The new year is bringing in a load of changes for everyone but Vaping Industries is handling the new FDA regulations smooth as butter.
The Deeming rule was issued last May, and took effect on August 8, 2016. According to the FDA regulations, 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. Additionally, manufacturers are required to submit pre market tobacco applications for all products they create or modify. All of that costs YOU cash.
Vastly higher prices on any store that rocks house juices or is home brewing their mods if manufacturer status is applied for are coming.
Many vapor shops 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 the
The following activities can be done without qualifying a vape shop as a manufacturer with the new FDA regulations
“Demonstrating or explaining the use of an ENDS (E-cig Mod) 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
four requirements listed above for these vape shops if, generally speaking, all modifications are consistent with the conditions of the FDA marketing authorization 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 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, the FDA regulations 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).
The FDA specifically explained that replacing coils with anything other than stock coils designed for a particular atomizer is prohibited. Different manufacturer, Different marketing authorization. So, no building of custom mods by shop employees for customers is allowed at all. Filling a
closed-system device is also specifically prohibited. So even if we have a capable mod specialist in store, we cannot make adjustments to customer mods.
Finally, the agency announced in this document that it will not enforce the requirement that all tobacco products “include an accurate statement of the percentage of foreign and domestic-grown tobacco used in the products.”
What does all this mean for you?
If the mod is in a sealed box and we carry the parts we got your back.
The hottest juice lines and the latest in hardware technology will still be available with no price hike as Vaping Industries will be following the non manufacturer guidelines to the T.
Mods and juices will be labeled slightly different in the future and we wont be able to make modifications to your cross brand or custom hardware, but if its in the box and sealed, we can still set you straight in the store. Our store polices may change in regards to the handling of hardware, but people looking for an awesome vape still have their one stop shop for all things vaping for the lowest price possible.
If you want to check out the new law in its entirety check out the post from the federal register