56 million smokers and vaping enthusiasts reached since 2015!
January 13, 2017

Good News For Vape Shops (And It's From The FDA!)

It’s about time…

The FDA will allow vape shops to change coils, assemble kits, and refill tanks on site for customers without being designated tobacco products manufacturers under the deeming regulations.

The federal agency has just issued guidance on the rule, for the first time spelling out in plain English what activities are allowed in retail stores. Since the deeming regulations were published, business owners have tried repeatedly to get such clarifications.

Many vapor retailers have interpreted the regulations to include prohibition of basic customer service activities

The deeming rule was issued last May, and took effect on August 8, 2016. According to the FDA, any retail business that “creates or modifies” one of the newly deemed “tobacco products” (which includes all e-cigarettes and vapor products) is considered a manufacturer, and is required to register as a manufacturer and list all products they sell, submit health documents to the agency, report ingredient lists, and report harmful and potentially harmful constituents (HPHC’s). Additionally, manufacturers are required to submit premarket tobacco applications (PMTA’s) for all products they create or modify.

Many vapor retailers have interpreted the regulations to include prohibition of basic customer service activities like changing coils, assembling a device from a kit for a new vaper, performing simple repairs, or explaining product functions. The FDA has avoided explaining exactly what is allowed during several online webinars, and in phone calls and e-mails with shop owners.

What’s changed?

FDA Approved

The following activities can be done without qualifying a vape shop as a manufacturer:

  • “Demonstrating or explaining the use of an ENDS product without assembling the product”
  • “Maintaining an ENDS product by cleaning or tightening fixtures (e.g., screws)”
  • “Replacing coils in an ENDS product with identical coils (e.g., same ohm and wattage rating)”
  • “Assembling a final product from the components and parts packaged together in an ENDS kit”

Additionally, the FDA says it will not enforce some activities that it does classify as “modifying” deemed products. According to its announcement, the 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 modifications the FDA will now allow 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”

In other words, they will allow shops to help a customer refill a tank, as long as no modifications are made to the device aside from what is recommended by the manufacturer (either in a marketing order or in printed directions).

They specifically explain that replacing coils with anything other than stock coils designed for a particular atomizer is prohibited. So, no building by shop employees for customers is allowed at all. Filling a closed-system device is also specifically prohibited. So if you’re an expert at hacking MyJet pods, for example, don’t do it for customers in your store.

Public comments being accepted

Take Action

The publication of the new draft guidance also opens a brief window for public comment. All retailers and customers of vape shops can offer specific criticism or advice on how the deeming rule affects transactions in vape shops. Comments can be made at the Regulations.gov site, under Docket No. FDA-2017-D-0120

The draft guidance closely follows two deadlines for manufacturers being postponed by the FDA. The due date for manufacturers to register with the agency was pushed back from December 31, 2016 to June 30, 2017. Soon after that, the FDA also delayed the deadline for submitting ingredient listings from Feb. 8 to Aug. 8, 2017. We have updated our deeming timeline to show the new dates for all required actions.

Finally, the agency announces in this document that it will not enforce the requirement that all tobacco products “include an accurate statement of the percentage of foreign and domestic-grown tobacco used in the products.” What a relief.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
Subscribe
Notify of
guest
43 Comments
most voted
newest oldest
Inline Feedbacks
View all comments
Laney Bowdoin
Laney Bowdoin
4 years ago

I am certainly not complaining, however it sure is rather difficult to keep up with what is going on with our industry. It seems as if the FDA must be related to my bi-polar ex-husband. Look, people are not stinking, people are not dying, people are enjoying life. People now have their taste buds healed and can taste how fabulous food is now. So many people have their entire life savings in these shops. We personally have 15 livelihoods in our hands. Please for the love of God, just let us get back to the business of helping people. My… Read more »

ApeScorpionDragonManJackson
ApeScorpionDragonManJackson
4 years ago
Reply to  Laney Bowdoin

Wow, I loved this story! Thank you so much for sharing this! It really got me right in the feels!! You sound like a wonderful person!!

Keri Eiding
Keri Eiding
4 years ago
Reply to  Laney Bowdoin

Wow…Laney!! Good for you!! I’m moved by your story!! I just watched my father die of lung cancer after smoking 2+ packs a day for 50+ years. He was only 66. I’m 36 and smoked for 15 years. I have been vaping for 3+ years now. I have worked in a vape shop (Kalamazoo Vapor in Ohio) for 3 years. Not because I need the money but I want to get people to quit smoking. I never want to sit in hospice ever again and watch someone die of lung cancer. Now I’m working on my mother to get her… Read more »

ApeScorpionDragonManJackson
ApeScorpionDragonManJackson
4 years ago
Reply to  Keri Eiding

Wow, I loved this story! Thank you so much for sharing this! It really got me right in the feels!! You sound like a wonderful person!

Ed Hunt
Ed Hunt
4 years ago
Reply to  Keri Eiding

I used to buy my liquid from your store on Pearl Rd. Seeing how you mixed is why I decided to make my own (I make a 30ml for about $4.50. I am getting good at the flavors too; my best is bourbon glazed cinnamon Danish.) you guys are still a close second.

Laney Bowdoin
Laney Bowdoin
4 years ago
Reply to  Ed Hunt

As of right this second, if you did not have that recipe in and proof of sales by last Aug. 8th. You will not be able to sell it.

Ed Hunt
Ed Hunt
4 years ago
Reply to  Laney Bowdoin

Oh I don’t sell it; the closest I’ll get is if someone has a flavor I want I’ll give them a 90ml bottle for the extract.

Keri Eiding
Keri Eiding
4 years ago
Reply to  Ed Hunt

That’s awesome Ed!! Mixing your own is the best way to go!! If you mix by weight…it’s even quicker!! Some people don’t want to waste the time to mix. To me…it’s worth the savings to do it yourself!! And you can mix to your liking!!

Keri Eiding
Keri Eiding
4 years ago
Reply to  Ed Hunt

That’s awesome Ed!! Mixing your own is the best way to go!! If you mix by weight…it’s even quicker!! Some people don’t want to waste the time to mix. To me…it’s worth the saving to do it yourself!! And you can mix to your liking!!

Laney Bowdoin
Laney Bowdoin
4 years ago
Reply to  Keri Eiding

Keep trying! I believe you can get her on the right path!

Keri Eiding
Keri Eiding
4 years ago
Reply to  Laney Bowdoin

I’ve gotten thousands of people to quit and she’s the one I just can’t get to fall in line!! Ever have that problem being an experienced shop owner? It’s like her crutch. I think she’ll vape when were’re there with her and as soon as we leave she lights up a cigarette!!

Jesse Bishop
Jesse Bishop
4 years ago
Reply to  Keri Eiding

your mom’s need An Icare mini and Mr Salty Menthol fruit I promise you this setup will have your mom quitting cigarettes for sure.. I own a shop myself and I’m telling you this will work. good luck do a little research but I promise you that’s the setup for your mom it covers all the bases that you just stated in the above. If you can’t find what I’m talking about please hit me back up I’ll take care of you personally….

Keri Eiding
Keri Eiding
4 years ago
Reply to  Jesse Bishop

The problem with the iCare is that she wants to hold it like a cigarette. I’ve tried an Ego, MVP, and Subox. And she only wants menthol. No fruity vapes. Mr. Salt is very interesting. Just googled it.

Jesse Bishop
Jesse Bishop
4 years ago
Reply to  Keri Eiding

with the mini you can and do hold it just like a regular cigarette… and yes the mr. Salties I’ve just been turned on to them the last month or two and I’m not a big menthol vapor at all but it is the best menthol I’ve ever Vaped I’m using it in my eye care Mini right now at 25nic strength and it feels like an amazing 3 anyways just an idea I thought I would throw out there… the combination the last month of these two specific items have been working great for me to bridge the gap… Read more »

Keri Eiding
Keri Eiding
4 years ago
Reply to  Jesse Bishop

Thank you for all you help! I definitely appreciate it! Can you taste a lot of fruit in the menthol Mr. Salty?

Jesse Bishop
Jesse Bishop
4 years ago
Reply to  Keri Eiding

Instant message me on Facebook and I’ll send you a simple setup of what I’m talking about you can instant message me on my Facebook page under my name or my shop which is cold Vapes 907 Wasilla

Jesse Bishop
Jesse Bishop
4 years ago
Reply to  Keri Eiding

a little it’s a 70-30 split Menthol vs. Fruit definitely more of just a menthol feel then a fruity flavor at all

Keri Eiding
Keri Eiding
4 years ago
Reply to  Jesse Bishop

Friend request sent!

Laney Bowdoin
Laney Bowdoin
4 years ago
Reply to  Jim McDonald

You are very welcome!

Jesse Bishop
Jesse Bishop
4 years ago
Reply to  Laney Bowdoin

was very nice to read thank you

Spero Branoff
Spero Branoff
4 years ago

With any luck, when Trump starts looking at regulations, most of these may go away. We have to keep writing letters and call our representatives after Trump is sworn in.

Laney Bowdoin
Laney Bowdoin
4 years ago
Reply to  Spero Branoff

That is our hope!

charlie
charlie
4 years ago

Drain the swamp.

charlie
charlie
4 years ago
Reply to  Jim McDonald

I’ve try to make the case for vaping in social media, including commenting on news stories so I’ve read a lot of news stories. I’m okay with honest differences of opinion but so-called public health (entirely different from the public’s health) seem to feel they are free to lie if that’s what it takes to get the public to do as they desire. On the ecig issue they have a direct conflict of interest. If everybody stops smoking and tobacco taxes disappear public health institutions (plus schools, and local governments) will see the biggest funding cuts. This is called a… Read more »

Gary Balkam
Gary Balkam
4 years ago
Reply to  charlie

Have yo noticed, how a lot of these “News” organizations do not allow comments? And some of those studies, such as “Vaping damages lungs in rats” where they vaporize 50ml per minute for 2 weeks…. I say, just drown the rat in the ejuice.. it is faster and cheaper.

Shawn Gauthier
Shawn Gauthier
4 years ago

It’s sad that so many people are affected by the FDA, even when the Health benefits are amazing when it comes to Vaping. I have COPD, smoked for 20+ yrs, I am 43 yrs old and am on oxygen permanently now because of smoking cigarettes! Since I have started Vaping, I may not be cured of my COPD, but I can tell ya that I can breath a lot better, my damn weezy chest isn’t weezing anymore, and yes I can taste my food, lol, my wife enjoys kissing me again. It’s funny I kinda missed that. Our clothes don’t… Read more »

Beany
Beany
4 years ago

Interesting aside – a recent e-cig injury was seemingly caused by a mixture of someone who had a hybrid mod without knowing how to safely use it, which was fine while his vape shop was maintaining it for him. As soon as they stopped doing that, because of the laws discussed in this article, he tried to rebuild it, and it had a rapid unscheduled disassembly. Into his face. Losing seven teeth and burning him badly. We can argue that the shop should never have sold him a device he didn’t seem to understand, but the fear of being hit… Read more »

Laney Bowdoin
Laney Bowdoin
4 years ago
Reply to  Beany

The argument is that the FDA took aware the shop’s ability to help the man. Period.

Beany
Beany
4 years ago
Reply to  Laney Bowdoin

That’s exactly what I’m saying.

I just took half a page to say it, rather than one sentence because I’m incapable of brevity. 😉

Best Beginner Vapes in 2020
LEARN MORE
Vaping360
FOLLOW US
© Vaping360, All Rights Reserved.