TALLAHASSEE \u2014 Companies that sell a byproduct of kratom, known as 7-OH, and users of the substance are challenging an emergency rule banning its sale and manufacture in Florida.<\/p>\n
Attorney General James Uthmeier on Aug. 15 issued an emergency rule prohibiting the alkaloid 7-hydroxymitragynine, known as 7-OH, and adding it to the list of the state\u2019s most dangerous drugs. The ban on the concentrated byproduct of kratom, which was sold in smoke shops throughout the state, went into effect immediately.<\/p>\n
The compound \u2014 available in such products as drinks, gummies and powders \u2014 has skyrocketed in popularity over the past few years. Doctors say 7-OH acts on the same parts of the brain and is as addictive as opioids.<\/p>\n
An administrative complaint filed Monday alleges that the emergency ban is invalid, in part, because Uthmeier\u2019s office failed to follow proper rulemaking procedures and it \u201cwas not adopted under a procedure which was fair under the circumstances.\u201d<\/p>\n
Florida law allows the attorney general to adopt emergency rules to classify a \u201cnew substance\u201d as a Schedule 1 drug on a temporary basis if necessary \u201cto avoid an imminent hazard to the public safety.\u201d<\/p>\n
Under state law, Schedule 1 drugs are substances that have a \u201chigh potential for abuse\u201d and have \u201cno currently accepted medical use in treatment.\u201d<\/p>\n
The complaint filed Monday at the state Division of Administrative Hearings alleges that \u201cthere is an insufficient factual or scientific basis\u201d to show that the banned products are \u201cbeing used in a manner\u201d that \u201ccreates a substantial likelihood of hazard to the user\u2019s health or the safety of the community,\u201d as required for an emergency rule.<\/p>\n
The complaint was filed on behalf of The Mystic Grove, LLC, a Florida-based company that operates two retail stores; Green Brothers Wholesale, Inc., which distributes hemp, kratom and other smoke-shop products; and six people \u2014 identified as K.T., B.M., J.E., A.G., A.R. and M.D. \u2014 who use 7-OH products. The businesses and the 7-OH users are represented by J. Stephen Menton of the Rutledge Ecenia, P.A. firm and Paula Savchenko of PS Law Group.<\/p>\n
Uthmeier\u2019s office \u201chas provided no evidence of widespread or habitual misuse, no documentation of diversion from legal channels, and no indication that 7-OH poses a greater risk than comparable over-the-counter botanical or nutraceutical products,\u201d the 44-page complaint said.<\/p>\n
Instead, \u201cepidemiological data and real-world usage patterns\u201d suggest that the substance \u201chas been widely used as a harm reduction tool\u201d by people addicted to illegal street drugs such as fentanyl or heroin or to address chronic pain.<\/p>\n
\u201cThe absence of overdose deaths attributable solely to 7-OH undermines any claim that the substance presents a substantial likelihood of harm under the statutory definition,\u201d lawyers wrote.<\/p>\n
During a news conference in August, Uthmeier said he planned to work with lawmakers during the 2026 legislative session on a measure to make the ban on 7-OH, which is effective for a year, permanent. The session will start in January.<\/p>\n
\u201cIt is a significant painkiller. It has been proven to be highly addictive and easily can be overdosed, so it\u2019s very dangerous,\u201d Uthmeier said at the time. \u201cWe are taking emergency action now because we see immediate danger.\u201d<\/p>\n
According to the newly filed complaint, the emergency rule left The Mystic Grove with \u201csignificant inventory of 7-OH that, although legal to possess and sell the day before, was suddenly illegal.\u201d The company\u2019s estimated economic losses run to several thousand dollars per month.<\/p>\n
Green Brothers\u2019 business dropped by about 60 percent after the rule went into effect, which \u201cis consistent with industry-wide contraction resulting from the ban,\u201d the complaint said.<\/p>\n
As an example of the people in the case, the complaint said that \u201cM.D.\u201d unsuccessfully struggled for years to kick his opioid addiction.<\/p>\n
\u201cWhile kratom powder initially helped him reduce his dependence on opiates, it was not until he discovered 7-OH tablets that he was able to achieve lasting control over his addiction,\u201d the complaint said.<\/p>\n
The emergency scheduling of 7-OH \u201cthreatens to upend his progress and poses a direct risk of relapse,\u201d according to the complaint.<\/p>\n
Uthmeier\u2019s action came weeks after President Donald Trump\u2019s administration took initial steps to add 7-OH to the nation\u2019s list of dangerous drugs as part of a broader effort to address opioid addiction.<\/p>\n
The rule challenge filed Monday maintains that no new science has emerged since the federal Food and Drug Administration dropped an effort to ban 7-OH in 2018.<\/p>\n
\u201cThere is no compelling new scientific evidence that has suddenly become accepted in the scientific community to support a claim of an imminent health crisis sufficient to reverse the 2018 FDA determinations,\u201d the complaint said.<\/p>\n
Florida in 2023 prohibited the sale of kratom, a plant whose botanical name is \u201cmitragyna speciosa,\u201d to people under age 21. But legislation aimed at regulating or banning sale or use altogether has not passed.<\/p>\n
The 7-OH alkaloid is one of the kratom\u2019s most potent active compounds. Levels of 7-OH levels are low in whole kratom leaves, while isolated or concentrated forms of the compound are much stronger and often are sold as natural or health supplements.<\/p>\n
Efforts to ban 7-OH in Florida and elsewhere have sparked a deep divide within the kratom industry, pitting manufacturers and consumers of the concentrated alkaloid against advocates for kratom in powder or leaf form.<\/p>\n
The rapid advent of 7-OH at gas stations, smoke shops and other retail stores made a significant dent in the sales of powdered and leaf-based kratom products, according to industry experts.<\/p>\n
David Bregger, whose son died of an overdose in Colorado, blamed the death on the toxic effects of a concentrated form of kratom mixed with diphenhydramine, the active ingredient in Benadryl, along with other over-the-counter sleep aids.<\/p>\n
Bregger, who called 7-OH \u201ca horrible dangerous substance,\u201d is pushing for strict regulations for the kratom industry.<\/p>\n
\u201cPure leaf kratom is safe. It shouldn\u2019t be banned,\u201d Bregger told The News Service of Florida in an August phone interview. \u201cYou can\u2019t overdose on it, really.\u201d<\/p>\n
But proponents of 7-OH contend that the number of opioid deaths nationally has dropped since 7-OH entered the market two years ago.<\/p>\n
\u201cWithout clear evidence of a surge in hospitalizations, toxicological alerts, or overdose deaths, there is no basis to suddenly declare an imminent hazard to public health,\u201d the complaint said.<\/p>\n","protected":false},"excerpt":{"rendered":"TALLAHASSEE \u2014 Companies that sell a byproduct of kratom, known as 7-OH, and users of the substance are…\n","protected":false},"author":2,"featured_media":51067,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[232,234,233],"class_list":["post-51066","post","type-post","status-publish","format-standard","has-post-thumbnail","category-tallahassee","tag-tallahassee","tag-tallahassee-headlines","tag-tallahassee-news"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/posts\/51066","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/comments?post=51066"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/posts\/51066\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/media\/51067"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/media?parent=51066"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/categories?post=51066"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us-fl\/wp-json\/wp\/v2\/tags?post=51066"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}