Agency alerts health care professionals and consumers of 7-hydroxymitragynine risks
The U.S. Food and Drug Administration today is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH ) products under the Controlled Substances Act (CSA).
The FDA is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products. 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. The FDA is releasing a new report to educate the public about the health concerns of 7-OH and its distinction from the kratom plant leaf.
“Today, we’re taking action on 7-OH as a critical step in the fight against opioid addiction,” said HHS Secretary Robert F. Kennedy, Jr. “We will protect the health of our nation’s youth as we advance our mission to Make America Healthy Again.”
This recommendation follows a thorough medical and scientific analysis by the FDA and is one of several efforts to address the agency’s concerns around the growing availability and use of 7-OH opioid products. There are no FDA-approved 7-OH drugs, 7-OH is not lawful in dietary supplements and 7-OH cannot be lawfully added to conventional foods.
“Vape stores are popping up in every neighborhood in America, and many are selling addictive products like concentrated 7-OH. After the last wave of the opioid epidemic, we cannot get caught flat-footed again,” said FDA Commissioner Marty Makary, M.D., M.P.H. “7-OH is an opioid that can be more potent than morphine. We need regulation and public education to prevent another wave of the opioid epidemic.”
The availability of 7-OH products is a major concern to the FDA, as consumers can easily purchase products with concentrated levels of 7-OH online and in gas stations, corner stores and vape shops. The FDA is particularly concerned with the growing market of 7-OH products that may be especially appealing to children and teenagers, such as fruit-flavored gummies and ice cream cones. These products may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom. The FDA has also published educational materials for consumers to be more informed about these harmful products.
In June, the FDA issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots. Today, the FDA is also issuing a letter to health care professionals and is warning consumers about the risks associated with 7-OH products.
Under the CSA, drugs, substances and certain chemicals are placed into one of five schedules based upon their medical use, potential for abuse and safety or dependence liability. The Drug Enforcement Agency is reviewing the recommendation and has the final authority on scheduling, which requires a rulemaking process that includes a period for the public to provide comments before any scheduling action is finalized.
Related Information
An unofficial translation of this announcement is provided below.
翻译参考：
FDA采取措施限制威胁美国消费者的7-OH阿片类药物产品
FDA提醒医疗专业人员和消费者注意 7-羟基米特拉吉宁的风险
美国食品药品管理局 (FDA) 今日采取果断行动，建议将某些 7-羟基米特拉吉宁 (7-hydroxymitragynine, 也称为 7- OH) 产品列入《管制物质法案》 (CSA) 监管范围，以保护美国人免受危险的非法阿片类药物的侵害。
FDA专门针对7-OH，它是卡痛 (Kratom) 植物的浓缩副产品，而非天然卡痛叶产品。由于 7- OH能够与阿片类受体结合，其滥用风险日益凸显。FDA 同时发布了一份新报告，旨在向公众普及 7-OH 的健康危害及其与卡痛叶的区别。
美国卫生与公众服务部 (HHS) 部长Robert F. Kennedy, Jr表示： “今天，我们针对 7-OH 采取行动，这是打击阿片类药物成瘾的关键一步。我们将在推进‘重塑健康美国’使命的同时，保护我国青少年的健康。”
这项建议是在FDA进行全面的医学和科学分析后提出的，也是FDA为应对7-OH阿片类药物日益泛滥和滥用的担忧而采取的多项措施之一。目前FDA尚未批准含7-OH的药品，7-OH不得作为膳食补充剂的成分，7-OH也不能合法添加到常规食品中。
“电子烟商店在美国的每个街区都如雨后春笋般涌现，许多商店都在销售浓缩7-OH等成瘾性产品。在经历了上一波阿片类药物泛滥危机之后，我们不能再次措手不及，” FDA局长Marty Makary博士表示， “7-OH是一种效力超过吗啡的阿片类物质。我们需要通过监管和公众教育，防止阿片类药物泛滥危机再度爆发。”
7-OH产品的可获得性是FDA关注的重点问题，因为消费者可以轻易地在网上、加油站、街角商店和电子烟商店购买到含高浓度7-OH的产品。FDA尤其关注日益增长的7-OH产品市场，这些产品可能对儿童和青少年特别有吸引力，例如水果味软糖和甜筒冰淇淋。这些产品的7-OH含量可能没有清晰或准确地标识，有时还会被伪装成卡痛 (Kratom) 产品或以卡痛 (Kratom) 产品的名义销售。FDA已经发布了教育材料，帮助消费者更好地了解这些有害产品。
今年6月，FDA向七家非法销售含有7-OH产品的公司发出了警告信，这些产品包括片剂、软糖、混合饮料和即饮型饮品。今天，FDA还向医疗专业人员发出了一封信，并再次警示消费者7-OH产品的相关风险。
根据CSA，药物、物质及某些化学品将根据其医疗用途、滥用可能性、安全性或成瘾性被列入五个等级管制清单之一。美国缉毒署 (Drug Enforcement Agency) 正在审查该建议，并拥有最终分级决定权。任何分级措施的确定都需经过正式的法规制定过程，其中包括一个公众提出意见的意见征集期。
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Sincerely,
Sarah McMullen
Country Director
FDA China Office
Office of Global Operations
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