FDA Guidance to Vape Shops Regarding "Manufacturing"
On January 13th, 2017, the FDA issued new draft guidance for vape shops regarding the previously vague “modification of tobacco products” statements in the deeming regulations. We have been waiting for this clarification for some time. Vape shops around the country suddenly stopped even touching the products in attempts to comply with the deeming regulations regarding “modifications” when the regulations were published. If deemed a manufacturer, a vape shop would be subject to FDA compliance with the costly application process that is still deeming. Velvet Vapors is a manufacturer of liquids, and we have been waiting for further guidance and potential blocks through the legal system to the FDA regulations in regards to our e-juice. It is our hope that the deeming regulations will be thrown out completely, and a new simpler regulation put into place with comments from the industry.
Retail vape shops assist customers in purchasing hardware including clearomizers, coils, etc. While it used to be common for vape shops to build RDA coils, it is now clearly banned. However, we expect more guidance in the future.
Here is the gist of the new FDA (draft) guidance for vape shops and the handling of hardware:
Vape shops MAY (without threat of being considered a manufacturer):
- Demonstrate or explain the use of an ENDS (Electronic Nicotine Delivery Systems--aka "e-cig" or vaporizer) without assembling it
- Maintaining an ENDS by cleaning or tightening fixtures, e.g. screws. (We believe this would include replacing parts like glass from the manufacturer)
- Replacing coils in an ENDS with IDENTICAL coils (same ohm and wattage rating)
- Assembling a final product from the components and parts packaged together in an ENDS kit. Meaning, the kit is sold as one product, not separate tanks and batteries from different manufacturers.
Vape shops MAY NOT (under threat of being considered a manufacturer):
- Refill a “closed” system ENDS (such as convenience store one-use ecigs)
- Repair or modify a part, such as a coil or battery
- Replace a part, such as a coil, that has a different ohm or wattage rating
- Assemble a custom final product (e.g. a tank from one manufacturer with a battery from another manufacturer.)
For more information on this guidance check out: https://www.fda.gov/TobaccoProducts/NewsEvents/ucm537006.htm