Latest news with #7hydroxymitragynine
Reuters
6 days ago
- Health
- Reuters
Botanic Tonics, Maker of feel free, Applauds Florida's Historic Ban on Synthetic 7-OH Drug Products
BROKEN ARROW, OK, August 13, 2025 (EZ Newswire) -- Botanic Tonics, opens new tab, maker of feel free, today applauded Florida Attorney General James Uthmeier's announcement making Florida the first state to ban the sale of 7-hydroxymitragynine (7-OH) products. The historic action, announced at Tampa General Hospital alongside FDA Commissioner Dr. Marty Makary, Florida Surgeon General Joseph A. Ladapo, MD, PhD, and other medical and enforcement officials, targets synthetic drug compounds that can be "more potent than morphine" while preserving access to traditional botanical products. Florida Targets Synthetic Drug, Not Natural Kratom Leaf Florida's ban specifically addresses concentrated 7-OH products that cause serious side effects including liver toxicity and seizures. These synthetic compounds are chemically distinct from the trace amounts that occur naturally in traditional kratom leaf through centuries-old drying processes. The FDA has expressed concern about widespread availability of concentrated 7-OH products in gas stations, corner stores, and vape shops — products that contain synthetic levels far exceeding what occurs in nature. Commissioner Makary previously stated that kratom leaf poses no significant public risk, while concentrated 7-OH represents an entirely different safety profile. feel free CLASSIC: Setting the Safety Standard Botanic Tonics' feel free CLASSIC exemplifies the clear distinction Florida's action reinforces. The product does not contain synthetic 7-OH, the compound now banned in Florida. Instead, feel free CLASSIC contains only whole kratom leaf sourced from noble varieties traditionally consumed for centuries in Pacific Island cultures, combined with kava root in water. With over 129 million servings sold since April 2020 and fewer than 0.001% complaints, feel free CLASSIC maintains the strongest safety record of any kratom leaf product on the market. The product contains no synthetic ingredients, no alcohol, and no concentrates — only natural botanical ingredients with every batch tested to ensure safe alkaloid levels. Clinical Validation Demonstrates Safety feel free CLASSIC remains the only product of its kind with proper clinical validation through a double-blind, placebo-controlled study published in the peer-reviewed medical journal Cureus. The research found no significant adverse effects across all dose ranges, confirming the safety profile of traditional botanical ingredients when properly manufactured and tested. Independent toxicologists from the University of Florida have reviewed all evidence and confirm the product presents no unreasonable health risks. The FDA conducted its own clinical trial using the exact same kratom leaf found in feel free CLASSIC and concluded the product shows no evidence of significant risk to consumers. Regulatory Leadership Creates National Framework Florida's decision creates a framework that other states may follow, with lawmakers set to codify the ban during the January 2026 legislative session. The action builds upon the FDA's July recommendation to schedule synthetic 7-OH under the Controlled Substances Act and June warning letters to seven companies illegally distributing these products. Botanic Tonics has consistently advocated for regulatory frameworks that distinguish between synthetic derivatives and traditional kratom leaf ingredients with documented safety profiles. The company manufactures all products in its FDA-registered, cGMP-certified facility in Broken Arrow, Oklahoma, using rigorous testing protocols that confirm product purity and natural alkaloid profiles. Consumer Education Remains Critical Florida's historic action validates the importance of consumer education about product distinctions in the marketplace. The difference between feel free CLASSIC and the synthetic 7-OH products now banned in Florida demonstrates why clear regulatory boundaries protect consumers while preserving access to traditional kratom leaf botanicals with proven safety records. Botanic Tonics remains committed to working with authorities at all levels to ensure consumers have access to safe, properly regulated botanical products backed by clinical evidence and manufacturing excellence. About Botanic Tonics Botanic Tonics is a plant-based, herbal supplement company headquartered in Broken Arrow, OK. Established in 2020, we produce kava-centric tonics under our feel free brand. Our signature product, feel free CLASSIC, is crafted with ancient functional plants to provide mood lift, chilled energy, and enhanced focus. Botanic Tonics' products are manufactured in an FDA-registered, cGMP-certified facility, and we actively support consumer safety regulations through transparent labeling and educational resources. Learn more at opens new tab. Disclaimer Warning: This product contains natural kratom leaf which, like caffeine and alcohol, may be habit-forming and harmful if consumed irresponsibly. Avoid if you have a history of substance abuse. When consumed as recommended, feel free CLASSIC has not been shown to cause any serious physical or social harm. Caution: Not for consumption by or sale to persons under the age of 21. May interact with certain medications — consult a licensed, qualified healthcare professional before use. Do not consume with excessive alcohol. This product is not intended for those who are sensitive to the active ingredients or women who are pregnant, nursing, or trying to become pregnant. To learn more, visit our Consumer Education page, opens new tab. Media Contact Botanic Tonicsmedia@ ### SOURCE: Botanic Tonics Copyright 2025 EZ Newswire See release on EZ Newswire
Reuters
31-07-2025
- Health
- Reuters
American Kratom Association Issues Policy Advisory to State Attorneys General Urging Immediate Crackdown on Dangerous 7-OH Products
WASHINGTON, DC, July 31, 2025 (EZ Newswire) -- Today, American Kratom Association (AKA), opens new tab issued a formal policy advisory to the attorneys general in every state that has enacted a Kratom Consumer Protection Act (KCPA), urging them to take immediate enforcement action against the unlawful sale of highly dangerous 7-hydroxymitragynine (7-OH) products that are misleadingly marketed as kratom. This action comes in response to the recent decision by the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) to recommend that 7-OH be placed into Schedule I of the Controlled Substances Act, opens new tab, citing overwhelming evidence of its opioid-like effects, high abuse potential, and serious risks to consumer safety. 'Let's be clear: 7-OH is not kratom,' said Mac Haddow, senior fellow on public policy for the American Kratom Association. 'It is a chemically altered, synthetic opioid analogue that hijacks the reputation of natural kratom to sell highly addictive and dangerous products to unsuspecting consumers. These are not traditional botanical kratom products — they are designer opioids with a new label.' 7-OH Sellers Exploiting Public Confusion The urgency of enforcement is amplified by recent reckless and disturbing communications from 7-OH product manufacturers, who are advising distributors not to remove these dangerous products from shelves despite the impending scheduling: "100% no reason to take 7-OH off shelves. Watch sales soar after this. You couldn't buy this kind of advertising!" — leading 7-OH manufacturer This brazen statement shows the callous disregard of bad actors for public health and safety. It is a direct attempt to capitalize on regulatory confusion while putting lives at risk. Every Sale Puts a Consumer at Risk The FDA has confirmed that 7-OH acts as a full mu-opioid receptor agonist, producing effects more potent than morphine, including respiratory depression, dependence, withdrawal, and overdose. Yet, these products are being marketed and sold over the counter in gas stations, smoke shops, and online platforms under the misleading guise of being kratom. 'Every 7-OH sale is a public health time bomb. Consumers have no idea they're buying a synthetic opioid, and the consequences can be fatal,' said Haddow. 'State attorneys general must act immediately to enforce existing laws under the KCPA and remove these products from the market.' KCPA Provides the Legal Tools While several states have enacted the KCPA, products that exceed safe 7-OH thresholds — or contain synthetically derived 7-OH — are explicitly illegal based on consumer protection laws designed to protect consumers from marketing deception. The AKA advisory urges attorneys general to use their statutory authority to: Federal Action Must Be Reinforced at the State Level With the DEA now considering the FDA's scheduling recommendation, state action is more important than ever to protect consumers in the interim period. 'The FDA has done its job. Now it's time for state enforcement agencies to do theirs. We are calling on every attorney general to step up and protect their citizens before any life is lost,' concluded Haddow. About American Kratom Association (AKA) American Kratom Association (AKA) is a consumer-based, nonprofit organization, focused on furthering the latest science as guidance for kratom public policy. AKA works to give a voice to millions of Americans by fighting to protect their rights to access safe and natural kratom. For more information, visit and learn more at Media Contact Mac Haddowmhaddow@ ### SOURCE: American Kratom Association (AKA) Copyright 2025 EZ Newswire See release on EZ Newswire
Reuters
30-07-2025
- Business
- Reuters
Botanic Tonics Applauds FDA Action on Synthetic 7-Hydroxymitragynine Products
BROKEN ARROW, OK, July 30, 2025 (EZ Newswire) -- Botanic Tonics, opens new tab today commended the Food and Drug Administration's announcement to recommend scheduling synthetic 7-hydroxymitragynine (7-OH) products, calling the action a critical step toward protecting consumers from dangerous opioid-like substances masquerading as natural botanical products. "The FDA's clear distinction between synthetic 7-OH concentrates and natural leaf kratom demonstrates the importance of science-based regulation," said Cameron Korehbandi, CEO of Botanic Tonics. "This action protects consumers while preserving access to the traditional botanical ingredients that millions of Americans rely on for their daily routines." Natural Leaf Kratom vs. Synthetic 7-OH: The Critical Difference Botanic Tonics has consistently advocated for regulations that distinguish between authentic kratom leaf products and synthetic derivatives. The company's feel free CLASSIC, opens new tab contains only natural leaf kratom with nearly undetectable levels of 7-OH, as confirmed by third-party laboratory analysis. "Our products contain trace amounts of 7-OH that occur naturally during the traditional drying process — levels that are dramatically different from the concentrated synthetic products now under FDA scrutiny," explained Korehbandi. "The difference between natural leaf kratom and synthetic 7-OH concentrates represents a night and day distinction in terms of safety and consumer protection." Supporting Evidence-Based Policy The FDA's action aligns with Botanic Tonics' long-standing position opposing the sale of isolated 7-OH products. The company has consistently maintained that: "We've been advocating for exactly this type of regulatory approach — one that protects consumers from synthetic derivatives while preserving access to traditional botanical ingredients with centuries of safe use," said Korehbandi. Commitment to Consumer Protection and Transparency Botanic Tonics manufactures all products in its FDA-registered, cGMP-certified facility in Broken Arrow, Oklahoma, using only natural leaf kratom that undergoes rigorous testing for purity and potency. The company's recent clinical trial, published in the medical journal Cureus, demonstrated the safety profile of feel free CLASSIC when used as directed. The company advocates for comprehensive regulatory standards that include: Looking Forward "Today's announcement validates our commitment to quality, transparency, and consumer education," concluded Korehbandi. "We will continue working with regulatory authorities and industry partners to ensure consumers have access to safe, properly regulated botanical products while protecting them from dangerous synthetic alternatives." Botanic Tonics continues to invest in clinical research, quality control measures, and consumer education initiatives to support the responsible use of traditional botanicals. About Botanic Tonics Botanic Tonics is a plant-based, herbal supplement company headquartered in Broken Arrow, OK. Established in 2020, we produce kava-centric tonics under our feel free brand. Our signature product, feel free CLASSIC, is crafted with ancient functional plants to provide mood lift, chilled energy, and enhanced focus. Botanic Tonics' products are manufactured in an FDA-registered, cGMP-certified facility, and we actively support consumer safety regulations through transparent labeling and educational resources. Learn more at opens new tab. Disclaimer Consume responsibly. feel free CLASSIC is for adults 21 years of age and older only. To learn more, visit our Consumer Education page, opens new tab. Media Contact Botanic Tonicsmedia@ ### SOURCE: Botanic Tonics Copyright 2025 EZ Newswire See release on EZ Newswire
Reuters
30-07-2025
- Health
- Reuters
Botanic Tonics Applauds FDA Action on 7-OH Products, Refutes Misleading Media Coverage Conflating Natural Leaf Kratom with Synthetic Concentrates
BROKEN ARROW, OK, July 30, 2025 (EZ Newswire) -- Botanic Tonics, opens new tab applauds the FDA's targeted regulatory action announced July 29, 2025, against concentrated 7-hydroxymitragynine (7-OH) products. We also seek to make our position clear and unequivocal following inaccurate media coverage that has confused consumers about the distinction between natural leaf kratom and synthetic concentrates. The Daily Mail's July 29, 2025 article about the FDA's 7-OH announcement contains key factual inaccuracies that conflate two very different categories of products. By including Botanic Tonics' product name and imagery alongside coverage of concentrated 7-OH substances facing potential federal scheduling, the article misrepresents both the nature of our offerings and the intent of the FDA's action. As FDA Commissioner Makary stated, the agency is 'not focused on natural kratom leaf products,' which contain only 'trace amounts' of 7-OH, in contrast to the 'semisynthetic 7-OH extracts' used to make new and more potent formulations. Botanic Tonics' feel free CLASSIC, opens new tab is made solely from noble kava root and natural kratom leaf. Misleading coverage like this not only spreads confusion in the marketplace but also risks undermining the FDA's own efforts to distinguish between traditional plant-based products and synthetic derivatives. About Botanic Tonics Botanic Tonics is a plant-based, herbal supplement company headquartered in Broken Arrow, OK. Established in 2020, we produce kava-centric tonics under our feel free brand. Our signature product, feel free CLASSIC, is crafted with ancient functional plants to provide mood lift, chilled energy, and enhanced focus. Botanic Tonics' products are manufactured in an FDA-registered, cGMP-certified facility, and we actively support consumer safety regulations through transparent labeling and educational resources. Learn more at opens new tab. Disclaimer Consume responsibly. feel free CLASSIC is for adults 21 years of age and older only. To learn more, visit our Consumer Education page, opens new tab. Media Contact Botanic Tonicsmedia@ ### SOURCE: Botanic Tonics Copyright 2025 EZ Newswire See release on EZ Newswire
Reuters
25-07-2025
- Reuters
Big Kratom Caught Paying Fake Protesters to Smear 7-OH Outside Las Vegas Trade Show
LAS VEGAS, NV, July 25, 2025 (EZ Newswire) -- This week, hired actors were spotted protesting 7-hydroxymitragynine (7-OH) outside the CHAMPS Trade Show in Las Vegas in a desperate attempt by Big Kratom to manufacture support for their campaign to pit kratom and 7-OH customers against each other. This ridiculous incident reveals just how far industry insiders will go to manipulate public perception and protect their own profits, even if it means faking public outrage and dividing the very community they claim to serve. A now-deleted Craigslist ad (see attached image) offered $100–$150 per day to 'peaceful protesters' for a one-day gig on July 23, calling for 75–100 'reliable individuals' to stage a 'high-visibility protest action.' The actors had matching t-shirts, but, according to people who engaged them, opens new tab, they did not have the slightest idea of what they were protesting. The paid actors had signs, opens new tab featuring a QR code (see also attached image) leading to a petition, opens new tab organized by John Ramsay, who works for MIT45, opens new tab: which is a founding member, opens new tab of the American Kratom Association (AKA) and a part of the Global Kratom Coalition (GKC), opens new tab. Both AKA and GKC are Big Kratom lobbying groups that have been attacking 7-OH in the media and with legislators across the country. Jeff Smith, national policy director of the Holistic Alternative Recovery Trust (HART), had the following statement: 'Buying protestors proves it: the war on 7-OH is a completely manufactured controversy. When you have to stage a protest, you don't have a real movement. Donors to the American Kratom Association and Global Kratom Coalition should be mortified that this is the kind of action that their donations are being spent on. 'Kratom in general, not just 7-OH, is facing an existential threat in state legislatures. Consumers lost kratom access in two more states this year, mostly because of a botched kratom industry strategy attacking 7-OH instead of promoting the positive about their own products. The evidence is clear: when the industry tries to divide customers into kratom and 7-OH blocks, we all lose. This industry has to accept that we succeed or fail together. I'd rather succeed. 'Big Kratom seems to think they can save their members' bottom line by burning the whole industry down, no matter how much their misguided strategy backfires. At HART, we fight for the rights of kratom and 7-OH users alike because we think people are more important than a silly industry turf war. 'HART is in Las Vegas this weekend at CHAMPS to call on the kratom industry to stop the infighting and join the push for evidence-based and reasonable regulations that protect access for everyone who relies on kratom and 7-OH, before it's too late.' About Holistic Alternative Recovery Trust (HART) Holistic Alternative Recovery Trust (HART) is a national nonprofit organization advocating for science-based policy, regulatory transparency, and access to safe, plant-based alternatives to opioids and other pharmaceuticals. 7-hydroxymitragynine (7-OH), a metabolite of mitragynine, the most abundant alkaloid found in kratom, is a new tool being used to combat opioid misuse and improve public health. HART strongly supports robust regulation to mandate that all 7-OH products are manufactured safely, are marketed transparently, and are kept out of the hands of children. Learn more at opens new tab. Media Contact HART Mediamedia@ ### SOURCE: Holistic Alternative Recovery Trust (HART) Copyright 2025 EZ Newswire See release on EZ Newswire
