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Tuesday, July 5, 2022

New Regulations Needed for Kratom and CBD

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Written by Pat Anson, Editor of PNN

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 that millions of Americans use to treat their pain and other medical conditions on their own.

FDA Commissioner Dr. Robert Califf testified Thursday before the House Appropriations Subcommittee, where he was asked why the agency has been slow in developing new CBD regulations and why it has remained opposed to kratom use. Cliff said new regulatory pathways are needed for both substances because they fall between loopholes in the current law that gives the Food and Drug Administration broad authority to regulate food and drugs.

“I don’t think the current authority that we have, both on the nutritional side and on the pharma side, is necessarily giving us what we need to get us on the right track going forward. We have to invent something new. I am very committed to doing that,” Califf said.

Califf was recently confirmed by the US Senate as Commissioner of the Food and Drug Administration, a position he previously held under President Obama. He noted that little progress has been made at the Food and Drug Administration in regulating CBD and other cannabis products since he left the agency.

“You know, when you come after six years into the job you were working at before and nothing really changed, it tells you that you can’t keep trying to do the same thing over and over again,” Califf said.

Some of the difficulties in regulating CBD come from the passing of the 2018 Farm Bill, which legalized hemp under federal law. At the time, it was believed that cannabis had little or no psychoactive properties and would be relatively harmless. But, As reported by PNNSome hemp companies have found ways to concentrate delta-8 tetrahydrocannabinol (delta-8 THC) derived from hemp and use it in foods to give consumers a mild intoxicating effect.

The Food and Drug Administration (FDA) considers delta-8 THC an unapproved drug, but because it comes from hemp — a legal substance — its regulatory status is unclear.

“The sheer amount of cannabis derivatives is really so profound and amazing, and they are already so widely used in a variety of ways. Most of the FDA’s efforts to date have been spent on researching what, if any, risks exist for the various uses of these substances in their forms. different,” Califf said. “The research so far has shown that there are some risks with CBD. Thus, we will need a different path than just the standard food path.”

FDA information on kratom is ‘too old’

Calif has taken 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 tonic and pain reliever. appreciate Two million Americans use kratom To treat their pain, depression, anxiety and addiction on their own.

The U.S. Food and Drug Administration has not approved kratom for any medical use. in file Online Fact SheetThe agency said kratom’s effects on the brain are similar to morphine and have “properties that expose users to risks for addiction, abuse and dependence.”

This led to a rebuke from Representative Mark Buchan (D-Wisconsin), who has supported efforts to keep kratom legal. He described the Food and Drug Administration’s position on kratom as “too outdated.”

“This update wasn’t a major update, and I think it’s very unfair to consumers who are legally consuming kratom in this country,” Buchan told Califf. “Frankly, not only are there arguable conclusions (in the update), but you’re linking it to outdated, incomplete, and inaccurate information.”

“I hope to get back to you on kratom in a couple of months,” Calif replied. “There are millions of people using kratom. We have real negative events, real negative things that have happened to people. And it interacts with several neurotransmitters.”

Kratom has been banned in several states, but a federal attempt to ban kratom nationwide in 2016 failed due to a popular protest. Department of Health and Human Services (HHS) later Withdrawal of the Food and Drug Administration’s request to classify kratom as a Schedule I controlled substanceNoting that there is no evidence that it can be abused. A former HHS official said the FDA’s request to schedule kratom had been rejected due to “embarrassingly poor evidence and data.”

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

“We will continue to work with NIDA and we will go where the science takes us,” Califf said. “But as I said in terms of hemp products, we need something different with these types of products that are not traditional foods and not traditional medicines.”

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