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cGMP compliance.

I'm new here but not new to kava. Been doing some research on creating a product that isn't just a label slapped on it and minimal effects.

Here's the thing, it seems damn near impossible for any start up to reasonably follow the FDA's GMP regulations. I mean, a clean room alone is expensive enough to set up but you literally need a facility made and dedicated for this stuff, likely 1 million$ +.

I thought I could contract manufacture it but prep, especially correctly, isn't something I think anyone does in a cgmp certified facility that is also contracting out. And the formulation I have is already complicated enough even after the prep.

Does anyone have knowledge or wisdom in this. I looked at every article from Steve and all the AKA stuff etc, but no one ever explains how to do it properly and without being the son of an oil king.

I see a lot of talk of how Kava should be done legally more as not to give it a bad name but it seems like the actual process of starting and running a legal and FDA compliant kava business is incredibly gate kept.
 
Just some extra information.

The root I buy would already be coming from a cgmp facility. But the process I use will almost inevitably not be aseptic. I am using other products (food) that of course is FDA compliant but still once again. Like breaking the sterile field, I assume the moment it comes to me and I assemble or create anything and sell it I'm automatically breaking the law no matter what I do.

Just really confused here and I've started a few business the wrong way before. But I want to be legit, insurance, lawyer on retainer the whole 9. But there's no way to start off that way and it's not like I'm selling home goods and appliances to Facebook moms.
 

Groggy

Kava aficionado
Admin
Been doing some research on creating a product that isn't just a label slapped on it and minimal effects.
Personally I am always wary of such products that imply somehow the kava experience will be better because you or anyone else added some extra food and/or flavorings to it. Kava works 100% of the time all on its own. My advice as a consumer and someone who has a fair bit of Knowledge in this area, is to create the kava business first, earn the clientele (and reputation) and then at some time in the future revisit your idea from above.
 
. My advice as a consumer and someone who has a fair bit of Knowledge in this area, is to create the kava business first, earn the clientele (and reputation) and then at some time in the future revisit your idea from above.
This is my pain point. Even if I were to go to Fiji for example and find a farmer, import and process; doing this legally is expensive.. borderline impossible to create a novel product without breaking FDA regulations, AND at a minimum sinking high 6 figures info it.

I understand what you're saying. But the problem exist no matter what lane I take in regards to kava.

And as of right now, it seems that no current Kava producers are willing to private label/ contract manufacture specific formulas (like KWK here reaching out to me just to say they only slap my label on their own product and nothing more).
 

Kalm with Kava

Kava Vendor
This is my pain point. Even if I were to go to Fiji for example and find a farmer, import and process; doing this legally is expensive.. borderline impossible to create a novel product without breaking FDA regulations, AND at a minimum sinking high 6 figures info it.

I understand what you're saying. But the problem exist no matter what lane I take in regards to kava.

And as of right now, it seems that no current Kava producers are willing to private label/ contract manufacture specific formulas (like KWK here reaching out to me just to say they only slap my label on their own product and nothing more).
Hey there,

I didn't know what you wanted your product to be or how you wanted it formulated. After hearing your request via email, there are a few reasons why we can't help. No need to throw stones. All the best to you and your product.

-Morgan
 
Hey there,

I didn't know what you wanted your product to be or how you wanted it formulated. After hearing your request via email, there are a few reasons why we can't help. No need to throw stones. All the best to you and your product.

-Morgan
You're right. I didn't mean to be so hostile. Just annoyed overall with the barrier to entry and got excited when you reached out and immediately let down.
 

Michael Nielsen

Kava Enthusiast
It seems easier to make products similar to karunakavas pre-made kava.

Kompared to supplements or pharmaceutical products that are more strictly regulated.

You need an investor that believes in you.
So you can hire compliant production facilities and personnel that can keep up with regulations from fda.
 
I would try looking into finding a co-packer with cGMP facilities. I was just talking to some about a maté product we're coming out with. It definitely can get a little spendy with formulation and packaging, but way less expensive than having your own facility. If you want, I could find the person I was talking to and shoot you his contact info so you can get an idea of associated costs. I lucked out as someone who owes me money has a cGMP facility with automated packing, so not gonna go with the other guy, but he was pretty helpful and has a lot of packing options.
 
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