FDA pushes to restrict synthetic opioid derived from kratom leaf
The agency is recommending to the Drug Enforcement Administration that 7-OH be classified as Schedule I, a tier designated to have no medical value and high risk of abuse.
That tier still includes marijuana, which federal officials under the Biden Administration sought to move to a less restrictive category. That issue remains undecided.
The law enforcement agency will review the 7-OH recommendation 'expeditiously', DEA Deputy Assistant Administrator Thomas Prevoznik said.
Federal health officials rolled out the campaign to stamp out 7-OH with the nation still in the throes of a drug crisis fuelled by illicit fentanyl, methamphetamine, and other synthetic compounds easily manufactured in clandestine labs.
Overdose deaths have dropped dramatically during the past year but still topped a staggering 80,000 in 2024.
Health and Human Services Secretary Robert F. Kennedy jnr, who himself battled a heroin addiction decades ago, said that public health agencies have been 'asleep at the wheel' on previous crises of addiction in the US.
The FDA's report presented scientific studies on 7-OH and advisories to consumers and doctors warning them of 'eye-catching' products sold as gummies, candies, and even ice-cream cones meant to appeal to young people.
This month, the FDA said it had sent warning letters to seven companies regarding allegations that they illegally marketed 7-OH products as dietary supplements or unapproved drugs that touted relief from pain or anxiety.
The scrutiny of 7-OH products adds another twist to the saga of kratom in the US.
Amid the nation's drug crisis, kratom has become increasingly popular as users seek alternatives for pain or relief from opioid withdrawal symptoms.
Smoke shops, service stations, convenience stores and online retailers across the US sell to devoted users who champion the health benefits of all-natural kratom products on social media.
Speaking at the news conference today, kratom advocate Melody Woolf drew a distinction between the powdered kratom leaf she takes to ease her chronic pain and 7-OH products.
Woolf said: '7-OH is not what helped me get out of bed and get the quality of life I enjoy'.
Kratom acts as a mild stimulant when taken in small doses. Experts say that in higher doses, kratom's compounds can induce euphoria similar to opioids, though with less potency than many legal painkillers.
One of kratom's many natural compounds is converted into the metabolite 7-OH, or 7-hydroxymitragynine, which produces an opioid-like effect in the brain.
Though kratom contains trace amounts of the compound naturally, companies use semisynthetic 7-OH extracts to make an entirely new and potent product, said Christopher McCurdy, professor of medicinal chemistry at the University of Florida College of Pharmacy.
'This is essentially putting legal morphine at the gas station,' McCurdy said.
Retailers have been slapped with wrongful-death lawsuits from families of people who died with kratom compounds in their blood, usually in conjunction with illicit drugs.
In 2016, the Drug Enforcement Administration announced plans to classify kratom compounds as controlled substances but shelved the idea after a fierce backlash.
More than a dozen states have passed laws regulating kratom, according to the American Kratom Association, a trade group representing the industry.
The association casts companies selling 'enhanced' 7-OH products as bad actors that offer 'chemically manipulated' products – usually concentrated shots and tablets.
The products distort the public's understanding of kratom and provide ammunition to critics who seek to ban plant products, said Mac Haddow, a spokesman and lobbyist for the association.
'We do not believe these products should be available over the counter,' Haddow said in an interview yesterday.
An opposing trade association, the Holistic Alternative Recovery Trust, said the criticism is part of an 'intra-industry turf war' between companies losing market share and those making better products.
'Consumers find it more effective and safer,' Jeff Smith, the group's national policy director, said of such 7-OH products.
Smith said the group supports measures such as warning labels, age restrictions and testing by third-party independent labs.
But he criticised the FDA's proposals, saying officials presented no science to support the alleged dangers of 7-OH. He predicted a ban would push users to return to more dangerous substances and destroy responsible businesses.
'The public needs to speak up to prevent dramatic regulatory over-reach,' Smith said.
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NZ Herald
30-07-2025
- NZ Herald
FDA pushes to restrict synthetic opioid derived from kratom leaf
'We think it's night and day in terms of the public health risk,' Makary said of 7-OH products. The agency is recommending to the Drug Enforcement Administration that 7-OH be classified as Schedule I, a tier designated to have no medical value and high risk of abuse. That tier still includes marijuana, which federal officials under the Biden Administration sought to move to a less restrictive category. That issue remains undecided. The law enforcement agency will review the 7-OH recommendation 'expeditiously', DEA Deputy Assistant Administrator Thomas Prevoznik said. Federal health officials rolled out the campaign to stamp out 7-OH with the nation still in the throes of a drug crisis fuelled by illicit fentanyl, methamphetamine, and other synthetic compounds easily manufactured in clandestine labs. Overdose deaths have dropped dramatically during the past year but still topped a staggering 80,000 in 2024. Health and Human Services Secretary Robert F. Kennedy jnr, who himself battled a heroin addiction decades ago, said that public health agencies have been 'asleep at the wheel' on previous crises of addiction in the US. The FDA's report presented scientific studies on 7-OH and advisories to consumers and doctors warning them of 'eye-catching' products sold as gummies, candies, and even ice-cream cones meant to appeal to young people. This month, the FDA said it had sent warning letters to seven companies regarding allegations that they illegally marketed 7-OH products as dietary supplements or unapproved drugs that touted relief from pain or anxiety. The scrutiny of 7-OH products adds another twist to the saga of kratom in the US. Amid the nation's drug crisis, kratom has become increasingly popular as users seek alternatives for pain or relief from opioid withdrawal symptoms. Smoke shops, service stations, convenience stores and online retailers across the US sell to devoted users who champion the health benefits of all-natural kratom products on social media. Speaking at the news conference today, kratom advocate Melody Woolf drew a distinction between the powdered kratom leaf she takes to ease her chronic pain and 7-OH products. Woolf said: '7-OH is not what helped me get out of bed and get the quality of life I enjoy'. Kratom acts as a mild stimulant when taken in small doses. Experts say that in higher doses, kratom's compounds can induce euphoria similar to opioids, though with less potency than many legal painkillers. One of kratom's many natural compounds is converted into the metabolite 7-OH, or 7-hydroxymitragynine, which produces an opioid-like effect in the brain. Though kratom contains trace amounts of the compound naturally, companies use semisynthetic 7-OH extracts to make an entirely new and potent product, said Christopher McCurdy, professor of medicinal chemistry at the University of Florida College of Pharmacy. 'This is essentially putting legal morphine at the gas station,' McCurdy said. Retailers have been slapped with wrongful-death lawsuits from families of people who died with kratom compounds in their blood, usually in conjunction with illicit drugs. In 2016, the Drug Enforcement Administration announced plans to classify kratom compounds as controlled substances but shelved the idea after a fierce backlash. More than a dozen states have passed laws regulating kratom, according to the American Kratom Association, a trade group representing the industry. The association casts companies selling 'enhanced' 7-OH products as bad actors that offer 'chemically manipulated' products – usually concentrated shots and tablets. The products distort the public's understanding of kratom and provide ammunition to critics who seek to ban plant products, said Mac Haddow, a spokesman and lobbyist for the association. 'We do not believe these products should be available over the counter,' Haddow said in an interview yesterday. An opposing trade association, the Holistic Alternative Recovery Trust, said the criticism is part of an 'intra-industry turf war' between companies losing market share and those making better products. 'Consumers find it more effective and safer,' Jeff Smith, the group's national policy director, said of such 7-OH products. Smith said the group supports measures such as warning labels, age restrictions and testing by third-party independent labs. But he criticised the FDA's proposals, saying officials presented no science to support the alleged dangers of 7-OH. He predicted a ban would push users to return to more dangerous substances and destroy responsible businesses. 'The public needs to speak up to prevent dramatic regulatory over-reach,' Smith said.
Scoop
29-07-2025
- Scoop
Study Calls Time On Vague ‘Drier' Homes Claims
As many New Zealanders contend with condensation, drafts, and mould this winter, a recent study challenges assumptions about what makes a home 'drier'. It urges green building rating tools to clarify how humidity and dampness are measured and understood. University of Auckland senior property lecturer Dr Mike Rehm, researcher Dr Rochelle Ade, and Dr V. Vishnupriya (Massey University) examined winter humidity levels in a 40-unit Auckland apartment building for residents aged 65 and older. The building is 7-Homestar certified under New Zealand's green building rating system (v4), which promotes warmer, healthier, and drier homes, representing best practice for New Zealand housing. The study found that relative humidity within the apartments often exceeded the recommended 40 – 60 percent range, which is commonly used to minimise condensation and mould risk. However, the researchers stress that elevated relative humidity doesn't necessarily mean the building is 'damp' or unhealthy. In fact, when the same apartments were assessed using absolute humidity - a measure of the total moisture in the air - they fell consistently within the epidemiologically acceptable range for health and comfort. 'Humidity and dampness are often used interchangeably, but they are not the same,' says Rehm. 'A building can have high relative humidity without being damp. That nuance is often lost, including in how certification tools like Homestar communicate 'drier' living conditions.' The findings raise questions about which humidity metrics best reflect health and comfort, particularly in New Zealand's naturally ventilated housing and humid coastal climates. Despite relative humidity being outside the ideal range, most residents in the study reported feeling comfortable in their homes. The researchers say this suggests relative humidity alone may not reliably reflect health risks or occupant satisfaction, especially for older people. The authors argue that green rating systems could improve clarity and effectiveness by explicitly defining 'drier' and considering both relative and absolute humidity. 'In cities like Auckland, where outdoor air is often humid, natural ventilation may not reduce relative humidity. But that doesn't automatically mean a home is unhealthy or inefficient,' says Rehm. He proposes relative humidity be used as a primary performance metric, with absolute humidity included in some cases, to better reflect actual indoor conditions. 'Certification systems like Homestar already play an important role in improving New Zealand's housing stock. Clarifying how terms like 'drier' are defined and measured could enhance their effectiveness and help align performance goals with occupant wellbeing,' he says. The paper, What is Drier? Understanding Humidity in Green-Certified Dwellings, is published in the Journal of the Royal Society of New Zealand and is part of a growing body of work calling for more precise, performance-based humidity guidelines in building standards.
Otago Daily Times
18-06-2025
- Otago Daily Times
'For jet lag and insomnia': Psilocybin to be prescribed, melatonin to be sold over-the-counter
The government has signalled melatonin will become available over the counter, and psilocybin - magic mushrooms - will be available for patients with treatment-resistant depression. Psilocybin will still be an "unapproved medicine" but will be able to be granted under the authority of one specific highly experienced psychiatrist. Melatonin is a natural hormone that helps induce sleep, and is used to treat insomnia and jet lag, but has been classified as a prescription-only medicine in New Zealand. It will be available in pharmacies as pills up to 5mg in packs with up to 10 days' supply, or pills up to 3mg. "Modified release doses" - pills, capsules, gels and medical devices which allow the drug to be administered over a specific period - could also be available with dosages of up to 2mg. No specific date has been set for when the changes will take effect. Associate Health Minister David Seymour announced the decisions on Wednesday afternoon, noting they were made by MedSafe rather than politicians. "Certainly I've discussed with some of them ... some of them were very enthusiastic about the melatonin but ultimately they respect that it's a technical decision for MedSafe." He said melatonin would become available once manufacturers began to export it to New Zealand. "You'll be able to go to any pharmacy and buy melatonin for jet lag and insomnia just as soon as it's available over the counter in New Zealand. Part of the purpose of my announcement today is to call on the melatonin manufacturers of the world to apply to bring their products into our country," Seymour said. "When we did this with pseudoephedrine, it was a matter of months before products were on the shelves and I hope we can beat that record. "Kiwis shouldn't be left counting sheep or desperate for options when other countries are already using these medicines. The government is committed to putting patients first ... this is a commonsense decision that will make melatonin more accessible in New Zealand than in many other countries." The change for psilocybin was a huge win for people with depression who had tried everything else, Seymour said. "If a doctor believes psilocybin can help, they should have the tools to try. The psychiatrist involved has previously prescribed psilocybin in clinical trials and will operate under strict reporting and record-keeping requirements." He said it would initially only be available from one specific psychiatrist, but he hoped more would apply. "Psilocybin is a medicine that can treat untreatable depression. It was first researched in the 1950s and '60s and more recently there's been extensive research and approvals by the FDA in the United States to be able to use these types of medicines. "Fair to say it's been driven by people in the profession - there's a lot of people very passionate about this because untreatable depression's an awful thing and there are clinicians who say there's stuff happening in the rest of the world and we need to be part of it." He had never taken either of them, nor pseudoephedrine. "No. No I have not inhaled melatonin but maybe I will. I've had some recent issues with jet lag of my own so hopefully in the future I'll be able to," Seymour said. "I used to go mushroom hunting with my dad as a very small kid, but I don't think we found any." The melatonin changes were confirmed in regulations gazetted by Medsafe group manager Chris James. The psilocybin changes were not yet gazetted, but it will mark the first time psilocybin will be legally available in New Zealand outside of clinical trials.
