{"id":124532,"date":"2025-08-06T20:49:25","date_gmt":"2025-08-06T20:49:25","guid":{"rendered":"https:\/\/www.europesays.com\/us\/124532\/"},"modified":"2025-08-06T20:49:25","modified_gmt":"2025-08-06T20:49:25","slug":"fda-marks-7-oh-kratom-compound-with-opioid-effect-for-csa-schedule-i","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/124532\/","title":{"rendered":"FDA Marks 7-OH, Kratom Compound With Opioid Effect, for CSA Schedule I"},"content":{"rendered":"\n<p>The Food and Drug Administration is recommending that 7-hydroxymitragynine, commonly referred to as 7-OH, be federally scheduled under the Controlled Substances Act. The agency <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers\" target=\"_blank\" rel=\"noopener\">announced<\/a> July 29 that it had initiated the review process with the Drug Enforcement Administration, and FDA Commissioner Marty Makary has <a href=\"https:\/\/www.cnn.com\/2025\/07\/29\/health\/kratom-derived-opioid-7-oh\" target=\"_blank\" rel=\"noopener\">suggested<\/a> that 7-OH should be classified as Schedule I.<\/p>\n<p>7-OH is an active byproduct of mitragynine, which is the main psychoactive compound in the Mitragyna speciosa plant\u2014similar to how delta-9-tetrahydrocannabinol (THC) is the primary psychoactive compound in Cannabis sativa. The Mitragyna speciosa plant is better known as <a href=\"https:\/\/filtermag.org\/kratom-mental-health-opioids\/amp\/\" target=\"_blank\" rel=\"noopener\">kratom<\/a>. Essentially, 7-OH is a more potent version of kratom.<\/p>\n<p>\u201cThe FDA is specifically targeting 7-OH \u2026 it is not focused on natural kratom leaf products,\u201d the agency <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers\" target=\"_blank\" rel=\"noopener\">stated<\/a>. \u201c7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors.\u201d<\/p>\n<p>Both mitragynine and 7-OH are considered partial opioid agonists, like <a href=\"https:\/\/filtermag.org\/microdosing-suboxone-fentanyl\/amp\/\" target=\"_blank\" rel=\"noopener\">buprenorphine<\/a>. In its accompanying <a href=\"https:\/\/www.fda.gov\/drugs\/information-consumers-and-patients-drugs\/hiding-plain-sight-7-oh-products\" target=\"_blank\" rel=\"noopener\">report<\/a> on 7-OH, however, the FDA stated that \u201cobservations suggest 7-OH has pharmacological properties representative of a full mu opioid agonist and an associated high potential for abuse.\u201d It also stated that \u201c[c]linical presentations include euphoria, sedation, respiratory depression and opioid-like withdrawal syndromes, with users acknowledging its significant addiction potential.\u201d<\/p>\n<p>It should be noted that all of these observations and clinical presentations refer to either lab testing involving petri dishes or mice, or posts on Reddit and other online forums like Erowid.<\/p>\n<p>The FDA\u2019s analysis did include human post-mortem toxicology data, but the agency cautioned that it \u201cgenerally cannot be discerned\u201d whether 7-OH specifically contributed to any deaths, so there are \u201csignificant limitations in making inferences from these data.\u201d<\/p>\n<p>What we do know is that both supply and demand for 7-OH, or similar higher-potency kratom products, have been growing at a faster rate since 2023 compared to previous years.<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>7-OH is not regulated, and so various products like chewable tablets or gummies can be legally sold at vape shops, gas stations, convenience stores and so forth.<\/p>\n<p>The Centers for Forensic Science Research &amp; Education has <a href=\"https:\/\/www.cfsre.org\/images\/content\/reports\/public_alerts\/7-Hydroxy_Mitragynine_NPS_Discovery_033125.pdf\" target=\"_blank\" rel=\"noopener\">described<\/a> mitragynine, AKA plant-based kratom products, in a manner <a href=\"https:\/\/filtermag.org\/stimulant-harm-reduction-synthetic-cannabinoids\/amp\/\" target=\"_blank\" rel=\"noopener\">that recalls synthetic cannabinoids<\/a>: \u201ca pharmacologically complex drug, exhibiting stimulant-like effects at low doses and sedative effects at higher doses.\u201d<\/p>\n<p>At a July 29 press conference, United States Secretary of Health and Human Services Robert F. Kennedy Jr. <a href=\"https:\/\/www.spokesman.com\/stories\/2025\/jul\/31\/fda-moves-to-restrict-7-hydroxymitragynine-an-opio\/\" target=\"_blank\" rel=\"noopener\">stated<\/a> that CSA scheduling was necessary to prevent 7-OH from becoming the fourth wave of the opioid-involved overdose crisis. It\u2019s <a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/add.16318\" target=\"_blank\" rel=\"noopener\">widely established<\/a> among drug-policy researchers that after prescription analgesics, then heroin, then fentanyl, the fourth wave already began <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC8154745\/\" target=\"_blank\" rel=\"noopener\">around 2018 with opioid-stimulant polysubstance use<\/a>. But the FDA has been using this \u201cfourth wave\u201d framing for 7-OH, too.<\/p>\n<p>Also on July 29, FDA Commissioner Marty Makary published an <a href=\"https:\/\/nypost.com\/2025\/07\/29\/opinion\/beware-synthetic-kratom-7-oh-powers-a-new-opioid-crisis\/\" target=\"_blank\" rel=\"noopener\">op-ed<\/a> in the New York Post warning that 7-OH could be the next wave to follow \u201cprescription opioids, heroin and fentanyl.\u201d He also leaned on tropes borrowed from the FDA\u2019s anti-vaping agenda, which the agency has been featuring heavily throughout its new <a href=\"https:\/\/www.fda.gov\/drugs\/information-consumers-and-patients-drugs\/hiding-plain-sight-7-oh-products\" target=\"_blank\" rel=\"noopener\">7-OH public awareness materials<\/a>\u00a0as well.<\/p>\n<p>\u201cVape shops are popping up in every neighborhood in America, but few people\u2014even doctors\u2014know that many of these shops are selling a dangerous new opioid,\u201d Makary wrote in the Post. \u201cPerhaps 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 \u2026 this synthetic opioid [is not] a safer alternative\u2014and store owners, too, should be aware.\u201d<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>Images (cropped) via <a href=\"https:\/\/www.fda.gov\/drugs\/information-consumers-and-patients-drugs\/hiding-plain-sight-7-oh-products\" target=\"_blank\" rel=\"noopener\">Food and Drug Administration<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The Food and Drug Administration is recommending that 7-hydroxymitragynine, commonly referred to as 7-OH, be federally scheduled under&hellip;\n","protected":false},"author":3,"featured_media":124533,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[151,210,66944,1060,2659,67,132,68],"class_list":{"0":"post-124532","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-fda","9":"tag-health","10":"tag-kratom","11":"tag-medication","12":"tag-opioids","13":"tag-united-states","14":"tag-unitedstates","15":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/114983794381067622","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/124532","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=124532"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/124532\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/124533"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=124532"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=124532"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=124532"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}