Consultation outcome

A consultation on the Tobacco and Related Products Regulations 2016 and the Standardised Packaging of Tobacco Products Regulations 2015

Updated 25 March 2022

1. Introduction

The UK now has a suite of tobacco control legislation which is among the most comprehensive in the world. Smoking rates are at their lowest ever on record in the UK. Despite this positive news, smoking still remains one of the biggest causes of death and disability across the UK.

Over recent years a range of legislation has been introduced to discourage young people from taking up smoking or vaping, encourage existing smokers to quit, and to protect others from the harmful effects of cigarette smoke. This has included a curb on advertising, establishing smoke-free places, introduction of prominent graphic health warnings, a ban on proxy purchasing of cigarettes and e-cigarettes and a ban on smoking in cars with children as well as the introduction of standardised packaging.

More recently, Parliament has introduced further regulation to strengthen tobacco control introducing the Tobacco and Related Products Regulations 2016 (TRPR), which regulated the presentation of tobacco and e-cigarettes, along with the Standardised Packaging of Tobacco Products Regulations 2015 (SPoT) which introduced standardised packaging for cigarettes and hand rolling tobacco.

Under both TRPR and SPoT, the Secretary of State for Health and Social Care is required to complete a review of the legislation within five years of the regulations coming into force. This is known as a post implementation review (PIR).

The Department of Health and Social Care (DHSC) is carrying out a public consultation as part of this review. The scope of this consultation concerns TRPR and SPoT only and provides an opportunity to provide feedback on the effectiveness of the legislation in achieving its objectives along with any unintended consequences that may have occurred. The department expects a wide range of industry, charities, academic researchers and members of the public to respond to this consultation.

In addition to a public consultation DHSC will review international and domestic research and statistics available on the impact of the legislation since the legislation was introduced to present time.

The TRPR and SPoT legislation applies UK wide and DHSC is consulting with the Devolved Administrations to ensure this reflects a UK position in its response.

The UK has now left the EU. The government has made the necessary legislative amendments to TRPR that came into force on 1 January 2021, so that rigorous tobacco control measures will continue to apply in Great Britain and that for products placed on the Northern Ireland market – the Tobacco Products Directive (TPD) will continue to apply as implemented in the TRPR.

Great Britain no longer has to comply with the EU’s Tobacco Products Directive and there is opportunity to consider, in the future, further regulatory changes that help people quit smoking and address the harms from tobacco. Any changes to do so will be based on robust evidence and in the interests of public health. This review may help to consider some of the potential changes to be considered.

The UK is a party to the World Health Organization Framework Convention on Tobacco Control (WHO FCTC) and as such the UK has an obligation to protect the development of public health policy from the vested interests of the tobacco industry. To meet this obligation, we ask all respondents to disclose whether they have any direct or indirect links to, or receive funding from, the tobacco industry.

2. Aim of the post implementation review (PIR)

Under TRPR and SPoT, the Secretary of State for Health and Social Care is required to complete a review of the legislation by 20 May 2021. The Secretary of State must:

• carry out a review of the regulatory provision made by the Regulations; and
• publish a report setting out the conclusions of the review.

The review must have regard to how the Tobacco Products Directive (transposed into UK law through TRPR) is implemented in EU member states. This has been reflected in the consultation questions set out below.

A report will be published following the consultation that will:

• set out the objectives intended to be achieved by the regulatory provision made by these regulations
• assess the extent to which those objectives are achieved
• assess whether those objectives remain appropriate
• if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision

The public consultation will help to inform the review of the regulations.

3. The regulations to consult on

For the purposes of this consultation, the tobacco legislation to be considered are:

• The Tobacco and Related Products Regulations 2016 (TRPR)
• The Standardised Packaging of Tobacco Products Regulations 2015 (SPoT)

The overarching policy objective of all smoking legislation is to improve public health, however, each individual piece of legislation also has specific aims and objectives as outlined below.

4. The Tobacco and Related Products Regulations 2016

4.1. Purpose of the instrument

The Tobacco and Related Products Regulations 2016 (TRPR) implement the majority of provisions from the Tobacco Products Directive (2014/40/EU) to:

• continue, and enhance in some areas, the reporting of ingredients and emissions of tobacco products
• increase the size of combined health warnings consisting of a text and photograph warning, increased in size to cover 65% of front and back of pack (previously 30% on front of pack and 40% on back of pack)
• prohibit misleading descriptors, such as ‘natural’ or ‘organic’ on tobacco and electronic cigarette labelling
• prohibit characterising flavours such as menthol in tobacco products
• provide for prior notification of the placement of novel tobacco products on the market
• regulate electronic cigarettes and associated refill cartridges (notification of placing on the market, adverse event monitoring, product standards, labelling and advertising)
• regulate herbal cigarettes (notification of placing on the market and labelling)

TRPR's public health policy objectives are:

• discouraging people from starting to use tobacco products
• encouraging people to give up using tobacco products
• protect young people from the harms of tobacco
• implementing elements of the World Health Organization Framework Convention on Tobacco Control

4.2 Questions on TRPR

The following section outlines the key regulatory provisions in TRPR to feedback on, with questions provided to determine their public health and regulatory impact. If there are some provisions not covered below that you think should be, there is an opportunity for you to use the Section 'anything else' in TRPR to state these and provide your views and evidence.

Health text and picture warnings

Introduced health text and picture warnings across tobacco products

This includes, graphic health warnings with photos, text and cessation information increased in size covering 65% of the front and the back of cigarette and hand rolling tobacco (HRT) packs. Depicting the social and health impacts of smoking, the warnings are designed to discourage people from smoking or encourage them to quit. However, not all tobacco products are required to have a picture warning, such as smokeless tobacco, novel tobacco products and individual cigars.

Question 1: How far do you agree or disagree that the introduction of rotating combined (photo and text) health warnings on cigarette and hand rolling tobacco has encouraged smokers to quit?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Question 2: How far do you agree or disagree that the introduction of rotating combined (photo and text) health warnings on cigarette and hand rolling tobacco has deterred young people from smoking?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Question 3: Should all tobacco products have a combined (photo and text) health warning on their packaging?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Characterising flavours

Prohibits characterising flavours, such as menthol in cigarettes and hand rolling tobacco (HRT)

The aim of this ban is to protect young people from starting to smoke. Cigarettes and HRT tobacco products no longer have characterising flavours such as menthol, vanilla or candy that mask the taste and smell of tobacco.

Question 4: How far do you agree or disagree that the prohibition of characterising flavours has helped smokers quit smoking?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Question 5: How far do you agree or disagree that the prohibition of characterising flavours has deterred young people from taking up smoking?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

E-cigarettes

Regulate electronic cigarettes and associated refill cartridges (notification of placing on the market, adverse event monitoring, product requirements, information)

The government continues to review the evidence of e-cigarettes including their harms and usefulness to aid stop smoking. There are around three million e-cigarette users in the UK and over half of those people have quit smoking. Although not risk free, current evidence suggests they are far less harmful to health than smoking, and can help people stop smoking ‒ even more so when combined with expert support from a local stop smoking service.

The independent Cochrane Collaboration recently published a systematic review finding that e-cigarettes were more effective for smoking cessation than nicotine replacement therapy. In addition, a recent UK-based trial of e-cigarettes found them twice as effective as best combination nicotine replacement therapy at one fifth of the price. There is also evidence that e-cigarette use in the community is contributing up to 70,000 additional quits per year in England.

The government believes in proportionate regulation of e-cigarettes, recognising that they are not risk free. The current regulatory framework in TRPR aims to reduce the risk of harm to children, protect against renormalisation of tobacco use, provide assurance on relative safety for users, and provide legal certainty for businesses.

We know that a small proportion of children are experimenting with e-cigarettes, but regular child use remains consistently low in England. Data from NHS Digital in the Smoking, Drink and Drugs data (11 to 15 year-olds) shows regular e-cigarette use to be 2.1% (2016) and 2% (2018). Youth smoking rates also continue to decline, with 5% of pupils aged 11 to 15 current smokers in 2018, down from 22% in 1996.

The government will continue its work to appraise the evidence on new products, including e-cigarettes, and their role in helping smokers quit and that the regulatory framework supports this.

On specifics

TRPR imposes safety and quality requirements that have been introduced for e-cigarettes containing nicotine. These examples include: maximum nicotine concentrations and maximum volumes for cartridges, tanks and nicotine liquid containers; e-cigarettes should be child-resistant and tamper proof and have a mechanism that ensures refilling without spillage to protect consumers. E-cigarette ingredients must be of high purity and e-cigarettes should deliver the same amount of nicotine for puffs of the same strength and duration.

Health warnings for e-cigarettes

Health warnings on e-cigarettes became mandatory advising consumers that e-cigarettes contain nicotine and should not be used by non-smokers. Packaging must include a list of all ingredients contained in the product, information on the product's nicotine content and a leaflet setting out instructions for use and information on adverse effects, risk groups and addictiveness and toxicity. Under TRPR, promotional elements are not allowed on e-cigarette packaging and cross-border advertising and promotion of e-cigarettes is prohibited. Advertising restrictions have been included to protect youth from taking up vaping, but these advertising restrictions are less than those imposed on tobacco products. For example, an e-cigarette may be advertised on a billboard, but a tobacco product may not.

Question 6: How far do you agree or disagree that the current regulations on e-cigarettes have been proportionate in protecting young people from taking up use of these products?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Question 7: How far do you agree or disagree that the current regulations have ensured that e-cigarettes are available for those smokers who wish to switch to these products?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Question 8: What effect do you think the regulations have had on smokers considering switching to e-cigarettes?

• encouraged
• neutral
• discouraged
• don’t know

Please provide a reason for your answer and any evidence to support this.

Question 9: Do you consider the restrictions on e-cigarette advertising to be an effective way to discourage young people and non-smokers from using e-cigarettes?

• yes
• no
• don’t know

Please provide a reason for your answer and any evidence to support this.

Novel tobacco products

Novel tobacco products

TRPR introduced notification requirements along with standards for novel tobacco products to be introduced on the UK market. Novel tobacco products included new products such as heated tobacco. Some heated tobacco manufacturers claim these products may be less harmful than smoking tobacco, but independent evidence is limited on this assumption. We do not know the long-term harm of these products and research and data is limited. The government continues to monitor developing evidence on these products. UK use of these products remains very low.

Novel tobacco products are not subject to the same regulatory standards as cigarettes in TRPR and some people have raised concerns that they should be. We welcome views if the current regulatory framework for novel tobacco products is proportionate.

Question 10: How far do you agree or disagree that the requirements of TRPR on novel tobacco products are proportionate?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Enforcement

Penalties and enforcement of the regulations

To help compliance with the regulations, penalties were introduced. The majority of the regulations are enforced by Trading Standards Officers (or Environmental Health Officers in Northern Ireland). These agencies are currently designated as enforcement authorities for existing labelling and consumer protection standards for the categories of product covered by the regulations. The rules for advertising electronic cigarettes are enforced by the agencies which enforce the rules on tobacco advertising. The Office of Communications (Ofcom) enforces the rules for broadcast media, and local authority trading standards will enforce the non-broadcast media rules with the Advertising Standard Authority undertaking a first line self-regulatory check on the industry.

The penalties as set out in TRPR:

"Penalties

1. A person guilty of an offence under these Regulations is liable—

(a) on summary conviction—

(i) in England and Wales to imprisonment for a term not exceeding three months, or a fine or both, or

(ii) in Scotland, to imprisonment for a term not exceeding twelve months, or a fine not exceeding level 5 on the standard scale, or both

(iii) in Northern Ireland, to imprisonment for a term not exceeding three months, or a fine not exceeding level 5 on the standard scale, or both; or

(b) on conviction on indictment to imprisonment for a term not exceeding 2 years, or a fine, or both."

Question 11: Do you agree or disagree that the penalties for a breach of the regulations are an effective deterrent to ensure compliance with the regulations?

• agree
• disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Other question

Question 12: How far do you agree or disagree that there has been an economic impact of TRPR, either positive, negative or both?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please state who you think TRPR has impacted on economically and provide any reasons or evidence to support this.

Anything else on TRPR?

Question 13: Is there anything else you would like to share on negative or positive impacts the regulations have had on topics not covered above? If so, please explain and include any evidence and research you may have to back your response.

5. The Standardised Packaging of Tobacco Products Regulations 2015

5.1 Purpose of the instrument

The Standardised Packaging of Tobacco Products Regulations 2015 (SPoT) require the use of specified standard colours for all external and internal packaging of cigarettes and hand rolling tobacco and only permit specified text (such as the brand and variant name) in a standard typeface.

The regulations do not affect other labelling requirements for tobacco products such as health warnings and fiscal marks or features such as authentication markings and security features. The regulations also permit only specified shape or type of packets and set a minimum amount of tobacco or cigarettes in each individual packet.

Many more countries throughout the world have or are introducing SPoT. The UK was one of the first countries to introduce such legislation and continues to be seen as a global leader in tobacco control to address harms caused by smoking. Some of the legislative requirements in SPoT were also part of the TPD.

SPoT's policy objectives are:

• discouraging people from starting to use tobacco products
• encouraging people to give up using tobacco products
• reducing the appeal or attractiveness of tobacco products, the misleading elements of packaging and the potential for packaging to detract from the effectiveness of health warnings
• having an effect on attitudes, beliefs, intentions and behaviours relating to the reduction in use of tobacco products

5.2 Questions on the Standardised Packaging of Tobacco Products Regulations 2015

The following section outlines the key regulatory provisions in SPoT to feedback on, with questions provided to determine their public health and regulatory impact. If there are some provisions not covered below that you think should be, there is an opportunity for you to use the Section 'anything else' below to state these and provide your views and evidence.

SPoT requirements

The requirements for packaging and labelling of cigarettes and hand rolling tobacco

Cigarette packs must have a cuboid shape to ensure visibility of the combined health warnings. Slim packs and other irregular shaped packs are not allowed.

Promotional and/or misleading features or elements are not allowed on tobacco packages. References to lifestyle benefits, taste or flavourings, special offers, suggestions that a particular product is less harmful than another, or has improved biodegradability or other environmental advantages, are not permitted.

Question 14: How far do you agree or disagree that the requirements on the packaging and labelling of tobacco products have been an effective way to protect young people from taking up smoking?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Question 15: How far do you agree or disagree that the requirements on the packaging and labelling of tobacco products have helped existing smokers quit?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Question 16: SPoT regulations apply to cigarettes and hand rolling tobacco. How far do you agree or disagree that SPoT regulations should be restricted to cigarettes and hand rolling tobacco (and not other tobacco products)?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Pack size

The introduction of a minimum pack size of 20 cigarettes and the introduction of a minimum pack weight of 30 grams for hand rolling tobacco

The purpose for this was to deter young age groups who are in the main on lower incomes from buying these products by increasing pack sizes to make them more expensive and therefore less attractive.

Question 17: How far do you agree or disagree that the introduction of a minimum pack size or weight is an effective way to protect young people from taking up smoking?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Appearance of cigarettes

The requirements for the appearance of cigarettes

Cigarettes may only be white with a matt finish and any paper surrounding the end of a cigarette that is not designed to be lit may be coloured in such a way as to imitate cork. Text may be printed on the cigarette to identify the brand and variant name of the cigarette but must meet certain conditions around presentation.

Question 18: How far do you agree or disagree that the requirements on the appearance of cigarettes are proportionate?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Enforcement

Offences and enforcement of the regulations

These regulations make it an offence to produce or supply tobacco products that have retail packaging that do not meet the provisions set out in the regulations, on the penalty on summary conviction would be imprisonment for a term not exceeding three months, or a fine of any amount, or both, or if convicted on indictment, would be liable to imprisonment for 2 years or a fine or both. These are enforced by Trading Standards Officers (or Environmental Health Officers in Northern Ireland).

Question 19: Do you agree or disagree that the penalties for a breach of the regulations are an effective deterrent to ensure compliance with the regulations?

• agree
• disagree
• don’t know

Please provide a reason for your answer and any evidence to support this.

Other question

Question 20: How far do you agree or disagree that there has been an economic impact of SPoT, either positive, negative or both?

• strongly agree
• agree
• neither agree or disagree
• disagree
• strongly disagree
• don’t know

Please state who you think SPoT has impacted on economically and provide any reasons or evidence to support this.

Anything else on SPoT?

Question 21: Is there anything else you would like to share on negative or positive impacts the regulations have had on topics not covered above? If so, please explain and include any evidence and research you may have to back your response.

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