New FDA Letter on Kratom: Mitrasafe guilty of misleading claims, inaccurate website
The United States Food and Drug Administration recently made public a letter addressed to Industrial Chemicals, LLC, declaring their product Mitrasafe to be illegally sold and marketed. Once again, Industrial Chemical have proven themselves to be among the bad actors in the kratom market.
The letter explains that although Industrial Chemicals submitted a New Dietary Ingredient Notification to FDA, thereby discharging a procedural requirement, FDA declared Mitrasafe to not meet the minimum threshold necessary for a reasonably expectation of safety. Hence, it can not be sold. Moreover, the letter also states that Mitrasafe is being marketed as a drug (i.e. with claims that imply it can prevent or cure disease), and not a dietary supplement.
Nonetheless, Industrial Chemicals decided to sell the product after receiving an FDA objection, taking the additional (and absurd) step of claiming to be in full compliance with applicable law. This, of course, is not true. A failed NDIN is insufficient.
However, many companies submit an NDIN, receive an objection letter, and go on to sell the ingredient for years without FDA interference. But in the case of Industrial Chemicals, not only did they claim full regulatory compliance on their website, they issued press releases to that effect.
Again, companies have done this in the past and gone on to enjoy uninterrupted sales for the better part of a decade without FDA sending a letter — but never with a product as controversial as kratom. Predictably, FDA took notice and responded (not with their usual apathy, but) with a letter explaining that it’s not enough to submit an NDIN, but that minimum safety thresholds for a new dietary ingredient must additionally be established.