Helping you build your brand into the America market with Food and Drug Administration (FDA) PMTA approval
On 10 May 2016, the American Food and Drug Administration (FDA) formalised its authority to regulate electronic cigarettes and vape pens under the Federal Food, Drug and Cosmetic Act, as amended under the Family Smoking Prevention and Tobacco Control Act.
Following the PMTA deadline of 9 September 2020, we announced ADACT had completed over 1,000 submissions on behalf of 20 major brands. Read more by pressing here…
PMTA stands for Premarket Tobacco Product Application and is a regulatory requirement for companies selling electronic cigarette and vaping products in the US that aims to raise standards in the industry and protect consumers.
The regulations aim to raise standards in the American vaping industry and protect consumers by ensuring all electronic cigarette and vaping products are safe to consume. The regulations pose massive challenges for businesses selling e-liquids and devices.
If you manufacture electronic cigarette or vaping products and want to sell them in the US market you will need a PMTA. This includes e-liquids and extends to companies who combine or modify affected products.
A PMTA is a detailed dossier of information which uses scientific data to demonstrate that a product is appropriate for the protection of public health which is sent to the Food and Drug Administration (FDA) who will reach a decision after considering;
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.
ADACT 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.
Through our experience with Europe’s TPD regulations, ADACT has proven that compliance is much more than ticking boxes – it is about building a platform that will be able to meet future regulatory changes for continued safety and accountability.
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 an ISO 17025 accredited testing laboratory for emissions testing.
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.
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.
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.
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 2019.
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.
Conducted in our own ISO 17025 accredited laboratory, we have built 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.
Then testing is 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 liquids tested in our PMTA pre screen.
After this, 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 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.
The final step on the PMTA journey is postmarket reporting in which your company is required to maintain records and report on factors the FDA will use to determine whether there are any grounds to withdraw or temporarily suspend your marketing order. The two types of reporting are:
This covers the most serious adverse experiences such as; death, life-threatening events, inpatient hospitalisation, incapacitation of user, birth defect or any other adverse or serious condition affecting quality of life. These reports must be filed within fifteen days of identification.
These are less urgent reports which are filed annually and cover; changes to manufacturing, facilities, or controls that do not modify the finished product along with inventory of ongoing and completed studies, summary of sales and distribution data, current product purchasers, labelling changes and marketing and advertising plans. This also covers certain manufacturing deviations which could cause serious health consequences or death which are required to be reported within fifteen days of identification.
PMTA is one of the most challenging areas of regulatory compliance within the electronic cigarette and vaping industry. It is vital that you work with experienced scientists who have a proven track record, and who are globally respected and trusted in the industry such as ourselves. ADACT do not directly undertake PMTA work. We engage our US partner, Adact Medical US LLC who offer the same level of expertise and excellence for the US market.
We care about our customers and ensuring they have access to affordable compliance services to enable their businesses to grow.
Compliance strengthens brands – consumers naturally have a higher level of confidence in tested, approved products. Compliant products have a leading edge in the market place, when compared to non-tested brands and products.