FDA at odds with Kratom

This week the FDA again cracked down on marketers and sellers of products containing the stongest kratom product, an herbal plant botanical used recreationally and as medicine but is not legally marketed in the U.S. as a drug or dietary supplement.

The FDA recently issued warning letters to Cali Botanicals of Rancho Cordova, CA, and Kratom NC of Wilmington, NC , ”for illegally selling unapproved, misbranded kratom. Making claims about their product’s ability to treat or cure opiate addiction and withdrawal symptoms.”

The latest legal warnings are just two of several the FDA has issued to alert kratom consumers about what it says are the serious risks associated with the use of the products. Of course we know big pharma is pressuring the FDA because kratom cuts into the suboxone profits.

The herb is legal on the federal level, although the Drug Enforcement Administration (DEA) has considering labeling it a Schedule I drug for years now . a category that includes heroin, marijuana, LSD, and ecstasy. Kratom is illegal in six states, Washington, D.C., and several cities, according to the American Kratom Association. It has been on the DEA’s list of drugs and chemicals of concern for years while the kratom lobby has gained congress members approval.

The FDA has approved no uses for green maeng da kratom powder, and the agency says it has received concerning reports about its safety, including claims of deaths. The two companies use websites and social media to make unproven claims, such as saying the plant acts like morphine, that it can be used to overcome opiate addiction and can manage chronic pain, help depression, anxiety, diabetes, and fatigue and protect against cancer, the FDA says.

By some scientists’ research, there are between 10 million and 15 million kratom consumers in the US alone. They are using the natural pain relieving substance for everything from chronic pain relief to replacement for their morning coffee. It is not an illicit substance; unless you live in one of the six states where kratom possession is criminalized, or are part of the US Army or Navy, which also banned the drug, kratom capsules, extracts, and teas are legal to buy and sell. However, after finding kratom in the systems of dozens of people who have died of drug overdoses, the federal government has been considering a total ban. It warns consumers of potential opioid-like effects, though scientists have questioned the FDA’s methodology in coming to that conclusion. Some people, like Day, will tell you kratom saved their lives. Others ask her if she’s selling “legal heroin.”

Like many high-value crops (especially semi-illicit ones), the kratom industry is also built on frequently exploitative labor practices, mostly in remote, rural areas in Indonesia. According to Day, who imports her kratom from the country, Indonesia’s drug enforcement agency, the BNN, has been under pressure from the US to ban kratom production by 2022, imperiling the native kratom farmers’ livelihoods.

So the DEA and FDA’s worries aren’t unwarranted. “They are rightly concerned about any substance that they have very little control over that patients and consumers are using to self-treat medical conditions,” the University of Florida’s Grundmann says. “When you talk about opioid or alcohol  withdrawal, depression, anxiety—that usually belongs in the hands of a medical professional.” Few seem to think that calls for a ban, though. “If we completely cut off any legal way for those consumers to get kratom, then we don’t have any oversight left.”

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