Double M Herbals | Kratom Forum

More Kryptonite for Kratom

On November 5, 2018, the U.S. Department of Justice, on behalf of FDA, filed a civil forfeiture complaint pursuant to 21 U.S.C. § 334 in the U.S. District Court for the District of South Carolina to seize a large quantity of kratom products, including finished kratom powder and capsule products labeled as supplements, as well as bulk kratom powder and capsules.

The government’s complaint alleges that there are serious concerns regarding the health impacts of kratom consumption and its potential for abuse. The complaint further alleges that the kratom products are dietary supplements and dietary ingredients within the meaning of the Federal Food, Drug, and Cosmetic Act and are adulterated under 21 U.S.C. § 342(f)(1)(B) because kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury.

***

This was packaged and labeled for sale as a supplement. They were not cGMP compliant and had not filed an NDI. So far no vendors have submitted an NDI so it's hard to predict whether compliance alone would have mattered.

explanation from nerds
Any product not in compliance with cGMP entering the market as a dietary supplement(most kratom products that arent inside something like actual soap) is considered adultered.

Because they havent raided any company that was cGMP compliant we dont really know if the lack of a good day letter from a submitted NDIN would survive an audit/inspection. We do know by law any vendor that isnt cGMP compliant is selling an adultered product. That's just how the law/regulations determine it. As most supplements/dietary ingredients marketed in the US are pre1994 cGMP is the requirement, Kratom being deemed an NDI adds a spin. It isnt clear that a good day letter is required as a vendor that is cGMP compliant could in theory fight it in court and present it as a pre 1994 item and possibly be able to show it's an old dietary ingredient, just none have. If you arent cGMP complaint though the FDa considers what is sold adultered.

That company had also had salmonella issues is my understanding and was importing massive amounts so created a perfect storm for themselves. Their products are in a lot of stores also, a whole lot of stores.

I know of several raids that had taken place In myrtle beach prior to this, and nothing had been taken. I’m going to ask my headshop friend next time I see him but that’s how they package theirs and not like I ever bought it or anything but damn that’s all I’m gonna say... time to buy another kilo from rva

It is disturbing to me that the feds chose SC as the state in which to make this stand, but not at all surprising given our current band of legislators. I've said it before and I'll say it again: the only reason kratom has not yet been banned in SC is because no interested party has yet offered our honorable representatives enough cash for the deed.

And it was indeed a choice: SC is a deeply red state with judges to match, and the feds would be hard pressed to find a friendlier court for any politically correct civil forfeiture. So out of all the kratom imports taking place via all the ports in the land, they chose SC to make this bust.

My own thinking is that the location wasn't accidental, and it wasn't just about that particular company's faults. I have no personal information on it either way, these are just my suppositions, but my guess is that -IF- this wasn't all about that one company that got its shipment seized, then this whole thing was a test run for the feds in preparation for doing the same elsewhere.

Time will tell.

Whiffs I know that part of the issue here was it being markerted as a For human consumption and the fact that they came more than once and didn’t do anything the first couple times means they were scoping them out I think.(trying to make it hurt the most) trying to send a message to a chain of headshops by hurting them financially a lot the $ they would have made off that is insane. This won’t just affect headshops in SC. I’m worried what’s gonna happen maybe all those foolish people will finally discover online vendors :/

I hear ya, Trailmix. Unfortunately, I think you're 100% right about everything you just said.

I guess we just wait and see.

Guys, forgive me for my naivete, but why do these vendors continue to label their products for human consumption if they know it will get them busted? Am I missing something here?

Vendors I deal with have very noticeable labels stating NOT for human consumption. I’m like you, why are some vendors not getting that concept lol

Easy advertising when your selling it at a headshop, I agree it probably wasn’t the best idea but they were clearly doing well for themselves.

aqtgirly4u wrote:Guys, forgive me for my naivete, but why do these vendors continue to label their products for human consumption if they know it will get them busted? Am I missing something here?

Nah, you're good; it's hard to make sense out of what is going on these days. This was about big headshop vendors in thinking they could get away with doing/saying whatever they want, and instead they ended up making themselves a very convenient target for the feds. It was a calculated chance they were taking, knowing full well what the law is, and they lost.

As long as fed action remains isolated to actual lawbreakers I don't actually care, but it remains something to pay attention to going forward because the feds can make this net much wider, and not necessarily in a fair or honest fashion. A single civil forfeiture can break even the biggest vendor if it's done right, and my concern is for the many smaller vendors who can't legally self-defend that kind of federal case.

I'm keeping my eye on it for sure.