US health officials crack down on kratom-related products

The FDA itself has warned consumers about concentrated 7-OH products, and both HHS Secretary Robert F. Kennedy Jr. and former FDA Commissioner Marty Makary have emphasized that federal enforcement efforts are focused on chemically manipulated 7-OH products rather than properly manufactured natural kratom leaf products. Current federal and state actions specifically target concentrated 7-OH products, not natural kratom leaf. According to recent news, Florida’s AG Attorney General banned concentrated 7-OH products, although kratom remains mostly legal. Despite their wide availability, kratom-derived and 7-OH products are not legally approved for sale for consumption online or in stores and are often misleadingly labeled and promoted as “safer" alternatives to opioids for the relief of pain and other issues.

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Americans most commonly use kratom for self-treatment of chronic pain and to help battle opioid withdrawal symptoms, he added. The concentrated byproduct has been linked to opioid receptors in the body, triggering the potential for abuse and various drug-related symptoms. It has also been used for pain management, and some individuals have turned to kratom to ease opioid withdrawal symptoms. Researchers say the rapid increase — including a significant spike last year — is tied to wider availability of kratom and the growing strength of newer products. That all changed around 2015, with the introduction of a second wave of “enhanced” kratom products.

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Susan Ash, the founder of the AKA, used kratom as a substitute for Suboxone, a medication used to treat OUD. Kratom comes from the leaves of a tropical tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. Although the main purpose of the placebo-controlled trial is to test the safety and tolerability of mitragynine – not whether it can treat OUD – the fact that NIH is even conducting such a study is being hailed as a “major milestone” by kratom advocates. Hopefully this work will lead to a new treatment option for people with opioid use disorder and support a path to recovery,” Joni Rutter, PhD, Director of the NIH’s National Center for Advancing Translational Sciences, said in a press release. In a small Phase One clinical study, NIH and University of Florida researchers will test a purified formulation of mitragynine on 32 healthy volunteers with a recent history of opioid use.

• Serious toxicity is relatively rare and generally appears at high doses or when kratom is used with other substances.
• Health and Human Services Secretary Robert F. Kennedy Jr. has announced plans to crack down on kratom, a plant ingredient whose opioid-like qualities have rattled health officials.
• Earlier this month, Idaho Falls, the county’s largest city, approved a ban, which takes effect 1 July, on sales of the drug.
• These products are sometimes known by slang terms like “legal morphine” or “gas station heroin.”“These products are really dangerous and basically act like synthetic opioids, and I have already heard from parents whose kids have become addicted to these products sold over the counter across the state,” said Attorney General Kris Mayes.

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Beginning July 1, however, Tennessee will join two dozen other states in banning or restricting kratom. She can't even drive on the same street as shops that sell kratom − the pull of addiction is that strong. The pain of withdrawal has kept many people trapped in the cycle of addiction.

Feel free® contains only noble kava root and natural whole leaf kratom — no synthetic ingredients, no alcohol, and no chemical extracts. CDPH is collaborating with the California Department of Alcoholic Beverage Control and California Department of Tax and Fee Administration to educate and inform California retailers about kratom and 7-OH products, which are not legally approved to sell or manufacture for consumption. These products, often sold in smoke shops and gas stations, are labeled with terms such as “plant alkaloids" or “alkaloid," and may be marketed as dietary supplements to address issues such as chronic pain, anxiety and depression, and opioid withdrawal. “Consumers who responsibly use natural kratom leaf fear losing access because of the reckless actions of those selling dangerous synthetics falsely marketed as natural kratom.” In July, the FDA recommended that the synthetic ingredient 7-OH, not the plant itself, be placed on the federal government’s restrictive list of illegal drugs. In the absence of regulation, last week the Orange County Board of Supervisors passed an ordinance prohibiting the sale, distribution or possession of synthetic kratom products in any form in the county.

“You see tons of people that have returned to a normal life for years by using that instead of dope, and then several get off it. Chaparro said he did not like the sedating effects of prescription opiates, so he turned to Kratom, which targets the same receptors. So, I constantly stay in pain on this side,” he said gesturing toward his body. While addiction is not a problem for everyone, some rehab centers said the potential for abuse is real. Experts also said there is a misconception that since it’s plant-based, it’s not addictive. “It’s so much stronger and the intoxicating effects can be so much more dangerous,” said OBN spokesperson Mark Woodward.

The U.S. Food and Drug Administration has not approved kratom to be used for any purpose and warns consumers of “serious adverse events, including liver toxicity, seizures, and substance use disorder.” The kratom leaf is harvested from a tropical evergreen tree indigenous to Thailand, Malaysia and Indonesia and imported into the United States. Clarke’s arrest and subsequent death has put a spotlight on kratom, they said, at a time when lawmakers in many states are deciding whether to regulate or ban it. Industry insiders and kratom critics say they are closely watching the medical examiner’s findings. The office would not disclose whether it will test for kratom, though it has screened for the plant’s active components in past death investigations. There, the 235 grams of kratom and 7-OH deputies said they found inside Clarke’s duffel bag carried the weight of a felony drug trafficking charge, one prosecutors put on par with heroin possession.

And just as 7-OH is like kratom on steroids, mitragynine pseudoindoxyl is like 7-OH on steroids. “So what they did is they increased the amount of a very potent ingredient in kratom, which is 7-OH.” “Vendors got smarter and they noticed, sids 2014 ‘OK, maybe we can enhance kratom,'” Stanciu said.