Latest news with #7-OH
USA Today
18 hours ago
- Health
- USA Today
Products with opioid-like effects sold at gas stations may be banned as illicit substances
The Food and Drug Administration (FDA) is recommending banning a compound found in unregulated tablets, gummies and drink mixes sold online and at gas stations and convenience stores, the Trump administration announced this week. The substance, known as 7-OH, will be scheduled as an illicit drug if the Drug Enforcement Administration − a branch of the US Justice Department responsible for classifying drugs as controlled substances − approves the sanction after a review. "Dark innovations in chemistry have exacerbated the addiction crisis in this country," US Department of Health and Human Services Deputy Secretary Jim O'Neil told reporters during a Tuesday, July 29, press conference in Washington DC. "Synthetic opioids like carfentanill and the substance we're here to take action on today: 7-Hydroxymitragynine." O'Neil said 7-hydroxymitragynine, 7-OH, is deliberately addictive and a powerful opioid agonist many times more potent than morphine. Calling it "a recipe for public health disaster," O'Neill, said 7-OH products are often sold without warnings or controls. "We've seen a disturbing rise in reports of overdoses, poisonings and emergency room visits linked to products containing 7-OH,' O'Neil said. "These substances are often sold online or in convenience stores with no quality control, no dosage control and no warnings." 'They've killed thousands and thousands' During the press conference, FDA commissioner Martin Makary spoke alongside US Health and Human Services Secretary Robert F. Kennedy, Jr., as they announced they planned to send warning letters to companies for illegally marketing products containing 7-OH in an effort to combat the country's opioid addiction problem. 'We have a history in public health of being asleep at the wheel,' Makary said. 'Public health is supposed to prevent disasters, not just clean them up after they've killed thousands and thousands of people.' Which states felt tsunami waves? See list of where it hit after Russia earthquake What is 7-OH? The compound 7-OH is a naturally occurring substance in the kratom plant (Mitragyna speciosa), according to the FDA, but only a minor component comprising less than 2% of the alkaloid content in natural kratom leaves. "However, 7-OH demonstrates substantially greater mu-opioid receptor potency than kratom's primary alkaloid constituent mitragynine, as well as other classical opioids such as morphine," the FDA wrote in its findings. Mu-opioid receptors, found in the brain and spinal cord, are primarily responsible for pain relief and other opioid effects like euphoria and respiratory depression, according to research published on the National Institutes of Health's National Library of Medicine. Contributing: Adrianna Rodriguez Natalie Neysa Alund is a senior reporter for USA TODAY. Reach her at nalund@ and follow her on X @nataliealund.
Associated Press
20 hours ago
- Health
- Associated Press
Stop Gas Station Heroin Coalition Applauds FDA for Recommending Scheduling of Dangerous 7-OH Gas Station Heroin Products
Lab-made drugs are hurting kids and fueling for-profit addiction in American communities The Stop Gas Station Heroin coalition today applauded the U.S. Food and Drug Administration (FDA) for recommending a scheduling action to control certain 7-OH (7-hydroxymitragynine) opioid products under the Controlled Substances Act (CSA). 7-OH is a chemical compound that occurs naturally in only trace amounts in the kratom leaf. Yet, the 7-OH products being sold in gas stations, smoke shops, and convenience stores across the country are not natural. Instead, they are the result of bad actors isolating that trace compound from the leaf and supercharging it into an addictive drug up to 30 times more potent than morphine. This recommendation marks a major milestone in the federal government's effort to curb the rise of Gas Station Heroin — an umbrella term for harmful substances that include high dose mitragynine isolates, 7-hydroxymitragynine isolates, tianeptine, nitrous oxide, and intoxicating hemp compounds — and prevent the next wave of the opioid epidemic. 'This FDA action is a tremendous step toward ending the Gas Station Heroin crisis that is robbing everyday Americans of their health,' said Dr. Nicole Avena, a Stop Gas Station Heroin board member and associate professor of neuroscience at the Icahn School of Medicine at Mount Sinai (formerly, the Mount Sinai School of Medicine). 'By moving to schedule 7-OH, the FDA has taken bold action to protect consumers from dangerous synthetic opioids.' The FDA made it clear to distinguish that its action is targeted at concentrated 7-OH products and not at the natural kratom leaf, which has been used safely for centuries and remains outside the scope of this recommendation. 'This is a huge win for science, common sense, and consumers,' said Dr. Avena. 'The FDA has drawn a clear line: 7-OH is an unapproved, dangerous opioid — not a dietary supplement. We now urge the DEA to act quickly to adopt the FDA's recommendation and ensure 7-OH is scheduled without delay.' As the Drug Enforcement Administration (DEA) reviews the FDA's recommendation, the coalition urges swift scheduling of 7-OH to protect families and communities across the country. Only then can we finally end the scourge of Gas Station Heroin in American communities. To learn more about Stop Gas Station Heroin and its mission, navigate to About Stop Gas Station Heroin Stop Gas Station Heroin is a national coalition that aims to educate consumers about harmful synthetic drugs and advocate for smart regulation that distinguishes between legitimate, natural botanicals and dangerous, synthetic drugs, combined with enforcement of current federal laws around unapproved drugs. To learn more, navigate to Media Contact Media Contact [email protected] ### SOURCE: Stop Gas Station Heroin Copyright 2025 EZ Newswire
NZ Herald
2 days ago
- Health
- 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.
India Today
2 days ago
- Health
- India Today
US health officials crack down on kratom products after industry complaints
US health officials are warning Americans about the risks of an opioid-related ingredient increasingly added to energy drinks, gummies and supplements sold at gas stations and convenience stores, recommending a nationwide chemical, known as 7- hydroxymitragynine, is a component of kratom, a plant native to Southeast Asia that has gained popularity in the US as an unapproved treatment for pain, anxiety and drug recent months, dietary supplement companies that sell kratom have been urging the Food and Drug Administration to crack down on the products containing 7-OH, portraying it as a dangerously concentrated, synthetic form of the original ingredient. The FDA action 'is not focused on natural kratom leaf products," according to a statement Tuesday by the U.S. Department of Health and Human agency said it was releasing a report to educate about the risks of '7-OH and its distinction from the kratom plant leaf.' Regulators are also recommending that the ingredient be placed on the federal government's most restrictive list of illegal drugs, which includes LSD and heroin.'7-OH is an opioid that can be more potent than morphine," said FDA Commissioner Marty Makary. "We need regulation and public education to prevent another wave of the opioid epidemic.'The agency's recommendation will be reviewed by the Drug Enforcement Administration, which sets federal rules for high-risk drugs including prescription medicines and illicit substances. A national ban wouldn't take effect until the agency drafts and finalizes new rules governing the regulators have been scrutinizing kratom for about a decade after reports of addiction, injury and overdose. But users and distributors have long opposed efforts to regulate it, saying kratom could be a safer alternative to opioid painkillers that sparked the ongoing drug addiction month, the FDA issued warning letters to seven companies selling drinks, gummies and powders infused with 7-OH. Regulators said the products violated FDA rules because they have not been evaluated for safety and, in some cases, claimed to treat medical conditions, including pain, arthritis and executives quickly applauded the FDA "demonstrated the exact kind of data-driven, proactive regulatory excellence needed to safeguard unwitting consumers across the U.S.,' said Ryan Niddel of Diversified Botanics, a Utah-based company that sells kratom industry group, the American Kratom Association, has lobbied Congress for years against restrictions on the plant. Legislation supported by the group would prohibit the FDA from regulating kratom more strictly than food and dietary Tuesday, a rival group that supports the availability of 7-OH drugs criticized the government's move, pointing to the influence of kratom suppliers.'Big kratom trade groups have spent years blaming 7-OH for harms caused by their own unregulated products, because it threatens their market share,' the Holistic Alternative Recovery Trust stated in an emailed a decade ago, the federal government came close to banning 2016, the DEA announced plans to add it to the government's most restrictive schedule 1, reserved for drugs that have no medical use and a high potential for abuse. But the plan stalled after a flood of public complaints, including a letter signed by more than 60 members of FDA then began studying the ingredient, concluding in 2018 that kratom contains many of the same chemicals as opioids, the addictive class of drugs that includes painkillers like OxyContin as well as heroin and then, FDA regulators have continued to issue warnings about cases of injury, addiction and death with kratom supplements, which are usually sold in capsules or recent months, the FDA has also issued warnings on other unapproved drugs sold as supplements or energy drinks, including the antidepressant tianeptine. Sometimes referred to collectively as 'gas station heroin,' the drugs have been restricted by several states, but they are not scheduled at the federal level.- EndsMust Watch
New York Post
2 days ago
- Health
- New York Post
Beware: Synthetic kratom 7-OH powers a new opioid crisis
Vape shops are popping up in every neighborhood in America, but few people — even doctors — know that many of these shops are selling a dangerous new opioid. It's concentrated 7-OH, a synthetic byproduct of the kratom plant that binds strongly to the body's opioid receptors — making it up to 13 times more potent than morphine. This addictive compound is ubiquitous, it's being pushed deceptively to consumers, and its use is quietly growing. Advertisement In previous waves of the opioid crisis — prescription opioids, heroin and fentanyl — the Food and Drug Administration realized too late that a public health crisis was raging, and got caught flat-footed. Let's not make that mistake again. On Tuesday, in collaboration with the Drug Enforcement Administration, the FDA began the process of reviewing whether products with unusually high levels of 7-OH should be classified as controlled substances. Advertisement To be clear, the kratom plant leaf, which contains trace amounts of 7-OH and has been consumed for centuries, is not our focus at the FDA. Rather, we are seeking to remove a dangerous synthetic opioid from retail shelves nationwide. As a part of this effort, the FDA issued seven warning letters earlier this month to prominent firms illegally marketing 7-OH products. Already a number of companies have stopped sales, another is recalling its products, and one company's website disappeared entirely. But a DEA classification and warning letters alone won't solve this problem. We must also educate the public to be vigilant about this threat. Advertisement Americans should know that synthetic, concentrated 7-OH products can be marketed as 7-hydroxymitragynine, 7-OH-mitragynine, 7-OHMG, 7-Hydroxy, 7-HMG or 7 — and all these compounds pose significant health risks. The potency of 7-OH greatly increases the risk of overdose and dependence. A 2025 National Institute on Drug Abuse study found that 7-OH resulted in respiratory depression at a magnitude three times more severe than morphine. Given how 7-OH interacts with the brain, we're hearing more and more stories of severe addiction in young people — and of major withdrawal symptoms, including insomnia, anxiety, body aches and sweats. Advertisement We don't have precise statistics about the use of 7-OH. Because it's unregulated, sales data and adverse-event reporting are close to nonexistent. But instead of waiting for a crisis before we respond, we're reading the signs and acting proactively. Despite the critical differences between natural leaf kratom and synthetic 7-OH, many of these opioid products are marketed as 'kratom extract' or 'enhanced kratom' and sold on the same shelves as kratom. Many 7-OH products do not even state how much of the substance the product contains. And since the vast majority of these products come from uninspected manufacturing facilities in India, users may consume inconsistent doses and unknown contaminants. Perhaps most alarming is that 7-OH products are often disguised as attractive candies, gummies and even ice cream cones that parents might never see as a risk. But let's be clear: No FDA-approved drug, food or supplement product contains 7-OH, and none of the health claims made about these products have been federally substantiated. Advertisement Public safety is a priority for President Trump and his administration. To support the FDA's broader actions on 7-OH, the National Institutes of Health will be initiating studies to better understand the substance's effects. While some 7-OH products claim to provide pain relief, clinicians and people struggling with addiction should not view this synthetic opioid as a safer alternative — and store owners, too, should be aware that 7-OH is not just another harmless product. A special FDA resource page, 'Hiding in Plain Sight,' provides more about the risks of 7-OH and how to avoid them. Historically, the medical establishment has been slow to understand and respond to new products as they come to market. Advertisement From cigarettes to social media, it often takes decades before we recognize pervasive harms. But as with tobacco, we know that public awareness can drive behavior change — and massive public health improvements can follow. Even better than rolling back a public health crisis would be never having one in the first place. Let's not allow 7-OH to drive the next wave of the US opioid epidemic. Dr. Marty Makary is the commissioner of the Food and Drug Administration.
