We are nearing the end of an era in the electronic cigarette market. The next 6 to 8 months will prove pivotal in the future of many of businesses, but also to many customer’s own day to day lives.
If your unaware of what the TPD is, it is the EU’s Tobacco Products Directive. There has been an immense amount of negative reaction among vapers concerning how stringent these regulations are. The main incendiary points that have ruffled feathers for businesses and individuals are the removal of bottle sizes over 10ml. Tank capacity cannot exceed 2ml. Furthermore nicotine strength’s cannot be higher that 20mg.
There are other rules in place and if you would like more information about these please take a look at https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products
Regulations bring both headaches and huge benefits to new industries. One of the best parts of the TPD is the strict testing procedures that need to be performed on e-liquid so that you as a consumer feel safe in what you are using day-to-day.
This is the most important thing for us here at Mist. Therefore we have partnered with the UK’s leading testing facilities, Broughton Laboratories to test all of our e-liquid. However simply telling customers that things have been tested is not sufficient. Claims like this will be being made up and down the country and customers need to be vigilant that companies are doing what they say, it’s a point we cannot stress enough.
We want to lead the way in this new era and give as much insight to our loyal customers as possible.
With this in mind we hit the road and met our brilliant team of dedicated Scientists who will be ensuring that all of your e- liquid is of the highest possible quality, anywhere in the world.
I sat down with Managing Director Chris Allen and Director of Biopharmaceutical Operations Leslie Henderson, of Broughton Labs to talk about their testing regimes and how they ensure safety and transparency for you.
Do you vape or smoke? – If so what is your set-up and flavour?
C: I have on occasion tried both. To be honest I’d probably go for a standard set-up something really simple and easy to use.
What is e-liquid and why is it important that it is tested to such a high standard?
C: You have two aspects, ongoing quality control (QC) which is making sure that the nicotine level is correct. We have seen variations in nicotine concentrations which are half, even ten times lower than it should be. So if the consumer is not getting what they paid for then clearly they need to be protected against that. There is another risk also associated with untested solutions, which poses a greater potential health risk that there is two or three times the amount of nicotine in the liquid than is quoted on the bottle.
For the TPD, it is just about trying to understand that under ‘normal or reasonably foreseeable conditions’ that the e-liquid does not generate harmful levels of toxic chemicals such as carbonyl compounds during vaping; primarily formaldehyde, acetaldehyde and acrolein.
From a hardware perspective its understanding if there’s any toxic metals that are coming off the coil into the vapour. Typically, when you’re looking at trace and heavy metals the safety limits by inhalation as opposed to ingestion are about 100 times lower. Inhaling anything has a much more potent effect as it is absorbed into the bloodstream in a more rapid way.
As a consumer and ex-smoker hearing this potentially for the first time, the idea of inhaling any amount of a toxic metal sounds very worrying, even when you compare it to one of the chemicals that you have mentioned such as formaldehyde. I think as an ex-smoker, we have become used to the idea that along with nicotine we are inhaling up to 4000 other chemical compounds. Should we be more concerned about the metals or the carbonyls?
C: It all depends on levels with both groups; metals such as manganese can have very nasty effects on the body. However long term exposure to dangerous levels of formaldehyde can increase risk of strokes and various other health concerns. It’ all about understanding what levels are dangerous over longer periods of time under normal and reasonably foreseeable conditions, and making sure businesses and consumers can access reliable information so they are aware of the potential risks.
What information should suppliers, provide to show that their concentrates will be/are compliant with the TPD?
C: There have been recent guidance out which states that you only need to provide the name of the flavouring on the bottles and anywhere else that you communicate with customers. I totally agree with this approach as it’s easier for customers to understand. You could have had a situation where instead of simply having blueberry or strawberry displayed, you’re faced with up to 6 or 7 individual aspects of the flavour concentrate which could cause confusion and be misleading.
Vaping over the past couple of years has changed immeasurably. Gone are the days of cig-a-like devices and standard eGo pens. We now have temperature control units, sub-ohm cloud chasing machines and the rise is high VG juices. What ramifications do these different vaping mediums have from a testing and safety perspective?
C: We were having this conversation yesterday actually, it’s a great point. There is limited information out there which fully explains how the rapid innovation in product design is affecting the composition of the aerosol being produced during vaping. We would love to be able to conduct a thorough study on this, however with such high demand for our testing services, we are fully concentrating on getting our client’s products tested for TPD notification.
For example, with higher VG juices. We have observed some interesting patterns to do with the PG/VG ratio, it’s an area that needs to be looked into more. It’s impossible to say currently that higher VG or higher PG results in potentially more carbonyl generation. There are far too many other variables not only in the hardware, but also in the way the user interacts with the device, like for instance how frequently they change their coil.
We’d like to be able to get to a stage where we could say, yes, this device is perfect for e-liquid with this ratio of PG/VG but currently there are too many variables. We estimate that we would need a minimum of year of solid testing of these conditions before we could give those recommendations.
Hopefully as testing for TPD continues throughout the industry, this information will naturally evolve and be available publicly.
Do you from a regulatory and safety standpoint think that there was too much innovation too quickly with things like sub-ohm vaping, or temperature control units?
L: If we go back to the earlier point, talking about the regulations as a whole. If you try to put restrictions in place, or try to control too closely when restrictions are put in place you throttle innovation. With vaping It’s generational leaps with innovation and progress.Although we have been dealing with a number of different variables in developing an analytical strategy for TPD testing. That isn’t necessarily a bad thing. For instance 12 months ago we had limited information of the scope of the variables and how they interact, they have informed our testing methodology so we are in a better place than we were 12 months ago. This has helped us narrow down and focus on the ones that have the potential to cause harm.
Pragmatically let’s use formaldehyde for example, we know that it’s a negative so lets focus is on the ones we are sure about first and control those. Then once we do that we can look for things that are less understood.
Steeping is something that has been around in the e-cigarette and e-liquid community since the early days. What can you tell us about steeping and the effect it has on eliquid from a chemical perspective?
C: We call these shelf life stability studies, people know e-liquids change colour and we understand it is thought to improve the flavour. However, it is in fact changing chemical composition, the nicotine degrades. Nicotine degradation is not just the loss of nicotine, when the nicotine degrades it breaks down to form other compounds, not simply just lost as some people might believe. The nicotine degrades into impurities, there will be other components present after this. In a pharmaceutical testing process there are severe limits on how many of these impurities are allowed to be present.
We hear a variety of stories of people trying to improve their e-liquid by doing a wide array of things to them such as heating them, or putting them in a sonic bath. Oxidation is the main part of that steeping process. If you put a nicotine solution in a warm humid atmosphere it will degrade significantly quicker than it would at room temperature.
How often would you recommend people should be changing coils?
C: This is a really, really important point that we would like to highlight. We only test on brand new coils at the moment. We need to get to a stage where we should be defining lifetimes for coils through stability studies. The reason there is no definition for how long a coil should last for, in terms of inhalations, is because there haven’t been any studies published around this particular part of the process yet. We’d like to see a robustness test for the age of coils to determine at what point it does start to release metals or anything else that could pose a risk to health.
Its quite interesting to hear as a stakeholder that a robustness and stability test has not been commissioned yet for this important part of the vaping process.
L: Stability studies cost a lot of money to do. You are testing over and over and over again until you notice the change. Whereas now what the regulators are saying is pragmatically ‘let’s just set a base line for understanding when a product is brand new, what the starting point is and how it performs so we can offer this guidance’. They are intentionally trying to keep the cost burden low for the industry, in order to keep it alive. These things will develop and there’s an element of payback involved. The businesses need to be allowed to continue and to bring in revenue and profit so that the tests can develop and there is an industry around to pay for these more in-depth tests later down the line.
Could you give us an explanation of each test and why it is done?
L: The types of testing we are doing now are the ones we believe to be the most important. Nicotine dose consistency, Carbonyls and metals currently. Academic research and testing is also very important as it builds the foundation of knowledge and hopefully good science. There are lots and lots of scientific papers out there which have focused on evaluations of different product types, or more importantly, comparing the harmful chemicals which are generated from smoking conventional tobacco cigarettes compared to e-liquid. I think we have gone past that stage now we don’t need to prove that anymore. This was typified by the PHE report which concluded that vaping is 95% less harmful than smoking.
The focus has shifted to ‘we know the performance of this, lets now try to look at that performance and improve it and make it even safer, to the point that all your actually getting is a 100% clean nicotine hit and nothing else along with it. That’s what we are working towards hopefully.
What happens if an e-liquid fails any of the tests – And why would it fail?
C: It’s not for us to decide. At the moment there is no such thing as a pass or a fail. It’s the responsibility of the producer or manufacturer to make that notification and declare that they believe that product to be safe. So if we come back to a company and say we have reported 400 micrograms per 10 inhalations of formaldehyde, that is for the toxicologists to decide if they think that is safe or not, and then put it into the notification. I don’t believe the MHRA, within reason, would come back and say we do not believe this to be safe. What they are looking for is that signature to say ‘we as a manufacturer are taking full responsibility for this product, we believe it is safe and if anything happens we will take responsibility for the liability.’
We have tried as much as possible to provide guidance. Most of the work we did earlier this year in the run up to this process was to do with work place safety. For instance, if you are an operator in a paint factory who uses formaldehyde or any of the other chemicals relevant to e-liquid to produce your paint or varnish, within that manufacturing process there is what is called ‘Workplace Exposure Limits’. These rules define the amount of time the operator can work in this environment before being taken out, or given some specialised protective equipment to protect their health. What we have done is to try and correlate that with a reasonably high level vaper. Circa 500 inhalations. When you work with us, we will inform you of our alert limit, this limit does not mean this one is safe and this one isn’t, but it does give you a frame of reference. It is still up to you if you would like to notify that formulation, or go back to the formulation and work on bringing it down.
What we have found in this industry is that there is a lot of people who do not have the scientific background to understand the potential harm that could occur. I’m not saying they don’t want to know, just that they don’t have access to the information. This is where we would like to educate businesses to the point where they understand exactly how their products are safe, and give them the confidence to put those products on the market. The more information we can provide the better and more informed the decision will be.
If a manufacturer’s product did come in at the alert limit, would you help in this re-formulation process to get that product within the guidelines you have developed?
C: Of course. That’s why we are scientists! We want to create data which is useful and helps to protect public health.
How many e-liquids have you tested?
C: E-liquids emissions testing we are well into 300 now. We are estimating that we will support over 1000 products in the run up to the TPD deadline. Because the guidance has been unclear up until now and there is a capacity limit we have to ensure we work within those constraints. We have had to double the size of the e-liquid team every two months in order to keep up with the demand.
What do you think about the TPD regulations?
C: From a testing and safety perspective here in the UK we think it’s good. It can only lead to more good science, more information for businesses and therefore a greater level of consumer confidence in what they are using. There are other member states however who have not done anything. We put this down to the lack of clarity from each member state on how they interpret the TPD.
The UK have defined their testing criteria, however if another member state has not, or the criteria are not as stringent as in the UK, technically they wouldn’t want to accept any products that don’t meet the same minimum requirements that the UK has set out. This is the problem, and that’s politics.
What will that mean for consumers?
L: EU wide until there is a time where there are standardised methods across all member states then there will be some confusion. Here in the UK and at Broughton we believe that our testing methods are strong and robust and based on good scientific principles. This comes from not only testing e-liquid but many, many other chemical and pharmaceutical products for the last twenty years we understand the concept of what a good test method is and what good results are.
What sets us apart is the testing method. The due diligence we can provide from our years of experience in the pharmaceutical industry. We have tested samples that have been previously tested and the tests have not picked up the same results we have. This is because the testing method prior consists of providing a ‘not present’ result on anything that was under 100 parts per million (PPM). Our testing is far more rigorous, our detection methods would report anything down to 1 parts per million. That for us is good science and we can then provide advice that consumers and manufacturers can be confident in.
What have you learnt from testing e-liquids? Have you any surprising finds?
L: We have found products that have roughly anything between zeroto 400 micrograms of formaldehyde in 10 inhalations. We would strongly advise that any products with these readings are investigated to find out what is going on before being notified. We have also seen products come in to us that have nicotine levels that are well below what is printed on the bottle, also products that have come in with nicotine levels well above what is printed on the bottles.
What should consumers be looking out for when purchasing e-liquid?
C: Consistency. Consistency comes from having good manufacturing processes that can deliver what is printed on the bottle, and what has come out of the reports every time without fail. This coupled with a stringent and robust testing procedure is what will make a higher quality product. If a manufacturer is unable to get their PG/VG levels and their nicotine concentration levels spot on every time then the more in depth toxicology assessments of the flavour concentrates are more likely not going to be consistent also.
Another part of the TPD that should be noted is the pharmacovigilance section. We have to have an adverse event notification. As part of the TPD manufacturers have to submit an annual report to the MHRA on any reports of adverse effects or reactions to a product. At one point we estimated that in Europe there were about 80,000 e-liquids on the market. There are probably more today. With this part of the TPD in force the amount of data that will be being gathered will be essential for scientists to spot trends in products. This leads to a great environment of self-regulation as any of those trends that are spotted and made public will result in unsafe products being removed. Subsequently there would be specific testing or research done into what causal relationship there was behind the adverse events increase.
Do you believe that within a 10-year period given the potential of this product, the growing levels of usage and data that’s available we could potentially say these products are safe to use?
Things in 10 years will be much, much clearer. We would never be able to say that something is totally safe simply because of the end-user’s effect. People are told to only take two paracetamols every four hours, but people do take more and then that is at their own risk. We can only provide science and advice up to a certain level.
People use their devices in untold number of ways, and there are millions of users who are constantly changing. The best case scenario would be that we could potentially say if you use this device, with this eliquid, at this setting for this amount of time every day we could potentially say, within reason, we believe it’s ok.
The insights gained from our team up at Broughton will have significant impact on the future. They may have de-mystified some of the misconceptions surrounding the testing of e-liquids and hardware.
– Ensure you understand how strict of a testing regime the company you are purchasing your e-liquid from has. PPM (parts per million) is the measure of accuracy used in these testing method. The lower the threshold i.e (1PPM as opposed to 100PPM) will give you much more confidence.
– Change your coil regularly! All e-cigarette studies tend to be tested on brand new coils. There haven’t been any studies that are being recognised by the government on what happens to a coil after it has been heavily used. Stay on the safe side and switch them out as regularly as possible. Don’t wait for them to burn out!
– The regulations are here to weed out companies that cannot provide these scientific information about their products. Anyone producing e-liquid at home or in their garage for instance. Only buy e-liquid from companies like us who can show a fully notified product and have a dedicated lab conducting tests. Companies should tell you if they do or they don’t, if they resist take it as a sign that they are not compliant!
– PG/VG ratio will become more important as testing procedures develop and we have more data. Stay on top of your research about what the best PG/VG ratios are. Higher VG eliquid does not mean it is of higher quality or more importantly safer, it could turn out to be just the opposite. Once we have this information we will share it with you.
E-liquid testing is a developing part of the industry. However it is essential that we all understand how and why these products are being tested. As mentioned by Leslie we have moved away from comparing these revolutionary products to conventional tobacco, but that does not mean we can ‘sit back on laurels’. We use these products day-in-day-out so we have a responsibility to make them as safe as we possibly can make them. This wont be achieved overnight, but by understanding the process yourself and engaging with companies like ours, we will get there.