FDA’s Mandatory Kratom Recall

April 25, 2018 Articles, Kratom Alkaloids, Kratom Research, News


Kratom news today is a much different thing than it was a few years ago. This ancient Ayurvedic herb has become a legal subject rather than a medicinal one.

Legendary journalist and civil rights advocate Hunter S. Thompson famously said, “We cannot expect people to have respect for law and order until we teach respect to those we have entrusted to enforce those laws.”

Those words have never been more apt than they are today. In the age of police misconduct, voter fraud, invasion of privacy and the repeal of Internet privacy rule, those who we trust to maintain law and order are all too often the ones breaking the rules.

This appears to be the case when it comes to the government’s approach to kratom and it’s having a far-reaching impact. As we saw earlier this year, Federal officials are willing and able to take kratom away despite the fact that it has not been made illegal in the United States as a whole.

This is nothing new to those who have advocated for the herb to be embraced by the FDA. When, in 2016, US Marshals seized almost 90,000 bottles of kratom capsules worth more than $400,000, we saw the FDA wielding its power over so-called dietary supplements.

When US Customs and Border Protection officers seized 5,400 lbs of kratom powder in Cincinnati, Ohio, the kratom community knew it was under fire once again. Now, the situation is only growing more dire.

On April 4th, it was reported that the Food and Drug Administration had issued a mandatory recall for kratom products made by the Nevada-based Triangle Pharmaceuticals. The recall was in response to a salmonella outbreak linked to kratom products.

Eight of 11 people hospitalized for the rare strain of salmonella said that they had consumed kratom in pill, powder or tea form. The kratom used by these patients was ordered by a number of different online kratom vendors.

As is their policy, the FDA asked companies selling kratom to voluntarily recall their kratom products. One Las Vegas company refused to discard products like Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ruby Red and Raw Form Organics Maeng Da Kratom Ivory White which were handled by agents of their operation.

It is unclear exactly why Triangle Pharmaceuticals failed to cooperate. Perhaps it was out of protest at government interference or it could just be failure by some company representative to bring the FDA’s messages to the attention of those in charge of such decisions.

In any event, the FDA took a firm hand by choosing to break with tradition and force the company to recall their kratom products. A mandatory recall notice was issued for a range of the company’s kratom products and this led to what can only be described as a kratom craze.

All across the country, kratom companies began quaking in their boots, racing to comply with the FDA lest they feel the agency’s wrath. On April 17th, Viable Solutions, LLC voluntarily recalled its kratom items. The Oregon-based outfit PDX Aromatics have also volunteered to pull their kratom products pending further testing.

It’s all well and good for the administration to protect the public from a salmonella outbreak, but the mandatory recall signals a much more troubling trend, one toward restriction of rights and establishment coercion.

The FDA gained the power to mandate a recall in 2011 when then-President Barack Obama signed the Safety Modernization Act into law. In the wake of this bill being passed, the FDA has been able to put the screws to companies like OxyElite Pro over the illegitimacy of their dietary supplements.

In the latter case, they cracked down on the company in question because their supplements contained a detrimental synthetic compound call DMAA which mimics the effects of amphetamines and can drastically elevate blood pressure at high doses.

There is no known correlation to be drawn, however, between drugs like DMAA and the research chemical kratom. Kratom, otherwise known as M. speciosa or Mitragyna speciosa, is a natural herb that has been known to have organic analgesic and anxiolytic (anti-anxiety) properties. Unlike DMAA, kratom overdose is not really a thing.

While the kratom plant does supposedly contain an opiate antagonist that becomes dominant over its active alkaloids (mitragynine and 7-hydroxymitragynine) as dosage increases, leading to possible nausea and vomiting, these effects are rare and rather mild when held up to the negative side effects of prescription pain killers and other drugs approved by the FDA.

So why, then, is the FDA seeking a kratom ban and putting so much undue pressure on kratom vendors? It’s simple. If every American discovered a natural remedy for their pain, anxiety, mood problems and sleep disorders, Big Pharma would be in deep dookie, and the FDA would lose out on the astronomical kick backs they get from those pharmaceutical giants.

It costs companies millions of dollars to get a drug approved by the FDA. A report by healthcare consulting firm Avalere Health even found that pharmaceutical companies have shelled out $7.67 billion to the federal agency since the Prescription Drug User Fee Act (PDUFA) was passed in 1992.

What will they do when the public learns the true statistics surrounding kratom or, for that matter, the drugs peddled by physicians across the country? The FDA has said that kratom is associated with 44 deaths, but they fail to acknowledge the underlying issues that led to these deaths.

For instance, in one case, a kratom user was a 45-year old man whose death was determined to be the corollary of deep vein thrombosis. This man also had a history of abusing prescription drugs.

According to the National Center for Health Statistics’ statistics, opioid painkillers like OxyContin and Percocet were involved in the deaths of 14,400 individuals in 2016 alone. That’s a whole helluva lot more overdose deaths than the 44 cases the FDA blames on kratom.

At low doses, kratom may induce a sense of euphoria, an increase in energy, more sociability, talkativeness and heightened alertness. Most cases of kratom overdose revolve around long-term use which can lead to dry mouth, insomnia, weight loss, constipation or anorexia.

As with all medicinal remedies, kratom use should be used on an as needed basis and should not be abused. Chronic kratom use is ill-advised, particularly among those suffering from hypertension or other cardiovascular conditions.

As the debate over kratom wears on, one must ask themselves, why does an administration that approved a drug with an overdose rate 100 percent higher than cocaine deserve to tell the public what they can and cannot put in their bodies? Do we trust an agency that would try to outlaw something gifted to us by nature while endorsing designer drugs? This reporter doesn’t think so and neither should you.

To learn more about kratom, its purported benefits and brewing legislation, our readers can visit the Botanical Education Alliance here and join the grassroots advocacy organization, American Kratom Association, right here.

#IamKratom #SaveKratom

Bob Freville
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