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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: AMA sent a letter to the FDA urging more regulation of botanical products. Risks related to kratom usage should be taken \u201cseriously.\u201d AMA wants the FDA to hold botanical products derived from substances such as cannabis and kratom to the same scientific standards they maintain for approving other conventional drugs. In a letter to the FDA, John J. Whyte, MD, MPH, AMA CEO and executive vice president, noted AMA is \u201cdeeply concerned\u201d about the widespread use of these \u201cnatural\u201d products without research-based evidence, and \u201cstrongly recommends\u201d the FDA regulate them and determine their efficacy through research and clinical trials.
Willie Underwood III \u201cAs botanical manufacturers develop increasingly potent products in everything from gummies and powders to oils and injections, consumers are becoming the real-world guinea pigs \u2014 and suffering tragic consequences, including dependence, substance use disorders, overdose, and death,\u201d AMA President Willie Underwood III, MD, MSc, MPH, said in a press release. \u201cCalling something \u2018natural\u2019 doesn\u2019t make it safe. We need science, not social media hype, to determine what belongs in our medicine cabinets.\u201d AMA \u201csupports innovation in drug design and development,\u201d but also \u201curge extreme caution\u201d when products are marketed outside of the scientific process, including botanical health products, Whyte wrote. Anita Gupta, DO, PharmD, MPP, FASA, adjunct assistant professor of anesthesiology and pain medicine at Johns Hopkins School of Medicine, applauded AMA\u2019s insistence on holding botanical drugs \u201caccountable.\u201d \u201cWe need better standards across the board to ensure that we\u2019re proving safety and efficacy for all ingested products,\u201d she told Healio. \u201cDay in, day out, patients come in to see their doctor, and they don\u2019t routinely mention these products, herbal, botanical, natural, however you want to describe them, because they don\u2019t think of them as drugs. That needs to change. These products can impact bleeding, blood pressure and metabolism of certain drugs. It\u2019s critical that we and patients treat botanicals for what they are, drugs that belong on a medication list.\u201d For instance, products made from kratom, a tropical tree from Southeast Asia, have been frequently used to self-treat various conditions, including anxiety, coughing, depression, diarrhea and pain, according to FDA. Healio previously reported the number of poison control calls related to kratom exposure increased 1,200% between 2015 and 2025. Whyte described AMA as \u201cpleased\u201d with the Drug Enforcement Agency emergency action against kratom compounds mitragynine pseudoindoxyl, commonly known as MGPI, MGM-15 and MGM-16. \u201cThe AMA supports legislative and other efforts banning synthesized, purified, or derivative products from kratom for marketing, distribution, promotion, and sale, including but not limited to unregulated mitragynine along with the 7-hydroxymitragynine [7-OH] and MGM-15 market,\u201d Whyte said. \u201cAccordingly, the AMA has worked with multiple medical societies to support new laws protecting consumers from kratom and 7-OH products within their states.\u201d Gupta emphasized the dangers of kratom should be taken \u201cseriously.\u201d \u201cPeople often self-treat with kratom when other medications for pain are not working appropriately, or their treatments have failed in some way,\u201d she explained. \u201cKratom has morphine effects, and 7-OH, which is a known compound derivative of kratom, has morphine effects. This is a red flag. Uncontrolled products are not the answer to pain treatment failure. There are rigorous trials for approved medications that we have very clear understanding how to dose, and we really need to have patients understand the risk.\u201d Gupta noted the same type of research that has been put into cannabis is needed for kratom. Healio has reported on multiple investigations into cannabis, healthcare and outcomes, including: AMA continues to support \u201cadequate and well-controlled\u201d studies investigating cannabis and related cannabinoids, and \u201cencourage expanded research,\u201d Whyte wrote. He added AMA wants \u201csufficient funding\u201d and supply of products and placebos for studies, and \u201csafeguards for cannabis clinical research protocols and the development of a model informed consent form for institutional review board evaluation.\u201d Whyte implored the FDA to \u201cnot\u201d allow political interests to \u201coverrule scientific evidence.\u201d Gupta described the current time as historic for the number of nonregulated products individuals take for their health, and emphasized \u201cnatural is simply a marketing word, not a safety standard.\u201d \u201cIf a product is potent enough to really help someone for a medical condition, it is also potent enough to cause harm,\u201d she said. \u201cIt should have to prove itself the same way every other drug does on the market.\u201d For more information: Anita Gupta, DO, PharmD, MPP, FASA, can be reached at www.anitagupta.com. Published by: Sources\/Disclosures Source:
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Disclosures:
Gupta reports serving as a former US FDA special government employee, senior advisor to Milken Institute, advisor to Gates Foundation and member expert to World Economic Forum.
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