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.<\/p>\n\n\n\n
Such a move by the Justice Department would restrict or prohibit access to the products, which are also currently sold online.<\/p>\n\n\n\n
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\u2019s more potent than morphine<\/a>, 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.<\/p>\n\n\n\n \u201cWe\u2019ve seen a disturbing rise in reports of overdoses, poisonings and emergency room visits linked to products containing 7-OH,\u201d Jim O\u2019Neill, deputy secretary of the U.S. Department of Health and Human Services, said at a news conference Tuesday.<\/p>\n\n\n\n He said 7-OH products are often sold without warnings or control over the quality or dosage.<\/p>\n\n\n\n \u201cThis is a recipe for public health disaster,\u201d O\u2019Neill said.<\/p>\n\n\n\n 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 \u201c7-OH\u201d contain a synthetic, concentrated version of the chemical, according to the FDA. Sometimes, 7-OH products are misleadingly marketed as kratom<\/a>.<\/p>\n\n\n\n The FDA\u2019s 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\u2019re based on a substance\u2019s medical use, public health risks and potential for abuse.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n The FDA currently warns people not to use kratom products because of the risk of serious side effects,<\/a> such as seizures and liver toxicity, and because it may lead to substance use disorder.<\/p>\n\n\n\n The DEA in 2016 said it planned to regulate<\/a> the active ingredients in kratom, including 7-OH, as Schedule I substances. But the agency dropped 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<\/a>.<\/p>\n\n\n\n Tom Prevoznik, an assistant administrator at the DEA, said at Tuesday’s news conference that the public will again have an opportunity to comment before a final decision is made.<\/p>\n\n\n\n \u201cDEA will do what we\u2019ve always done: follow science, follow the law and do what\u2019s right to keep our community safe,\u201d he said.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n He added that 7-OH products are \u201cmarketed for children. They\u2019re gummy bears, they\u2019re bright colors, they\u2019re candy flavored. This is really a sinister, sinister industry.\u201d<\/p>\n\n\n\n The FDA issued warning letters in late June to seven companies<\/a>, 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.<\/p>\n\n\n\n Dietary supplements don\u2019t 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\u2019s up to the FDA to test products and determine whether they\u2019re unsafe before the agency can remove them from the market.<\/p>\n\n\n\n Makary said Tuesday that the FDA is focused on 7-OH rather than kratom, noting that the agency\u2019s recommendation distinguishes trace amounts of 7-OH from synthetic, concentrated amounts.<\/p>\n\n\n\n \u201cWe are going after the killer first,\u201d he said.<\/p>\n\n\n\n The Holistic Alternative Recovery Trust, which advocates using plant-based compounds to address opioid addiction, said the FDA\u2019s recommendation Tuesday disregards how 7-OH is used in the real world.<\/p>\n\n\n\n \u201cIf 7-OH posed the kind of urgent danger that would justify emergency action, evidence would have been presented. It was not,\u201d Jeff Smith, the group\u2019s national policy director, said in a statement.<\/p>\n\n\n\n Proponents of kratom say it\u2019s useful for pain management and can help people with substance use disorders wean off more dangerous opioids.<\/p>\n\n\n\n The American Kratom Association, which advocates on behalf of kratom users, has said it\u2019s not opposed to the FDA regulating kratom products<\/a> 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. <\/p>\n\n\n\n