WARNING: This product contains nicotine. Nicotine is an addictive chemical.

Vape Shop Owners Rejoice! FDA Clearly Defines Regulations!

Last year when the FDA announced it would begin regulating vape shops, as manufacturers of tobacco products, many shop owners feared it would be the end of their business. With the high costs of testing each liquid and ENDS device, the vape industry would have been wiped out in just a few years.

Now, with the guidance the FDA released last August, we can all breathe a little easier. At first, they would avoid detailing what exactly counted as tobacco manufacturing in their original regulations. Many interpreted the regulation to prohibit helping customers in any way including basic repairs, explaining how a product works and changing a coil. The new regulations make it very clear what is included and what is not.

According to the new regulations, the following activities can be performed without being deemed a tobacco manufacturer:

  • Performing maintenance such as cleaning or tightening screws.
  • Explaining to a customer how an ENDS device works without assembling one.
  • Replacing a coil with another coil of the same ohm and wattage rating.
  • Assembling an ENDS device from a pre-packaged kit.

“In addition, FDA is providing a compliance policy for certain activities that do qualify as modifying the tobacco product. The guidance explains that FDA does not intend to enforce the five requirements listed above for these vape shops if, generally speaking, all modifications are consistent with the conditions of the FDA marketing authorization (MA) or if the original manufacturer provides specifications and all modifications made are consistent with those specifications. Examples of these scenarios include:

  • Refilling an open system ENDS if no further modifications are made to the device or to the e-liquid before, during or after the refill that are outside the FDA marketing authorization (MA) order;
  • Refilling an open ENDS system if no further modifications are made to the device or the e-liquid before, during or after the refill that – if there is no MA order – are inconsistent with the manufacturer’s specifications.”

The conditions for which a vape shop would be considered a tobacco manufacturer are:

  • “Modifying a product outside of a FDA marketing authorization (MA) order;
  • Refilling a closed system ENDS;
  • Repairing and modifying a part (an atomizer head, for example) outside the conditions of an FDA marketing authorization (MA) order;
  • Replacing a part (a coil in an ENDS product, for example) – that was on the market as of August 8, 2016 but that does not have an MA order – with a different part (for example, a coil that has a different ohm or wattage rating from that used by the original manufacturer); and
  • Assembling a custom final product.”

The PDF for the FDA Vape Industry Guidance can be found here:

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM536997.pdf

Original FDA Web Statement:

http://www.fda.gov/TobaccoProducts/NewsEvents/ucm537006.htm