Laws And Regulations

FDA Regulations: What it Means to the Electronic Cigarette Community

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I've wanted to write about this for a while as this is an extremely controversial topic to E-Cig users and non E-Cig users alike.

I’ve wanted to write about this for a while as this is an extremely controversial topic to E-Cig users and non E-Cig users alike. In the past, I’ve said that regulation could be a good thing as there are cases that some vendors are unhygienic and do not use simple safety precautions when creating E-Juice.

However in a previous article where I visited two separate E-Juice manufacturers I’ve shown this is not always the case. There are many vendors out there that do take the time and energy to make sure nothing is being contaminated, measurements are being done precisely, and everything is clean and sterile. I agree needs to be some sort of regulation for the vendors not being as meticulous about their E-Juice making as others; however, the proposed level of regulation by the FDA are preposterous and will put a lot (even the vendors doings things properly) out of business.

Let’s start by looking at the FDA’s list of reported adverse effects of electronic cigarettes which I found to be alarming, but not so much the list itself but rather the footnote left of what they define as an adverse effect:

“Whether e-cigarettes caused these reported adverse events is unknown. Some of the adverse events could be related to a pre-existing medical condition or to other causes that were not reported to FDA.”

Of the adverse health risks listed include pneumonia, congestive heart failure, disorientation, seizure, hypotension, and other health problems. Although alarming at first, when reading the footnote, I could not take anything on this list seriously. Basically, any of these adverse health risks listed could all be preexisting conditions that patients had prior to using electronic cigarettes. The FDA hasn’t bothered to separate these potential pre-existing from actual adverse effects that may be directly caused by electronic cigarettes. In short, a pregnant woman can go into the hospital, and if it is reported that she does use electronic cigarettes, it could be listed as one of the adverse effects of electronic cigarettes; that is electronic cigarettes can cause pregnancy!

Although this may be a very crude hyperbole, it isn’t far from the truth of how this is being handled. I mention this because this acts as a taste of the attitude and demeanor that the FDA is treating electronic cigarettes resorting to scare tactics by throwing out words such as “congestive heart failure,” I’m a bit shocked they didn’t throw in the word cancer in as well (http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm ).

So what does this proposed new regulation mean if it gets passed?  In short, electronic cigarettes will be treated like normal tobacco cigarettes. With that in mind, here is a list of what would occur (http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-20870):

  • Selling of electronic cigarettes would be prohibited to minors (younger than 18 of age) no matter what state you live in. Currently, only certain states have age limitations.
  • Warning signs and child proof caps would be required on all E-Juices
  • Free samples would no longer be allowed.
  • All recipe and ingredients would have to be submitted to the FDA for approval prior to selling. New products and recipes cannot be sold until FDA approval.

Let’s break each of these down and see how they will affect each e-cig user as well as the vendors. I am all for prohibiting the sale of electronic cigarettes to minors as the stimulate nicotine can have adverse effects to the development of a growing child’s brain chemistry. This can be controlled simply by checking for ID when purchasing E-Liquid or electronic cigarettes. However, most websites that sell E-Liquid and/or E-Cigs and its accessories do not have an age verification tool in place aside from the screen you get asking for your age in which someone can easily lie on. With the FDA crack down, these vendors would have to purchase age verification service or tool that would be used to check the age of the customer prior to check out. Seems simple enough but most of the online vendors that we all know and love would not be absorbing the cost of this extra service, in fact, I’ve talked to several vendors that say the customers would be the ones absorbing the costs and thus the cheaper prices you see online (v.s. local B&Ms that is) would go up.

Having child proof caps would incur additional costs as well to both local and online vendors.  Although I agree it is a definite must for this growing industry, a lot of vendors do not use child proof caps especially those who use glass bottles and droppers. Vendors who only use glass bottles and droppers would either have to convert to plastic bottles or buy much more expensive glass bottles and droppers with child safety lock built into the bottle.

The lack of free samples would be a game changer as well. For new people who plan to convert to electronic cigarettes, it is a daunting task especially the long time smokers out there. They see the high price tag on an electronic cigarette, and most people do not want to buy a high price item that might not work. This is where E-Juice sampling comes in to play where local vendors have a section of the store setup for potential and current E-Cig users to try out new flavors.

Although the FDA is vague on what classifies as a free sample or not, this regulation may take away the sampling station all together. Online vendors also like giving out a small bottle of E-Juice with every order as part of their marketing structure to allow newer clientele to try different flavors. This would be an obvious no-no with the new regulation.

Up to this point most vendors and E-Juice manufacturers have been okay with the proposed regulations. Any cost that would be incurred would be a minor inconvenience. However having to register every single recipe to get approved by the FDA is where the trouble begins. There are companies (such as Mt Baker Vapor) who have hundreds and hundreds of different flavors. Having to register each flavor would be a nightmare of a task to do. Not to mention approval would not happen instantaneously either as it would take several weeks or months just to see if the recipe would be approved by the FDA and allowed to be sold to the public.

The paperwork aside, each recipe registered would have an application fee to go along with it; a fee that has been rumored to be several thousand dollars. Most electronic cigarette companies do not have the capital to do afford to register every single flavor that they have. The smaller companies would most have to close up shop, and the larger and medium size companies would only be able to afford to release a handful of flavors without going under.

Now, of course, the Big Tobacco companies that are beginning to emerge from the sidelines would be able to afford the FDA’s requirements and application fees for all their devices as they have billions of dollars to back up their electronic cigarette line. Their electronic cigarette line, of course, is stuck in the “stone age” when compared to what most vapers use today. Throwing out words such as innovative and best electronic cigarette on the market when they are just selling pre filled cartridges with their Cig-a-Like electronic cigarettes.

I’ve always been an advocate of treating electronic cigarettes like regular cigarettes when it comes to age restriction, child proof caps, labels that reflect warnings and safety procedures, and even never using an electronic cigarette where regular smoking isn’t allowed. However, the way the FDA wants each recipe to be handled is going overboard. It’s one thing if the FDA just wants the paperwork submitted, but for small businesses to swallow tens of thousands of dollars just to be able to sell their E-Juices would force these small business owners to close up shop.

 

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