FDA Kratom Investigation Comes to a Close

July 05, 2018 Articles, News

On July 2nd, the US Food and Drug Administration reached its final conclusion regarding kratom. After a Salmonella outbreak led to months of investigation and much blowback from the kratom community at large, the FDA issued a statement, concluding that it is just not safe for the public to take a gamble on products containing the leaves of the Mitragyna speciosa plant.

It all started in May when a multistate outbreak was traced back to kratom products. At the time, the Center for Disease Control & Prevention (CDC) reported a 50 percent increase in the case count in a span of just three weeks.

After a substantial number of those cases were hospitalized for the illness, the FDA stepped in to get to the bottom of it. On April 3rd, they ordered an unprecedented mandatory recall on Triangle Pharmaceuticals after the company refused to voluntarily recall their kratom products.

The recall order called for all powdered kratom products manufactured, processed, packed or held by Triangle Pharmaceuticals, LLC to be handed over. This came after the usual voluntary recall order with which other kratom vendors had glady cooperated.

At the time, it seemed as though everything could be easily resolved. After all, most reputable kratom vendors regularly submit their inventory for third party testing to ensure quality and safety. But that no longer appears to be the case as the FDA is now going after kratom like it stole their lunch money.

They are saying that kratom not only has addictive properties and potential for serious harm but, also, a significant risk of Salmonella. All of this is true, to an extent, but kratom users can be excused for feeling like they are using an isolated incident to push a national agenda.

As most of us already know, the DEA has been trying to ban kratom for a number of years and came close back in 2016 until societal outcry convinced them to postpone the scheduling of kratom and open it up to public comment.

Of the 23,232 comments they received in a six-week period, 99.1 percent supported kratom remaining legal. This was shocking to no one familiar with kratom since an overwhelming number of US citizens have found it useful. People believe kratom can help manage their anxiety, relieve their pain and treat their depression, to say nothing of its anti-oxidant and antidiarrheal properties.

Nevertheless, the FDA has made up its mind and FDA Commissioner Scott Gottlieb has said, “It appears the Salmonella problem with kratom uncovered earlier this year has probably been occuring for some time and is ongoing. We have closed our outbreak investigation, concluding that anyone consuming kratom may be placing themselves at a significant risk of being exposed to salmonella.”

This is funny to those who follow the news or even so much as make weekly visits to a grocery store. Earlier this year, the largest E. coli outbreak in more than a decade was linked to romaine lettuce sold at supermarkets across the country.

This outbreak caused the death of five people, but the CDC closed the book on it prematurely, assuming the outbreak had been contained. Now, just two days ago, the strain was traced back to a tainted irrigation canal in Yuma, Arizona.

Commissioner Gottlieb announced this in a statement, but gave no reason for why it took so long for them to discover the origins of the bacteria. Perhaps he was too busy concluding that kratom is a dangerous substance.

One thing he most certainly wasn’t doing was informing the public of all the facts. No deaths related to the kratom Salmonella outbreak have been reported and only 38 people were hospitalized. This is rather contained when compared to the worst Salmonella outbreaks in recent US history.

For instance, in 2009, PCA peanut butter left 714 people ill and nine dead. In 2011, Cargill ground turkey caused 136 cases of serious illness and one death. In 2013, Foster Farms chicken led to 634 documented illness and, finally, in 2015, cucumbers from Mexico resulted in a staggering 907 illnesses and one death.

Food-borne illnesses are more than common, they’re almost expected at this point. Over the years, we’ve accepted the fact that if we order a Taco Salad or a Power Bowl at Taco Bell that we might end up with E. coli. We’ve come to terms with the possibility of contracting C. diff from eating out.

Despite all of this, you don’t see the FDA coming out and telling people that cucumbers are dangerous or that peanut butter kills. But the battle to ban kratom forges on regardless of studies that have proven its efficacy as a natural analgesic (pain reliever) and anxiolytic (anti-anxiety herb).

Instead, we are told that we should avoid it at all costs as if it were heroin or Oxycodone or Roxycodone or Xanax or Hydrodone or Fentanyl or any of the other countless drugs pushed on us by Big Pharma, all of those heavily addictive and dangerous drugs that are approved by…wait for it…the FDA!

Commissioner Gottlieb’s closing statements are, perhaps, the most revealing. “As we have previously stated, there are no proven medical uses for kratom and the FDA strongly discourages the public from consuming kratom. The subsequent findings of this investigation only strengthen that public health recommendation. Kratom is an inherently addictive product that can cause harm, which is reason enough not to consume it.”

Fair enough, but then Oxycodone is an inherently addictive product that can cause harm. So why, then, did the FDA approve it for medicinal use? Maybe it has something to do with the fact that developing a drug and bringing it to market costs billions of dollars and millions of that money are stuffed in the FDA’s pockets.

As of 2016, a prescription drug application with clinical data carried a fee of $2,038,100. That’s a lotta cheddar.

Greed aside, Gottlieb’s claims that no medical uses have been proven is like saying that one cannot prove that the ocean is made up of water. After all, specialists have even used kratom as part of their treatment programs.

A diverse coalition of supporters have also attested to kratom’s purported benefits and have come out of the woodwork to advocate for it since learning of recent legislative attempts to schedule it as a controlled substance.

There is much concern at the moment for the future of kratom in the US as the House of Representatives have passed the SITSA Act, a bill whose vague language about substances similar in nature to controlled substances could land them on a list of controlled substances themselves.

Kratom users are urged to contact the American Kratom Association to learn more about how you can affect change in Washington and make sure that kratom remains a legal Ayurvedic herb. The FDA’s investigation may be over, but the fight to protect this plant from censure, seizure and stigmatization has just begun.




Bob Freville
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