While e-cigarette sales have grown rapidly as some of the U.K.’s 7.6 million smokers seek out healthier ways to get their nicotine, regulations (which, in the UK have been more lenient than in most other countries around the world) are an obstacle to further growth. Some countries — including Australia, Brazil and Japan — have banned the sale of e-cigarettes altogether.
Tobacco Products Directive (TPD)
In February 2014 the EU agreed a revised Tobacco Products Directive (TPD). The TPD strengthens the rules on how tobacco products are manufactured, produced and presented in the EU including regulations regarding electronic cigarettes.
The TPD introduced new rules designed to ensure:
• standards for the safety and quality of all e-cigarettes and refill containers
• that sufficient information is given to consumers allowing them to make informed choices
• children are protected.
Tobacco and Related Products Regulations
The TPD was transposed into domestic law on 20th May 2016, via the Tobacco and Related Products Regulations. There was a transitional period for electronic cigarettes, allowing non-compliant stock to be sold off. Non-compliant electronic cigarettes or refill containers could be sold until 20th November 2016 and from 20th May 2017 all products on sale in the UK had to be fully compliant with the TPD.
How does the TPD affect the sale of e-cigarettes?
Electronic cigarettes which contain up to 20 mg per ml of nicotine were regulated as consumer products as required by the TPD. Zero nicotine products were not included in the TPD and products containing over 20mg per ml of nicotine now need to have a medicinal licence.
Under the TPD, advertising, promotion and sponsorship of electronic cigarettes and re-fill containers is prohibited on cross-border platforms including the internet, television, radio, newspapers and magazines.
The new product rules under the TPD for electronic cigarettes:
• Introduced a size limit for e-liquids of 10ml for dedicated refill containers and 2ml for disposable electronic cigarettes, cartridges and tanks.
• Required products to be child and tamper proof.
• Required the pack to include a health warning covering 30% of the surfaces of the unit packet and any outside packaging stating ‘This product contains nicotine which is a highly addictive substance.’
• Required instructions for use, information on addictiveness and toxicity on the packaging and accompanying information leaflet.
• Banned certain promotional and misleading descriptors on packaging.
• Ensured that all substances contained in the product and information on the product’s nicotine content are declared on the label.
• Required manufacturers to inform Member States before placing new or modified products on the market and notify a range of product information concerning composition, emissions and sales/marketing data.
• Introduced a registration scheme for businesses engaged in cross-border distance sales of electronic cigarette products.
• Prohibited the advertising or promotion, directly or indirectly, of electronic cigarettes and re-fill containers on a number of media platforms, including on television, radio, newspapers and magazines;
Medicinally licensed electronic cigarettes
Products which contain more than 20 mg per ml of nicotine or which make smoking cessation claims will be prohibited unless they are licensed as medicines. These products will require authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
A producer is anyone who manufactures or imports e-cigarette or refill container products and anyone who re-brands them as their own. A producer of new Products (a new product would include an existing product which has been substantially modified) must submit a notification to MHRA six months before they intend to put the Product on the UK market. Once the notification has been published, the producer can launch the product on the UK market immediately.
Notification only needs to be submitted once so if the manufacturer of the Product has already submitted a notification for the Product, then there is no need to submit another notification. If the manufacturer has notified details of a product that has been re-branded, and the brand name is already listed in the manufacturer’s notification, then again there is no need for a further notification.
A producer of Products must inform MHRA if they suspect that a Product is unsafe, of bad quality or does not comply with TPD regulations and provide details of the risk and any remedial action taken.
Labelling and leaflets
Regulation 37 of the Tobacco and Related Products Regulations 2016 sets out the requirements for labelling of e-cigarette and refill container products.
The government has provided guidelines for the interpretation of Regulation 37, as follows:
All ingredients in the product should be listed on the label where they are used in quantities of 0.1% or more of the final formulation of the e-liquid.
Where a flavour ingredient contains several component chemicals, it is sufficient to describe the ingredient on the label by the general descriptive name of the flavour, for example ‘vanilla flavour’. Companies who wish to keep some information confidential may describe individual ingredients which make up less than 0.1% of the final formula by category, such as ‘other flavourings’.
This recommendation applies only to labeling and not to notifications where a full list of ingredients must be included.
All packs of Products must include an information leaflet regarding safe use.
Producers should ensure leaflets include advice on product storage (including advice (where applicable) on how to prevent the battery from malfunctioning).
Where all the required leaflet information can fit on the unit pack and other labelling within the pack without loss of legibility to the consumer, the government’s guidance is that the packaging can contain the wording otherwise required in a separate leaflet provided all required information can be included legibly on the packaging.
Additional statutory labelling requirements may also apply, such as the European Regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical substances (CLP).
If the Product does not contain nicotine when sold, but can be used to contain nicotine, the warning statement ‘this product contains nicotine which is a highly addictive substance’ must still be applied. To provide clarity for consumers, the government recommends additional wording to the effect that the warning applies when the product is used as designed and charged / filled with nicotine-containing liquid. The warning statement should be included on all notified e-cigarette products.
When sourcing new supplies of any e-cigarette or e-liquid product, a retailer should check that details of the notification for the product have been published.
If the product is not listed on the MHRA website, the retailer should seek confirmation from the supplier that the Product complies with the TPD and has been notified to MHRA. If a producer has not notified the Product or it does not comply with the TPD, the producer may not supply it to you.
Retailers do not need to notify any Products sold unless they are also the producer of the product.
If a retailer imports or re-brands products, they should check with the supplier whether a UK notification for the specific product to be sold has been made. If it has, a further notification is not required.
The TPD requirements on nicotine concentration (20mg/ml maximum) and size of presentation (10ml maximum for refill container and 2ml maximum for e-cigarettes) apply to products sold to consumers whether or not the consumer intends to modify the product).
The requirements do not apply to ‘trade sales’ i.e. where industrial quantities are being sold to another business and the sale is not directed to a consumer. But for all sales (trade and to consumers) the tank capacity of a refillable e-cigarette must not exceed 2ml.
Cross Border Sales
A supplier of e-cigarette products via cross-border distance sales to consumers, for example online sales (this doesn’t apply to business to business sales), must register their business.
This applies to:
• businesses established in the UK selling e-cigarettes and/or refill containers to consumers in another state in the European Economic Area (EEA);
• businesses established in the EEA or third country selling to UK consumers.
Registration is a legal requirement under the TPD. Without confirmation of registration, businesses must not supply a relevant product to a consumer via a cross-border distance sale. The UK notification requirement applies to products supplied to UK consumers via a cross-border sale.
Public Health England have uploaded a list of EEA Member States that have either confirmed they are permitting cross-border distance sales of e-cigarettes and/or tobacco products or are yet to confirm domestic rules in this area, and a list of registered retailers. All other Member States have banned cross-border distance sales, and it would contravene the law to trade in those countries. Businesses who intend to trade in countries where the sales confirmation, registration website or contact details are yet to be confirmed are advised to contact the national authorities before commencing supply.
What are the likely effects of the new regulations on the vaping industry
Some of the new regulatory requirements are seen as a positive move by the industry as they will increase quality control and safety. Nevertheless, product registration is costly and therefore the new requirements are likely to lead to a reduction in product variation (both in terms of strength and flavour). The additional costs involved in compliance are also likely to lead to smaller businesses shutting down and increased cost of products for the consumer.
The vaping industry has warned that the new regulations are likely to lead to a rise in homemade versions of e-liquids due to the new laws limiting dosage strength and to vapers buying stronger products from the black market or the internet that do not meet safety standards.
The other danger, the vaping industry has warned, is that vapers who had been using high levels of nicotine will end up going back to cigarettes now that the higher doses are no longer available under the new rules.
There is some debate at the moment between health officials and scientists regarding the relative health risks of vaping and smoking. A report produced in August by Public Health England suggested that vaping is 95% less harmful than smoking. On the other hand, health experts from the London School of Hygiene and Tropical Medicine and the University of Liverpool claim the report was flawed, based on inconclusive evidence and bias due to vested interests.
Several studies have pointed to health risks from e-cigarettes and claimed they encourage teenagers to smoke tobacco. The National Institute for Health and Care Excellence, (Nice) has also warned that currently there is ‘little evidence’ on their benefits or risk.
In October, MPs launched an enquiry to establish the health and economic impact of
electronic cigarettes and heat-not-burn devices as the number of people using such
products approaches 3 million in the UK. The inquiry seeks to address gaps in the
understanding of e-cigarettes and to re-assess the suitability of current regulations.
The current debate centres around those who see e-cigarettes as valuable tools to reduce
the number of people smoking ‘conventional’ cigarettes, and those who see them as
‘re-normalising’ smoking for the younger generation.
Conventional smoking fell to 7.6 million adult smokers in the UK in 2016, and quitting
success rates are now at their highest for a decade – 19.8 per cent in the first six
months of 2017, compared with an average of 15.7 per cent in the past 10 years.