By Pat Anson, PNN Editor

The head of the Food and Drug Administration says his agency will need new authority from Congress to regulate both kratom and cannabidiol (CBD), two natural substances used by millions of Americans to self-treat their pain and other medical conditions.

FDA Commissioner Dr. Robert Califf testified on Thursday before a House Appropriations subcommittee, where he was asked why the agency was slow in developing new regulations for CBD and why it remained opposed to the use of kratom. Califf said new regulatory pathways were needed for both substances because they fall between the cracks of existing law that gives the FDA broad authority to regulate food and drugs.

“I don’t think the current authority we have, on the food side and the drug side, necessarily gives us what we need to have to get the right pathway to move us forward. We’re going to have to come up with something new. I’m very committed to doing that,” said Califf.

Califf was recently confirmed by the U.S. Senate as FDA commissioner, a job he previously held under President Obama. He noted that little progress had been made at the FDA in regulating CBD and other cannabis products since he left the agency.

“You know, when you come six years later to the job you had before and nothing has really changed, that’s telling you that you can’t just keep trying to do the same thing over and over,” said Califf.

Some of the difficulty in regulating CBD comes from passage of the 2018 farm bill, which legalized hemp under federal law. At the time, it was believed that hemp had little or no psychoactive properties and would be relatively harmless. However, as PNN has reported,  some cannabis companies have found ways to concentrate delta-8 tetrahydrocannabinol (delta-8 THC) derived from hemp and are using it in edibles to give consumers a mild intoxicating effect.

The FDA considers delta-8 THC an unapproved drug, but because it comes from hemp – a legal substance – its regulatory status is unclear.

“The amazing plethora of derivatives of the cannabis plant is really quite profound and astounding, and already in widespread use in a variety of means. Most of the FDA effort so far has been spent on research to figure out what the risks, if any, are of various uses of this material in its different forms,” said Califf. “The research so far has shown that there are some risks with CBD. And so, we’re going to need a different pathway than just the standard food pathway.”

FDA Kratom Info ‘Extremely Antiquated’

Califf took a similar stance on kratom, an herbal supplement that comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. An estimated two million Americans use kratom to self-treat their pain, depression, anxiety and addiction — even though the FDA has not approved kratom for any medical condition.

In a recently updated online fact sheet, the agency said kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

That brought a rebuke from Rep. Mark Pocan (D-WI), who has supported efforts to keep kratom legal. He called the FDA’s position on kratom “extremely antiquated.”

“That update was not much of an update and I think it’s being very unfair to the consumers who are legally consuming kratom in this country,” Pocan told Califf.  “Honestly, there are not only arguable conclusions (in the update), but you are linking to outdated, incomplete and inaccurate information.“

“I hope to come back to you on kratom in a couple months,” Califf replied. “There are millions of people using kratom. We do have real adverse events, real negative things that have happened to people. And it does interact with multiple neurotransmitters.”

Kratom is banned in several states, but a federal effort to ban kratom nationwide in 2016 failed due to a public outcry. The Department of Health and Human Services (HHS) later withdrew an FDA request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused. A former HHS official said the FDA request to schedule kratom was rejected because of “embarrassingly poor evidence & data.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse (NIDA) concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects. NIDA recently had a public hearing on kratom to further explore its therapeutic uses.

“We’ll continue to work with NIDA and we’ll go where the science takes us,” Califf said. “But like I said with regard to cannabis products, we need something different with these kinds of products that are not traditional foods, not traditional drugs.”