Pre-Market Tobacco Product Application

How to legally market your products in the United States

On 10 May 2016, the FDA formalised its authority to regulate e-cigarettes and vape pens in the United States under the Federal Food, Drug and Cosmetic Act, as amended under the Family Smoking Prevention and Tobacco Control Act.

Pre-Market Tobacco Product Application Marketing Order (PMTA) was introduced to ensure all vaping products are safe to consume. The regulations aim to raise standards in the American vaping industry and protect consumers.

What is PMTA?
Who does PMTA apply to?
What does PMTA require?
What is the PMTA deadline?
Our approach: Statistical modelling
ADACT’s pedigree of delivering compliance
Data set
Toxicology Assessments
HPHC
Stability
Devices
Environmental Assessment
Public Health Impact Assessment
Label Templates & Readability
Back-end IT Support
The Costs
The Risks
What is PMTA?

PMTA is short for Pre-Market Tobacco Product Application Marketing Order. They are issued by the FDA and permit tobacco products to be legally marketed in the US. To issue a PMTA, the FDA first evaluates a product based on a public health standard that considers the risks and benefits of the product to the population as a whole, for users and non-users.

Who does PMTA apply to?

PMTA applies to anyone wishing to sell e-liquids, e-cigarettes and vaping products in the US. It includes existing and new products. There are no products which are exempt.

What does PMTA require?

The FDA has provided guidance to the full requirements in it’s document available to download from www.fda.gov/media/127853/download.

In brief, the PMTA must include:

  • A battery of product tests and toxicological information on its components
  • Full reports of all information published concerning investigations that show the health risks of the tobacco product and whether such product presents less risk than other tobacco products;
  • A full statement of the tobacco product’s:
    • Components
    • Ingredients
    • Additives
    • Properties, and
    • Principle(s) of operation;
  • A full description of the methods used, and the facilities and controls used for the manufacture, processing, and when relevant, packing and installation;
  • An identifying reference to any tobacco product standard, which would be applicable to any aspect of the product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard, or adequate information to justify any deviation from such standard;
  • Samples of such tobacco product and components, as required by the FDA;
  • Specimens of the labelling to be used; and
  • Other information relevant to the subject matter of the application as the FDA may require.
What is the PMTA deadline?

We recommend applying for PMTA before the end of February in order to meet the deadline for PMTA of 12 May 2020.

The FDA anticipate that the submission process will take up to ten months, so time is of the essence if your business is aiming to sell in the US market in 2020. Providing companies submit an application for PMTA before 12 May 2020, they may continue to sell products that were in market on 8th August 2016 whilst evaluation is taking place.

Our approach: Statistical modelling

We have identified the potential for companies to come together and share the cost of producing base data that can support a large number of PMTAs. The FDA guidance references modelling and bridging data many times. On that basis, we see a great opportunity to generate data that meets the FDA’s requirements and reduces the overall cost.

ADACT’s pedigree of delivering compliance

ADACT was extremely successful in delivering TPD in Europe. We built a huge toxicology database of over 750 chemical reports. We invested in a software system that correctly formats notifications for a central data set and that has massive data upload capability. Further to this, we established a testing laboratory with industry protocols.

Our investment paid off, and we were able to offer compliance to businesses at highly competitive rates. We serviced over 320 customers, have nearly 4,000 flavour concentrates in our system, have tested over 23,000 TPD products, and uploaded over 1,500,000 presentation in Europe.

Today, we are looking to bring that same approach to our PMTA offer.

Data set

Phase 1 is to build the basic data set:

  • Environmental assessment
  • Public health impact data
  • Labelling and readability
  • Environmental assessment
  • Public health impact data
  • HPHC emissions
  • Toxicology data etc

For each of these areas there will be a core data set that will be of significant size and scope, and many times the size that is required for a single product. This core data will be statistically mapped out so that individual products can have a minimal amount of work conducted to plug it into the larger statistical model.

From this we can draw acceptable conclusions and work efficiently to bridge into a larger dataset, which makes up Phase 2. For this to make economic sense, we need a critical mass of products and flavours – we calculate 200 will be sufficient to kick-start our PMTA drive, and ultimately create the maximum level of saving for you.

Toxicology Assessments

Our inhalation toxicologist is world renowned and has developed a methodology for mapping the toxicology of individual chemicals to the risk profile of vapers which was presented at the Association of Inhalation Toxicologists (AIT) Conference in 2018.

This has given us the capability to assess in a meaningful way the chemicals to support PMTAs. The first step is to map the individual chemicals across the products in Phase 1 to assess the critical mass for each chemical. If a chemical is proving challenging but is only represented in a handful of products, we can make a judgement as to whether it should be dropped from the program or if it is worthy of the additional investment.

In Phase 2 we will conduct testing on individual products so we can use the large shared data set to draw meaningful conclusions. We will conduct some laboratory testing and computer modelling to support certain chemicals, which will be costed in and shared across multiple products, as appropriate.

HPHC

So that our simplified approach works fairly for everyone, we will pre-screen any liquids we deem ‘high risk’ in Phase 1 to filter out any high risk products from the start. Emissions or HPHC testing as a stand alone is a significant cost. These costs will be shared across companies, thus reducing the overall individual cost. As we are instead bundling this as a shared cost, it can be massively reduced.

We will build a statistical model of how a liquid will be expected to behave across a range of variables, such as; intensity, flavour type, category, nicotine strength, time since manufacture and stability. This will be done in triplicate across the board so that we can look at the variability potential from batch to batch to build that into our model. This model can be built using some standard products and enhanced by the two hundred data points generated in our PMTA pre screen.

For Phase 2 each product will be tested at a minimal number of points within the model that makes most sense for the product type and its user profile. This will then be mapped to the full model so that we can complete the HPHC component of the PMTA in full without a full battery of testing on each individual product.

Stability

Stability testing is where we look at each liquid and see how it degrades over time. Part of that requirement from the FDA is also to look at how degradation impacts on HPHC results which we will map in the above statistical model.

Prices in excess of £300,000 have been indicated for this section of the PMTA alone but we will bring this price down as we will be able to complete minimal non-aerosol stability assessments and statistically map out the HPHC component. To confirm results, a single confirmatory test may be required which will again be factored into the cost and appropriately shared.

Devices

Devices are also covered by PMTA. By understanding the basic dynamics of HPHC we can map out the full profile of the products from minimal testing. Devices may not be able to realize some of the full saving as liquids in this program but significant savings will still be available.

Environmental Assessment

We believe this will be the easiest component to scale as a single detailed assessment of all product categories can be developed and product specific conclusions constructed as needed for the PMTAs. With the supporting data from Public Health Impact Assessments, highly insightful data will be available.

Public Health Impact Assessment

This is perhaps the most complex component of our program of Phase 1 work. Once completed, it can be adapted to individual products with minimal effort in a similar way to the Environmental Assessments. The public health impact needs to consider all aspects of vaping behaviour and hence impact.

From stopping smoking (either fully or partially) to non-smokers taking up vaping, the issues of youth uptake or how particular categories and routes to market will be taken into consideration. This information will be mapped to biomarker data in order to have physical data to support our conclusions and claims on how public health is impacted.’

We plan to use a lot of primary research on volunteers (mostly behaviour reporting data) combined with data that participating companies may grant us access to. The value in data from third parties can be realized through reduced billing for participation where appropriate and all commercial data being fully protected and respected.

We will be able to map how each individual product type, category and flavour profile will have a positive impact on public health and predict how it will impact the market for all user groups. This base data will be costly and time consuming to develop, but once in place product specific conclusions can be quickly generated.

Label Templates & Readability

The PMTA requires example labels to be provided for each product, along with readability assessments to ensure the public fully understand the data presented on packaging and contained on marketing materials. This kind of readability assessment is important and costly, however by having some standardised components shared across multiple products the cost of conducting readability assessments can be massively reduced.

Back-end IT Support

The other component that needs to be considered is the compilation of the PMTAs. We will be relying on holding significant data in one place to support all PMTAs, we will also be constructing an IT system to support the production of PMTA submissions which will help in producing them largely automatically by combining standard component reports and the bespoke components together to a standard format output on an XML backbone (A standard technical document format) that the FDA are used to receiving and handling.

The Costs

At this stage we are predicting a cost of £12,500 per flavour for early stage participation. This will cover the pre-HPHC screening and generate the revenues to fund the toxicology mapping, full HPHC model building with stability component and allow us to complete the public health impact work and environmental assessments.

Phase 2 will be charged on a per product basis and will be dependent on the chemical profile of products, categories and flavour types. We are predicting a cost of between £20,000 to £30,000 per product for individual product testing, some HPHC testing, a confirmatory in-vitro toxicology screening and bespoke medical writing. As each product that goes through the full assessment we will further strengthen the statistical modelling, the more products we can confirm for Phase 2, the larger the savings should be.

After the initial two hundred products, we will then be opening up the program to other companies and products on a for profit basis and will be charging multiples of what early adopters have paid to gain access to the value embedded in our earlier program of work.

The Risks

Our predicted Phase 2 costs are based on the extensive experience ADACT Medical Ltd have in similar related fields. For complete clarity, we must say that our predicted costs could increase or decrease however we are confident in our forecasts. In the scenario that the final bill is larger than expected, it is important to remember that this is a cost you will need to have paid anyway and there is not a risk that you will not get PMTA. Thanks to our experience in reducing costs in this sector, we believe this scenario is extremely unlikely and that significant savings can be realised from rigorous modelling.

You may be concerned if the Stage 1 statistics go against us and Stage 2 does not work out as cost effective as hoped. 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. Statistical modelling in 99% of instances, saves money.

Your next step

Please note the first 100 places have already been taken so please act fast to secure your place. To discuss PMTA testing please ADACT to arrange a teleconference. We expect these two hundred spaces will fill up fast, so don’t hesitate to get in touch.

Menu