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Since the TPD came into force in May 2016, all e-liquids and e-cigarettes that contain nicotine should display a health warning on the label. So what should warning say and how should it appear?
Article 20.4 (b) iii of the TPD relates to the warning label and it states:
“unit packets and any outside packaging of electronic cigarettes and refill containers [shall] carry one of the following health warnings:
‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by non- smokers’.
or
‘This product contains nicotine which is a highly addictive substance.’
The warning should conform to certain rules. The TPD articles for the specification of the warning can be summarised as follows:
“printed in black Helvetica bold type on a white background.”
“appear on the two largest surfaces of the unit packet and any outside packaging”
“shall cover 30% of the relevant surface of the unit packet and any outside packaging.”
Below is an demo showing how the warning should be presented along with other packaging requirements.
Notes:The UK health warning is used in the example. The text cannot be directly translated into other languages for other markets due to variation in requirements (see below). Black border around health warning is optional.
Each EU market can decide on which of the two statements to use. Also, the rules on the specification can differ market to market.
Learn about more country-specific rules here
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We are a London-based regulatory affairs consultancy providing services to the e-cigarette, cosmetic, biocide, pharmaceutical and medical device industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and analytical testing services.