FDA Rejects American Botanicals Corp. Kratom NDI
The Food and Drug Administration has rejected another New Dietary Ingredient Notification for Kratom.
The New Dietary Ingredient Notification was submitted by American Botanicals Corporation, a company tied to Vivazen, the brand of liquid kratom shots that was forced to remove the kratom from their product after numerous complaints were filed with the FDA.
What we have here, and the reason this notification failed, is that we are seeing a company trying to peddle a proprietary extract without having performed a single study on their product. If you’re trying to use something other than plain kratom leaf, then you need studies on something other than plain kratom leaf (i.e. on the version you’re trying to sell). In this case, very little of the safety evidence for kratom was relevant to the actual kratom-based product being sold.
In short, this NDI attempt failed for much the same reason the last one failed. It’s often said that the only true failure is in not trying. I disagree — the failure here was twofold as the company failed to submit a valid NDIN and additionally failed to learn from the mistake(s) of their predecessors.
This (spectacular and embarrassing) failure is mildly surprising, as the lawyer who reportedly submitted the NDIN happens to work for the same white shoe law firm currently representing the American Kratom Association.
Anyway, if you want a lesson in how to completely fail when attempting to file an NDIN, this one is a great place to start.