Please find here the statement we have put out in response to the new reports about vaping deaths in the US over the weekend (we have previously commented on earlier reports). John Dunne was also on BBC News discussing the story on Saturday and LBC this morning.
We have tweeted the statement and uploaded it to the website, so if you could all please share our tweets and our statements across your social media channels that would be greatly appreciated. We are keen to ensure that consumers are not put off by these stories so it’s important for us to circulate our response as widely as possible.
For those who may need to reassure customers you might find the following points useful:
Public Health England have also made it clear that the situation in the US is very different to the UK and remain confident that vaping is 95% less harmful than smoking. Their statement is:
“A full investigation is not yet available but we’ve heard reports that most of these cases were linked to people using illicit vaping fluid bought on the streets or homemade, some containing cannabis products, like THC, or synthetic cannabinoids, like Spice. Unlike the US, all e-cigarette products in the UK are tightly regulated for quality and safety by the Medicines and Healthcare products Regulatory Agency and they operate the Yellow Card Scheme, encouraging vapers to report any bad experiences.
Our advice remains that e-cigarettes are a fraction of the risk of smoking, and using one makes it much more likely you’ll quit successfully than relying on willpower alone. But it’s important to use UK-regulated e-liquids and never risk vaping home-made or illicit e-liquids or adding substances, any of which could be harmful.”
Further to this, we have written to All Party Parliamentary Group for Vaping members and other supportive MPs to reassure them and ensure that we keep them engaged with the UKVIA. We have already had responses from a number of MPs, thanking us for the information.
We are also are touching base with MHRA to ensure that there has been no similar reports in the UK.
At ADACT medical we offer a full compliance service for the Hemp and CBD industry in the UK and Europe, one of the questions that frequently what law governs CBD products, and the answer to that there is no one single law, but here is a rundown of the key areas of interest.
The core regulation is not about CBD at all it’s the Misuse of Drugs Act, and that covers the illegal cannabinoids that can be in as a contamination, THC, CBN, THCV, and some other minor ones. You only allowed these as a contaminant, and its less than 1mg in the total product. Not a percentage, the often made mistake is thinking its 0.2% but this is not the case, that is a legal limit on growing and processing industrial hemp, for finished products is 1mg in the pack. Beyond that the rules break down:
Growing Industrial hemp (you limited to using the stalks and leaves) and you need a home office license for that activity and the same for processing, if you want to use and extract the full plant you will need a controlled drugs license for growing hemp.
Making products, this often comes under local council remit, you need to register as a food manufacture and be subject to food hygiene inspections.
If you have other questions then please get in touch.
The CBD market is an interesting beast and one that continues to grow quickly, At ADACT we have three members of the team that come from a pharmaceutical background, manufacturing and product regulation, and the one thing that we take for granted is knowing that you can’t test quality into a product, what this means is two fold:
1. You must test your incoming and outgoing goods, especially your incoming goods, once you have made it no matter how much testing you do your product will still be wrong if your raw materials are wrong. Now this is obvious but how many companies blindly rely on supplier certificates, twice this week we have tested CBD isolate that was 10% out of specification. You have to remember that isolate is being made not to cGMP standards and in-batch variability is an issue. Its imperative you test your incoming goods
2. This is the most important point, you need to know where your product has come from, not just a vague awareness that its come from the USA or Europe, but you need to know, where it was grown, where it was extracted, whos hands its passed through to get to you, what standards are they operating to, when we test an isolate and say yes is 98 or even 99% CBD, what is in that other 1-2% it could be plant waxes and esters, or it could be something much more unpalatable. Relying on your broker to maintain the quality of your product is find if you have done the work and conducted the audits.
If you want help with auditing you supply chain just Ask ADACT, we can help you with this important task, we have the qualified staff and know what to do.
ACAS E-cigarette guidance.
ACAS has published its guidelines on vaping in the workplace. The full document can be found here – https://www.acas.org.uk/index.aspx?articleid=4900
It clearly states that Vaping is not covered by the smoking ban so is at the discression of the employer.
Its makes the case, not strongly that vaping is a route to quiting smoking.
But does come out and highlight that there are social issues with some inconsiderate vaping.
Overall it’s a balanced approach to the topic and all employers should review this when forming their policies. The UKVIA, of which ADACT is a board member, have been campaigning for proportionate and reasonable regulation of vaping. This is another example on how that kind of lobbying can have a positive effect where normally the response is to just lump vaping in with smoking and ban it.
For those of us who have been working in the vape industry we know that MSDS (material safety data sheets) are required for any chemical mixture that is sold, but its not a requirement for food goods. However as many CBD companies start to produce vapes and cosmetics, you will find you are in the domain of needing MSDS sheets. These sheets basically give the safe handling procedures and labelling requirements for the product and it’s a legal requirement to provide these to a consumer on request. They should be sent to wholesale customers with the first order and any orders after you update the document, here are a few facts about MSDS sheets that you need to consider.
Each product should have a specific MSDS sheet, its not one size fits all, different flavour or strength requires its own MSDS sheet
Your MSDS needs to be EU standards, US ones are different and will not suffice
Your MSDS sheets need to be kept up to date, classifications are always changing
Do your labels match up with the requirements on the MSDS sheet
At ADACT Medical we have always held that shortfills are a regulated product, they should not be a way to dodge regulation, under the GPSR 2005, a catch all piece of legislation, it imposes TPD standards on shortfill products and that cant be disputed, but many did. See our earlier article on GPSR, but there are many companies that continue to pursue shortfill business as a way to avoid safety and testing standards, this kind of behaviour has started to bring the obvious response from the European Legislators, in Greece they require all shortfills to be tested and submitted through the TPD portal, you can still sell bit bottles, but only if they are notified. In Holland you have to register your shortfills in the same way as your 10ml and we believe that larger bottles are not going to be allowed. Austria are bringing in similar rules to Holland and we have just had notification from the Latvia authorities to the same effect.
Below is an extract of the notification from Latvia.
Dear Mr. Damien Bove,
Thank you for your email. The Health Inspectorate is the surveillance body for e-cig liquids in Latvia, therefore, I would like to take this opportunity to inform you about the changes in the law “Tobacco products, herbal smoking products, the electronic devices and their liquid movements law”. It has been amended on 04.04.2019. Amendment is available in Latvian here: https://likumi.lv/ta/id/306295-grozijumi-tabakas-izstradajumu-augu-smekesanas-produktu-elektronisko-smekesanas-iericu-un-to-skidrumu-aprites-likuma.
Some of my customers have had some unexpected letters from the German Authorities this week, the letters entirely in German have arrived out of the blue. Having translated one the letters we can confirm that it is confirmation that an application for cross boarder sales has been accepted. We applied for these in 2016, so it has taken some time to process. Now many of my customers forgot all about cross boarder sales, but its worth thinking about it again.
Cross boarder sales of tobacco products is prohibited in Europe, defined as selling from one country to a consumer in another country, so when electronic cigarettes came under tobacco legislation this was considered and a provision was made that countries would be given freedom to allow cross boarder sales of electronic cigarettes and eliquid or not. Where they are allowed an application / notification had to be made to both the country the company was based in and the country they planned on selling to. The latest list of countries can be found on the public health England website https://www.gov.uk/government/publications/tobacco-products-and-e-cigarette-cross-border-sales-registration/member-states-that-permit-cross-border-distance-sales-of-e-cigarettes-andor-tobacco-products
So you can check,
There is a list of registered companies – you can check your status here https://www.gov.uk/government/publications/tobacco-products-and-e-cigarette-cross-border-sales-registration
And if your not registered you can fill in the form and get yourself on the list, do remember however that you need to also apply at the target country – a link to this is provided on the PHE website (link above) , it is an offence to engage in cross boarder sales without applying first. The big anomaly in this process is Denmark, that state you can engage in cross boarder sales, have a website, but then write to anybody who applies and tell you your not allowed to engage in cross boarder sales.
I have been involved in the vape business since 2007, and the world has changed dramatically during that time, the first products were cig-a-likes with little or no regulation, but were being pursued by the MHRA to obtain medical licenses. Since then the market has changed in some noticeable ways: huge market grown, diversion of technologies, explosion of flavours, many many new companies forming and now the race to get discount business. However as margins squeeze companies generally, but those with large portfolios of products are finding some of the hidden costs of compliance. The initial registration and notification fees are not the end of compliance expenditure but just the start, normally there are annual renewal fees to pay, these are on hold until April 2020, but then fees of £60/sku will be charged by the MHRA. Changes to branding also attract administration fees, or time if you do your compliance in house, if you have a large number of products these fees can quickly add up.
I have always advised people from notifying product in countries that they don’t sell in, but we still have customers wanting their products notifying in all free counties, but in my experience this is folly. Nothing is free, their might not be notification fees, but you have ana administrative burden to cover, sales data to notify and upload through the portal is just one example. Also several countries did not publish fees or announced no zero fees, only to change policy and increase fees or start charging them. When you withdraw products from a market because they have introduced fees, it takes time and comes with a cost. So my advice is always the same only notify in countries that you are either selling in or have plans to sell in.
But the biggest lesson is to build into your cost model the cost of compliance.
The other big news that is moving the industry is the opening up of the United Arab Emirates for the vaping industry, and the news is a little good and little bad. Basically they are wanting TPD standards and notification but with some key differences that do add to the complexity of and expense of it. Firstly you have to show your products are stable for the duration of your shelf life, that requires a stability study, in an accredited laboratory, not a big job but slow and has some costs associated with it. Then you need to do your emissions test in an accredited laboratory, for the TPD you just need validated tested not accredited testing so it’s a lightly higher bar. Finally you need to manufacture the product to ISO standards, which for a lot of companies is something they are already doing, for others it would be a big step up. Once you have all this data ready you need to submit it for approval, and you cant sell until your approved. The filing costs are £1500 (TBC) and you can file 20 SKUs at a time. So the market is there and I am sure a lot of companies will be heading over there. We have had several enquiries to date.
As have discussed before that there is a misconception that short fill vaping products are not regulated when they are in fact covered by the GPSR 2005, which to cut a long story short means TPD without the notification applies to shortfill products. However in Holland, Austria and now Greece, the world has gone all official with short fill regulation. These are now regulated as TPD products, which means you have to do a full TPD notification of the products and file them through the EU portal, you can put the larger bottles through, your not limited to 50ml but they want them notifying and where appropriate notification fees will be payable. This trend looks set to spread to other European States, at the moment there is no sign that the UK will ask the same. However we should watch this space and to help you make sure your shortfil products comply with GPSR 2005 here is a quick checklist: