Mitrasafe is touted as a dietary ingredient that’s intended for human consumption. The kratom capsules that contain this supposed “dietary ingredient.” The brand’s website refers to their product as an ingredient in “dietary supplements.”
As anyone in the industry can tell you (although they probably won’t), such claims are a big no-no. The FDA is extremely selective about the substances they approve as dietary supplements and kratom—in any form—is not one of them.
Despite the dubiousness of these claims and the FDA’s explicit warnings against the launch of Mitrasafe Kratom Extract, the brand has become one of the most buzzed about names on the smoke shop circuit.
This is concerning for a number of reasons, all of which we’ll explore in today’s comprehensive review. I think you’ll agree that this is one safe that ain’t worth cracking.
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Mitrasafe bills itself as purified mitragynine, the dominant indole alkaloid in Mitragyna speciosa (the ketum tree). It has been presented as “offering the benefits of kratom in an extracted Mitragynine alkaloid that is water soluble and ready to use.”
Mitrasafe is said to possess 99% purity which is a bold claim by any metric. The product of Industrial Chemicals, LLC and their partners at INI Botanicals, Mitrasafe was first introduced in 2017 in a NDIN (New Dietary Ingredient Notification).
This was when the company went public with information about the product, but it wasn’t the first the time government agencies had heard of it. The FDA first received notification in 2016 when INI Botanicals submitted Mitrasafe for review.
After thorough analysis of all submitted materials, the Administration determined that Mitrasafe’s manufacturers were in violation of legal requirements. As their response letter of February 26, 2018 clearly stated, www.mitrasafe.com “includes inaccurate and misleading statements about the legal status of Mitrasafe.”
The Administration also found that the company failed to demonstrate sufficient evidence that their product was safe for human consumption. This kind of failure to comply is emblematic of the biggest problem plaguing the kratom industry—a preponderance of sketchy vendors refuse to follow GMP (Good Manufacturing Practices).
Over the last few years, we have witnessed a rash of public health scares, FDA recalls, law enforcement seizures and other low-rent scams associated with kratom products. In May of 2018, the FDA issued a mandatory recall of Mitragyna speciosa powder and caps after they were traced to a multistate salmonella outbreak.
Earlier this year, I flagged a number of kratom vendors such as Zona Kratom and Chameleon Kratom for their internal problems or lack of transparency. Failure to demonstrate safety or compliance is something that is all too prevalent in the world of ethnobotanicals.
Mitrasafe.com does not appear to be active at the moment. In its place in search engine results is the domain mitrasafe.us which redirects to something called strangefullthiggngs.com, a blacklisted URL which is aborted by free protection software and flagged as a threat.
Some have argued against the FDA’s “gaslighting,” suggesting that INI Botanicals’ supposed attempts at producing a safer and cleaner form of kratom were deliberately stonewalled by the Administration. Of course such an argument is not backed by any discernible facts.
One reviewer who made such an argument referenced the company showing a lab test to the FDA, but no Certificate of Analysis was ever provided to the Administration. This renders any argument pointless since you cannot demonstrate purity without showing unbiased third party analyses that supports such a claim.
As of 2020, a slew of social media influencers have done their part to shill for the Mitrasafe brand. This is potentially dangerous for casual consumers who may rely on YouTube and similar platforms for news about the latest innovations in the industry.
It also bears mentioning that most trusted kratom vendors have an extensive background in botany, pharmaceuticals, Eastern medicine or the sciences. Many have worked in the kratom industry for decades before establishing their own business.
By contrast, Industrial Chemicals, LLC was founded in 2015 with the sole intent of creating Mitrasafe. INI Botanicals CEO David Reynolds Derian appears to be an entrepreneur who has dipped his toes into the world of nootropics (see: BotanaWay) just as he has dipped it into craft beer (see: Lickinghole Creek Craft Brewery).
All of this is to say that there is no sign that the creators of Mitrasafe care about the storied history of the Ayurvedic herb or the value it could have for millions of voracious consumers. There is also no clear evidence of their commitment to quality control.
Then there’s the aforementioned 99% purity which seems to be the one thing virtually all kratomites can agree on. As one seasoned reviewer wrote, “The Highest Percentage I have ever seen in a True Product was about 25%. Sounds like a Selling point to be called FDA Compliant.”
A moderator at one of the best online kratom forum communities was quick to respond, writing, “It may contain a proprietary extract that is 99% pure mitragynine, but that will be considerably diluted in the final product.”
This same individual confirmed that, to his reading, the FDA’s comments show this product is not ready to roll out in the U.S. Marketplace.
I have always been wary of kratom extracts since they can pose a serious health risk to those who use them without proper instructions. Since consumers lack the ability to test these liquid kratom shots for themselves there is no easy way for them to know exactly what they are getting.
Fortunately I have encountered a small but superb group of trustworthy vendors over the last five plus years, many of whom carry their own proprietary extracts. Some are available in powder form while most are offered in tinctures. Form will vary, but quality never does.
The following is a short list of my favorite domestic suppliers of kratom extract. Each has been thoroughly vetted, and is known for consistency, transparency and potency.
Before you buy kratom online, you should always do your due diligence. Look into a vendor’s background, check to see if they have a positive consumer reputation and make sure they offer detailed information about their catalog. Be safe, be smart and be well.
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