If until then, the application of the regulations imposed by the FDA (Food and Drug Administration) on e-cigarettes was still cloudy for vape shops, the federal agency has finally given details in a recent publication. A clarification that may relieve many vape shops.
CLARIFICATION ON WHAT IS AUTHORIZED IN VAPE'S BOUTIQUES
The federal agency has therefore just published directives concerning the regulation of e-cigarettes which for the first time clearly explain what activities are authorized in vape shops. Since the publication of the regulations, business owners have repeatedly tried to obtain such clarification, this moment has finally arrived.
We therefore learn that for shops that are not designated as manufacturers of tobacco products under the regulations, the FDA will allow them to change the coils, assemble the kits and fill the tanks of their customers. While awaiting this clarification, many stores had anticipated and interpreted the regulations by including the ban on customer service activities.
According to the FDA, any retailer who "creates or modifies" any of the new "tobacco products" (which includes all electronic cigarettes and vape products) is considered a manufacturer and therefore must register as a manufacturer. They will also need to list all the products they sell, submit documents to the agency, declare their ingredient lists, and report the harmful and potentially harmful constituents included (HPHC). In addition, manufacturers are required to submit to tobacco pre-market applications (PMTA) with respect to all products they create or modify.
WHAT IS REALLY CHANGING IN THE REGULATIONS?
Many vape shops have interpreted the regulations by including the prohibition on helping customers change their coils, prepare a beginner's kit, make simple repairs or even explain the functions of the products. Despite the many requests, the FDA has so far avoided explaining what was allowed or not.
Without the qualification of "manufacturer" the following activities can therefore be carried out :
- "Demonstrate or explain the use of an ENDS without assembling the product"
- "Maintain an ENDS by cleaning it or tightening fasteners (for example screws)"
- "Replace resistors in an ENDS with identical resistors (for example, same value and rated power)"
- "Assemble an ENDS from components and parts packed together in a kit"
Additionally, the FDA says certain activities it classifies as "modifying" deemed products will not apply. According to its statement, the FDA “does not intend to apply the five requirements listed above for vape shops if all changes comply with the FDA market authorization requirements or if the original manufacturer provides specifications and that all modifications made conform to these specifications. »
The vape shop will be permitted to help a customer refill their tank, provided that there are no modifications to the device other than what is recommended by the manufacturer (in a release order or in the printed instructions). However, filling a closed device is prohibited. (On some e-cigarettes cartridge, it is possible to disassemble the system so as to divert to fill it, this practice is prohibited in the shop!)
The FDA specifically explains that the replacement of resistors by other than those intended for this model is prohibited. Thus, it will be forbidden for shop employees to make assemblies on atomizers for their customers.
THE POSSIBILITY OF COMMENTING THESE INSTRUCTIONS
With the publication of this new guidance project, there is also a possibility for the public to leave comments. All store and vape owners and customers can leave specific reviews or advice on how these guidelines might affect transactions. These can be done on the site Regulations.gov under the file number FDA-2017-0120-D.
Regarding the registration of manufacturers with the agency, the deadline has been extended from December 31, 2016 to June 30, 2017. Recently, the FDA also extended the deadline for the submission of ingredient lists from February 8 to August 8, 2017. Finally, the FDA announces in this document that it will not enforce the requirement that all tobacco products “include a precise statement of the percentage of foreign and domestic tobacco used in. ".
Source : Vaping360.com
