What do the regs say about coils?


#1

We received this question via email from a shop owner:

“My understanding is that we can only sell coils as they come from the manufacturer. ie 5packs, 3 packs. Is that accurate?”

The regs are convoluted in many ways and many questions are not answered specifically. I do know this: recently the FDA clarified that making small adjustments to your customer’s hardware is allowed, which includes coil replacements.

Guide To Vaping has a great roundup post on that here:

Here’s the direct link to the clarification:

How are other vape shops handling coils? Are you selling them in packs or individually?


Recent slow downs in vape shops across the country
#2

Coils we carried prior to August 8th we sold individually as long as they could be split at a perforation or cut and remain sealed in their bubble. We have continued based on our best understanding that we could since we were doing it prior.

Any new product coils received after August 8th (TFV8, Scion, etc) we have sold full package only to be on the safe side.

We are grooming our customers to buy full packages and are trying to phase out individual coil sales.


#3

I called our Ohio Congressman shortly after the regs went into action. Fortunately, I spoke with a representative in his office who had a direct connect with a Tobacco Rep with the FDA. Thus, e-mails were sent back and forth between the three of us, as I was asking some questions the Rep was getting extremely frustrated with because he didn’t know the answers to the questions either! He asked me several times where I was getting the questions I was asking, and I explained they are questions any vape shop owner would be asking. Additionally, they are posted all over vape boards, etc. Needless to say, both of the people I was communicating with were overwhelmed because they didn’t know much about the vaping industry when these rules went into affect.

With that said, I have been selling the coils individually. The reason being, I was told since there weren’t many members of the FDA who understand the regs themselves, they wouldn’t be enforcing anything they didn’t know for sure, and the vaping industry is much more complicated and certainly more intricate than they knew. We both agreed to this upon my first question being about the discussions had/we have with our customers about battery safety and battery wraps… which has not been answered to date. Moreover, with the coils being individually wrapped, we are not manipulating the coil but splitting off one coil from the rest.

When the conversation among the three of us began to wind down, the original person I spoke with asked if I was going to want the conversations had, over the phone, put into a written format (Lol… she knew I would!), and I quickly replied that I did. A summary of those conversations were sent to my e-mail whereby I filed them for future reference, or if needed in the case anyone comes into my shop representing any organization who would question me regarding these regulations.

In my opinion, utilize the documentation Jesse posted and anything that is not explained beyond the point of being “vague”, continue to use your judgment and common sense until it is made more clear by the powers that be!

~Melanie w/EveryBuddyVapes
Cincinnati, Ohio


#4

Excellent response. Thanks so much for the great detail.


#5

We just hosted an FDA compliance webinar and our resident expert lawyer advised that if you remove the coils from the package and sell them individually, you could technically be in violation because that is considered a “manufacturing activity” This means you could possibly be considered a manufacturer.

The lawyer’s advice is to not sell as individual coils.

NOTE: This is not legal advice and should not be considered as such in the operation of your business.


#6

Thanks Jesse, as always!

In response to the information you obtained during the FDA compliance webinar, I know it’s not your rule so my response/opinion is by no means personal. It sees extreme with respect to us then walking the line of being a manufacturer if/when we’re separating one from the rest of the same coils, within the same box. :pensive:

I say this from a pharmacy technician perspective, which I am - CPhT. We deal a lot with blister packs, which we filled our own. Since we were taking the medications from the original bottle and repackaging them into blister packs made by another manufacturer, this was riding the line with respect to manufacturing. However, we’re talking two different packages made by two manufacturers in this scenario. Considering we’re simply cutting one from a pack and doing absolutely nothing else to it (e.g… not writing on it, not listing it and/or ringing it up as something different, not bundling it with something from a different manufacturer), I think I’ll continue to sell them individually until we have a more direct and clear ruling on this. :disappointed:

Again, my response is not at all directed towards you, and I greatly appreciate the time you spend on keeping us informed and in keeping the community communicating with each other through this forum!!! Whether you can say it or not, I’m sure you too must feel and/or know that they are seriously strangling our industry… Such a shame!

Have a GREAT rest of your day!

~Melanie


#7

Thank you so much for your great engagement here. You are one of the reasons this Forum is so active and growing every day. Please keep it up!

Your business, your decision! (I would do it too BTW)