Reminder: FDA clarifies retail compliance

Just because you are filling tanks for customers doesn’t mean you must register as a manufacturer. Not long ago, retailers viewed vapor regulations to mean they could not perform services including filling tanks, changing coils, assembling a device or discussing how it works. Retailers felt they could not longer perform some of the simplest repairs. These activities, it was believed, was cause to classify shop owners as manufactures by the U.S. Food and Drug Administration’s (FDA) deeming rule for new tobacco products.

This is no longer true. In January, the FDA clarified the rule saying vape shop staff could explain how products work, as well as clean and perform maintenance on a purchased product. Retailers can also replace coils with new, identical coils, as well as assemble products for the customer (from the components packaged with the device).

The clarification also allows retailers to refill tanks, as long as no modifications are made outside of what is recommended by the manufacturer. Shop owners, however, are still banned from building coils and devices for customers, unless they register as a manufacturer.

The FDA requires vape shops that are tobacco product manufacturers be subject to the agency’s rules to provide ingredient listings, report HPHCs, and submit health documents. Vape shops that modify a product so that it is a new tobacco product are required to comply with the premarket authorization requirements. Finally, vape shops that are engaged in the manufacture, preparation, compounding, or processing of tobacco products (including e-liquids) are required to comply with establishment registration and product listing in accordance with the deeming rule.

The date for registration is quickly approaching.  Late last year, the FDA revised guidance concerning its “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” U.S. manufacturers of newly regulated tobacco products who first began manufacturing prior to Aug. 8, 2016, were given until June 30, 2017, to comply.

To read the new FDA compliance document released in January, click here.