Latest news with #DEA
NZ Herald
2 hours 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.
NBC News
9 hours ago
- Health
- NBC News
FDA asks Justice Department to classify gas station products with opioid-like effects as illicit substances
The Food and Drug Administration on Tuesday recommended classifying 7-OH, a compound with opioid-like effects found in unregulated tablets, gummies and drink mixes sold in gas stations and convenience stores, as an illicit substance. Such a move by the Justice Department would restrict or prohibit access to the products, which are also currently sold online. The chemical, formally known as 7-hydroxymitragynine, is often marketed as a way to help people relax, relieve pain or improve their mood or focus. But studies suggest it's more potent than morphine, and the FDA has warned it could damage the heart or liver and potentially lead to seizures, digestive issues, shallow breathing, withdrawal symptoms or even death. 'We've seen a disturbing rise in reports of overdoses, poisonings and emergency room visits linked to products containing 7-OH,' Jim O'Neill, deputy secretary of the U.S. Department of Health and Human Services, said at a press conference Tuesday. He said 7-OH products are often sold without warnings or control over the quality or dosage. 'This is a recipe for public health disaster,' O'Neill said. 7-OH is found naturally in the leaves of a tropical evergreen tree. An herbal extract made from those leaves, known as kratom, is also sold as an unregulated dietary supplement. Kratom products contain trace amounts of 7-OH, whereas products sold under the name '7-OH' contain a synthetic, concentrated version of the chemical, according to the FDA. Sometimes, 7-OH products are misleadingly marketed as kratom. The FDA's recommendation Tuesday will trigger a review from the Drug Enforcement Administration, the branch of the Justice Department responsible for classifying drugs as controlled substances. There are five potential classifications, corresponding to varying degrees of regulation. They're based on a substance's medical use, public health risks and potential for abuse. FDA Commissioner Martin Makary said Tuesday that the FDA is recommending that 7-OH be classified as a Schedule I substance, meaning it has no accepted medical use and a high potential for abuse. Other drugs in that class include heroin, marijuana and ecstasy. The FDA currently warns people not to use kratom products due to the risk of serious side effects such as seizures and liver toxicity, and because it may lead to substance use disorder. The DEA in 2016 said it planned to regulate the active ingredients in kratom, including 7-OH, as Schedule I substances. But the agency nixed the effort after considerable pushback from kratom advocates. Around 1.9 million people ages 12 and up in the U.S. reported using kratom in 2022, according to the National Survey on Drug Use and Health. Tom Prevoznik, an assistant administrator at the DEA, said at Tuesday's press conference that the public will again have an opportunity to comment before a final decision is made. 'DEA will do what we've always done: follow science, follow the law and do what's right to keep our community safe,' he said. Health and Human Services Secretary Robert F. Kennedy Jr. recalled the availability of heroin fueling his own addiction decades ago, and expressed concern about the widespread distribution of 7-OH products near schools, military reservations and in low-income neighborhoods in the United States. He added that 7-OH products are 'marketed for children. They're gummy bears, they're bright colors, they're candy flavored. This is really a sinister, sinister industry.' The FDA issued warning letters in late June to seven companies, which it said were illegally marketing products containing 7-OH. According to the agency, the chemical cannot be lawfully added to conventional foods or dietary supplements because there is not enough information to demonstrate its safety. Dietary supplements don't require FDA approval to be sold or purchased, but the agency mandates that companies that manufacture, package, label or store supplements test their ingredients and limit contamination. It's up to the FDA to test products and determine whether they're unsafe before the agency can remove them from the market. Makary said Tuesday that the FDA is focused on 7-OH rather than kratom, noting that the agency's recommendation distinguishes trace amounts of 7-OH from synthetic, concentrated amounts. 'We are going after the killer first,' he said. The Holistic Alternative Recovery Trust, which advocates for the use of plant-based compounds to address opioid addiction, said the FDA's recommendation Tuesday disregards how 7-OH is used in the real world. 'If 7-OH posed the kind of urgent danger that would justify emergency action, evidence would have been presented. It was not,' Jeff Smith, the group's national policy director, said in a statement. Proponents of kratom say it's useful for pain management and can help people with substance use disorders wean off more dangerous opioids. The American Kratom Association, which advocates on behalf of kratom users, has said it's not opposed to the FDA regulating kratom products via labels, age restrictions or limiting the concentration of 7-OH. However, it maintains that kratom does not have a high potential for abuse or warrant classification as a controlled substance.
Daily Mail
9 hours ago
- Health
- Daily Mail
Inside the wildly popular gas station drug RFK Jr. wants to ban to prevent the next opioid crisis
Robert F. Kennedy Jr. is cracking down on an opioid-like substance that has gone wildly viral for its addictive properties, misleading marketing and its wide availability. The Department of Health and Human Services recommended on Tuesday that the Drug Enforcement Agency schedule 7-hydroxymitragynine (7-OH) - a compound that appears in kratom leafs - as a class one illicit substance. Kennedy says the hope is that scheduling it as a controlled substance will help 'prevent the fourth wave of addiction' in the U.S. and Food and Drug Commissioner Marty Makary says it's 13 times more potent than morphine. Currently, drinks, gummies and supplements with trace amounts of 7-OH from the kratom plant are widely available for purchase at smoke shops and convenience stores. Some kratom plant products – like Feel Free botanical tonics – have recently gone viral with consumers claiming they quickly became addicted and dependent on the substance available at their local gas stations. HHS recognizes the increase in reports of overdoses and emergency room visits linked to products containing 7-OH, many times from young people, veterans and people suffering from chronic pain. Many who consume 7-OH claim they were not aware they were taking an addictive product. Others who bought it thought they were purchasing a product with the potency of an energy drink. RFK Jr. and Makary warn that if 7-OH is allowed to remain on shelves, it will result in another opioid-crisis like in the 1990s and 2010s. During a Tuesday press conference, the two officials announced they are initiating the process to have the DEA classify 7-OH as an illegal controlled substance. They cited its opioid-like effects on the brain as justification for the scheduling. It can take months and even years for drugs to get official scheduling by the DEA, but leadership at HHS and FDA make clear that this is a priority and suggest the process will be expedited. The DEA must review the recommendation, which can take between two and six months. Then the rule must be opened for a public comment period, which is between 30 and 60 days. During this time, advocates for the use of kratom leaf are likely to come out in opposition of the drug classification. There are many kratom leaf products, like teas and other drinks, that do not fall in the same category as products that have trace amounts of 7-OH. Makary made very clear that the FDA was not focusing on kratom leaf and only the 7-OH compound. Companies that use kratom leaf with trace amounts of 7-OH in their products claim they help with relaxation and pain, as well as assist with productivity and focus. Makary said: '7-OH is not just like an opioid, it does not just have opioid binding properties. 7-OH binds to the mu receptor, which means, scientifically by definition, it is an opioid.' Products with 7-OH claim to help people with relaxation, pain management, productivity and focus. FDA Commissioner Marty Makary said at a press conference on Tuesday: '7-OH binds to the mu receptor, which means, scientifically by definition, it is an opioid' 'And yet it is sold in vape stores, in smoke shops and convenience stores and gas stations that are popping up all over the United States, and nobody knows what it is,' Markay lamented during a press conference at the HHS building on Tuesday. 'It is a synthetic concentrated by-product of kratom. Our focus is not on kratom. Our focus is on 7-OH,' he added. Deputy HHS Secretary Jim O'Neill warned: '7-OH carries a high risk of addiction, on purpose. It is a powerful opioid agonist, many times more potent than morphine,' sold online and in stores with no quality or dosage constraints. 'Young people, veterans and people who suffer from chronic pain or addiction are being misled into thinking that these are safe alternatives. They are not,' he concluded. RFK Jr. opened up about his years-long struggle with heroin addiction and said part of the HHS effort to schedule 7-OH is also to educate the American public about the threat it poses. 'When there is availability that can become a crisis,' Secretary Kennedy said. 'And my addiction started because of, let me say this, it was precipitated by availability.' Kennedy said that he met with Attorney General Pam Bondi this week regarding the action and that she showed the correlation between a high concentration of vape and smoke shops to areas where addiction-related deaths are happening in higher volumes. 'Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH,' Makary said. 'After the last wave of the opioid epidemic, we cannot get caught flat-footed again.'
Time of India
19 hours ago
- Business
- Time of India
India's Q1 trade shines: Core merchandise exports up 7.2 per cent; rupee, forex reserves show resilience, says Economic Affairs department
Representative AI image India's trade performance showed strength in the first quarter of financial year 2026, as reported in the Monthly Economic Review by the Department of Economic Affairs (DEA). The report, cited by ANI, indicated total exports, encompassing goods and services, increased by 5.9 per cent year-on-year (YoY) in April-June FY26. Core merchandise exports, excluding petroleum and gems & jewellery, registered a growth of 7.2 per cent YoY. These statistics demonstrate India's robust external sector performance amidst global economic challenges. The report further claimed, "Amid shifting global trade patterns, India's trade performance remains resilient in Q1 of FY26." Foreign exchange reserves maintained sufficient levels, ensuring import coverage exceeding 11 months, signifying India's economic stability and protection against external disturbances. The Indian rupee displayed stability despite global oil price variations and a short-term Middle East conflict, with the exchange rate remaining stable through June 2025. The assessment addressed the wider global trade situation, noting that ongoing geopolitical tensions have introduced additional uncertainties to international trade flows. Global trade in goods and services showed stability in the initial half of 2025, with a USD 300 billion increase. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like These Are The Most Beautiful Women In The World Undo UNCTAD's July 2025 assessment revealed that global trade experienced a slowdown in 2025's first quarter, followed by recovery in the second quarter. Developed nations led trade growth, whilst developing countries showed reduced performance compared to previous quarters. Trade-related uncertainty showed improvement. The Trade Policy Uncertainty Index, reaching its highest in April 2025, decreased by approximately 35 per cent month-on-month by June 2025, suggesting enhanced stability in global trade policies. Nations worldwide are increasingly adopting bilateral discussions to address trade disagreements. Additionally, countries are strengthening supply chain stability through domestic production incentives in essential sectors and geographical diversification of suppliers. These strategies seek to maintain sustainable and stable trade operations in the current divided global economic landscape. Stay informed with the latest business news, updates on bank holidays and public holidays . Discover stories of India's leading eco-innovators at Ecopreneur Honours 2025
Business Standard
19 hours ago
- Business
- Business Standard
Early data from FY26 indicate potential for a turnaround in foreign investment flows says DEA
Department of Economic Affairs or DEA stated in a latest monthly update that in the face of ongoing global uncertainty, India achieved a capital and financial account surplus of USD 21.7 billion in FY25 on account of higher NRI deposits (USD 16.2 billion) and external commercial borrowings (USD 18.4 billion). However, during FY25, both net Foreign Direct Investment (FDI) and net Foreign Portfolio Investment (FPI) inflows declined vis-?-vis FY24, primarily influenced by cautious global investment trends shaped by geopolitical tensions and tighter financial conditions worldwide. Early data from FY26 indicate the potential for a turnaround in foreign investment flows. flows. Gross FDI inflows grew by 5 per cent (YoY) in April-May FY26 and stood at USD 15.9 billion. There are notable improvements in equity inflows and a lower incidence of repatriations, signalling fresh confidence in India's long-term growth prospects, particularly in sectors like digital infrastructure and manufacturing. On the portfolio investment side, net FPI amounted to USD 0.4 billion during Q1 FY26. While the debt segment witnessed outflows of USD 4.1 billion, these were offset by inflows of USD 4.5 billion in the equity segment. This suggests that global investors are selectively re-entering Indian equities, driven by expectations of stable inflation, credible fiscal consolidation, and ongoing growth in domestic demand. The government noted that during July 2024 to mid-July 2025, there has been a cumulative inflow of USD 7.5 billion through the Fully Accessible Route (FAR).
