The most recent article on Kratom Cafe discusses how Kratom would no longer be under scrutiny from the Food and Drug Administration (FDA) if it could be proven that Kratom was marketed for human consumption in the United States before October 1994, since any supplement marketed before that date is grandfathered in and does not need to be approved by the FDA.
Unfortunately, it has been quite difficult to prove this despite massive efforts over the years to find such evidence. However, there is another way. Kratom could be approved as a new dietary ingredient (NDI) by the FDA, and then Kratom would be in compliance with regulations.
The FDA makes the NDI application process sound quite simple, and says that the application for an NDI needs to describe the product, describe how to use the product and the conditions for use, history of use or other evidence establishing the safety of the product, in addition to copies of scientific papers if any are referenced in the applications.
Indeed, if it were really this simple, then Kratom would easily become an NDI. There are numerous peer reviewed scientific papers proving the safety and efficacy of Kratom, and Kratom has a history of being safely used by humans since ancient times, and currently 15 million Americans use Kratom and there has never been a scientifically proven Kratom death.
However, since the FDA is completely in charge of the NDI application process with zero oversight, and since the FDA is biased against Kratom, no matter how good a Kratom NDI application is, they come up with infinite frivolous reasons to reject it.
Indeed, at least a few NDI applications for Kratom have been rejected, including a Kratom extract called Atomic K in 2015, a Mitragynine isolate called Mitrasafe in 2016, and another Kratom extract in 2018.
Right off the bat on the Atomic K application from 2015, the FDA says that while the scientific name Mitragyna Speciosa was submitted, the application was in violation because the author of the name was missing, which is presumably Pieter Willem Korthals.
Then the FDA questions whether Atomic K was made with Kratom at all, and says that tests are needed to prove the identity of Kratom material, and this requires authoritative botanical descriptions or authenticated botanical reference materials.
Then the FDA demands that the conditions of cultivation and propagation for Kratom growing be specified. Also, the FDA demands to know exactly what part of the plant is harvested, the maturity of each specific Kratom tree harvested, and details about Kratom growing seasons.
All of the above regarding Kratom growing seems totally irrelevant to the safety of Kratom, and just seems like a way to reject any Kratom product via saying that different trees have different alkaloid concentrations.
The FDA then says they need a properly prepared and curated voucher of the Kratom material, which seems intentionally vague.
Then the FDA demands a list of ‘adulterant’ species that must be excluded from the production of Kratom, and this is incredibly vague to the point it doesn’t make sense.
The FDA then says that no history of use for Kratom extract was presented, basically catching Atomic K with a loophole, since there may be history of safe Kratom use, but there is far less data regarding the history of safe Kratom extract use.
Finally, the FDA deals a death blow and says Atomic K is a drug based on what the application said, and ultimately the FDA said that the application was too incomplete to even begin evaluating the safety of the product.
In the next NDI rejection, the FDA gaslights Mitrasafe from the beginning by saying that they could not establish the identity of the product, even though Mitrasafe is literally a 99% Mitragynine isolate.
Basically, even if a lab test shows that Mitrasafe is 99% Mitragynine, the FDA says that’s not enough to prove the identity of a substance.
The FDA goes on to demand flow charts and details about Mitrasafe’s manufacturing and quality control. While this is reasonable, the FDA says the lack of this data is why they can’t identify the product, even though the lab tests scientifically identify the product as 99% Mitragynine.
The FDA then says that they require more lab tests and more certificates of analysis than what was already provided. Then the FDA demands that Mitrasafe basically write an entire scientific paper on the analytical methods used for lab testing.
Then the FDA says that because they are not able to identity the substance, despite it clearly being a 99% Mitragynine extract, that the history of use and scientific information showing the safety of Kratom is meaningless.
However, the FDA reviewed the history of use and science, and then used the same excuse that they gave to Atomic K, which is that history/science proving the safety of Kratom does not prove the safety of Kratom extracts.
Then the FDA demands peer reviewed scientific studies about Mitrasafe itself, which seems like an incredibly absurd demand, and refuses to look at scientific studies which prove the safety of other Kratom extracts.
Aqueous Extract Of Kratom Leaf
The final NDI rejection is an aqueous extract of kratom leaf which is standardized to contain 500 micrograms per milliliter of Mitragynine. Notably, this was the 2nd time this NDI was submitted, which means that this NDI application corrected the mistakes and criticisms from the previous application. Despite that, the FDA blasted this application with a whole new round of criticisms.
First off, the FDA uses the excuse again that the history and dosage of Kratom leaf cannot be compared to Kratom extracts. Further, the FDA says that this simple Kratom extract is not even comparable to Kratom leaf since it might have slightly different alkaloid levels due to the extraction process.
Then the FDA demands serving sizes, frequency of dosing, etc. for different uses and target populations, which is something you never see on a supplement bottle.
The FDA then nitpicks through the massive amount of scientific studies submitted with this NDI application, ignoring all the findings about the safety and benefits of Kratom, and aggregating anything that could be considered negative. Then after the FDA cites negative facts from those studies in order to build their case, they proceed to shoot down the studies and say they were conducted wrong.
Unlike the other rejection letters, the FDA then cites scientific studies that were not included in the NDI in order to find more negative data about Kratom.
Of course, this is the absolute definition of bias, and if the FDA did this with all other supplements and drugs, nothing would ever be approved, especially considering Kratom is literally the safest supplement.
Laughably, the FDA states that analgesia (pain relief) and euphoria (happiness) are adverse effects of Kratom.
Time To Submit An NDI For An Extremely Low Dose Kratom Leaf Product?
Thus, the FDA has made it incredibly clear that no matter how extensive and thorough an NDI application is, they will always find a reason to reject it.
That being said, no one has yet submitted an NDI for natural Kratom leaf, apparently because natural Kratom leaf has varying alkaloid levels and could be contaminated in nature.
However, here’s an idea: Someone should submit an NDI for a 0.5 gram tea bag filled with organic Kratom leaf, with a serving size of just 1 dose, with the purpose of the product being that it provides a nice aroma and taste.
The FDA would have no way of saying that such a dose is unsafe, since it is below threshold. Also, the FDA wouldn’t be able to say there are any false health claims, since there are no health claims.
Further, the Kratom used to make this product should be grown in a tightly controlled indoor environment, with every aspect of that environment and the growing process being described in detail, so that the FDA cannot say that the growing conditions aren’t specific enough, nor could the FDA argue that the growing process causes contamination, nor could the FDA argue that the alkaloids would vary.
Finally, this product should be put through a thorough sanitization process and then lab tested every which way to prove that it is free of any impurities and microorganisms.
If someone could do that the FDA would have zero legitimate excuses to reject the NDI, although of course they could just make an illegitimate excuse and reject it. Either way, it’s certainly worth a try.