cGMP Compliance Worth

December 5, 2018

Key points from an article I will credit at the end:

Two years ago……

“In August of 2015, a kratom manufacturer submitted a new dietary ingredient notification (NDIN) to the Food and Drug Administration. September of that year, the FDA replied with an objection letter. Nonetheless, over the past week, rumors of newly filed NDINs for kratom have been circulating.”

It’s only a “Good letter” at this point:

“First of all, submitting a successful NDI notification does not get you FDA approval. The FDA doesn’t approve dietary supplements, period. The best possible outcome after an NDIN is a “good day letter,” which says that the FDA doesn’t object.”

Perhaps temporary pass…..PERHAPS.

“Second, if you submit the NDIN, it exclusively covers you and your specific ingredient. It doesn’t cover everyone selling that ingredient in general. This is a tough one for most people to grasp, but in essence, what I’m saying is that if someone receives a good day letter for their kratom, that’s doesn’t apply to kratom as a whole. It doesn’t mean the whole industry is covered?—?it means one company just got a (perhaps temporary) monopoly on FDA-compliant kratom.”

“Obviously whoever gets the first kratom NDI passed can share it with his or her competition”….. Yeah, we will see how that goes once that happens.

“I can’t remember an instance where a New Dietary Ingredient passed through the NDI process successfully, and a different manufacturer was prosecuted for not having their own.”

“A few years ago, fish oil was made into a prescription drug (Lovaza), but that didn’t result in it being removed from the dietary supplement market.”

Here is the best part:

“Not for Human Consumption

Not for human consumption? That type of disclaimer provides literally zero protection for the manufacturer. Green House Kratom tried telling the FDA they were selling it for making soap. The FDA checked out their website and some online forums and established that the intent was for human consumption.

I’ve seen this happen with research chemicals more than once, and you’ll have to trust me when I say that so has the FDA. Vendors who put that on their labels are just embarrassing themselves.”

LMAO!!!!! Thank you! Thank you, sir, for pointing that out.

Should you be cGMP compliant? Yes, definitely. If you’re a business and you’re profiting as a business, then it’s worth that extra mile. As for the “good letter”, I wouldn’t waste your time (applying for an NDIN). Now is the time to decide if kratom is the line of business you are called to do….. We have too many honestly. I encourage the clean up of those that simply cannot afford the business.

Moreover, a vendor should take being cGMP compliant serious if they do not already. This is about trusting the supplier and keeping what you receive in a good, healthy, clean environment. When it leaves their hands into the vendors, it becomes the vendors responsibility to sell it from there (right). What is “there”? A dirty garage? A room full of cats and litterboxes?

If you cannot afford to run a business like a business, then you’re not ready for a business. Period. It’s unfortunate, but such is the business world.




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