Mitra Safe??? FDA Approved???
Guys, all of the popular youtubers are talking about a product call “mitra safe” that is a .99% extract. They say it was approved by the fda and will be included in a product called “Max Relax” (dietary supplement) in February.
I can find denied applications for this from this one vendor, but nothing saying it was approved. Very well known Kratom reviewers keep talking about the pros and cons of the rights being given to this one chemical company and everything surrounding it. Everyone says it will be released in February and no one knows the stipulations. I just want to find a source saying this definitely happened and go from there. Anyone...?
Can anyone find their sources? I sure can’t.
They didn't say "FDA approved," they just said it is FDA "compliant". I read the FDA's reply to their submission and it listed some major questions remaining about the sufficiency of the proof they submitted that this product is safe.
Anthony Roberts recently published an article in Medium. He included the FDA's comments that, to my reading, show this product is not ready to roll out onto the U.S. market any time soon.
It may contain a proprietary extract that is 99% pure mitragynine, but that will be considerably diluted in the final product.
The FDA does not approve New Dietary Ingredient Notifications, it merely stops asking for more proof of safety or other information. They are not at that point yet.
That Does Sound Interesting August Noon. 😕 I would say it won't be near 99% pure. There is no way you could sell a 99% Extract. I would be Leary of buying it. The Highest Percentage I have ever seen in a True Product was about 25%. Sounds like a Selling point to be called FDA Compliant. I would stay away from any Extracts or Enhanced Version of Kratom. They are just not pure Leaf. Some have been Extracted or Enhanced in a way that makes them not Genuine 100% Plain Leaf.
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Paul, thanks for the input, but this is what I was talking about. Maybe we can’t believe the actual chem company but I believe they released the FDA letter.
I have concerns about this. Lots of them. And I mostly agree with you Max concerning extracts, though PDO has marketed two extracts and I trust Jeff like a best friend. One of them was great. Didn’t boost my already ridiculous tolerance (17ish grams at a time) even after the whole bag. But I am a plain leaf advocate for the most part. Also, I don’t think the final product will be anywhere close to 99% lol. I think that’s just the base for the FDA.
Thanks Nan. This is the article all the YouTubers were referencing. I hope nothing changes with the plain leaf market and this stuff is just freely available to those that want it. Though I don’t expect this.
Anyway, thanks for all the replies guys.
Do you think this is part of that Mitragynine patent one of the companies of Big Pharma has? Could this be how they're rolling it out?
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