Part 3 of 4: US FDA Deeming and Damning (?) Regulations on the Vapor Industry [No more free samples, bureaucratic hoops and implications] (includes links and sources)

in politics •  2 years ago

The hoops and challenges of the US blue collar vape shop owner or juice manufacturer to stay in business are going to be astronomical. Coincidentally, many of these challenges could also be seen as supreme advantages by Big Pharma and Big Tobacco.

You can check out the first two articles in the series here:

Part One: Editorial Overview
Part Two: Goodbye Custom and Full Customer Service

A little background on me and my vape history can be found here

3. No more free flavor testing and no more "free samples"

The general sentiment of the industry is that we, as a whole, really would have preferred if the FDA would have at least spelled some of these issues out for shop owners and manufacturers. The Deeming Regulations, in all 499 pages of their glory, is worded awkwardly intentionally, and according to the document text, shops are allowed to continue offering samples as long as they do not charge an "insufficient amount," however, nowhere in the document does it state what "efficient" is, let alone defining "insufficient."

As a result of this, US vapor consumers can see a price difference anywhere between $.01 and $5.00USD. It's because no one knows exactly what is supposed to be charged, and it is ultimately up to each shop owner to determine what the charged amount is.

Also, it is noteworthy that the FDA doesn't seem to have a plan to collect this sample money from the businesses, just that stores can no longer allow sampling for free.

Shops who have affiliation with trade advocacy organizations such as SFATA (et al.) have at least some help in this realm, as they are providing one-on-one assistance to shop owners with some of the legal decoding, as well as offering open conference calls with advocacy attorneys as an avenue for the industry to get the best answers possible. However, most shops in my metro area do not have this affiliation, therefore are relying on information relayed to them either by the community, or left to reading and interpreting it the best they can.

If the FDA were to come in to a store and catch them charging an insufficient amount for tasting liquid, then that store could be subject to fines at minimum and a complete shut down of the shop at max.

There are so many gray areas.

So what?

Many people looking to kick the tobacco habit are genuinely scared about the process, and the sampling bar makes this process less scary. Once they pick out a unit, having access to 100+ flavors can be overwhelming, but mostly, it eases their mind as to the possibility of finding "the right" juice.

Eliquid is not cheap. While it is much less expensive when compared to both the financial and physical costs involved with smoking analog cigarettes, and although juice can be cheap, it is my firm belief in this industry, in general, you get what you pay for, and the sampling process has become very important in the vaping world. Most vapers do not want to waste anywhere from $20-50.00 on a bottle of juice they might like.

4. The introduction of new products or ejuice lines are frozen

One area that is not gray is that for the foreseeable future, new products and juice lines are not going to be seen. Anything that was on the market and had sold at least one unit before the August 08 could stay as long as the manufacturer goes through the regulatory process to bring these products to market (see #5 below).

So what?

Technology, and its quick evolution, have driven this industry through its boom over the past 5 years especially.

When I started vaping 3 years ago, the number of options available to me were only a fraction of what is available to my customers now. The evolution of technology has made it easier for vapor techs to connect their customers with the best vape for their individual needs.

With a frozen market, what we have now is what we have for the foreseeable future.

5. The cost for most small business who produce their juice lines in-house will not be able to survive the speculated fees

The first deadline for ejuice manufacturers comes at the end of December, when full listing of products, ingredients, and proof of existence prior to August 08 among other dotted i's and crossed t's is due.

According to one juice manufacturer I spoke with, it took over 150 man hours to document and list his entire juice line of around 25 flavors. That is obviously an expense that isn't even going to the FDA but is an expense nonetheless when it comes to the cost of regulatory compliance. This is an industry of small businesses, and the costs will assuredly hurt them, some assuredly fatally.

The fees involved with the FDA application process are still in limbo and we are still not quite sure how much money will be involved with registration and testing of product lines, and the implications of this factor on the average small business owner who is trying to keep their business open will assuredly be negative to many. The appeal of entrance into the industry was the low overhead, and this changes everything.

So what?

At the end of this initial 2-year compliance period, a huge chunk of the local vapor shop economy will close under the weight of either the paperwork or the fees.
Your favorite juice line will no longer be available.
Your grandma won't be able to find "the right" flavor and won't stop smoking.
This is life and death.

In my final piece of the series, I'll be discussing the ignored science involved with the regulatory hammer, as well as the reserved right of the FDA to ignore all of the industry applications for compliance and put a halt to 99% of the vaping industry at the end of the 2 year regulatory compliance period.

For tutorials, reviews, and other free-speech related vape goodies, also be sure to follow @dburklen as well.

I have consulted these sources below as well as others I will add to the list throughout the series. I highly recommend checking out the links below, as I will be citing them at large over this series, and they're just great resources in general.

External Links and Sources

Don't take anyone's word for it--no one truly understands the full implications of these Deeming Regulations yet. I encourage you to read further into some of these articles, research reviews, interviews, and studies I've cited for this article. There are a million more out there as well.

Read for yourself:

Historical Timeline of Ecigarettes (They're Older Than You Might Think)

FDA Deeming Regulations

Retailer Overview of FDA Regulations for Selling Tobacco Products

Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments

CASAA: Consumer Advocates for Smoke-Free Alternatives Association

Editorial Note: CASAA has a literal plethora of amazing resources and FREE PRINTABLES and images that can be used in just about every possible scenerio where people have questions. Also-membership is FREE and keeps you up-to-date on all the latest news. Even an RSS Feed, if that's your bag.

Article "5 Ways The FDAs New Regulations Will Transform The Vaping Industry" Published by Vice in May

New York Times article about British Royal College of Physicians

Public Health England's Offical Report

CASAA Compilation of Scientific Research and Published Data Regarding "The Science" of Vaping

All photos, unless otherwise credited, are taken or edited/altered by me and are all hosted at Imgur.

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It's terrifying. I'm always worried that I'm just one slip-up away from being a smoker again. One too many drinks in a social setting and I could be buying packs of squares again in a heartbeat. Regardless of the fact that every time I make new juice I get one step closer to 0mg nic (we drop by about .5mg/ml a week or so), I still feel like I could easily fall off the wagon. Do I want to eventually quit vaping? Sure. But I need to do it my way, I cant be forced. With the additional recent ruling against Kratom for pain, the FDA and big pharma really have been going after even scientifically PROVEN sources of help for the general populace. Grr.


@quantumanomaly they actually just reversed their position on the Kratom issue, so that's a good thing and people will begin seeing it returning to shelves (it's already back on the shelves in Springfield), but the FDA and Big Pharma are so in bed with each other it is scary. Between Big Tobacco and Big Pharma, the FDA receives $1.2B annually from those groups and their lobbyists, and obviously that's a huuuuuuuuge factor in how they make their rulings. Scary, indeed.

"The one who has the gold makes the rules." -from Aladdin


Good to hear they reversed on kratom, hopefully the same will happen for vaping!


fingers crossed :)