said to a House subcommittee May 19. “We just know more because we’ve done more research.”
The hearing covered a range of topics from CBD regulation to the current baby formula shortage to the potential therapeutic use of the plant kratom.
Califf said the agency has been active doing research into the potential risks of hemp-based extracts, noting, “the amazing plethora derivatives of the cannabis plant [are] surely quite profound and astounding and already in widespread use for a variety of means.”
Rep. Dan Newhouse (R-WA), pointed out that the FDA's reticence to establish regulations for CBD, hemp edibles, extracts and derivatives has created an atmosphere of unpredictability for growers, product makers, and retailers.
“Currently the industry is in a state of uncertainty because of no direction,” Newhouse said.
“Currently the industry is in a state of uncertainty because of no direction.”
— Rep. Dan Newhouse (R-WA)
Califf suggested that the agency would need greater regulatory authority from Congress to build an enforceable framework for hemp extracts and derivatives, according to Marijuana Moment reporter Ben Adlin.
“I don’t think the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward,” Califf said. “We’re going to have to come up with something new. I’m very committed to doing that.”
Rep. Mark Pocan (D-WI) pointed out that the FDA currently considers CBD sales illegal.
“What is FDA’s plan to clarify that CBD could possibly be regulated as a food or food additive, and is there any timeline?” he asked.
“The research so far has shown that there are some risks with CBD, so we’re going to need a different pathway than just the standard pathway,” Califf replied.
Jonathan Miller, a lawyer for the U.S. Hemp Roundtable, an industry association, told Marijuana Moment he was “quite encouraged by the tone of Commissioner Califf’s remarks […] as well as his repeated commitment to identify pathways for CBD.”
“I don’t think the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”
— FDA Commissioner Dr. Robert M. Califf
Califf's May 19 appearance was before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies — but another federal lawmaker recently asked the FDA to answer for its delays in regulating hemp-based products.
In mid April, US House Rep. James Comer (R-KY), a ranking member of the House Oversight and Reform Committee, called for a committee-level hearing with the FDA to address the agency’s failure to establish regulations for the sale of hemp-derived extracts.
“Across the United States, inauthentic products are sold under the likeness of legal hemp but are improperly labeled, contaminated with harmful chemicals, and marketed to children,” Comer wrote.
May 4, the FDA sent warning letters to businesses allegedly selling delta-8 THC products. And on May 13 the agency published an advisory statement about "copycat" THC products that look like popular snacks and cereals, warning of the risk of accidental THC ingestion, especially by children.
However, the agency has yet to say it’s made substantial progress on a regulatory framework for cannabinoids.