Premarket Tobacco Product Application (PMTA)

Do sell eliquids and devices in America?
Are your products PMTA approved? Are you aware of PMTA?
Before a new tobacco product can be legally marketed, the FDA must issue an order permitting marketing of that product. To issue a Premarket tobacco product application (PMTA) marketing order, the FDA must evaluate that product based on a public health standard, which considers the risks and benefits of the product to the population as a whole, including tobacco product users as well as non-users.

The deadline for PMTA is 12 May 2020.

ADACT’s pedigree of delivering compliance
ADACT changed the European vaping industry by charging ten percent of the industry average fees for TPD compliance. Today, we’re bringing our high-quality and competitive pricing to PMTA testing where we hope to have the same impact.

After many requests from our customers, we have decided to put our efforts into making an affordable, compelling PMTA package. We are able to use a shared data approach so we are not charging everybody for all the data over and over, and instead we will only need to produce the results once and charge for them once.

Stage one
Our efforts will go towards the initial HPHC testing (expected to be due in December 2019 for larger companies and March 2020 for smaller companies) which will be bundled with the preparation stage of our PMTA work. Our testing and formulation review will map the compounds in your product and create a toxicology framework so you can ensure your products are served in the full PMTA as it develops. This will then be written up in a detailed report with the full toxicology data you need to support your PMTA.

The next component will be the public health impact assessment with certified clinical assessment groups. As we revolutionised TPD testing, we are able to massively reduce the burden of testing as we will be doing the statistical modelling on all the HPHC testing data generated. The more data we have the more powerful it is, so let us share this data and reduce the burden of testing.

To make the PMTA offering as cost effective as possible, we are looking for 200 flavours who want to get on board with this programme of work which will help us deliver it for an amazing £12,500 per flavour.

Stage two
As part of stage two, we will expand the toxicology paperwork to the laboratory that will include cell viability testing and genotox testing. We will extend to the additional HPHC testing, which allows us to map your products to the full statistical model and will represent a massive reduction in the total burden. We will then:

map the public health impact of your products,
write a suitable conclusion with highlighted data points,
complete stability testing
and finally pull all the data together in a detailed final report.
The fees for this are yet to be confirmed but we estimate between £20,000 and £30,000 per flavour.

HPHC testing only
The other option is to do a single SKU HPHC test so you can file in time for your company deadline. We recommend that the test is done on the highest nicotine strength you sell as this will be done at two levels (high and low aerosol production) and in triplicate. The cost for HPHC testing only will be £6,500.

The risks
You maybe thinking, ‘What if the stage one statistics go against us and stage two does not work out cost effective?’ Should this occur, you will still have your base HPHC test data, toxicology paperwork and public health impact statement, so you will still have made a huge saving and you will be prepared going forward.

Resources:
Premarket Tobacco Product Applications (PMTA)
Industry guidance: PMTA for Electronic Nicotine Delivery Systems (ENDS)

Your next step:
To discuss how PMTA will affect your business, and more importantly to keep your products on the market, please call ADACT on +44 (0)1302 986 088 or email damien@adactmedical.com to arrange a teleconference with Damien.

Time Effective
With the Pre-Market Tobacco Application (PMTA) deadline for HPHC testing looming, it is important to submit testing. For the first 200 flavours we test, we guarantee you will be able to file your application in time or you’ll get your money back.

Cost Effective
ADACT Medical Ltd changed the European vaping industry by charging ten percent of the industry average fees for TPD compliance testing. We’ve been working hard to bring our PMTA offer to market with similar savings for valued customers.

Proven Experts
ADACT has over 20 years experience in medical product regulation across the world. We will support your company by providing advice and guidance on all matters relating to current electronic cigarette and vaping regulations around the world.

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