DIY Ejuice After FDA Deeming
There is an elephant in the room, and its dung is piling up in the corner. The elephant is the FDA deeming rules that were finalized this month. These rules were hastily written by a government agency clearly overwhelmed by the rapid innovation and adoption of vaping by smokers over the past several years.
We have been getting the question from a lot of our DIY customers: what are you going to do? In this post I will try to explain how we view the situation, and our general strategy going forward. I also want to ask that you engage with us and others to take action where I think we can still make an effective change.
The FDA’s deeming authority is a windfall for big tobacco companies that are losing market share when people quit smoking combustible cigarettes. Without action by congress, the new rules which have been written by unelected civil servants at FDA require every tank, coil, flavor, ejuice, battery, display, circuit, program and spring associated with vaping to undergo the same studies and applications for approval required of Marlboro Reds.
We estimate this will cost well over $1,000,000 just to submit an application for a single flavor/concentration. And then there is no assurance that this application would even be accepted. That means that if you are trying to quit smoking and you start with a 24mg ejuice and step down to 18mg then 12mg/9mg/6mg/3mg and finally 0mg, every one of those concentrations will have to be approved by the FDA for that single flavor. Even 0mg nicotine!
That’s right, there is no exclusion for 0% nicotine ejuice even though that is just three simple componants that have no connection to tobacco, cigarettes, or nicotine. To the FDA, everything that smokes is considered tobacco, and everything that could be used for an ecigarette is a tobacco product.
The deeming regulations are very dishonest. They literally “deem” that a product which is not a tobacco product, is by regulatory imagination, a tobacco product.
Won’t DIY ejuice be safe from these new FDA rules?
If you are doing it yourself, and not selling anything, that should be ok, right? Don’t count on it. There is no language in the deeming rule that provides an exemption for individuals to engage in DIY ejuice, or for businesses to supply them with the products that they need to mix their own juice. As a matter of fact, the components and supplies like flavoring are specifically called out by the deeming rules as subject to the new regulations and restrictions.
A cat and mouse game of relabeling, or repurposing the readily available components used for DIY ejuice will be very difficult because of the liability of being caught selling those components. Sure, you can buy PG sold as non-toxic antifreeze, nicotine sold as a pesticide, and flavoring formulated for candy and beverages, but anybody selling or manufacturing these products will be obligated to prevent you from buying them for vaping, and perhaps report you if you do.
Some popular flavor companies have already begun to disassociate from the ejuice market, even while knowingly selling their flavors to vapers and mixers. But how long will they be able to explain away the obvious intended use of their Habbano or Burley tobacco flavors, or the no diacetyl added alternative versions of their custard and strawberry to an FDA inspector with deeming on his mind?
When it comes to tobacco enforcement, you can be sure that the FDA will be looking to make a heavy handed example of somebody according to their deemed rules.
A BATF battering ram at your door because you refuse to go back to combustible cigarettes would be a very sad and twisted outcome of this deeming regulation. Yet, according to the federal government, “tobacco products” are in the same category as alcohol, firearms, and explosives. Because of deeming, when you mix flavors into PG/VG, or twist a metal wire to be a coil, you will be manufacturing an accessory tobacco product. In the eyes of federal enforcement, this would be treated just like RJ Reynolds rolling cigarettes, colt machining handgun receivers, or dow chemicals making Comp B for bombs.
We can only hope that there will be a legal safe haven for DIY ejuice, but none currently exists in the deeming regulations that I can find. Without this safe haven, everyone who mixes their own ejuice or sells flavoring, PG or VG to people who do will be dealing in a de facto regulated tobacco product. That is a tremendous amount of liability for an individual or business to take on. So that even if you can mix and vape in the privacy of your own home, you may have to pay with bitcoins on some darknet back alley for the safest and most trustworthy components.
The Headwinds of FDA Deeming
Rather than embracing electronic cigarette innovation as a superior—and likely safer—form of nicotine delivery, the deeming rules in their current form will essentially ban vaping as we know it. This is the bottom line that even many ecig trade organizations seem afraid to acknowledge: under deeming, vaping in the US will be controlled by big tobacco, or become a black market.
For a company like ours that has built a line of flavorings from the ground up for vapor, there is no path forward in the deeming rules yet. Our product line could be eliminated by the 2007 SE date, or the costly and vague PMTA requirement just like all other vaping related/associated products.
We will continue to invest in new and better vapor flavors, but if it costs millions of dollars and several years to bring one to market, that will significantly hinder the experience of our community and drive prices up. It will also make the rich variety of flavoring notes and diversity and creativity of DIY and small batch ejuice essentially impossible. …that is if the rules are not confronted and changed.
Our Commitment at Flavorah
At Flavorah, our goal has been to develop a line of flavorings with the intended use of vapor. We have been anticipating new regulations all along like the rest of the industry, but our expectation was for the regulations to be designed for health and transparency like the ones adopted in the EU, not for the gradual prohibition and central control of vaping.
For the last several years, people both commercial and DIY ejuice mixers were content to use flavorings that were intended for use in baking, candy and beverage because those were the only thing available.
We knew that the compounds that are generally recognized as safe (GRAS) for ingestion in food flavorings may not be as safe for inhalation, so for two years we (Flavorah) have been dedicated to only selling flavorings made from a select list of compounds which have undergone review by a toxicologist for use in vapor. When new compounds of concern like diketones have been identified, we have been as transparent as possible and published 3rd party reports for our customers.
We are still committed to releasing new flavors for ejuice.
Our Strategy to Keep Vaping
We are not going to give up, or accept this as the end of the golden era of tobacco cessation and vaping in the USA. We will continue to invest and release new flavors, and we will continue selling our existing line of flavoring for ejuice until it is 1) no longer legal to sell and vape them or 2) hell freezes over. We will comply with the rules as long as we are still in business and can do so without the deep pockets and lobbying efforts of a big tobacco company.
There is still a growing market and movement for ecigarettes in the USA and abroad. Around the world, electronic cigarettes are winning the battle against combustible death sticks (cigarettes) and that will continue because people recognize they are better. Other governments that are taking a more measured, responsible and open minded approach to the inevitable regulation of vaping—like the European Union and UK where they have recognized how ecigarettes can achieve progress in the fight against tobacco addiction—may become a beacon of light where the FDA has failed us.
Can you help the DIY Ejuice Community? Yes.
Big tobacco would like to absorb and destroy the ecigarette community because they cannot compete with it, and the FDA has created rules to help them do that, but there is still time to act.
The first priority is to make our voices heard in Congress
We have reported on this blog before when Congressman Robert Aderholt prevented FDA rule making action from snuffing out our movement over a year ago. A similar strategy in appropriations could be used to halt the FDA again.
New congressional action is needed. The Cole Bishop Amendment is one piece of legislation that will buy time. But further action beyond the Cole Bishop Amendment is needed that protects smoker’s freedom in the USA to vape for the future.
Ask your congressman to support legislation that will reverse FDA Deeming
To begin with, legislation is needed that recognizes electronic smoking is:
- Not a tobacco product and should not be deemed one if it does not contain tobacco
- A potential public safety asset for reducing the harm of cigarettes and other combustible tobacco products
We will post resources for contacting your member of congress, and links to other organizations that are standing up for our right to vape. I will also post suggestions for what would help insure that the heart and soul of international vaping and tobacco cessation—that is the DIY ejuice movement—survives. Please stay tuned.
