products are going to start to come undone as notifications and the
TPD move away from just the administration to an age of complexity.
We are seeing the age of enforcement and scrutiny upon us.
Just in the past five or six months we have engaged in some pretty
rigorous toxicology assessments for compounds that are critical to
some successful flavours, but on the face of it may be banned. By
engaging in highly detailed toxicology reports that look at the overall
exposure from various vaping patterns, metabolism of the products
systemically and in the lung, and excretion of those metabolites,
we have been able to look at the safety of certain compounds
and set detailed exposure limits. This has always been part of
toxicology assessments but the detail of these reports is now
extremely advanced and the methodology has been presented
at the Association of Inhalation Toxicologists (AIT) conference in
the US.
We are also doing the same for degradant products as although
this has some distance to go, the regulators are taking a strong
interest in moving beyond reporting and looking for high peaks
but start to put real safety protocols together. My concern is that
as the regulations mature, the requirements for compliance will
become increasingly complex and many companies will not have
the regulatory experience to manage the situation. The industry
has fallen into the trap of viewing compliance as a one-hit task,
rather than an ongoing responsibility.
KEY REGULATORY
SHORTCOMINGS AND
ENFORCEMENT
These are the key regulatory shortcomings we keep seeing:
So we have been updating the technical files for a number of our
customers and re-submitting products. There was a minor difference
in how they want the branding and sub-branding submitted, including
nicotine strengths, so we have been updating those at the
same time.
All-in-all, if you’re in Belgium you need to be checking your submissions
and probably updating them.
COMPLIANCE IS NOT JUST
BOX-TICKING.
· PACKAGING NOT BEING CORRECT, FOR BOTH
CLP AND TPD
· NOT NOTIFYING MULTIPACKS UNDER THE TPD
· PUTTING OUT PODS UNDER THEIR 10ML
NOTIFICATIONS
At ADACT, we have seen quite a bit of enforcement action in the
past few months, on untested short-fills, online retailers breaching
pack sizes, lots of branding issues with passing off and appealing
to children and devices not being notified, RDAs in particular. So,
if you think these might apply to you and your business, now’s a
good time to get things sorted.
For more information on any of the topics covered in this feature,
contact ADACT Medical on +44 1302 98 60 88 or email
[email protected]. For more information about ADACT
Medical, go to adactmedical.com
We have been saying it for years. Although it’s obviously self-serving
advice for us, that compliance is not just box-ticking, the initial
submission of notifications was fairly formulaic and we have seen
quite a few low cost operators out there offering compliance on
the cheap, or companies cobbling together toxicology data where
they can and fudging together notifications. However, some of those
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