It was finally made 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 counted as tobacco manufacturers under new regulations.
The federal agency has just issued guidance on the new regulation, which for the first time spells out 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 and 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 service activities such as replacing coils, assembling new kits for vapers , repairing products, or explaining product functions. The FDA did not clearly explain to shop owners what they could and could not do in online seminars, phone calls, and personal 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 outlined above to vape shops if all alterations are within the marketing authorization or the original manufacturer’s instructions detailing all changes to the device and all alterations by store personnel 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 allowable framework in the manufacturer's instructions.
The FDA also made it clear that replacing any coil with a different one than the one provided by the manufacturer is strictly prohibited. So, store employees are not allowed to build coils for customers.
Community opinion accepted
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 has 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.
