FDA is cracking down on the illegal marketing of Kratom, saying it is not a cure for opioid addiction. The Centers for Disease Control and Prevention (CDC) says that kratom, an herbal supplement, was a cause of death in 91 fatal overdoses in the United States from July 2016 to December 2017.
Federal health officials issued warnings to two companies that allegedly made unproven claims about the potential health benefits of the supplement.
The US Food and Drug Administration said that Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina, illegally sold products containing kratom that claimed to treat or cure opioid addiction and withdrawal symptoms, among other health conditions that the supplement is not proven to treat.
“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” said Acting FDA Commissioner Ned Sharpless in a statement. “As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.”
Kratom, a plant that is native to SouthEast Asia, is currently not FDA-approved for any medical use. With increasing attention from the FDA concerning the marketing strategies used to sell the herbal supplement, the agency issued warnings against the companies.
Advocates of kratom say that the risks have been blown out of proportion by health officials. They say that the supplement can be used to help addicted individuals wean themselves off of harmful opioids. However, the FDA says that kratom carries risks of abuse and addiction, similar to opioids. In fact, the product has been linked to cases of overdose deaths.
In its warning letters, FDA cited examples of both companies claiming that kratom can treat addiction—despite not being approved by the FDA for such uses. Click the link to see Oklahoma's top rehab placement programs.
Furthermore, the FDA also said that these companies made unproven claims relating to other benefits of kratom such as pain, depression, anxiety, and cancer. The agency then gave the suppliers 15 days to respond, or otherwise face law enforcement action.
“Health fraud scams like these can pose serious health risks,” the FDA said in a statement. “These products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies.”
The American Kratom Association, an advocacy organization for the supplement’s potential benefits, said that up to 5 million people in the US are using kratom. The National Institute on Drug Abuse says that the herbal supplement interacts with opioid receptors in the brain to ease pain and produce sedation and pleasure. CDC said kratom has become increasingly more popular in recent years, but they also said that kratom was behind at least 91 fatal overdoses in the United States.
Kratom is commonly sold at smoke shops, gas stations as a powder or in a capsule. It is also available online. However, both the FDA and its advocates have raised concerns over kratom tainted with other harmful contaminants being sold.
The current opioid epidemic is now being considered the worst drug crisis in US history, with over 130 people dying from opioid-related overdose every day.
Kratom supporters, however, cite past reports suggesting it has low toxicity and has milder withdrawal symptoms than opiates. The FDA said more research is needed on the safety of kratom, including how it interacts when mixed with other drugs.
If someone in the family is struggling with opioid or alcohol addiction, it is important to seek help. A combination of medical detox and behavioral therapy can go a long way in the fight against drug abuse. But because every individual is affected by addiction differently, a comprehensive program tailored to their specific needs is necessary. Look for a nearby addiction treatment facility today and find out how drug treatment programs work.
SOURCE: Press Advantage [Link]
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