FDA Enforcement / Warning Letter on Kratom: Cali Botanicals

I ran across this warning letter:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cali-botanicals-llc-575320-06112019

They overstepped their bounds, trying to make claims for kratom.  FDA loves cracking down on companies that claim nutritional supplements  "are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease."  Kratom, though, is not legally marketed in the United states as a dietary supplement.[1]

"Mitragyna speciosa (Korth.) Havil."by Ahmad Fuad Morad is licensed under CC BY-NC-SA 2.0

This specific instance they had claims on their website, Facebook page, and Twitter that kratom can be used for treating opiate addiction and withdrawal.

Another interesting point they nail them on is that "it fails to bear adequate directions for its intended use(s)."  Which if kratom is intended to be used for opiate withdrawal it can only be done under a doctor's direction.  Also there is no FDA-approved application for kratom.

[1]https://www.fda.gov/news-events/press-announcements/fda-issues-warnings-companies-selling-illegal-unapproved-kratom-drug-products-marketed-opioid

Kratom: Scratching the Surface

I heard of Kratom through a documentary on Netflix: "A Leaf of Faith."  It was not terribly convincing.  One of the executive producers distributes Kratom.  But as a gym-goer, I thought I might try some for pain relief without having to take an anti-inflammatory.  By happen-chance my local convenience store added a CBD/Kratom display.  Of course this is the place for high-quality nutritional supplements!  But, for science, I'll risk it.  I have had a hernia pain and/or pulled groin muscle for at least six months and was very sore from making gains on my squats in the gym.

"Mitragyna speciosa (Korth.) Havil."by Ahmad Fuad Morad is licensed under CC BY-NC-SA 2.0

The package was ziploc/foil.  The Kratom was in capsules.  The package said to take five capsules.  I took three.  I definitely felt something after an hour.  I took another two.  After another hour, I would say that the effects were on par with oxycodone.  After having hernia surgery, I would say on par with 5mg oxycodone.  So my initial impression was: "How is this stuff legal?"  Second time I took it, my impression was the same.  I was glad I was not driving when it hit.  Now for the GI effects;  At more than a dose or two in a day it will give you diarrhea.  Not crazy, but definitely "loosens the stool."

But, after taking Kratom maybe twice a week to once every two weeks for three months, I would say I am not as scared of it being available at a convenience store as I once was.  For me, even though Kratom acts on the mu receptors same as opioids, my tolerance quickly builds and any desire to increase dosage would be met by a greater incidence of the "galloping trotskys" to the bathroom.  Research has also noted that kratom has stimulant effect too.

So, I take it for DOMS, especially on legs, to ensure that I’m not taking an anti-inflammatory that might interfere with muscle growth.

Now outside the effects and side effects of the drug:  "What is in these capsules?"  Having done laboratory testing on pharmaceuticals and nutritional supplements, I would want to know that my nutritional supplement has been tested for potency and any contaminants.  Possible contaminants include heavy metals, mycotoxins produced by fungi, and pesticides.  Since this is the same gamble with you take with Kratom a most nutritional supplements off the shelf in the U.S. my perceived risk is about the same as the valerian root I take sometimes to fall asleep.  My lab coworker used to test valerian root for aflatoxins, the most powerful naturally-occurring cancer causing agent.  How many valerian root nutritional supplement distributors test for aflatoxins?

"Kratom Capsules"by stockcatalog is licensed under CC BY-NC 2.0

Further complicating the problem is that kratom, like CBD oil, is mired in a mix of differing state laws.  I'm not sure if my local convenience store is way ahead of the curve or just too ignorant of the law.

Update:

My fears about heavy metals were on point as the FDA conducted laboratory analyses of kratom products for heavy metals.  FDA Heavy Metals Analysis on Kratom  Some kratom had lead levels above 1,000 nanogram/gram.  If you take 5, 1-gram capsules you are above your threshold of 5 microgram/day of lead per the FDA's guidance on elemental impurities in drug products.  

Medical Marijuana Sales In Oklahoma

I was born and raised in Oklahoma and this is one of the last things I would think I would see in this state.  I moved to North Carolina in the late 90s.  When I left Oklahoma you could only buy 3.2% beer outside of a liquor store and tattoos were not legal.  The Daily Oklahoman, the biggest newspaper, was very conservative.

Economically Oklahoma could be doing much better.  The only reason I left Oklahoma was for a decent job.  With my background in science, I was just not getting the kind of available jobs that led me to believe I had a future there.  I was actually working a scientific job in the day, and washing dishes at night to make ends meet before I left Oklahoma.

I believe, in Oklahoma, that medical marijuana was only legalized as a path toward recreational marijuana use.  Although Oklahoma is conservative, there's a lot of people that are not politically active that do not want the government telling them what to do à la a bit of the wild west still.  I am a libertarian and my beliefs stem from growing up in Oklahoma.  Wide open spaces, self reliance, low taxes, and more freedom were things I enjoyed growing up.

Oklahoma is also geographically uniquely positioned.  It has Interstate I-35 running right through the middle North to South.  It has Interstate 40 running from Tulsa in the Northeast into the panhandle of Texas.  The amount of illegal pot transported through the state must be unimaginable.  The panhandle of Oklahoma shares a border with Colorado, which has legalized recreational marijuana.

When I was a teenager, friends would drive to Kansas or Texas to get "6-point" beer.  And in Northern Oklahoma, it was known if you wanted to get a tattoo to drive up to "Ark City," Arkansas City, Kansas to get one legally.  So what the politicians of Oklahoma did not provide the interstates and a tank of gas did.

So, I think it was combination of what the people of Oklahoma wanted and politicians hungry for tax revenue led to medical marijuana becoming available.

Medical marijuana sales in Oklahoma top $4.3 million in January

Introduction

The purpose of this blog is to discuss the quickly changing regulation of marijuana, vaping, and other "fringe" drugs and supplements; New regulations, guidance, news and try to provide insight onto how I see the future of regulations and how to comply.

I have twenty years in the pharmaceutical manufacturing field.  I started out in a small contract chemistry laboratory doing wet and analytical methods.  These included USB, BP, EP, and JP methods.  Instrumentation included HPLC, GC, AA, TOC, and IC.  Wet methods included USP titanium dioxide assay, arsenic, and lead.  Mostly pharmaceutical active ingredients and finished products, but also nutritional supplements, and water (purified, waste, and potable).

Facilities I have worked in include: laboratories, Grade A injectable filling lines, medical device filling lines, transdermal delivery solutions,  vaccines, immuno-oncology product, and a compounding pharmacy.  

-Copperhead Consulting, LLC