Government Response to Consultation on Tobacco Products Directive (‘TPD’)
Background
The Government will be regulating the electronic cigarette industry under the Tobacco Products Directive, which will come into force in May 2016. These regulations will require e liquid and e cigarette suppliers and manufacturers to provide products in compliance with the Directive. The aim is to ensure that e cigarette products meet safety and marketing standards. For example you will no longer be able to buy e-liquids above a 20mg strength of nicotine from one year after the TPD is brought into force. A consultation took place with vaping shops, health professionals, regulatory officers and the public for their views on some questions asked by the Government. The Government’s questions and attendee answers related to electronic cigarettes are summarised below.
Key Views
Key views put forward by the vaping attendees were that any regulatory regime should recognise the harm reduction offer by electronic cigarettes. Reference was made to the Public Health England report ‘E-cigarettes: An Evidence Update’ which found that e cigarettes are 95% healthier than tobacco cigarettes (read our post for further information on the Public Health England report here https://www.vapourdays.co.uk/public-health-england-vaping-95-safer/). Attendees felt that the TPD regulatory requirements were out of proportion for e-cigarettes and were being based on tobacco legislation. That products without nicotine should also be included in the TPD because non-nicotine products should meet the same standards of quality as equivalent nicotine products.
Should Cross-Border Sales of E-Cigarettes Be Prohibited to Consumers?
It is already a legal requirement to be aged at least 18 years and over to buy or be given electronic cigarettes or associated products. Legislation will require sellers, whether on-line or in person, to unambiguously confirm a consumer’s age.
Should Novel Tobacco Products be Subject to a Notification Scheme?
It was requested for the Government to provide further guidance on what constitutes a novel tobacco product, and whether e cigarettes fall under this. Responses also wanted the regulation for tobacco and e cigarette groups to be separate. Procedures will be implemented by the Government for the notification of novel tobacco products. It was originally proposed for there to be a requirement for manufacturers and importers to provide information on the toxicity of the product, the ingredients and emissions; how addictive the product is, as well as its emissions; the expected effects of the product on the cessation of tobacco consumption by existing users of tobacco products; and the perception of the product by consumers or potential consumers. It was concluded from the consultation that only data available on this information would be required to be submitted. No additional testing or surveys would be required to notify of this information.
The Government Plans to Use the Definitions of an ‘Electronic Cigarette’ and ‘Refill Container’. Will This Pose Inconsistency Problems With the Definitions in The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations?
Although responses to the proposed use of the words ‘Electronic Cigarette’ and ‘Refill Container’ were that it would lead to confusion, the Government has concluded that it would use this terminology under the TPD.
The Government Proposes in the TPD to Oblige Manufacturers, Importers and Those Renaming a Product to Ensure that there is Always a Person in the UK Who Collects Information About Suspected Adverse Effects in Relation to E Cigarettes and Refill Containers.
As a result of the consultation, the Government will not require a nominated person to collect any adverse events information. There will be a requirement for businesses to investigate and report incidents to the Authority as well as any action they may have taken.
The Government Proposed to Give the Secretary of State for Health (SoS) Power to Prohibit or Recall a Product if he/she Considers them a Serious Risk to Public Health.
Most respondents felt further powers for the SoS were unnecessary and considered that there are already robust systems in place. The Government decided to give the SoS the proposed powers if he/she considers the e-cigarette product a serious risk to public health.
The Wording Prescribed in the Health Warnings to Appear on Packs of E-Cigarettes and Refill Containers. Member States Must Choose Either a) ‘This product contains nicotine which is a highly addictive substance’; or b) ‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers’.
Several responses disagreed that that nicotine was ‘highly addictive’ with evidence being provided disputing that electronic cigarettes are highly addictive. Arguments were made requesting why addictive items such as sugar and caffeine were not also subject to such regulations. The Government will amend the implementing regulations to require the warning ‘This product contains nicotine which is a highly addictive substance’ on e-cigarettes and refill containers.
Should the Government Charge the Industry Proportionate Fees to Recover Costs Associated with the TPD?
Vaping respondents expressed the following views: The principle that firms should bear regulatory costs is fair providing the regulations are well-founded. There was no consultation, impact assessment, scientific basis for the measures and negligible scrutiny on article 20 of the TPD, which violated legal requirements and good policy making. It is not fair to ask companies to assume burdens associated with such poor policy-making, over which they have had little or no say. Fees should be proportionate to the size of the business.
The Government notes the opposition on charging fees for services provided to producers of e-cigarettes and concerns that this may limit innovation in the e cigarette sector. The health authority will undertake a light touch regulatory regime to minimise costs to the electronic cigarette industry whilst meeting obligations under the Tobacco Products Directive. A separate consultation on the proposed fee structure will be carried out shortly.
Should Retailers and Importers be Given the Proposed Transition Period until May 2017 to sell through Old E Cigarette Products?
All e-cigarette respondents agreed with this proposal although some e-cigarette industry respondents wanted a longer transition period. The outcome of the consultation is that the Government will adopt the transition periods to allow old e cigarette stock to be sold until May 2017.
Full Consultation Document
To read the full Government Consultation Document, follow this external link: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/489981/TPD_Cons_Gov_Response.pdf