It was finally clear: helping customers fill their tanks was not “production.”
Finally…
The FDA will allow the Vape shops allow customers to swap coils, assemble devices and fill tanks in-store without being considered tobacco manufacturers under new regulations.
The federal agency has just issued guidance on the new regulation, for the first time clarifying what activities are allowed in retail stores, a clarification that business owners have been clamoring for since the regulation was enacted.
The regulation was enacted in May and took effect on August 8, 2016. According to the FDA, all retailers that “assemble or modify” products that are considered “tobacco products” (including e-cigarettes) will be considered manufacturers, and will be required to register as a manufacturer, declare all products for sale, submit health and safety documentation to the agency, report manufacturing ingredients, and report toxic and potentially harmful substances. Additionally, manufacturers will be required to pay PMTA fees for all products they manufacture or modify.
Vape retailers thought the regulation covered basic services like replacing coils, assembling new vape kits, repairing products, or explaining how products work. The FDA did not explain to shop owners what they could and could not do in online seminars and through personal phone calls and emails.
What has changed?
Vape shops can engage in the following activities without being considered a manufacturer:
“Demonstrate and explain how to use a vape product without assembling it.”
“Maintaining a vape product.”
“Replace the coil of a vape product with a similar coil.”
“Assemble a complete product from available parts of a kit.”
Additionally, the FDA said it would not prohibit certain activities that would be considered “alterations” to regulated products. According to the agency’s announcement, the FDA “does not intend to apply the five requirements to vape shops if all modifications are within the marketing authorization or the original manufacturer’s instructions detailing all modifications to the device and all modifications made by store employees are within those details.”
Examples of changes the FDA allows:
“Fill a new tank without making any changes to the device or e-liquid before or after filling.”
“Fill an open ENDS system without causing any changes to the device or e-liquid during, or after the fill process.”
In other words, the FDA will allow stores to help customers refill tanks, as long as no changes are made during the process that go beyond the manufacturer's instructions.
The FDA also clearly explains that replacing any coil with a different type than the one provided by the manufacturer is completely prohibited. So, airline employees are not allowed to build coils for customers.
Community Opinion Approved
The draft of the new law also includes a small public comment window. All retail store owners and vape shop customers can submit their comments and requests for changes to the law.
Finally, the FDA announced in the final draft that it will no longer require all tobacco products to “include the exact percentage of imported or domestic tobacco in the product.” This should ease the burden on vapers.
This article was published on Vaping360 by Jim McDonald and translated by The Vape Club.
