Good news for vape shops (and it’s from the FDA!)

Finally the feds spell it out in plain English: refilling a tank is not "manufacturing"

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FDA Logo

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.

Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.
  • Laney Bowdoin

    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 name is Laney Bowdoin and I am the Vice President of Uptown Vapor. I have spent the vast majority of my adult life in real estate, in which I managed huge multi million dollar projects. All that changed for me in a short amount of time.

    My grandmother, who raised me, got lung cancer and spent a long time in hospice dying. I would drive 7 hours each Friday to see her. While there I would go outside and smoke. When I picked out her coffin, I walked out and smoked. When we had her funeral, I smoked. Then it dawned on me. Would my kids or grandkids be visiting me in hospice? Then my health insurance was raised bc I was a smoker. I researched alternatives and learned about Vaping. I called the insurance company and they told me if I went 12 months Vaping I would be considered tobacco free. (Although NOW with the new FDA regs this is no longer true. Since the FDA has labeled VAPING a tobacco product) I did not even know we had a shop here. One day I was driving home and I saw a small Uptown Vapor sign. I did a u turn and got my starter kit. Jeff helped me. The second visit I fell in love with Jeff. We grew the company and now have 2 stores and about 15 employees. My mission is to keep grandkids from having to go to hospice to visit their grandmas.

    I have noticed vaping in a heck of a lot of movies lately. It really makes me mad when it is always in a light that they are vaping drugs. It doesn’t show the elderly man that has his wife of 60 years that continuously is cleaning dip off of his shirt and bedding. It doesn’t show the husband that is smoking 2 packs a day from stress, who’s wife divorced him because she couldn’t take the smell. It doesn’t show the mentally handicapped person who quit and started vaping to keep from catching things on fire. It doesn’t show ME. That’s right me, because I want so badly to be the first woman in my family that doesn’t die the horrible death of lung cancer in hospice.

    I have been cigarette free for about 4 years. I sincerely hope being able to get your support on THE COLE/BISHOP AMENDMENT AND “CHANGE THE PREDICATE DATE” will be on the agenda. Imagine all the jobs that will be lost. Business owners loosing life savings, the dream of having a business just thrown away.

    • Jim McDonald

      What a beautiful comment. Thanks for posting it!

      • Laney Bowdoin

        You are very welcome!

        • Jesse Bishop

          was very nice to read thank you

    • Keri Eiding

      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 to quit. The only thing she will use are cig-a-likes and will only vape menthol. It’s a work in progress!! Keep up the good fight!!

      • Laney Bowdoin

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

        • Keri Eiding

          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

            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

            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

            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 4 people over the age of 50 that’s still want that mouth to lung feel still having a cigarette in their hand.

          • Keri Eiding

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

          • Jesse Bishop

            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

            Friend request sent!

          • Jesse Bishop

            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

      • Ed Hunt

        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.

        • Keri Eiding

          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!!

        • Keri Eiding

          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!!

        • Laney Bowdoin

          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

            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.

    • ApeScorpionDragonManJackson

      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!!

  • Spero Branoff

    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.

    • Jim McDonald

      Good point! Before, during and after. Visit August8th.org

    • Laney Bowdoin

      That is our hope!

  • charlie

    Drain the swamp.

    • Jim McDonald

      Well…hopefully we can get a fix for the deeming before the swamp fills back up.

      • charlie

        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 conflict of interest. When that arises honest honorable people in a position of trust excuse themselves from discussion and decision making on that issue. In other words they shut up and butt out. All the whiners are tax supported. They don’t acknowledge the conflict. DRAIN THE SWAMP!

        • Gary Balkam

          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

    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 smell, in fact they smell alot nicer now. I also don’t have to watch my wife die from 2nd hand smoke, I get to enjoy her Beautiful smile a little bit longer. It’s sad though that the Federal Drug Administration and our retarded organization Health Canada,can be so quick to try and put a stop to something as good as Vaping, it’s helping a lot of people do what they have not been able to accomplish, and that’s get people to quit. The Government is losing tax money, the tobacco companies are feeling the loss of revenue, the pharmaceutical companies are also losing money, this is why there is so much opposition. To Hell with them I say, My Health, My Life.

  • Beany

    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 by these regulations is apparently what drove the shop to stop servicing him.

    This is the very definition of unintended consequences of ‘safety regulation’.

    I just thought that was interesting.

    Steven R

    • Laney Bowdoin

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

      • Beany

        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. 😉

  • Tinkergnome

    Fuck the FDA. Vapes are in no way tobacco products. Ignore their rulings until they at least attempt to acknowledge fact over lobbying. It’s not like anyone can’t ‘manufacture’ a fully functional vape with juice from household junk.

  • Gary Balkam

    Hopefully, showing a customer HOW to wrap a simple coil as long as that coil is not used will be allowed. It is unfortunate though, since shop employees that do build coils are pretty much expert at doing it, and have more accountability than some china based web site. Personally, I would rather have the guy I buy my mod from show me how to build the coils for it, than some yahoo on youtube.

    • Jim McDonald

      Yeah, I agree. However, remember that vaping started in China and spread in the US and Europe online. YouTube and vaping go together like peanut butter and jelly!