GPS ON TPDIn this article Vape Compliance Ltd have gone full out to cover some of what we have encountered along the TPD trail. The clock has ticked rather quickly in countdown to notifications, I hope when reading this, shivers do not down your spine and that you have prepared your best justifications to the member states going begging.

I say begging because half of them are so wrapped up with tobacco bonds their governments are ignoring the new science and public opinion regarding the E-Cig revolution.

Those of you who sat and completed the XML file creator for submission, I bet you are looking forward to round two, for us we bulk uploaded nearly 5000 notifica-tions into ten di�erent member states, reported on almost half a million CAS numbers and glad to welcome this festive season in before next years work-load increases.

Cross border sales look as if they will give parity of notification and a common ground is one we should establish espe-cially when looking across the pond and the potential strangle hold the tobacco industry has on vaping.

The sad thing is that so many people are unaware of this fact and many will shake heads, in disbelief and in shame.

We will not be talking questions in this issue because lets face it… the game is up. You are either ready or not. No more coddling and convincing clients, consum-ers, politicians, and regulatory boards to change or step up. Time is up on hitting the ground compliant and we want to show you what we have done to make that possible and what we have been through along this quest!

THIS ISWHERE YOU

ARE SUPPOSEDTO BE

As we in the industry go through the daunting steps of TPD and the repetitive sand sorting that was the Regulatory Commissions provided tools… we are forced to assess “What really comes of this?”

Regulation is needed, for most industries, especially those that can directly a�ect the health of a human being. But by what benchmark is that being held to or com-pared?

Is it our new designation as a tobacco product?Is it by an invisible double standard that isn’t yet explained or even hammered out but we will find out after they assess our collective results and try to divine a standard of acceptability?

The truth is; we can only speculate. Noth-ing is or has been finite in this process, but one thing. The desire and need to tax the product across the board. Like children filing into desks in a high school classroom, roll call is underway.

We are being deemed fit for unabridged taxation and judgment. There will be no questions asked and very few opinions taken.

Outside of that, we can only give you the answers we think are revealing and truth-

ful from our view:What really comes of this: TAXATION.

Control of Market Elasticity to counter the loss of profits from converted combusti-ble tobacco smokers.

Even if a country wants a state of quitters, they lose the revenue. It is that simple. Not just tax revenue, but healthcare reve-nue and investment by the end users who are not as sick as often. Pharma loses money, blah blah it is a trickle down e�ect and it can be measured in dollars and no common sense.

But by what benchmark are these regula-tions being held to or compared to: With these new regulations it is basically a blind leading the blind contest.

Essentially every study in our industry, from both sides, but a slim few have been non-replicated and mostly buckshot poor assessments of the product.

Vapers can’t keep screaming 90% safer with zero concrete validation and the government until lately didn’t have any unbiased tests to validate their claims of gateway alternatives and unknown chemicals.

NEXT YEARTODAY…

A FLASH TO THE FUTURE

This non-scientific view of the Vaping Indus-try does not allow for any real movement forward. Do not get excited if you were an E-Liquid Manufacturer who got your juice tested. Because with no real defined STAN-DARD METHOD OF TESTING, again… results cannot even readily be compared to each other, or replicated to reach an ultimate standard of practice. It is a wash. As are those results.

Let alone the fact that if we are now a tobac-co product, the bar is pretty low on what END USER SAFETY EXPECTATIONS are. Or is it a double standard? You’re tobacco but you have to have zero carbonyls, plain packag-ing, no marketing, heavy taxation, answer to a regulatory body that is threatened by you but has the power to crush you, but not your competitors?

Tobacco has swung a big axe for a big long time… and these commissions; even countries have been sued into mone-tary oblivion at times. Even if they win, mostly they lose, financially. Defending yourself against billion and trillion dollar giants is no cheap feat.

And it appears we are being punched with the full wrath of years of being impudent with our competitors. In their overzealous approach to regulations within our industry, they have given Tobacco another arena to champion. It will be interesting to see how they fair in round two against the giants. Let the shit show begin.

What is really being regulated at this point, what we put in our product? We’ve been deemed tobacco now… essentially we can put all this in there: Ammonia, Arsenic, Ben-zene, Butane, Carbon monoxide, Cadmium, Cyanide, DDT, Ethyl Furoate, Lead, Formal-dehyde, Methoprene, Maltitol, Napthalene, Methyl isocyanate, Polonium. No wait we cannot yet we are deemed tobacco, punished as tobacco, heavily regu-lated as tobacco, with none of the benefits of

tobacco, if you call poisoning your end user a benefit.

We do not want the privilege of killing our end user, which these commissions have so blatantly given to the Tobacco industry. But we would prefer not to be punished as though we are. And we would prefer to have the science speak for itself and the integrity of that science to mean something.

These are lives we are a�ecting. The science should reflect that. Handing down regula-tions with no scientific method of determina-tion was reckless abandonment of logic.

Unfitting of a regulatory board making deci-sions and recommendations for a massive populous of people WAS disappointing.

With TPD winding down, and Phase two rolling in, the industry

needs to take o� the blinders, work together and demand a

fair regulation system. One that allows the science to thrive, not

just any old method decided by whoever is doing testing on your product.It’s comparative to ordering steak well done, but having to live with the fact that the chef believes that means red inside because no real standard exists… WE HAVE A STAN-DARD FOR COOKING STEAK… I think we should have one for testing products that go in our lungs. End of…….

So where will we be next year? We are going to be in PMTA hell, still cleaning up the mess from TPD nightmares and fighting for some semblance of scientific integrity in the indus-try.

That is the future that is tomorrow today, and yesterday now.

Improvement in this process, from upload to practice needs to be brought to task. There were serious flaws in this Regulation and they have more than become known. Stand up for yourself and start asking about next year, today.

What do we here in the industry do now?We move forward…while we wait and see what happens because none of that has been defined. We do not know what they are planning to do with this rickshaw of information they have compiled. But in the meanwhile there are things we can do:• Prepare for PMTA’s

• Build your CAS libraries and do it right.

• Know your supply train, seriously… even if you are co-packed. Take an active interest in the product that pads your wallet.

• READ THE REGULATIONS. You need to know these inside and out. They are not open for interpretation. So know them and when you have questions call and ask now. Do not wait. Trust me you are

NOW WHAT?running out of time.

• Get a compliance o�cer. Because you need one. We saw how TPD went down. You are not getting compliant for one test my friends, you need to remain compli-ant, and it is a full time job.

• Start saving your money. Because they are going to be putting you through new hoops very soon. They will be costly and repetitive. “They” being whatever regula-tory commissions you will be answering to.

• Be proactive. Regulation is a process. You are in the throws of becoming Cor-porate Regulated. Forevermore, a grown up business who answers to many outside forces.

“If flavour houses are to continue reaping massive amountsof money from this industry they need to comply”

“The obstructive, dishonest and the down right irresponsible behaviorliterally leaves a bad taste in your mouth”

FLAVOURHOUSES ANDTHE BIG BAD WOLF

What about our intellect?In a regulated industry your intellect does not trump public health.

Who is enforcing this?Each participating member state will be enforcing their TPD along side theEU COMMISSION.

Do we have to do this?Should you choose to continue selling your products in this industryyou would have to!.

Can we refuse?You are well within your rights to refuse, but your company will shortly become obsolete in this industry.

Format of submissionsThere is a standardized submission method. But there is a lot of informationthat you need to know we are looking for. It is time to template this process.

Dear Mr FlavourHousin’

CAS numbers. I hate them now. If I never see one again it will be too soon. But I digress. . .

If you don’t know why I want your CAS numbers yet, you’re truly in a world of trou-ble. It’s been a complete displeasure trying to wrestle these numbers out of you.

From the industry point of view, You Mr Flavourhousin’, are like a petulant children stomping their feet and refusing to share their toys for fear of people stealing them.

Should you wish to continue marketing your wares to this industry, its now regulat-ed, so sir, you best get inline. Because its over now, the gold rush has ended. The liquid diamonds you have been selling are under the spotlight and you need to be able to quantify their contents or you won’t be allowed to keep making a lot of money from the liquid manufactures.

We’ve watch four flavor houses expand in the last 5 years because of the money pouring in from this industry. SO refusing to hand over the info needed so that you can keep making money is stupid on your part. Something happened during TPD that you should know about Mr Flavourhousin’, E-Liquid Manufactures started talking. And

LETTER TO

they are reformulating. They are reformu-lating your stubborn, noncompliant ways right out of their products and only working with companies that will be transparent.

Mr Flavourhousin’ We ask for your CAS. In the proper format, with all the information, all the MSDS/SDS, The FEMA, The EC number, The Flavis Number, The Reach Number and the exact inclusions in the flavours we use.

We don’t need percentages, we need solid state numbers. SO DO IT RIGHT.It’s your dollar Mr Flavourhousin’, it’s up to you. But we will be spreading the word. Your di�cult behavior makes you replace-able. With that we take our piece of the “PIE FLAVOUR” else where.

We are now a measurable force. Taxed and Monitored. It behooves us to only work with the best, and most qualified. Unless you can follow the rules, that’s no longer you.

It is my deepest regret to have to be so hostile towards you, but you’ve made my life miserable for months and jeopardized the Regulatory process for my clients and their products.Good Day Sir…

MR FLAVOURHOUSIN’

THE PATH TO

COMPLIANCE

STRAIGHT AHEAD

On a serious note, Dealing with flavour houses during this exercise has been exhausting.Most were incredibly un-cooperative and not willing to work with people. When they did it was not timely and the information was presented in ways that made it very di�cult to use.I could spend hour’s here pointing fingers at those busi-nesses or I could look at real solutions. It is our firm belief that the MHRA and the EU commission should have held the flavour houses accountable as well. They are a unique fold in the chain of supply. Unlike any other industry, most of our potential and perceived dangers are in the flavour concentrates. A productive step would be to regulate the product they’re allowed to put into the mix, hence eliminating the most dangers, at the source.Flavour houses make a huge portion of the money within the e-cig industry. Money that is not considered by gov-ernments when they assess the value of our product in the global and local markets.Here’s a closer look at market elasticity and the untamed wild card that flavour houses are.

Once a company has formulated an E-liq-uid flavor it is particularly di�cult to change things without upsetting the apple cart.

Costumers and clients know the di�er-ence. One small flavour change and they start a typhoon of complaints. In this industry, a shiny label on the bottle means carved in stone and forever to remain the same. The demand for consis-tency is absolute and there is zero forgiveness.

With this in mind companies have a di�-cult time facing the reality of reformula-tion. Some of these flavours make them millions of dollars. They are invested in the revenue stream. Changing it could create a huge dent in that stream. A mon-etary a�ect that can be seen, even antici-pated. “Our consumer base does not like change and can be savage in spreading the word.” A manufacturer told us.

It becomes near impossible to make them reformulate flavours that contain ingredients that should n0t be there.Even when flavour houses have figured out that certain flavours are not safe for vaping, they still sell them to companies they know are using them for vaping.Even they know that they are measuring in dollars and cents.

Nobody likes Custard V2 , its not even close to Custard V1. There are good reasons for that, lots of the CAS ingredi-ent library that contributes to the great TASTE of that flavor in its version one formula has been deemed unsafe for inhalation or is on the direct strike list handed down to us by the Commission.

So how is it still being used in our indus-try? Because although flavour houses say “Oh we don’t sell that anymore for that use…” its a bold face lie. They absolutely do.

We put it to the test with three flavour houses during this time. Made open inquires, made sure our company name clearly represented what we were using the flavours for and made multiple forms of contact in regards to the flavours.

Not only were we allowed to buy them for that purpose, we were told directly by two of the flavour houses in print and over the phone that they were aware that they were not supposed to be used for vaping but the other versions didn't taste as good.

They claim by putting not for vaping tag lines in their product descriptions that that there is the extent of their legal expectation. But should it be?That is the real question. Because once an industry becomes regulated, it can become an expensive task to do so. Would the government rather chase down thousands of E-Liquid makers, or thirty flavour houses when it comes down to the regulation of formulation control.

With that formulation control, by regulat-ing that ingredient selection in the indus-try, a CAS library would be a mandatory component of participation for the flavour houses.It would eliminate many of the issues we came across in trying to get the informa-tion we needed to represent our clients and industry the way it needed to be represented.

It would also remove flavours from the market that were being used knowingly although it has been made clear they shouldn’t be there, “Testing at the source” so to speak.

We also found that many of the flavours that flavour houses were claiming to have changed, were not all that changed. This matters, because there is no way to hold them accountable.

These specific CAS items are engineered

for human consumption so long as that consumption is food or drink based.Without direct regulation of the products that flavour houses wish to keep selling in the E-cig Industry, in the Vape Game they answer to no one. We need to e�ect change in that area now.

Really think about how much money these flavour houses make from this industry. To remain solvent at this point after regulations, Manufacturers should hold them responsible for clear and direct transparency.

If they want to keep making money, then they should have to have their specific ingredients tested for proof… as our products need to be. They should as well have to keep an active, updated CAS library that is supplied and verified for integrity.

As flavour houses remain a staple part of the industry, it is our recommendation that commissions and governing bodies turn their strong eye of FLAVOUR MORDOR on them.

They should have to submit each of their flavours for testing should they want them to be used in the market. Each flavour should then be registered with an ECID number just like our products so that the track and trend system actually has scientific value at some point.

The day of the flavour houses has almost come to an end, we are being mapped, and you should be too. It is only a matter of time.

“HEATED” CONVERSATIONS

What it all comes down to is “decomposition”. There is no getting around it.

When most flavors are heated, especially at the extremes we are vaping them at, combined with PG and nicotine, they break down. It’s in that cycle where we find the most damaging chemical compilations and it’s those particular chemicals that people get up in arms about.It’s time to break this cycle down and stop the fear-mongering.

Let’s get into a “heated“ discussion about chemical decomposition.

RESISTANCEIS FUTILE

Chemical decomposition for dummies so to speak, this book needs to be written.Especially now in our industry with fear mongering at its highest level and propa-ganda running the streets. Many of the claims against the product are not formu-lated from sound scientific bodies of knowledge.

Most of what is said about our product is distorted and is about the carbonyl read-ings. There is a measure of truth to the argument, but only when taken out of context.

So how can I make this make sense to you? Let’s talk Decomposition and what that means.

Chemical Decomposition is the breakdown of chemical compounds. Chemical com-pounds generally cannot remain stable when exposed to things like Acidity, Heat, and Humidity. There are a few types of decomposition, Catalytic, Thermal, and Electrolytic. We will be addressing thermal decomposition for the most part.

Thermal decomposition is a chemical reac-tion whereby a chemical substance breaks up into at least two chemical substances when heated. I am going to keep it that simple. It is got more to it, but it’s not needed to make the point.The decomposition temperature of a substance is the temperature at which the substance decomposes into smaller substances.

What are you going to do with all this info? Well here’s the deal. Some E-liquids look great on paper. CAS library is awesome, all around well-sourced ingredients with great certificates of analysis. But then they go for

testing and they are just full of the things that are on the NO-NO list.

The manufacturer is usually devastated and immediately upset and wants retest-ing. But the truth is… CHEMICAL DECOM-POSITION.

Once heat is applied to a chemical com-pound the breakdown of your CAS library into a bunch of other CAS created by that process is unpredictable. And with the many ingredients we cook together, there is bound to be some issues.

The real question is what is the measure of those issues. If formaldehyde shows up in your product due to that break down… which is a bit of Thermal Decomposition and Catalytic Decomposition, what is the measurement of acceptability?

0µg, 100µg, 1000µg… I mean really is there a chart? From rug/carpet installations to new furniture, new cars and multiple other fabric installations in your life, you are exposed to the inhalation of formaldehyde in some seriously high numbers.

There are regulations for those, they are not closely monitored, but they are there.The issue is no real applicable study has been done to say how that directly a�ects you, Cancer, or mutagen…no robust scien-tific body of evidence exists at this point as its all merely speculations and screamers, but none with valid data.The problem becomes: when comparing apples to apples, if we are a tobacco prod-uct our levels are generally well lower than our parent product.

But comparing our results to a baseline of Zero, then we also have problems.This is where the fear mongering and bull crap tactics “what about the children” are hatched!

This is such a loosely guided measurement system. But the chemicals and compounds we are measuring have been made out to strike fear in the souls of the every mother swaddling a baby and raising a teenager. It’s hard to defend ingredients when there is no true bar of acceptability.

One thing we know for sure: The more heat applied, the more decomposition takes place. This brings us to the only control factor outside of ingredient contri-bution that we have.Resistance.

The hotter you run your coils, the more decomposition takes place, that is before even considering the Catalyst e�ect which is basically the introduction of two chemi-cals which makes an environment that breeds other chemicals.So what is safe and what is not? Well I suppose that is what we are trying to deter-mine. We have got a ball park idea that certain chemicals should and can be avoid-ed, such as, arsenic. Yeah we shouldn’t be creating or adding that knowledgeably. Acrolein, Ethylene glycol, Diacetyl, Dieth-ylene glycol, sure these ones can be actively avoided for the most part.

But this: Preservatives liable to release formaldehyde… this is a crap ton harder, and not even in direct context to what they are outlying.

With or without preservatives, the actual creation of formaldehyde in our products is a result of many factors. As it is being used as the biggest defense against our product right now, as was Diacetyl a bit back it is this one reasoning that makes it hard to establish a guideline.

When our products are being tested, the method in which they are being tested can create those negative results. Dry pu�s and poorly timed intervals for inhalation techniques, tanks that haven’t been tested on they own for a baseline of data to remove from the liquid data itself, as well as at what point in the testing these compounds are being measured for… All of this a�ects results. Hence a standard method needs to be made.

But comparatively to our new designation as a tobacco product, we are nothing like our parent products. No matter what anyone tells you, we can say without hesi-tation, that the results produced from this round of TPD are nowhere near those neg-ative results from cigarettes.

I have seen thousands of results, for both products and I can attest to that.But unsafe decomposition in this arena is usually created by unsafe heat levels not actually required to use the product in a normal capacity.

Cloud chasers and tricksters choose a di�erent path, but keeping your heating device for vaping products at lower tem-peratures can curb many of those negative chemical decompositions.

In this case Resistance Is Futile.

RESISTANCEIS FUTILE