Custom builds in your shop... Is there a loophole?


#1

Hey everyone. Being able to do custom builds in your shop is critical, yet the FDA’s regs have been hard on a shop’s ability to do that.

However, after reading the FDA’s guideline doc released in January 2017 (about 15 times :smirk:), I think there may be a loophole. Here is the link to the doc, and my reasoning behind this “loophole”. I’d love know your thoughts, and what you are doing in your shop.

First, here is the doc:

Here is my interpretation:

VIDEO: https://www.youtube.com/watch?v=P24i2U4s28g

It IS possible to create a modification for your customer, but the manufacturer must provide specifications and submit via PMTA…

From the doc:
Line 205: “For products that do not yet have marketing authorization orders, modifying a product would generally result in a new tobacco product” (i.e. can’t make a custom build)

BUT…

Line 210: “However, if the original manufacturer has provided
specifications for the tobacco product, FDA does not intend to enforce these requirements if the vape shop modifies a tobacco product consistent with the specifications provided by the manufacturer”

AND…

From the footer: "For the purposes of this guidance, a manufacturer’s specification includes instructions provided with the product, or other apparent markings or information on the product or its package noting specifications. For example, an original coil included in an ENDS apparatus may be marked with wattage compatibility or ohm resistance.
Alternatively, an ENDS apparatus package may list ENDS components or parts, by model number or other criteria (e.g., wattage), that the original manufacturer represents would be compatible with the product.

SO…

If the original manufacturer provides specifications that outline what modifications you CAN make to this specific product, then you can make any build you want so long as the Mfg has submitted a PMTA that describes every possible combination of what can be done to modify that product.

Right now there aren’t any Mfg’s that provide these specifications (that I’m aware of), but it IS possible that a Mfg could provide a “kit” or a category of products that, combined, would create hundreds of iterations of the same product by “customizing” the collection of products that were approved through the PMTA process.

Am I missing anything?


#2

Let me run this by you…when someone wants to see what a configuration looks like, I am showing them how to do it, then I take it back apart, and sell it as intended by the individual pieces manufacturers. Then, after purchasing the products, it is now Their’s and are free to put it back together for themselves. If they need assistance putting it back together, it is a free Service and is not me recommending that they make the configuration, just providing assistance to them to put together Their own now-owned pieces/products in the way that They want it, since it is their personal property and can do what they like with it after I have sold the pieces to them in the manner the manufacturer intended them to be sold. Is this not the real loophole ?


#3

If I’m understanding you correctly, what you are basically saying is: “This may or may not be a configuration you could use, and I am not necessarily recommending it, but if you want to try it, here are the parts. You can build it yourself.”

Now that they have built it themselves, since you did not create the “new tobacco product” then you can service it for them without falling into the regs.

Yes, I suppose that’s “true”. Although I suppose this theorized example would never really happen, because if the customer can put their own build together, why would they need your help servicing it? Aren’t they “hobbyists” at that point and would rather do it themselves anyway?

This is why the regs are so funny. the FDA just doesn’t understand the vaping culture, so there are so many weeds that haven’t been accounted for (like this one). There’s just no way for them to enforce the rules down to the minutia like this.


#4

Yes, I give them a ‘demonstration’ of how a configuration can be built, without any recommendation, and then take it back apart, sell it to them, and then ‘assist’ them with putting it back together again, basically.


#5

I wouldn’t call it water tight, but I also can’t find any leaks.


#6

If we’re talking about coils, could a person not give away custom builds (Claptons etc…) with the purchase of something else.
Say I were to have some special cotton that costs a bit more than the other options. With that cotton they would get a free set of coils…


#7

I don’t see a problem with that model at all.