Short fill – Shake n Vape – Regulation

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What are short fill ‘shake n vape’ eLiquids?

 

Short fills – also known as shake and vape – are 0mg nicotine eLiquids typically sold in 60 ml or 120 ml bottles that are under-filled by the manufacturer to allow room for the addition of a 10 ml flavour-free nicotine e-liquid – known as a nicotine shot – into the bottle after sale by the consumer.[/vc_column_text][vc_empty_space css=”.vc_custom_1521027048623{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_empty_space height=”250px” css=”.vc_custom_1521027019109{background-image: url(https://medicpro.london/wp-content/uploads/2018/03/short-fill-shake-vape-eliquid-cropped.jpg?id=4354) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_empty_space height=”80px” css=”.vc_custom_1521027645302{background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][/vc_column][vc_column width=”1/3″][vc_btn title=”Get Support” style=”flat” shape=”square” color=”danger” align=”center” link=”url:https%3A%2F%2Fmedicpro.london%2Fcontact-us%2F|||”][vc_empty_space][vc_column_text css=”.vc_custom_1528729031700{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: rgba(67,211,216,0.38) !important;*background-color: rgb(67,211,216) !important;border-left-style: solid !important;border-right-style: solid !important;border-top-style: solid !important;border-bottom-style: solid !important;}”]In this guide you will learn:

• What is a short fill, how they work and how they came about
• About the safety of short fills
• Short fill compliance with General Product Safety Regulation (GPSR)
• Industry and MHRA views on short fill regulation
• About our short fill regulation and testing service.

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Why did short fill e-liquids come about?

 

Short fills came about because of a clause in the Tobacco Products Directive. Since May 2016 manufacturers of e-liquids have had to comply with the laws of the TPD. The rules in the TPD mean manufacturers must:

 

• Get e-liquids tested at a specialist laboratory
• Get toxicological information on the e-liquid ingredients
• Notify the product with the authorities (submit product information (including results of lab test and toxicology) to the health agencies (such as the UK’s MHRA) 6 months before they intend to market.

 

There are also restrictions on the bottle design. Under TPD, the bottle can be no bigger than 10ml and the bottle nozzle must comply to certain specifications.

 

But the TPD only applies to nicotine-containing e-liquids[/vc_column_text][vc_empty_space height=”150px”][vc_column_text css=”.vc_custom_1555767930598{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: rgba(0,0,0,0.07) !important;*background-color: rgb(0,0,0) !important;border-left-color: rgba(0,0,0,0.46) !important;border-left-style: solid !important;border-right-color: rgba(0,0,0,0.46) !important;border-right-style: solid !important;border-top-color: rgba(0,0,0,0.46) !important;border-top-style: solid !important;border-bottom-color: rgba(0,0,0,0.46) !important;border-bottom-style: solid !important;}”]

The clause that made way for short fills

 

In the definition section of the TPD, e-liquids are given the term ‘refill containers’ and the definition of a refill container is as follows:

 

‘refill container’ means a receptacle that contains a nicotine-containing liquid, which can be used to refill an electronic cigarette;

 

Also, under Article 20 paragraph 3, Member States must ensure that nicotine-containing liquid must be contained in bottles that meet certain design characteristics (Note: it does not refer to non-nicotine containing liquid):

 

is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml,

 

SO…

 

So if the e-liquid does not contain nicotine then the TPD regulations do not apply: manufacturers are not required to test products, acquire tox information on ingredients, notify the product with the authorities (well, this is not strictly true but we’ll come back to that) or use containers with max. volume of 10 ml.[/vc_column_text][vc_empty_space][vc_empty_space height=”150px”][/vc_column][vc_column width=”1/3″][/vc_column][/vc_row][vc_row][vc_column width=”1/2″][vc_column_text css=”.vc_custom_1521030954911{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: rgba(89,214,0,0.44) !important;*background-color: rgb(89,214,0) !important;border-left-color: rgba(0,0,0,0.56) !important;border-left-style: solid !important;border-right-color: rgba(0,0,0,0.56) !important;border-right-style: solid !important;border-top-color: rgba(0,0,0,0.56) !important;border-top-style: solid !important;border-bottom-color: rgba(0,0,0,0.56) !important;border-bottom-style: solid !important;}”]

How shake n vape work

 

To make a shake and vape you require 2 things:

 

1. Short fill eliquid (typically 60ml or 120ml)
2. Nicotine shot (typically 18mg nicotine strength)

 

To get the desired nicotine strength in the final formulation takes a little calculating but to give you an idea we’ve prepared a quick reference guide:

 

Mixing with 18mg nicotine shot

 

• Adding all of 18mg nic shot (10ml) to a 50ml short fill will make a 3mg e-liquid.
• Adding 4 x 18mg nic shot (4 x 10ml) to a 80ml short fill will make a 6mg e-liquid.

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An 18mg Nicotine shot by Just Nic It

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What is a nicotine shot?

 

A nicotine shot – or nicotine booster – is a TPD-compliant 10ml bottle of flavour-free nicotine e-liquid (it has been tested by a lab and notified to the authorities etc).[/vc_column_text][vc_empty_space][/vc_column][vc_column width=”1/2″][vc_column_text css=”.vc_custom_1555767944692{border-left-width: 1px !important;padding-left: 20px !important;border-left-color: rgba(0,0,0,0.72) !important;border-left-style: solid !important;}”]

The Nicotine Shot Calculator

 

If you require help with the calculation to get the right nicotine strength in the final mix then fortunately there are nicotine shot calculators. For example, the Just Nic It calculator:

Just Nic It Calculator

 

(We do not endorse the nic shot calculator)[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”80px”][vc_separator][vc_empty_space height=”150px”][/vc_column][/vc_row][vc_row][vc_column width=”2/3″][vc_column_text]

Short fills: Are they less safe than TPD compliant products?

 

This is a tricky question. As mentioned, the products do not undergo the same scrutiny as TPD compliant products: they may not have been tested at a laboratory and the toxicology of the ingredients may not be reviewed. However, it would be misleading to suggest that TPD-compliant products are safer. This is partly because, currently, the health authorities seem to be taking a light touch approach in enforcing the TPD regulations for e-liquids.

 

Overtime we will see closer scrutiny of TPD compliant products by the health agencies and so it is likely that there will come a time when we can say a TPD compliant product is safer than shake n vape.

 

For the time being, on the safety of shake n vape (as well as and TPD compliant products), we’ll defer to the UK government’s endorsement of e-cigarettes in general: E-cigarettes around 95% less harmful than tobacco[/vc_column_text][vc_empty_space height=”150px”][/vc_column][vc_column width=”1/3″][/vc_column][/vc_row][vc_row][vc_column width=”2/3″][vc_column_text css=”.vc_custom_1526905419433{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: rgba(0,0,0,0.07) !important;*background-color: rgb(0,0,0) !important;border-left-color: rgba(0,0,0,0.57) !important;border-left-style: solid !important;border-right-color: rgba(0,0,0,0.57) !important;border-right-style: solid !important;border-top-color: rgba(0,0,0,0.57) !important;border-top-style: solid !important;border-bottom-color: rgba(0,0,0,0.57) !important;border-bottom-style: solid !important;}”]

Do the TRPR/TPD regulations apply to short fills?

 

No. The UK’s health authority, the MHRA, have said at various industry conferences that short fills are out of scope of the TRPR (The Tobacco and Related Products Regulations 2016). They have also stated that they are not responsible for regulating the products.

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If not the TPD/TRPR, which regulations apply to short fills?

 

As mentioned, the TPD/TRPR rules do not apply to short fills. In the UK, when a product does not fall in scope of a dedicated regulatory framework (such as nicotine containing products) we defer to the The General Product Safety Regulations (GPSR).

 

The GPSR states:

 

General safety requirement

5.—(1) No producer shall place a product on the market unless the product is a safe product.

(2) No producer shall offer or agree to place a product on the market or expose or possess a product for placing on the market unless the product is a safe product.

(3) No producer shall offer or agree to supply a product or expose or possess a product for supply unless the product is a safe product.

(4) No producer shall supply a product unless the product is a safe product.

 

How can we help?

 

We provide regulatory support to retailers, wholesalers and manufacturers of short fills to help them comply with the GPSR. We will help you understand your regulatory obligations, get a test report from a lab, among other things.

 

Looking for MSDS & SDS for your short fill range? Click here.[/vc_column_text][vc_empty_space height=”32″][vc_btn title=”Learn more about our Short fill Testing Service” style=”flat” shape=”square” color=”danger” align=”center” link=”url:https%3A%2F%2Fmedicpro.london%2Fshort-fill-shake-n-vape-testing%2F|||”][vc_empty_space][vc_column_text]

Should short fills be notified to the MHRA?

 

The MHRA have indicated at the Science Committee meeting that currently there is no requirement for short fills to be notified to the agency. Their position may change in the future – so watch this space.

 

MHRA to test short fills

 

We understand that short fills will be in scope of a special sampling scheme – conducted by Trading Standards and with the support of the MHRA – whereby marketed e-cigarettes and e-liquids are tested for compliance with GPSR at an analytical lab. As part of the test, they may look into the presence of banned ingredients like diacetyl.

 

If you are concerned about the GPSR compliance and short fills please do not hesitate to contact us.[/vc_column_text][vc_empty_space][/vc_column][vc_column width=”1/3″][vc_btn title=”Get Support” style=”flat” shape=”square” color=”danger” align=”center” link=”url:https%3A%2F%2Fmedicpro.london%2Fcontact-us%2F|||”][/vc_column][/vc_row][vc_row][vc_column][vc_separator][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column width=”2/3″][vc_column_text]

What have Industry stakeholders said about regulating shake n vapes?

 

At a recent meeting of industry players and the UK Parliament’s Science and Technology Committee shake and vapes was discussed. The meeting was part of a review into vape regulation in the UK. The committee invited responses from the vape industry and the general public.

 

Video footage and excerpts of the discussion are available here along with all written responses.

 

Participants that were invited to present their views in person included:

 

First session:

 

• Professor Peter Hajek, Professor of Clinical Psychology, Queen Mary University of London,
• Professor Mark Conner, Professor in Applied Social Psychology, University of Leeds,
• Professor Riccardo Polosa, Professor of Internal Medicine, University of Catania,
• Dr Lion Shahab, Senior Lecturer Health Psychology, University College London
• Dr Jamie Brown, Deputy Director, Tobacco and Alcohol Research Group University College London
• Professor Paul Aveyard, Co-ordinating Editor, The Cochrane Tobacco Addiction Group
• Dr Ian Jones, Vice President, Reduced-Risk Products, Japan Tobacco International,
• Dr Chris Proctor, Chief Scientific Officer, British American Tobacco,
• Dr Moira Gilchrist, Vice President, Scientific and Public Communications, Philip Morris Limited,
• Dr Grant O’Connell, Regulatory and Scientific Affairs, Fontem Ventures,
• Professor David Harrison, Chair of the UK Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (COC),
• Dr Lynne Dawkins, Associate Professor, Centre for Addictive Behaviours Research, London South Bank University

 

What did they say about the regulation of short fill eLiquids?

 

The majority of stakeholders that took part in the review agreed that essentially, due to safety concerns, short fill regulation should adopt a framework not dissimilar to nicotine-containing products.

 

Medic Pro took part in the review and we agree with this position on the regulation of short fills. We believe they should at least undergo a toxicology review of the ingredients.[/vc_column_text][vc_empty_space height=”80px”][/vc_column][vc_column width=”1/3″][/vc_column][/vc_row][vc_row][vc_column width=”2/3″][vc_column_text]

Second Session:

 

• Rob Morrison, Senior Regulatory Policy Executive, Advertising Standards Authority
• Professor John Newton, Director of Health Improvement, Public Health England
• Professor Gillian Leng, Deputy Chief Executive, National Institute for Health and Care Excellence (NICE)
• Dr Ian Hudson, Chief Executive, Medicines and Healthcare products Regulatory  Agency (MHRA).
• Steve Brine MP, Parliamentary Under-Secretary of State for Public Health and Primary Care
• Dr Tim Baxter, Deputy Director of Healthy Behaviours, Department of Health and Social Care.

The transcript can be found here.

 

What did the MHRA say about the safety of short fills?

 

Dr Hudson from the MHRA said “I think we will have to see the evidence as it emerges.”

 

The evidence Dr Hudson refers to is the research the MHRA are conducting, in collaboration with the Department of Health, Public Health England and Trading Standards Institute, into e-cigarette in general.[/vc_column_text][vc_empty_space][/vc_column][vc_column width=”1/3″][/vc_column][/vc_row][vc_row][vc_column][vc_separator][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column width=”2/3″][vc_column_text]

Shake and Vape regulation in other EU markets

 

Despite the fact that TPD rules only apply to nicotine-containing products, EU countries have the option to regulate 0mg along with nicotine eLiquids. France, Estonia and Czech Republic are some of the countries that have opted to do just that.

 

This is one of the many areas where country-specific rules apply.[/vc_column_text][/vc_column][vc_column width=”1/3″][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”50px”][vc_btn title=”Get Support” style=”flat” shape=”square” color=”danger” align=”center” link=”url:https%3A%2F%2Fmedicpro.london%2Fcontact-us%2F|||”][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space][vc_separator][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]About this article: This article has been optimised by Vape SEO.[/vc_column_text][/vc_column][/vc_row]