Guidance Holes Filled

In a not too unsurprising move, the MHRA has recently updated its E-Cigarettes: regulations for consumer products guidance. This latest update has provoked a fair amount of discussion along with theories as to who (or whom) have been badgering either the Commission or the MHRA for “clarification”.

Let’s just say I have my suspicions on that and leave it there.

The update, rather innocuously, is in the “Further Information” section of the guidance page which seem intent on clarifying some definitions.

‘Electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. E-cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges.

Seems straightforward enough so far. Though the term “electronic cigarette” – while a term used by many – isn’t the only term for the product. Unfortunately, in the eyes of the MHRA it’s the only term that is used.

Products that require a notification are limited to the e-cigarette product and component elements sold separately that specifically contain, or could contain, nicotine in the form of e-liquid. Therefore e-cigarette products such as disposable units and tanks will require a notification; however e-cigarette equipment such as mouthpieces, batteries and other elements that would qualify as an individual component will not.

Well this is interesting. On the face of that statement, any component part that specifically contains or could contain e-liquid as its intended use must now be notified. That would therefore include the Aspire Cleito extension glass (for the original Cleito) among other such clever solutions imposed by the 2ml (by volume) restriction.

It’s also clear in the Product Type guidance paper:

Individual parts of the electronic cigarette sold separately also fall within the scope of the TPD. These only need to be notified if these are essential elements of the electronic cigarette and capable of containing nicotine. This would include the tank, atomiser or cartridge but would exclude other components
such as replacement batteries or mouthpieces.

It could also, in theory apply to the Cleito skinny coils that can be used with the new Cleito EXO, which has a chunky coil as standard, but swap that for a skinny one and presto, you have a 4ml tank.

Replacement e-cigarette parts that could contain nicotine only require notification if they have not already been notified as part of a device or e-cigarette kit. Identical replacement parts that have already been notified as part of another notified e-cigarette product do not need to be separately re-notified if it is clear on the labelling what notified product the part is for. Any non-identical replacement part, particularly one that alters the consumer safety profile of a product (for example by changing its refill capacity), would require a separate notification.

Using the Cleito EXO and the original Cleito as my examples here, the coils for the original Cleito would not need to be notified twice as long as it is clear what product it is for (which it is), however the Cleito “Fat Boy” glass would need a notification as there isn’t an identical product that it can be used for (as far as I know).

But note the specific example the MHRA cite – for example by changing its refill capacity – which is exactly what the Cleito “Fat Boy” does. Same with the Nautilus X extension glass. There are other unique solutions out there that will now fall foul of this amended guidance

Someone, somewhere has “requested clarification” on these unique workarounds to the 2ml problem, and this is the result.

For those of you that use drippers or RTA’s exclusively, you haven’t been left out either:

Rebuildable devices come within the definition above and require notification.

Naturally, now that the implementation transition period is done, any new product now has to meet the stringent guidelines in the TRPR, so I suspect you can see parts for your drippers and RTA’s slowly but surely disappear from the authorised market.

Interestingly, on the guidance page is this snippet:

Products that do not meet the definition (such as disposable e-cigarettes that do not contain nicotine and 0% nicotine e-liquids) are out of scope of the TPD and do not have to meet its requirements.

We already knew that no-nic liquids were exempt from the TRPR, but the inclusion of no-nic disposables is fairly recent (as far as I am aware).

It would seem that there are active, ongoing discussions between various entities and as a result, the UK implementation of the TPD is becoming more restrictive.

So much for “light touch” regulation.

Quite.

(image credit TheBlackRhino/shutterstock.com)

2 thoughts on “Guidance Holes Filled

  1. One thing I’ve noticed in this article is the negative inference that looking for clarification is a bad thing. Surely a business looking to invest large sums of money has the right to understand if a product is under the guidelines or not in order not to lose their investment. Equally, what about manufacturers, not the big ones, but the little guys trying to work towards a ‘home grown’ product, clarification for them means a greater understanding as to whether their hard work and product will be a success or failure from a regulatory perspective.
    Clarification on these things isn’t a bad thing, it allows perspective and knowledge, but also it allows vapers to band together with a focus as to what they’re fighting. In my humble opinion, more information is absolutely required with regards to testing procedures of rebuildable products, or how they are to be included in the TRPR framework. Trying to hide it under the carpet isn’t going to help the industry at all, it will hurt small business, producers, retailers, and distributors, because without solid guidelines all the products they’ve made/bought/distributed could suddenly fall under the hammer and be worthless – I’m sure you agree, not something most could afford.
    A ‘workaround’ is never a long term solution as it inevitably isn’t viable for extended periods of time.

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    • The thing is, we already had clarification that certain elements (such as drippers, and extensions) were going to be exempt from notification – David Dorn covers this extensively on VTTV. We also had assurances of “light touch” regulation and “Italian Style” enforcement (which was mentioned in the House of Lords). What has happened since, is a swing from Italian Style enforcement, to actual enforcement. Products that were originally not to be notified now are.

      Now, think for a moment. A dripper (as a prime example) cannot, by definition, be compliant under the TPD. Neither can an extension glass for the Cleito as it alters the tank size. These loopholes that have just been closed will add further restrictions on available product which we were assured – by MHRA – would not happen as they “understood” the benefits of light touch regulation.

      MHRA don’t want the TPD and neither do the DoH, yet some parties – and whether they are UK or based in another MS is beside the point at this juncture – are determined that the array of products available under the TPD are to be dull, compliant and, for the most part, worthless.

      The TPD is designed to make it as difficult as possible to produce the kinds of products that millions use as a preferred alternative to smoking. The additional clarification by MHRA is an indication that things are going to get worse, clarification only goes one way.

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