All Kinds
At Oasis, no one seems concerned about the hubbub in Washington. Owner Robert Roskind says the controversy has only improved business by focusing attention on what he says is still a little-known plant with huge benefits and few drawbacks. “Except for the rare upset stomach or lightheadedness, it has helped nearly everyone,” he said. “And it’s cheap. I have about 300 customers and most come here several times a week. Some buy take-home packages.”
With subdued lighting, soft music and mystical artwork, Oasis has a peaceful vibe. Customers are happy to talk about their reasons for taking kratom, and they vary widely.
A group of University of North Carolina students from nearby Chapel Hill sit on floor pillows in a corner, reading and working on laptops. Kratom sharpens their focus when they need to study for an exam, one student said. "It's like coffee without the jitters."
A 27-year-old tattooed chef from Brooklyn said he started drinking kratom to relieve withdrawal symptoms after he decided to quit heroin on his own three months ago. A conservatively dressed 22-year-old fraternity brother said kratom has helped him stop binge drinking.
A woman in her 40s, recovering from brain cancer therapy, says it relieves her anxiety and improves her sense of well-being. Two women who work with preschoolers say it lowers their stress level. And a 29-year-old construction worker says it keeps his fibromyalgia symptoms, including pain and fatigue, at bay so he can get up and work every day.
Even among the diverse crowd here at Oasis, Bob Whyte, a well-dressed 80-year-old businessman from Chapel Hill stands out. A self-described straight-laced "boy scout," he said he’s been drinking kratom three times a day to relieve severe back pain from failed surgery.
"I'd been taking tramadol and hydrocodone consistently for two years when I found out about kratom," he said. Whyte said his doctors didn't want him to keep taking the highly addictive prescription painkillers, and they had no objections when he told them he was switching to kratom.
At first, Whyte said he was a little fearful of trying the plant-based medicine. Roskind gave him a kratom brownie and suggested he eat half of it at home.
"I picked a day when I wouldn’t be driving and sat on the front porch and had half a brownie. I waited a half-hour and felt fine, so I had the other half. That’s when I had a little happy moment there on the porch," he said sheepishly.
Since that July morning, Whyte said he's figured out what dose is best for him — enough to bring his pain down to a tolerable level without feeling drowsy. Now he says he's telling everyone he knows about kratom.
Bob Whyte (left) chats with Robert Roskind, owner of Oasis cafe in Carrboro, North Carolina, over a cup of kratom. Christine Vestal, The Pew Charitable Trusts
Research Needed
Despite rave reviews from kratom users, most physicians and researchers argue that research using human clinical trials is needed to accurately determine the leaf powder’s potential harms and benefits. They also insist that oversight of commercial sales of the plant is needed to ensure consumers are getting high-quality, uncontaminated products.
But scientists and other stakeholders differ about whether sales of the plant should be curtailed in the meantime.
The American Society of Addiction Medicine argued in comments to the DEA last year that the whole botanical product, like the powder sold at Oasis, should be made illegal to prevent people with addictions from trying to use it to recover. Since three FDA-approved medications exist that have proven safe and effective, using kratom to treat opioid addiction presents an unnecessary risk for people with addictions, the group said.
At the same time, they recommended that what appears to be the plant’s primary active ingredients, mitragynine and 7-hydroxymitragynine, should remain legal so they can be researched for their pain relief and addiction treatment potential.
Oliver Grundmann, an associate professor of medicinal chemistry at the University of Florida College of Pharmacy, has surveyed kratom users and found that very few report becoming addicted and most use it to treat chronic pain, mental health conditions and drug addiction.
"I'm questioning whether we are doing any good by banning kratom," Grundmann said. If states and the federal government make kratom illegal, he said, it would not only slow the progress of research, but it would also leave many kratom users no choice but to switch back to painkillers or heroin.
The US Food and Drug Administration today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs.
The warning letter explains how the claims made in the promotional materials for Legal Lean Syrup and Coco Loko demonstrate that the products are intended to be used as alternatives to illicit street drugs and that the products, as labeled and marketed, may pose safety concerns. Drug abuse is a serious public health issue, and the FDA is concerned that products like Legal Lean Syrup and Coco Loko encourage drug abuse in individuals, including minors. Street drug alternatives are products that claim to mimic the effects of recreational drugs and are intended to be used for recreational purposes to affect psychological states.
“As a physician and a parent, I’m deeply troubled by the unlawful marketing of these potentially dangerous products, especially since they are so easily accessible by minors. Encouraging the use of snortable chocolate as an alternative to illegal street drugs is not acceptable – there are very real consequences to snorting any powder, not to mention the societal dangers of promoting drug abuse,”’ said FDA Commissioner Scott Gottlieb, M.D. “At a time where drug addiction is threatening the fabric of American society, we must take action when we see efforts that may further fuel illicit drug abuse. We’ll continue to vigorously target bad actors that sell unapproved products, including products that contain undeclared drug ingredients.”
Coco Loko is described as a “snuff” and promoted to be “snorted” (inhaled intranasally). Intranasal administration of a powder substance can trigger spasms of the vocal cords making it difficult to speak or breathe (laryngospasm) or tightening of the muscles that line the airways in the lungs (bronchospasm) and may also induce or exacerbate asthma. The ingredients listed on the product label for Coco Loko also include taurine and guarana, neither of which have been evaluated for intranasal administration.
An FDA laboratory analysis found that Legal Lean Syrup contained the active pharmaceutical ingredient doxylamine, which was not included in the product labeling. FDA-approved products that contain doxylamine warn against its use with alcoholic beverages and instruct people with certain medical conditions to consult a physician before use. Furthermore, the inclusion of undeclared doxylamine in Legal Lean Syrup poses a potentially serious risk to those who have already had adverse reactions to this ingredient and whose physicians have advised them to avoid it. In general, products that contain undeclared drug ingredients pose a serious health risk, because consumers with underlying medical issues may take the products without knowing of any potential side effects or interactions.
The FDA has requested that Arco Globus Trading LLC (dba Arco Globus International), Legal Lean LLC and LegalLeanStore.com respond to the FDA within 15 working days and include a statement of how the issues noted in the warning letter will be corrected. The warning letter also states that failure to correct violations may result in regulatory action such as seizure or injunction.
Health care professionals and consumers should report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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