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TOPIC: Questions about FDA's laws regarding the selling of kratom

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Questions about FDA's laws regarding the selling of kratom 1 year 4 months ago #10365

  • goldengate
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How is it that almost all the vendor websites selling kratom are able to make claims about health benefits of kratom and give dosage suggestions and instructions for taking their products? Isn't this a HUGE no-no in the eyes of the FDA? It seems they are blatantly violating multiple laws set forth by the FDA. How is it possible that they get away with this and don't get busted?
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Questions about FDA's laws regarding the selling of kratom 1 year 4 months ago #10384

  • michaels
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Hey GoldenGate,

This is a huge no-no in the eyes of the FDA at this point, but there aren't actually any laws set forth by them. The standards that the Kratom industry goes off of are those set by similar industries and they've learned from the mistakes of those who have gotten in trouble for mislabeling products.

Now I'm wondering which websites you're talking about though. One of the requirements to be an "Approved Vendor" on ILK is that you cannot make any medical claims for your product. You're not speaking about any of our vendors are you?

Hope to hear from you soon,
-michael@ilovekratom.com
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Questions about FDA's laws regarding the selling of kratom 1 year 4 months ago #10394

  • goldengate
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No, I'm not talking about any of the ILK vendors specifically. To be honest, I haven't even checked out this site's approved vendors yet, I just joined the forum yesterday. To throw a name out, ensobotanicals.com is one of the many sites I've noticed that openly promotes the consumption of the products they're selling and have a blog that gives instructions on how to use kratom to treat medical problems.

I've been scouring the web for weeks trying to understand the legal grounds that Kratom is currently being sold on. Correct me if Im wrong, but the FDA's regulations towards kratom seems to prohibit vendors from making any hint that their product is intended for human consumption. And they don't allow any claims to be made about kratom being intended to treat any illnesses. And yet that is exactly what some vendors are openly doing. Am I missing something obvious here? Or is it just a matter of time before the FDA steps in and does something about it?

Whats the best way to learn and comply with all the rules and regulations that govern the selling of kratom? All the info that I've compiled so far through google searches seems incomplete and unclear. Is there a vendor guide somewhere online that outlines all the legal Do's and Dont's? Or maybe a knowledgeable member of this forum who could I could possibly contact with some questions?

Thanks
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Questions about FDA's laws regarding the selling of kratom 1 year 4 months ago #10434

  • michaels
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You've pretty much hit the nail on the head here!

There are no actual "Laws" put into place by the FDA governing the sale of Kratom. All we can do is speculate based off of what similar products have gone through and previous actions taken by the FDA towards Kratom. When you put all of it together you come out with your conclusion, vendors cannot make any medical claims about their products and they also cannot sell their products for human consumption.

Now the medical claims part of the deal goes for nearly all dietary supplements, even those found in stores like CVS and Rite-Aid. You can't make medical claims, although they may be true from thousands of testimonials, your company cannot make the claim that your product is...pain relieving for example. This is something that will never change in the sale of Kratom.

As for the consumption part, Kratom would have to be deemed "Reasonably safe to consume" by the FDA before vendors could openly sell it for consumption. Now you'd think that thousands and thousands of testimonials, multiple studies, and even statements from medical doctors claiming that Kratom does carry medicinal value would be enough, but not for the FDA. An NDI (New Dietary Ingredient) would have to be prepared and presented to them, which hasn't been properly done by anyone. In the future, Kratom could very well be sold for consumption purposes if the proper steps are taken.

To answer your question, yes, it is only a matter of time before the FDA goes and shuts down sites like the ones that your mentioning. I know that none of the vendors on this site are at risk because in order to be approved you must meet these requirements.

Feel free to shoot me an e-mail with any questions

-michael@ilovekratom.com
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