WHY DID YOU DECIDE TO ENTER
THE VAPING INDUSTRY?
Our founder and Chief Regulatory Officer, Damien Bove, was
initially involved in nicotine products pre-TPD for medical licencing,
specifically e-cigarette projects. When TPD was announced, Damien
identified that he could provide a cost-effective solution for the industry
in registering products under TPD. This is the reason Adact are the
single largest submitter in the industry.
Managing Director Robert Sidebottom joined Adact in July 2017
as he could see the huge opportunities that the sector provided.
Robert has the specific brief of driving the company forward in its
ambition to provide a comprehensive compliance solution for the
US vaping market while maintaining Adact as the most successful
compliance agency in Europe. Damien, Robert and the Adact team
are proud to serve the industry and provide productivity solutions
such as TPD Expert (adactmedical.com/tpd) and the Adact PAP.
You can read more about that on pages 50 - 51
WHAT REGULATIONS ARE
SHORT-FILLS SUBJECT TO?
All zero-nicotine products fall out of the scope of TPD. However,
these products are regulated under the General Products Safety
Regulations 2005 (GPSR). Section five of the regulations is clear:
no producer shall place or supply a product unless it is safe.
There are several sections of the GPSR that give more detailed
directions on how to ensure that products are safe. However, our
advice is to use the TPD as a due diligence process to ensure
that zero-nicotine products are safe for the consumer. Mark Oliver,
Trading Standards Business Hub Manager, Cambridgeshire and
Peterborough Trading Standards says,
“Following the TPD as a due diligence process is a robust method
to help ensure these products meet the requirements of the General
Product Safety Regulations.”
As a minimum you should test, analyse and produce safety data
sheets using the same methodology as TPD. Adact provides a
comprehensive testing solution for zero-nicotine products, when
clients have their products tested and analysed with us. The
products are also listed on Zero Expert (adactmedical.com/zne), a
voluntary national notification database for all zero-nicotine products.
HOW DO WE GO ABOUT
SUBMITTING E-LIQUIDS
TO THE FOOD AND DRUG
ADMINISTRATION?
There is a two-tier approach for products that were on the market
in the US before August 2017. Small companies need to file their
recipes with the FDA by November and large companies by May
of this year. In theory, no new products were allowed onto the
market after August 2017 without first going through a full Pre-
Market Tobacco Authorisation (PMTA) with the FDA.
All products need to be processed by 2022. US-based companies
will have already been required to list their product and register
their premises with the FDA. Adact provide a comprehensive PMTA
submission service. Please contact us directly for moe information.
WHO IS RESPONSIBLE FOR
REGULATING CBD E-LIQUIDS?
The responsibility for regulating CBD in e-liquid form currently
falls with the Medicines and Healthcare products Regulatory
Agency(MHRA), particularly with regards to medical claims. As a
zero-nicotine product, CBD e-liquids are regulated under GPSR.
The Cannabis Trades Association UK (CTA UK) are currently in
early discussions with the MHRA regarding setting up an exclusive
regulator for all CBD products.
Adact are one of two preferred testing organisations for the CTA UK
and we strongly advise all companies involved in the manufacture,
production and sale of CBD products to join the CTA UK, which
can provide detailed assistance and advice regarding this game-
changing product.
WHAT ARE THE IMPLICATIONS OF
THE PROPOSAL TO EXEMPT VAPE
PRODUCTS FROM THE TPD?
The Private Member’s Bill second reading regarding exemption of
vape products for TPD has been deferred to the end of April. The
fact that the bill was seventh on the agenda in March indicates
that it may have been used as a parliamentary tactic to jam up the
legislative timetable.
If the bill achieves legislative success in the future then we would
revert to the same position as pre-TPD, unless another proposal
for regulation was implemented. Adact do not feel that this bill
will achieve legi