
Beware this common medical device scam: ‘There is no way to know'
Vagus nerve stimulators are making waves as a potential way to relax, sleep better and improve gut health.
But an expert on the vagus nerve warns that noninvasive VNS devices may not deliver as promised.
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'There is no evidence that using these devices to deliver electricity into the ear or skin of the neck is actually stimulating the vagus nerve,' Dr. Kevin J. Tracey, president and CEO of Northwell Health's Feinstein Institutes for Medical Research, told The Post.
6 Dr. Kevin J. Tracey, president and CEO of Northwell Health's Feinstein Institutes for Medical Research, wrote a new book about the vagus nerve, 'The Great Nerve.'
Lee S. Weissman /Northwell Health
Tracey — who wrote the new book, 'The Great Nerve,' and is often called the 'founding father' of bioelectronic medicine — cuts through the noise of vagus nerve therapy to distinguish the beneficial from the buzz.
What is the vagus nerve?
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The vagus nerve is a complex network of over 200,000 fibers that acts as an information superhighway between the brain and major organs.
It's a paired structure — think two thumbs or two kidneys — with one on each side of your brainstem at about the level of your ears, descending through the neck and chest to reach the heart, lungs and gastrointestinal tract.
6 This diagram shows the branches of the vagus nerve in the neck.
vonuk – stock.adobe.com
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It regulates essential bodily functions like heart rate, breathing and digestion.
'The vagus nerve is the 10th cranial nerve and the longest nerve in your body,' Tracey said. 'It is also the only nerve that would cause death if cut on both sides.'
How can you stimulate the vagus nerve?
Deep breathing, gargling, humming, singing and cold water immersion are commonly suggested ways to stimulate the nerve, but Tracey cautions that 'the scientific understanding and proof for most of these suggestions are lacking.'
'Humming might stimulate a few hundred fibers connected to your voice box, but these aren't the same fibers that go to your heart or regulate inflammation,' he added.
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6 Humming is a harmless activity that may or may not stimulate your vagus nerve.
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Tracey does support implantable VNS devices that the Food and Drug Administration (FDA) has approved for the treatment of epilepsy, depression and stroke rehabilitation.
A pulse generator, similar to a pacemaker, is implanted in the chest, and a wire connects it to the vagus nerve in the neck. A doctor programs the equipment to deliver electrical stimulation at set intervals.
The noninvasive stimulators, meanwhile, are designed to be placed on the ear or neck to send the impulses.
6 There are two types of vagus nerve stimulators — an implantable device (shown here) and a non-invasive device that the user places on the neck or ear.
Pepermpron – stock.adobe.com
Tracey compared these devices to TENS units, which have been used for decades to deliver electricity through the skin to stimulate nerves and relieve pain.
He noted that small clinical trials suggest at-home VNS may ease headaches, back pain and anxiety, but there's a lack of large, well-controlled, randomized clinical trials to support these claims.
'There is no way to know whether the TENS unit is stimulating a branch of the vagus nerve or stimulating many other nerves as well,' Tracey said.
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'Stimulating a small number of fibers in the neck or ear is quite different from stimulating the vagus nerve itself as occurs by implanting an FDA-approved device.'
6 Non-invasive VNS devices are similar to TENS units (pictured here), which have been used for decades to deliver electricity through the skin to stimulate nerves and relieve pain.
praisaeng – stock.adobe.com
What conditions does VNS target?
'It is likely that the first conditions to be treated by vagus nerve stimulation will be rheumatoid arthritis, inflammatory bowel disease and multiple sclerosis, but rheumatoid arthritis is likely to be the first indication in the US,' Tracey said.
Rheumatoid arthritis is a chronic autoimmune disease that causes joint inflammation and pain. VNS can help by signaling the brain to tamp down inflammation.
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6 VNS may improve rheumatoid arthritis, a chronic autoimmune disease that causes joint inflammation and pain.
Khunatorn – stock.adobe.com
VNS is also being explored for longevity. World-famous biohacker Bryan Johnson, 47, said he applies electrical impulses to his ear 'at the first potential signs of sickness,' such as a sudden drop in heart rate variability.
Vagus nerve dysfunction can cause heart rate and blood pressure changes, digestive issues like nausea and bloating, fainting episodes, difficulty swallowing and chronic inflammation.
'If increased vagus nerve activity decreases chronic inflammation, it's reasonable to suggest it might improve health span and quality of life as people age,' Tracey mused. 'These ideas are being studied in laboratories and clinical trials worldwide.'
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Before purchasing a VNS device
Tracey recommends consulting with a physician before using a TENS unit or similar gadget to make sure you don't have cardiac, neurological or other risks. And buyers should beware.
'Calling a TENS unit a 'vagus nerve stimulator' does not mean the unit is actually stimulating the vagus nerve. It may or may not be,' Tracey said.
'It is not a requirement for marketing such devices that the name of the device has been proved to correspond to what is actually happening.'
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While they're readily found online, in brick-and-mortar stores and even gas stations as catch-all solutions to everything from fatigue to opioid withdrawal, the Food and Drug Administration says kratom and its key components are 'not lawfully marketed' in the US as a drug product, dietary supplement or food additive. The products, though, are gaining attention on social media, as TikTokers reveal disturbing interactions with teens going great lengths to get their hands on drinks like Feel Free. The shot-like capsules of kratom and other 'botanic' ingredients look innocent enough and line some gas station checkouts. National poison control centers documented 1,807 calls about kratom exposures between 2011 and 2017, and 'it's only been increasing since then,' Dr. Michael Greco, an emergency medicine physician in Florida, said. Patients on kratom 'can have a lot of agitation, sometimes even psychosis,' he added. 'You get sweating, you get dizziness, you get very high blood pressure or elevated heart rate.' On the other end of the spectrum, he noted, 'people might be totally unresponsive or just extremely drowsy and out of it.' While documented deaths from kratom are rare and typically involve other substances like fentanyl, critics say consumers are unaware of kratom's potential dangers. Manufacturers aren't required to verify if what is listed on the label accurately reflects what's inside the product. McKibban, for one, was told it was impossible to overdose on kratom; that he'd just throw up if he took too much, Mauldin said. The green cellophane bags he left behind had no instructions or warnings. 'I find it so frustrating when I get a recall from Costco over lettuce or they have a recall over some potato chip … and they pull it all off the market,' Mauldin, whose lawsuit alleges kratom is 63 times more deadly than other 'natural' products sold to consumers, noted. 'There have been hundreds of people killed from this, and they don't pull it. The government doesn't step in,' she added. An even more potent danger Experts are especially concerned with a highly potent, highly addictive kratom offshoot called 7-hydroxymitragynine, or 7-OH, which seems to have infiltrated the market in the past few years, said Dr. Robert Levy, an associate professor at the University of Minnesota who's board-certified in both addiction and family medicine. Many people don't know the difference. 'There's always been concern around kratom because if you take enough of it, kratom does act like an opioid, and people can become addicted to it and have withdrawal from it and overdose on it and ruin their lives on it, like anybody else that has a substance use disorder,' Levy said. 7-hydroxymitragynine, though, 'is much more addicting and much more problematic.' In fact, just last week, the FDA recommended classifying 7-OH as an illicit substance. '7-OH is an opioid that can be more potent than morphine,' FDA Commissioner Marty Makary, said in a press release. 'We need regulation and public education to prevent another wave of the opioid epidemic.' In the meantime, according to Levy, parents should be having open conversations with their kids about the appeals, dangers and addictive potential of kratom — and the fact that 'all-natural' or 'plant-based' doesn't necessarily mean safe. 'Arsenic is also from a plant,' he says. As for people who say kratom helps them wean off other substances 'and they can control their use and they're getting their life back together, then who am I to judge?' Levy said. 'I just worry that because they can't control the use of something, the part of their brain that controls the use of psychoactive drugs is fundamentally broken, and I worry they'll continue to take more and more of it until they develop a kratom use disorder.' '[If] the part of their brain that controls the use of psychoactive drugs is fundamentally broken, I worry they'll continue to take more and more of it until they develop a kratom use disorder,' he said. 'If your child or you or whoever is suffering from a substance disorder, you're not alone,' Levy added. 'Lots of people suffer from substance disorder. There is help, treatment works.' 'No money on my child's life' For Jennifer Young, that message came too late. The mom in Columbus, Ohio, first googled kratom a few years ago after her son, Johnny Loring, mentioned he was using it for anxiety. What she found didn't alarm her. 'I saw it's this 'all-natural, safe alternative,' and then people are like, 'It's wonderful, it saved my life, helps with my anxiety, helps with my pain, it's a cure-all,'' Young remembered. 'So I didn't really think it was that bad.' Plus, Loring, a delivery driver for a flooring company who loved fishing and playing guitar, found kratom helped him stay alert and communicate with his customers. He valued those relationships. 'Everybody loved Johnny,' Young said. 'He was the kind of guy that would give you the shirt off his back, the last dollar in his pocket. He didn't care if you needed a ride, he'd give it to you. Anything you needed, he would be there for you in a heartbeat.' Even when Loring started having seizures, neither Young nor clinicians traced them back to kratom. At the hospital, 'they told me that everything was fine and they referred me to a seizure clinic,' Young added. Loring never got the chance to go. Weeks later, at age 27, he collapsed during an annual mushroom hunting trip with the men in his family and his new girlfriend. By the time the ambulance got to him, he was dead. A toxicology report revealed deadly levels of mitragynine and gabapentin, a prescription painkiller, in his system. 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New York Post
8 hours ago
- New York Post
Our sons died on kratom — people don't realize it's so dangerous
Months before Jordan McKibban collapsed in his bathroom and never woke up, the 37-year-old prepared smoked salmon and home-grown canned peppers to entertain his big, blended family in their quiet Washington state community. Weeks before, he told his mom, Pam Mauldin, things were getting serious with the woman he was dating — his 'one big desire' to have kids was finally in reach, Mauldin recalled. Days before, he helped a friend plant a flower garden for a baby shower. 'He loved life. He loved doing things outdoors,' Mauldin told The Post. Advertisement Then, on the day of his death, McKibban went to his longtime job at an organic food distributor. When he got home, he mixed a tablespoon of a powdered kratom supplement into his lemonade. 11 Jordan McKibban died at age 37 while taking kratom, an 'all-natural' supplement available online and in stores. Courtesy Pam Mauldin 11 Jordan's mom, Pam Mauldin (second from right), spoke to The Post to warn other parents — and thinks kratom should be pulled from shelves. Courtesy Pam Mauldin Marketed as an 'all-natural' way to ease pain, anxiety, depression and more, kratom can appeal to health-conscious people like McKibban, who Mauldin says wouldn't even take ibuprofen for the arthritis in his hands. Advertisement But on that Tuesday in April 2022, a compound in the substance called mitragynine took McKibban's life, an autopsy report later showed. When Mauldin broke into his bathroom after a call from her grandson that day, she found McKibban lifeless. She performed CPR on her own son and shielded her eyes when medics carried his gray body away. 'I've lost my son. I've lost my grandchildren that I could have had, I've lost watching him walk down that aisle, watching him have a life that I get to watch with my other kids. I've lost enjoying these years with him,' Mauldin said. Advertisement 'I have to go to the cemetery, and I hate going to the cemetery. He shouldn't be there,' she added. From dizziness to nonresponsiveness Kratom products — sold in powders, gummies and energy-looking drinks — come from a plant native to Southeast Asia and can act like a stimulant at lower doses and a sedative at higher ones. 'Kratom does act like an opioid, and people can become addicted to it and have withdrawal from it and overdose on it.' Dr. Robert Levy, addiction and family medicine doctor While they're readily found online, in brick-and-mortar stores and even gas stations as catch-all solutions to everything from fatigue to opioid withdrawal, the Food and Drug Administration says kratom and its key components are 'not lawfully marketed' in the US as a drug product, dietary supplement or food additive. Advertisement 11 Kratom, which comes in powders, gummies and drinks, can have serious side effects. AP The products, though, are gaining attention on social media, as TikTokers reveal disturbing interactions with teens going great lengths to get their hands on drinks like Feel Free. The shot-like capsules of kratom and other 'botanic' ingredients look innocent enough and line some gas station checkouts. National poison control centers documented 1,807 calls about kratom exposures between 2011 and 2017, and 'it's only been increasing since then,' Dr. Michael Greco, an emergency medicine physician in Florida, said. Patients on kratom 'can have a lot of agitation, sometimes even psychosis,' he added. 'You get sweating, you get dizziness, you get very high blood pressure or elevated heart rate.' On the other end of the spectrum, he noted, 'people might be totally unresponsive or just extremely drowsy and out of it.' 11 Feel Free, shot-like capsules of kratom and other 'botanic' ingredients, have recently earned attention on TikTok. Feel Free Tonics While documented deaths from kratom are rare and typically involve other substances like fentanyl, critics say consumers are unaware of kratom's potential dangers. Manufacturers aren't required to verify if what is listed on the label accurately reflects what's inside the product. McKibban, for one, was told it was impossible to overdose on kratom; that he'd just throw up if he took too much, Mauldin said. The green cellophane bags he left behind had no instructions or warnings. Advertisement 'I find it so frustrating when I get a recall from Costco over lettuce or they have a recall over some potato chip … and they pull it all off the market,' Mauldin, whose lawsuit alleges kratom is 63 times more deadly than other 'natural' products sold to consumers, noted. 'There have been hundreds of people killed from this, and they don't pull it. The government doesn't step in,' she added. 11 'I've lost my son. I've lost my grandchildren that I could have had, I've lost watching him walk down that aisle, watching him have a life,' Mauldin said. Courtesy Pam Mauldin 11 'I have to go to the cemetery, and I hate going to the cemetery. He shouldn't be there,' Mauldin said. Courtesy Pam Mauldin An even more potent danger Experts are especially concerned with a highly potent, highly addictive kratom offshoot called 7-hydroxymitragynine, or 7-OH, which seems to have infiltrated the market in the past few years, said Dr. Robert Levy, an associate professor at the University of Minnesota who's board-certified in both addiction and family medicine. Advertisement Many people don't know the difference. 'There's always been concern around kratom because if you take enough of it, kratom does act like an opioid, and people can become addicted to it and have withdrawal from it and overdose on it and ruin their lives on it, like anybody else that has a substance use disorder,' Levy said. 7-hydroxymitragynine, though, 'is much more addicting and much more problematic.' Advertisement In fact, just last week, the FDA recommended classifying 7-OH as an illicit substance. '7-OH is an opioid that can be more potent than morphine,' FDA Commissioner Marty Makary, said in a press release. 'We need regulation and public education to prevent another wave of the opioid epidemic.' 11 People on kratom can experience agitation, psychosis, sweating, dizziness, hypertension and elevated heart rate. Courtesy Pam Mauldin In the meantime, according to Levy, parents should be having open conversations with their kids about the appeals, dangers and addictive potential of kratom — and the fact that 'all-natural' or 'plant-based' doesn't necessarily mean safe. 'Arsenic is also from a plant,' he says. Advertisement As for people who say kratom helps them wean off other substances 'and they can control their use and they're getting their life back together, then who am I to judge?' Levy said. 'I just worry that because they can't control the use of something, the part of their brain that controls the use of psychoactive drugs is fundamentally broken, and I worry they'll continue to take more and more of it until they develop a kratom use disorder.' 'The level of kratom shocked me. It overwhelmed me. It made my gut sick. I didn't realize it was so addicting.' Jennifer Young '[If] the part of their brain that controls the use of psychoactive drugs is fundamentally broken, I worry they'll continue to take more and more of it until they develop a kratom use disorder,' he said. 'If your child or you or whoever is suffering from a substance disorder, you're not alone,' Levy added. 'Lots of people suffer from substance disorder. There is help, treatment works.' 11 Jennifer Young's son, Johnny Loring, was taking kratom — and she didn't worry because it's marketed as an 'all-natural, safe alternative.' Courtesy Jennifer Young 'No money on my child's life' For Jennifer Young, that message came too late. The mom in Columbus, Ohio, first googled kratom a few years ago after her son, Johnny Loring, mentioned he was using it for anxiety. What she found didn't alarm her. 'I saw it's this 'all-natural, safe alternative,' and then people are like, 'It's wonderful, it saved my life, helps with my anxiety, helps with my pain, it's a cure-all,'' Young remembered. 'So I didn't really think it was that bad.' 11 'Everybody loved Johnny,' Young says. 'He was the kind of guy that would give you the shirt off his back, the last dollar in his pocket.' Courtesy Jennifer Young Plus, Loring, a delivery driver for a flooring company who loved fishing and playing guitar, found kratom helped him stay alert and communicate with his customers. He valued those relationships. 'Everybody loved Johnny,' Young said. 'He was the kind of guy that would give you the shirt off his back, the last dollar in his pocket. He didn't care if you needed a ride, he'd give it to you. Anything you needed, he would be there for you in a heartbeat.' Even when Loring started having seizures, neither Young nor clinicians traced them back to kratom. At the hospital, 'they told me that everything was fine and they referred me to a seizure clinic,' Young added. Loring never got the chance to go. Weeks later, at age 27, he collapsed during an annual mushroom hunting trip with the men in his family and his new girlfriend. By the time the ambulance got to him, he was dead. A toxicology report revealed deadly levels of mitragynine and gabapentin, a prescription painkiller, in his system. 11 At age 27, Loring collapsed during an annual mushroom hunting trip with the men in his family and his new girlfriend. By the time the ambulance got to him, he was dead. Courtesy Jennifer Young 11 'Our house is silent now. The void of Johnny is just loud,' Young says. 'I just hope that someday I can get back to enjoying things, because I know he would want me to. But right now, I don't enjoy anything.' Courtesy Jennifer Young 'The level of kratom shocked me. It overwhelmed me. It made my gut sick,' said Young, who later found about 20 packs of kratom, which he drank with orange juice, around Loring's room. 'I didn't realize it was so addicting.' Like Mauldin, Young is pursuing a wrongful death lawsuit. But, she added, 'there's no amount of money I could put on my child's life.' After Loring's death last spring, she spent a year in bed and got on antidepressants for the first time. One of her other children has been hospitalized for panic attacks. Christmas was 'miserable,' she said. 'Our house is silent now. The void of Johnny is just loud,' Young added. 'I just hope that someday I can get back to enjoying things, because I know he would want me to. But right now, I don't enjoy anything.'


New York Post
a day ago
- New York Post
Addictive natural drink Feel Free is hooking young people with horrible consequences: ‘literal flakes of skin flying off'
Feel Free appears as innocuous as a trendy new Kombucha, and it's billed as a natural way to get a little boost. Manufacturer Botanic Tonics advertises the drink as filled with 'plant ingredients' and perfect for 'whenever you want a mood lift, a caffeine-free energy boost, or a little extra focus.' But some hapless customers who picked up a little blue bottle at a convenience store or gas station learned the hard way the drinks — which contain kava and kratom extracts — can be severely addictive. Advertisement Jasmine Adeoye cut out alcohol in 2022 for a 'lifestyle change,' and heard about Feel Free on the Skinny Confidential podcast, where it was billed as a good alternative to social drinking. 9 Jasmine Adeoye started using Feel Free as an alternative to alcohol. Courtesy of Jasmine Adeoye 'The two hosts were actually taking a hiatus from alcohol and they were talking about Feel Free and how it was a really great alcohol alternative for sober people, and I was looking for something like that,' Adeoye, 30, of Austin, Texas, said. Advertisement When she heard about it yet again on Joe Rogan's show, she decided to try it. 'I wanted to overcome the social anxiety of not having alcohol anymore, and it made me feel really good, but from then on, it was just a slow progression,' she recalled. 'I had no idea, going into it, that it was addictive.' She was able to use it moderately for a year when in social drinking situations, but then a stressful job as an account manager pushed her into addiction in 2023. 9 Adeoye was using as much as twelve bottles of Feel Free a day at the peak of her addiction. Courtesy of Jasmine Adeoye Advertisement 'It started to progress to, one a day slowly, and then two to three a day, and then upwards of five or six, and at the absolute worst, like twelve bottles a day,' she admitted. 'I was spending easily $3,000 a month.' Pharmacist Ethan Melillo warns the combination of kava and kratom, both of which are legal ingredients in the US, is highly addictive. 'This combination is something you don't want to be mixing together,' he told The Post. 'I definitely think it should be banned. They're both regularly available supplements, but what concerns me is the combination of the two of them.' Kava is a depressant, while Kratom is a stimulant — which means they have opposite effects on the body. Advertisement Melillo, who is based in East Greenwich, Rhode Island, explained that kratom and kava each bind to different receptors in the brain, and can be extremely overstimulating in combination. 9 Pharmacist Ethan Melillo warns that the combination of kava and kratom makes Feel Free especially addictive. Courtesy of Ethan Melillo Kava, which is used to reduce stress and anxiety, binds to the same receptors as benzodiazepine drugs, like Xanax and Valium. Kratom interacts with the same receptors as opioids, which poses a risk of addiction and withdrawal. 'What I'm seeing is people [consuming] like two, three, four [drinks] a day, because once you build that tolerance, your body will want more of it,' he explained. 'I'm not surprised that people are getting addicted to this, and that's what's so concerning about supplements. Usually they will only get pulled after people are having side effects.' Adeoye went to great lengths to hide her dependence: 'I would hop around from gas station to gas station because I was so embarrassed about the amount that I was buying. I would even get them on UberEats sometimes so I didn't have to face anyone.' She says her addiction took a toll physically and emotionally. 9 Jasmine Adeoye was able to quit Feel Free cold turkey but went through withdrawal. Courtesy of Jasmine Adeoye Advertisement 'I was lethargic, depressed, anxious, barely able to get out of bed,' she said. 'I was throwing up from the kratom, and the kava can make your skin dry, like alligator skin, literal flakes of skin just like flying off.' But she finally fessed up to her fiancé and her mom in March of 2024 and cut herself off cold turkey. She went through four days of miserable withdrawal, followed by two weeks of strong cravings, and finally felt fully back to herself after six months. Although FeelFree is a 21+ age restricted item, kids have been figuring out how to get their hands on them. Instagram creator Michael Brown posted a video to his followers warning about the drink after he says he was approached by 'a child' who was 'maybe fourteen years old' at a gas station begging him to purchase a Feel Free for him. Advertisement 9 Feel Free is marketed as a natural, plant-based way to get a quick boost. Feel Free Tonics 9 Feel Free is available for purchase at gas stations, convenience stores, and CBD shops. Feel Free Tonics 'He comes up to me and he says, 'Hey can you buy me some Feel Free,'' Brown alleged. When he informed the attendant, he was told she has some customers coming in five to six times a day to purchase it and that 'people act like… they have heroin addictions over this little drink.' Some users of Feel Free start using the product because they think it's a healthy alternative to other drugs. Advertisement Chris Oflyng first started using kratom powder at age 19, as a natural way to ween off of prescribed Adderall. 'I was like, 'Oh, [the Adderall] is not a positive thing in my life, it's something I should stay away from,' he told The Post. Five years later, in 2021, Feel Free hit the market — and Oflyng found himself hooked on its combination of kava and kratom. 9 Chris Oflyng has struggled with an on and off addiction to Feel Free for years. Courtesy of Chris Oflyng 'Products like Feel Free are really, really awful,' the 28-year-old from Madison, Wisconsin, said. 'I developed a codependency of using kava and kratom, due to the introduction of that product, and I don't think I knew it was as addictive as it could be in that combination.' Advertisement He describes the sensation as 'something like relaxation, but also stimulation.' 'At first it worked really, really well and gave me what I perceived to be an enhanced focus,' Oflyng, who works in donor development, said. 'I was able to accomplish more. But then the effect started to fade, and once you're addicted to it, it's just chasing the relief after cravings.' Oflyng has struggled with addictions to Feel Free 'on and off for the past couple years' and has been in and out of treatment for his addiction. 9 Oflyng says Feel Free products made him feel depressed. Courtesy of Chris Oflyng 9 Oflyng claims he has spent at least $40,000 on Feel Free and kratom products throughout the years. Courtesy of Chris Oflyng 'I would buy Feel Frees every time I would relapse,' he explained. 'You could just get them from a smoke shop or a gas station. It's just so readily accessible.' Oflyng says Feel Free derailed his life. 'The biggest downside was the depression that came with it for me,' he recalled. 'I've made a lot of progress, but, looking back and talking about it now, it's just like, why haven't I seized a lot of opportunities in my life? And I can point it all back to kratom and kava.' Oflyng estimates he's spent 'at least $40,000 over the years' between kratom powder and Feel Free drinks. 'A lot of people might be like, 'Oh, it's a plant, it's natural,' but it will catch up with you,' he warned.