Consumer Safety Methodology
The CONSUMER SAFETY section of CORE COMPLIANCE focuses on your post-sale exposure and relates to your ability to monitor and process consumer data. If you employ these steps you will begin to build genuinely robust processes and demonstrable due diligence, as well as meeting your regulatory obligations.
Adverse effects tracking
Tracking safety concerns (or adverse effects) around your products is a standard part of product stewardship and is now a legal requirement for the vapour industry. Safety concerns tracking is a requirement for most, if not all of the regulated markets for vapour products (Europe, Canada and in time the USA).
You must have a suitably robust system to record and monitor the safety concerns and where appropriate to inform the competent authorities. You need to have a system that can cope with a batch failure and potential subsequent product recall. This system must work in all markets you are present in and be appropriate for the volumes that you sell.
As with your labelling, packaging and documentation, you must be able to record everything in local language. It is also wise to use a system that covers all time zones to improve the volume of reports that come to you direct instead of the member state regulator.
Having the ability to rate a safety concern is the difference between managing your safety concerns internally and pushing everything through the competent authority. Having control and managing your safety concerns in house before they are lodged with the regulatory bodies allows you to rate severity in house and quickly handle, close or escalate the issue.
Member state regulators are keen to collect as much data as possible to assist in making crucial decisions around the further regulation of vapour products.
It is not currently obligatory to undertake any consumer preference surveys, but if you do collect data on any of these subjects, then you are obliged to submit them annually.
The data surrounding youth uptake is hot on the lips of all competent authorities and any information they can collate on this topic is of interest. It is advisable you do everything possible to avoid your brand being associated with any “youth uptake in vaping” news article.
Flavour preference data is another hot topic with competent authorities, with many proposing a ban on flavours other than tobacco flavours. If your brand is predominantly flavour based then it is in your interest to collate data to support this.
For more information on CORE COMPLIANCE, please contact us