US FDA (Finally) Explains Deeming Regulations and Unties the Hands of Vaping Industry
After the 499-page FDA Deeming Regulations regarding vapor products, tobacco classification, and regulation were dropped on the United States vaping industry in early 2016, and ultimately went into effect on August 08, 2016, the entire climate of the vaping community has been different.
As a manager of a retail vape shop and a local community vaping advocacy leader, I was personally blown away when the initial regulations were released last year. It seemed that everything we were once allowed to do was being stripped from us, including (but not limited to):
- Replacing pre-built atomizer units in vaporizers
- Explaining how to use vaporizer systems to new users
- Executing basic repairs on devices (like tightening screws, et al)
- Cleaning clearomizer reservoirs (tanks) out for in-shop flavor changes
- Providing general guidance to users
Here's the rub:
The language in the original 499-page document was intentionally worded in a legalistic fashion, and mom-and-pop shops around the country started scrambling to their trade industry lawyers for help.
Even the attorneys couldn't agree on solid answers as to what the FDA meant concerning a lot of things, so for many shops, it was deemed better to act on the side of caution and suspend these behaviors to avoid penalty and even the closing of their businesses.
The owner of the brick-and-mortar where I work sat through a number of conference calls with attorneys and representatives for SFATA discuss the possible meanings of the text in context to their hazy definitions. It has been a struggle.
What it looks like:
For a shop that had built a reputation on expertise and patient customer service, we had to tell customers that we couldn't touch their device, couldn't advise them on battery safety, couldn't perform simple maintenance tasks for elderly users, couldn't explain how to use their device in a fully formed way...basically we couldn't help customers without feeling in fear of breaking the new law.
Our hands have been tied...
Until now.
Five days ago, the United States FDA released a concise and much more clearly worded 11 page document outlining and defining some of the more confusing elements of the Deeming Regulations, including a few caveats which the FDA does not intend to enforce for the average vape shop.
A vision of the next year or so:
Until the full effect of these regulations slam down in 2018, many shops can go back to a sense of business as usual.
The big confusion concerning the original regulations had to do with what defined modifying a device. There were many actions which could be considered modification depending on a subjective view of an objective definition.
Here are the big things vapor stores can go back to doing without fear of penalty from the FDA and without applying for a manufacturing license:
refilling and cleaning out tanks
replacing pre-built atomizers
explaining how to use vaping systems
assembling starter kits for customers
tightening screws on devices (and other incredibly basic maintenance activities that do not specifically modify the device)
Stores can still not legally build coils for customers!
This one is heavily contended among the vaping community, as it became a really common practice, but I think this particular ban is completely okay and understandable. Trusting unknown individuals to build coils for a vaporizer is dangerous business, and it has always been my personally held belief that if a person doesn't want to learn how to and rebuild their own coils, that they should run a device that doesn't require hand-built coils. Any advanced vaporizer is going to have a certain level of assumed risk and I think some shops do not take the responsibility of informing their customers. It isn't a matter of scaring anyone away, rather to educate people so they are aware of their purchase. No surprises.
Some closing thoughts:
I'm incredibly happy to have my hands untied when it comes to working with our customers who have come to know us as providing the highest level of customer service, and I'm thankful that the FDA finally issued documentation that spells out some of this stuff that we will and will not be subject to throughout this regulatory period and into the future. It is truly a breath of fresh air.
To read the original 499-page FDA Deeming Regulations, click here, and to check out the new 11-page definitions, click here. They're both worth your time if you're into vaping and you enjoy totally knowing your shit when it comes to debates.
I wrote a series of articles on vaping related to the FDA Deeming regulations a few months ago that you're more than welcome to check out as well:
Part Two
Part Three
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Awesome! Thank you, @steemnews.online for helping to spread this great news!! Much appreciated!!
Great post!
"As a manager of a retail vape shop and a local community vaping advocacy leader" - That's awesome!
I would personally like to see more vape related content on Steemit. I hope this post has a good payout & encourages more people to use the #vaping tag 😀
Additionally, I have despised these FDA rules. All they attempted to do is create online black markets for the vaping industry, whether they realized it or not.
@slickwilly Thank you! I am glad to see that people are interested in vape-related content here! I made a few posts a few months ago, and some attempts to draw community together here on Steemit, but didn't get the troops rounded up as efficiently as I had hoped. I've had great response from this article, as well as some conversation in chat as a result, so I am very happy to be adding to the conversation on the topic, as it is one that's been a huge issue since last year when those regulations were initially dropped on us.
Completely agree with you, here. I was blown away at the general misinformation dealing with these regulations, and I fielded a number of calls from concerned vapers who were contemplating buying DIY supplies in a prepper-style stock up, and had to explain to these folks that they didn't need to stock up just yet, and perhaps never--as we have seen, 2 years is a very long time in the vaping industry. A lot can happen.
Obviously we still need people to stand up and tell others how vaping has changed their lives, as anecdotal evidence seems to go alot further than scientific in the public eye (and even in government, it seems), and we still need more research.
I'm honestly of the mindset that if we research the hell out of these, that the FDA and the critical public will have no other option than to see that vaping does come correct and that it is much less harmful than smoking traditional analog cigarettes.
Thank you for taking the time to reply to the post, and I'm glad you enjoyed it. Vape on...for freedom!!