Posted on May 9th 2016
How is the FDA is helping big tobacco part I.
This morning I had to take my kid to school. After I dropped her off I decided I would grab a cup of coffee and a quick sandwich at McDonalds. As I left the restaurant I saw a couple of young ladies in their smoking area vaping. I walked over and talked to them about their mods, flavors, etc., and asked what they thought of the new FDA regs. They both told me that they knew nothing about them. I explained what I know and asked them to get ahold of their congressman, senators, etc. The nice young ladies told me they were a little disappointed that they knew nothing about what was going on with the deeming regs and that they were just in their local vape shop yesterday to get juice.
I am writing this blog for a couple of reasons. 1 - to get out some information on the deeming rights and 2 - to ask and beg others in the industry to please get the information disseminated. If our customers do not know they cannot get involved in getting things changed.
As most in the vaping world knows the FDA has now passed 499 pages of new regulations deeming that vape/E-cigarettes are now a tobacco product. Personally I find this is kind of odd since nicotine can be extracted from cauliflower, tomatoes, potatoes and even lab made. That being said, I will admit that any of the nicotine we use in this store does in fact come from the tobacco plant.
I wondered myself what right the FDA had to get involved in tobacco products and found that in 2009 President Obama signed into law the “ Family Smoking Prevention and Tobacco Control Act” giving the FDA the ability to make regulations regarding tobacco. At the time, no prevision was made for vaping. The regulation did in fact give the FDA the right to deem products made with nicotine as tobacco products. On May 5 th 2016 the FDA came up with the very reaching and ill-informed 499-page deeming regulations that directly affect vaping by deeming it and anything that can be used with it a tobacco product. All the way to the point of claiming that we will not be able to give free samples of our juice and that we have to label 0mg juice with the following label “This product is made from tobacco.”. How is there tobacco products in a 0mg juice. This shows the absolute lack of understanding of the products we sell by the government entity that is put in charge of overseeing our industry. (Now this I just learned. The FDA is not a federal entity as I had thought until now this is a private held corporation. More on this in another blog post.)
The FDA as part of its statistics about ENDS use (ENDS is a new acronym coined by the FDA to mean Electronic Nicotine Delivery System. To normal people these are Mods or E-Cigarettes)
Here is what the FDA in the article the put out labeled statistics about ENDS use.
This is a quote off of that page.
Components” or “parts” include, among other things, software or an assembly of materials intended or reasonably expected alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or to be used with or for the human consumption of a tobacco product. For a full definition of ENDS components, parts, and accessories, please read the Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act. Examples of components and parts of ENDS include, but are not limited to:
A glass or plastic vial container of e-liquid
Cartomizers and clearomizers
Digital display or lights to adjust settings
Flavorings for ENDS
Let me address a bit of this.
1 - in the preface to the statement the FDA made a comment that all of those devices are parts of ENDS (Electronic Nicotine Delivery Systems) but the list is not complete. This is the governments usual way of leaving a door open to be able to regulate whatever they want ,whenever they want. All they will have to do is say sorry guys/ladies that was not a complete list you now need to add these other products. This sort of grey area in a law in unconscionable.
E-liquids – right on. I am all for some oversight on what I put in my body. But isn’t that already there? We are using FDA approved items mixing them so common sense would be that we still have an FDA approved item. Kind of like, if you are making a pound cake. 1-pound flour, 1-pound eggs, 1-pound butter, 1-pound sugar. All items are ok according to the FDA. Does that make the pound cake I want to make ok or do I need their approval on the final cake? Not according to the FDA when it comes to E-Juice. We mix their approved items and then need approval again. We use Vegetable Glycerin, Propylene Glycol, flavoring, nicotine, and on some occasions water. All FDA approved and may I point out that propylene glycol is actually used in nebulizers as the carrier for people with breathing issues.
Now reasonable regulation would be to dictate what I should not use in my juice. To require millions of dollars of testing for each flavor is ludicrous when using all approved items. More crazy is requiring the same testing when all the same flavoring is being used and just a difference in nicotine level. Come on FDA. Come out with a list of disapproved items and set a max nicotine level of like 24 milligrams. I know this is privately held company but small mom and pop businesses cannot possibly compete. Oh wait that might be the idea.
A glass or plastic vial container of e-liquid – Really? Did I possibly just read this? Ok common sense seems to have been lost. Again a food analogy. If I decided to make Mayonnaise and bottle and sell it would I actually have to pay $300,000 dollars to $3,300,000 dollars to get approval. And pay that fee again if I have more than one size bottle or decide to use 2 shapes. This is what we are being asked. Reasonable regulations would dictate a list of approved and/or disapproved materials.
Cartridges – Come on people a little description here of what you mean. I assume you are talking about the cartridges that carry the E-Liquid to VUE of Blu pens. Isn’t this the bottle of vial you talked about above? I will assume it is so. No need to rewrite this as the only difference is these are prefilled and sealed.
Atomizers – This is the heating coil for our vapes. Basically a heating element wrapped.
Certain batteries – Nice. Will someone point me to where there is an edible battery. Were do I invest? If this is a food and drug issue, how are my 18650 batteries able to come under the authority of the FDA? These batteries are used all over in many products. Rechargeable lanterns, cell phones, you name it. How is my battery now a product that can be regulated by the FDA? Is this a little over reach?
OK, as you are starting to find I like analogies. The battery is the ignition source for my atomizer (The part that makes vape.) So yes it is an integral part of vaping. But in my car I have an ignition source for a cigarette, it is called a cigarette lighter attached to a battery housed in an automobile. Therefore, my car is an ignition source for a tobacco product. Hmmmm, someone give Ford a call and tell them they have 90 days to submit their paperwork. Joking here a bit but as I see it, both situations make about equal sense.
Cartomizers and clearomizers – if these are going to be allowed to pass at all isn’t this more of a materials issue worrying about outgassing etc.? So, like with bottles, give some guidance and let innovation find a way to make new and safer products.
Digital display or lights to adjust settings – how about doing like is done with any labeling on cigarettes, there is a requirement for a reasonable minimum font size and readable font to ensure the end user can actually see the display.
Tank systems – This would appear to have the same issues as the cartomizers clearomizers. No need to cover it again.
The one on my particular favorite mod happens to be anodized stainless steel. Why with a material qualified to run medical oxidizers does it take FDA approval for its use?
Flavorings for ENDS – I covered most of this with the E-Juice but all flavorings are already FDA approved and are regularly used in other industries. I will touch more on this in a later paragraph.
Programmable software – I could write a book on the over reach on this one but suffices to say how does the FDA have the authority or the knowledge to be able to check proprietary software?
Now let’s look at that mod in your hand. There is almost certainly a flavored E-juice, a drip tip, a tank of some sort, a battery, an atomizer, and some sort of software. That is considered separate regulated items. The numbers I have heard would between $300,000 and $3,300,000 to get through the FDA approval process. With 5 items that is 1.8 million dollars to 18.8 million, assuming they do get approved. Is this a reasonable number for a product that is in its fledgling stages? Who can afford this? To big tobacco this is a drop in the bucket. But to the little guy that is hanging on trying to bring some innovation this is an insurmountable number. And who do you think is going to pay for this new certification? The consumer!!!!!!
Considering the FDA is a private held company that is loosely attached to the US government, it is not surprising that there is over reach beyond logic and that this is a new revenue stream for this private company that calls itself The Food And Drug Administration.
The FDA is standing by the fact that we as the vape industry are marketing to children and I horribly disagree.
First 40 of the 50 states have already passed laws not allowing vape or vaping products to be sold to people under the age of 18 or now in Hawaii and California 21. So this accusation is groundless and simply makes a good sound bite . Here is a list of the state regulations.
Secondly the accuse us of making flavors that appeal to children. This is equally wrong. I will grant you I have in my line up both bubblegum and blue raspberry. Did I make this for children? NOPE!!!! These were 2 of the first flavors I made because I like them. Now to put this in perspective I turn 51 tomorrow so I may have socks that are of legal age to buy. Just because flavors are good does not mean that adults don’t like them. Let’s take a look at a major Vodka producer UV in their lineup they have blue raspberry, lemonade, cake, etc. etc. These are also not marketed to children nor are they required to go through this sort of scrutiny to bring it to market.
I have also been told that this is causing children to start smoking. I am trying to find the data that they based it off of but as the FDA does it makes accusations and it is our job to find the data. So here is what I found.
Is vaping safer than smoking. In an article put out by the department of Public Health in England the following was stated.
Recent studies support the Cochrane Review findings that EC can help people to quit smoking and reduce their cigarette consumption. There is also evidence that EC can encourage quitting or cigarette consumption reduction even among those not intending to quit or rejecting other support. It is not known whether current EC products are more or less effective than licensed stop-smoking medications, but they are much more popular, thereby providing an opportunity to expand the number of smokers stopping successfully. Some English stop smoking services and practitioners support the use of EC in quit attempts and provide behavioral support for EC users trying to quit smoking; self-reported quit rates are at least comparable to other treatments. The evidence on EC used alongside smoking on subsequent quitting of smoking is mixed.
Now lastly (At least for this article.) I have been told to just wait out what happens. Well the deeming regs will be submitted tomorrow and start in 90 days. We can’t wait or just stand by. Call your Senators and Congressman. Tell them how vaping has helped you or a loved one quit smoking. If you call be professional. Be nice. Explain how this will destroy an industry that has helped you. That the regulations are insurmountable. Share this post. If you think I missed something let me know. This is the first of a few blogs on this so I will edit this or add to the next post.
All prices are in USD