The guidance explains that the FDA does not consider certain activities performed by vape shops to “modify the tobacco product” and, consequently, vape shops that perform these activities are not required to obtain premarket authorization for their products. In addition, the FDA does not intend to enforce the other four previously mentioned requirements for these vape shops. Examples of these activities include:
- Demonstrating or explaining the use of an Electronic Nicotine Delivery System (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
In addition, the FDA is providing a compliance policy for certain activities that do qualify as modifying the tobacco product. The guidance explains that the FDA does not intend to enforce the five requirements listed above for 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 these scenarios 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 system ENDS 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.