Finally the feds spell it out in plain English: refilling a tank is not "manufacturing"
By Jim McDonald - January 13, 2017
The FDA will allow vape shops to change coils, assemble kits, and refill tanks on site for customers without being designated tobacco products manufacturers under the deeming regulations.
The federal agency has just issued guidance on the rule, for the first time spelling out in plain English what activities are allowed in retail stores. Since the deeming regulations were published, business owners have tried repeatedly to get such clarifications.
Many vapor retailers have interpreted the regulations to include prohibition of basic customer service activities.
The deeming rule was issued last May, and took effect on August 8, 2016. According to the FDA, any retail business that “creates or modifies” one of the newly deemed “tobacco products” (which includes all e-cigarettes and vapor products) is considered a manufacturer, and is required to register as a manufacturer and list all products they sell, submit health documents to the agency, report ingredient lists, and report harmful and potentially harmful constituents (HPHC’s). Additionally, manufacturers are required to submit premarket tobacco applications (PMTA’s) for all products they create or modify.
Many vapor retailers have interpreted the regulations to include prohibition of basic customer service activities like changing coils, assembling a device from a kit for a new vaper, performing simple repairs, or explaining product functions. The FDA has avoided explaining exactly what is allowed during several online webinars, and in phone calls and e-mails with shop owners.
The following activities can be done without qualifying a vape shop as a manufacturer:
“Demonstrating or explaining the use of an ENDS product without assembling the product”
“Maintaining an ENDS product by cleaning or tightening fixtures (e.g., screws)”
“Replacing coils in an ENDS product with identical coils (e.g., same ohm and wattage rating)”
“Assembling a final product from the components and parts packaged together in an ENDS kit”
Additionally, the FDA says it will not enforce some activities that it does classify as “modifying” deemed products. According to its announcement, the FDA “does not intend to enforce the five requirements listed above for these vape shops if, generally speaking, all modifications are consistent with the conditions of the FDA marketing authorization (MA) or if the original manufacturer provides specifications and all modifications made are consistent with those specifications.”
Examples of modifications the FDA will now allow include:
“Refilling an open system ENDS if no further modifications are made to the device or to the e-liquid before, during or after the refill that are outside the FDA marketing authorization (MA) order”
“Refilling an open ENDS system if no further modifications are made to the device or the e-liquid before, during or after the refill that – if there is no MA order – are inconsistent with the manufacturer’s specifications”
In other words, they will allow shops to help a customer refill a tank, as long as no modifications are made to the device aside from what is recommended by the manufacturer (either in a marketing order or in printed directions).
They specifically explain that replacing coils with anything other than stock coils designed for a particular atomizer is prohibited. So, no building by shop employees for customers is allowed at all. Filling a closed-system device is also specifically prohibited. So if you’re an expert at hacking MyJet pods, for example, don’t do it for customers in your store.