MHRA statement after TPD vote supports amendment 170

[dnglos]

Oct 10, 2013 16:27:24 GMT barrynorton said:

Where does the 4mg come into this?

I was under the impression that any products which purport to aid smoking cessation would have to be licensed and that their nic content would be limited to 2mg per device and 4mg/ml (although the council is looking to reduce that to 1mg & 2mg/ml) - everything else will be limited to 30mg/ml. Is that not right?

[barrynorton]

Sorry, I am being dumb, right?

That's what Article 18 reverts to, in the absence of Amendment 71, if the exclusion in Amendment 170 doesn't apply?

[inigomontoya]

Oct 10, 2013 16:27:24 GMT barrynorton said:

Oct 10, 2013 14:58:35 GMT inigomontoya said:

Because proposed nicotine content is at about 4mg/ml - which won't do anything for anyone who actually needs to quit!

Sorry, I must be getting confused. Proposed by whom?

The amended EU directive places no constraint on medically-authorised devices (though the poisons legislation puts a cap of 7.5% on it).

British American Tobacco's Vype product has the following characteristics:

Vype Red contains 18.6mg, Vype Blue contains 12.5mg and Vype Green contains 12.6mg of nicotine.

They could, and very well might, seek medical authorisation for this.

Where does the 4mg come into this?

(I must have just lost the thread)

The MHRA proposals for medical e-cigs were 4mg/ml. So I'm assuming that they haven't changed their tune, correct me if I'm wrong. AFAIK nothing on the market would pass their requirements.

Oct 10, 2013 18:26:35 GMT barrynorton said:

Sorry, I am being dumb, right?

That's what Article 18 reverts to, in the absence of Amendment 71, if the exclusion in Amendment 170 doesn't apply?

Insofar as I understand it.

[Karma]

Oct 10, 2013 18:53:13 GMT inigomontoya said:

Oct 10, 2013 16:27:24 GMT barrynorton said:

Sorry, I must be getting confused. Proposed by whom?

The amended EU directive places no constraint on medically-authorised devices (though the poisons legislation puts a cap of 7.5% on it).

British American Tobacco's Vype product has the following characteristics:

They could, and very well might, seek medical authorisation for this.

Where does the 4mg come into this?

(I must have just lost the thread)

The MHRA proposals for medical e-cigs were 4mg/ml. So I'm assuming that they haven't changed their tune, correct me if I'm wrong. AFAIK nothing on the market would pass their requirements.

I thought the 4mg limit was the proposal for e-liquid that was not classed as medicinal, i.e. only the medical expensive cig-a-likes would be above 4mg, the lovely liquid we like would only be available at strengths up to 4mg  ???


I could be wrong though, I often am and this whole thing is just so confusing 

[barrynorton]

Yeah, I'm confused too.

(I hope my questions don't come off as sarcastic - they're not meant to be, they're honest - but I know I sometimes come off that way)

[dnglos]

Oct 10, 2013 19:07:22 GMT barrynorton said:

Yeah, I'm confused too.

(I hope my questions don't come off as sarcastic - they're not meant to be, they're honest - but I know I sometimes come off that way)

They don't sound sarcastic at all - I'm confused too. Looking at Amendment 170 I can't figure out what the limit is for licensed products, although sections 1a, 1b & 1c appear to have been left intact.

[inigomontoya]

Oct 10, 2013 18:57:18 GMT Karma said:

Oct 10, 2013 18:53:13 GMT inigomontoya said:

The MHRA proposals for medical e-cigs were 4mg/ml. So I'm assuming that they haven't changed their tune, correct me if I'm wrong. AFAIK nothing on the market would pass their requirements.

I thought the 4mg limit was the proposal for e-liquid that was not classed as medicinal, i.e. only the medical expensive cig-a-likes would be above 4mg, the lovely liquid we like would only be available at strengths up to 4mg  ???


I could be wrong though, I often am and this whole thing is just so confusing 

I was quoting the pre-71/170 MHRA limits, which would see all e-cigs medicinal and nicotine mg levels in line with nicorette (4ml).

I am also confused as to what they'd limit things to now - but I presume they won't want to shift much.

Sorry for sticking my nose in, I'll leave you all to ruminate