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 ), 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:
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)
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”
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.
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?