Vaping and the Regulatory Landscape – Steps to Launching a Product

Posted on Thursday November 1, 2018

 

Stephen Cartwright

By Stephen Cartwright, Trainee Solicitor

The rise of vaping and electronic cigarettes (commonly referred to as “e-cigarettes”) in the UK and across the globe has turned the spotlight on the relevant laws that govern them. In this jurisdiction, the Tobacco and Related Products Regulations 2016 (“TRPRs”) is the main piece of legislation governing and regulating the vaping industry. The TRPRs came into effect on 20 May 2016 and transpose the Tobacco Products Directive 2014/40/EU (“TPD”).

The TRPR introduced the following provisions, which are set out in Part 6 of the regulations. In short, it provides for:

  1. a restriction on the max volume of e-liquid in a single bottle/container to 10ml;
  2. a 2ml restriction on the tank sizes of vapes;
  3. restrictions on maximum nicotine strength/content limit to 20 mg/ml
  4. a requirement for e-liquid caps to be child resistant and tamper evident;
  5. a requirement that all products include stringent labelling and warning display requirements;
  6. a ban on certain ingredients including colourings, caffeine and taurine; and
  7. a mandatory notification process to a competent authority before e-cigarettes and e-liquids can be sold in the United Kingdom.

It is important for businesses who operate within this industry to comply with the TRPRs before launching any product which falls within its scope as failure to do so can result in an unlimited fine and even up to two years’ imprisonment. If you wish to launch a vaping product what are the necessary steps that you need to take?

How to Launch a New Vaping Product
Regulation 31(1) of the TRPRs states that a ‘producer’ must submit a notification of the new product to a ‘competent authority’ in accordance with the regulations. A ‘producer’ is defined as anyone who manufactures or imports these products or re-brands any product as their own. In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is the competent authority who receives and processes your notification.

Regulation 31(6)(c) of TRPRs states that you must file a notification to MHRA at least six months before you intend to first supply a product or a modified product. This notification must be accompanied by a fee, which is set out in the Electronic Cigarettes etc. (Fees) Regulations 2016 (“ECR”). In short, the fee payable generally is £150 except where the notification is a substantially modified product in which case the amount is £80 (Reg 2 of the ECR). Once your notification is complete it will be published in the public domain and as soon as this is complete, you are free to offer your products for sale in the United Kingdom.

If you would like further assistance on any of these issues, please contact +44 (0) 20 7240 0521 or email stephen.cartwright@mackrell.com