Cali Botanicals, LLC (MARCS-CMS 575320): That Which is Not Heroin Can Still Get You High

Everyone has a Facebook friend they added by accident and haven’t gotten around to blocking yet. The most entertaining of mine is Karen_¹. Graduated from college in six years with a major in Global studies she cobbled together and set off to find herself, ending up in South America somewhere. Nowadays she posts twice a week about the American prejudice against cacao leaves that prevent her from bringing them across the border. Apparently it does wonders for her productivity. As the kids say, that’s cocaine, Karen.

If you never read another post, remember this: if a supplement sounds too good to be true, it is. The supplement kratom, traditionally ingested by brewing the leaves of the kratom tree into tea, is the newest hipster fad. Cali Botanicals touts on Facebook that Kratom “has natural pain relieving properties” and “eases the effects of opiate withdrawal”. The active ingredient in Kratom is mitragynine, which oxidizes to 7-hydroxymitragynine, a u-opiod receptor antagonist one tenth as potent as morphine. If it looks like a duck, swims like a duck, and quacks like a duck, that’s heroin, baby.

Figure 1. Morphine, codeine, and heroin vs. mitagynine and 7-hydroxmitagynine² structures. The functional groups (business ends) of the molecules are highlighted.

Enter the FDA. This warning letter states that “Claims on your website establish that the above-mentioned products are drugs “ (as opposed to supplements) “because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, including opiate withdrawal and addiction”. Cali Botanicals aren’t the only ones to make this mistake. A quick Google search brings up dozens of other warning letters sent out for the exact same thing.

Figure 2. All of these warning letters were issued (second column) within a week. Taken from the FDA’s website, here.

Why does it matter if kratom is a drug or a supplement? Both supplement and drug manufacturers have to prove that their products are pure and correctly labeled (essentially, that the product is what they say it is). Unlike drugs that must be proven safe and effective for their intended use, the FDA does not approve dietary supplements for safety or effectiveness. Supplements are considered safe until proven unsafe. Thus, the FDA has the responsibility for showing that a dietary supplement is “unsafe,” before it can take action to restrict the product’s use or removal from the marketplace. Drugs are considered unsafe until they are proven safe. Advil manufacturers have to prove that it relieves pain and reduces fever. Fish oil manufacturers don’t have to prove that it will lower cholesterol or cure heart disease.

This warning letter is aimed at a manufacturers selling kratom as a drug, not a supplement. Already illegal in several states, the FDA is working to classify kratom’s primary alkaloids (mitragynine and 7-hydroxy mitragynine) as schedule I substances, making its manufacture, possession, and sale illegal. A seller’s best defense is to argue that kratom is a dietary supplement, not a drug. Then the FDA would have to prove that it was unsafe before they could force manufacturers to take it off the market.

Cali Botanicals messed up by advertising that kratom could cure your opioid addiction. If kratom is used to treat opioid addictions, a medical condition, then it’s a drug and must “bear adequate directions for intended use”. This means that it must come with directions under which a consumer can use a drug safely and for the purposes for which it is intended. Because quitting opioids requires the supervision of a doctor, no instructions can tell a patient how to use it. This makes kratom misbranded (i.e. mislabelled), the manufacturer is making misleading claims. Both the sale and delivery of misbranded drugs is very, very illegal.

 Al Capone got caught for tax evasion, and kratom sellers will go down for labeling that “fails to bear adequate instructions for intended use”. Turns out, kratom sellers are a much easier target than the Sackler family³. As of the time of this writing, Cali Botanicals still has a fully functional website, with a standard disclaimer “All products offered on this website are not intended to diagnose, treat, cure, mitigate, or prevent any disease”. They also have a military discount, of all things. There are easier ways to get drummed out of the military, but not funnier ones.

TL,DR; Don’t start taking kratom because your friend said it makes you feel good and doesn’t have any side effects. That’s the same thing the Victorians said about cocaine.

More on the wild west of the kratom industry later.

¹name changed to protect the stupid

² for all of you organic chemistry nerds, look at how oxidizing the carbon double bond adds another functional group (an alcohol)

³the owners of Purdue pharma, makers of oxycontin and occasionally blamed for the opioid epidemic