Kratom Rejected by FDA as New Dietary Ingredient
The latest New Dietary Ingredient Notification submitted to the Food and Drug Administration for a Kratom product has been rejected. The product was trademarked Mitrasafe and the application was submitted by INI Botanicals on September 8th, 2016.
Additional information was provided to the FDA by the NDIN applicant on subsequent occasions, ending with a final submission on September 20th and a list of references on October 11th.
In a reply from the FDA stamped December 20th, the applicant was informed that the agency had serious safety concerns with this New Dietary Ingredient, that there wasn’t adequate basis to establish that the product is safe, and can therefore not be sold legally.
Who is INI Botanicals?
According to this article in Bloomberg Businessweek, INI Botanicals is Lucky Kratom (both are owned by David Derian):
“Derian, 43, started using kratom about six years ago, after enduring more than a decade of addiction to opioids prescribed for chronic back pain. In September, the company he founded, INI Botanicals, became the second kratom marketer to formally seek FDA acceptance of its products as dietary supplements. (Another company’s application was rejected by the FDA last year.)
In preparation for the submission, INI stopped selling its kratom offerings, which it sells under the brand Lucky Botanicals, and started commissioning scientific studies. “We wanted to become part of the solution and not add to the problem,” Derian says. He calls working with the FDA “refreshing and exciting,” adding, “they’ve been nothing but helpful.” If the DEA continues its tactical retreat, Derian plans to start selling a kratom product called Mitrasafe.
Lucky Kratom, for anyone who’s interested, was once implicated by police in a murder for hire plot against an ex-employee:
Mr. Derian ended up as a defendant in the related civil lawsuit, which was settled out of court:
I wonder how refreshing he finds working with the Feds now…
Who is Industrial Chemical?
Simultaneously, as this NDI Notification was submitted, a company calling themselves Industrial Chemical began issuing public statements on Mitrasafe and talking about the NDIN:
Cool story, bro. I’ll send a letter to my congressman promoting your brand of kratom.
Does this make kratom illegal?
This failed application doesn’t do anything except make Mitrasafe illegal. (Which it would have been anyway, had they sold it without submitting an NDI)
The applicant wasn’t trying to legitimize or legalize kratom in the eyes of the FDA. If their NDIN was successful, they would have had a de facto legal monopoly on the legitimate kratom market.
Let’s take a look at Industrial Chemical’s comments on Reddit:
“Unfortunately, raw kratom would not fit under this particular NDI and it is not likely that raw kratom will ever be an FDA NDI.”
I disagree wholeheartedly with the second part of that statement (although the first part is correct). All of the published studies used to support Mitrasafe were essentially done on “raw Kratom” — ergo, the preponderance of evidence not only fails to specifically support Mitrasafe, it preferentially supports the safety of raw kratom (if it supports anything).
However, the applicant wasn’t notifying the FDA of intent to sell raw kratom, but rather a proprietary “99%+ pure extract” called Mitrasafe. In nature, kratom is not a 99% pure extract. Therefore, even if kratom were totally legal to sell, this extract would require its own NDI Notification.
Had the FDA not objected, and this NDIN were successful, that wouldn’t have made all kratom legal, but rather only this one specific extract. Hence, these comments by Industrial Chemical are significantly misleading:
“Yes, the NDI would allow any company to create their own mitragynine containing supplement so long as it fits within the FDA recognized parameters for production…”
In truth, the only people legally selling kratom under this NDI would have been INI Botanicals, who would would have effectively cornered the market. And since they specifically requested that certain portions of their application be redacted, “any company” would not know how to replicate the NDIN or produce their own version.
There were over a hundred pages of redacted information included with this submission that constitute proprietary information, without which, nobody else could claim to be selling the same product (and be FDA compliant).
Let’s review: If you’re selling kratom, and this NDI were accepted without objection by the FDA, it wouldn’t have helped you at all. It would have given your INI Botanicals (your competition) a monopoly on FDA-compliant kratom. Despite rumors to the contrary, the average kratom vendor would have received zero benefit from the success of this NDI. For most vendors, it’s likely better that it was rejected.
For the consumer, it would have at provided a single ingredient that was compliant.
On a personal note
I don’t sell kratom and am not a regular user. I’ve never sold kratom. My involvement in fighting to keep kratom legal has been at a net financial loss, and I stand to make no money either way.
The people telling you that this NDI would have helped the community, and those who filed it, can not say the same. I realize that I’m poisoning the well here, but you may wish to take those factors into account, should motives be called into question.
On the submission itself:
This NDI Notification was amateur hour. The applicant needed to continuously send additional information to the FDA because the necessary data wasn’t included in the original submission. And by the end, they still hadn’t supplied enough for the FDA to reasonably determine the identity or safety of the ingredient.
The only demonstrably unique information in this application was the “comprehensive toxicology report,” which was a review of the preexisting literature, and didn’t itself add new information.
It seems obvious that the applicant failed to hire a lawyer who was competent to file this type of submission with the FDA, and knew what kind of information would have been necessary. As a result the application failed to remotely display even the most base level of familiarity with the NDI process or requirements.
Why was this NDI Notice rejected?
Had this NDIN been filed appropriately, and without the staggering level of incompetence seen throughout, it still would have been rejected. This application was for a trademarked Kratom extract/concentrate called “Mitrasafe.” But there are no studies on this extract. Kratom isn’t a a 99%+ pure extract in nature, so to prove that it’s safe, one would need data on that specific extract.
Put another way, eating poppies is a lot different than consuming a 99%+ pure opium extract.
Without data on the specific concentration or purity of the extract you’re selling, it can’t be proven to be safe. Anyone who is even vaguely familiar with successful NDIs would know this.
What happens now?
This was the only kratom NDIN filed during the time between the DEA’s attempt to Emergency Schedule kratom and the current year. I don’t (yet) know if these applicants intend on refilling a similar NDI or have already refiled one.
I still believe a legitimate and successful kratom NDI can be filed…and should be. However, based on this most recent NDI, I have no confidence that a subsequent one filed by the same party wouldn’t be another de facto attempt to corner the market and gain a monopoly.
Having an NDIN passed successfully through the FDA is an important part of the equation to make it legal. But submissions like this one are unlikely to help anyone except the applicant.