Four tips to help you submit a successful PMTA
As of 9th September 2020, manufacturers of any e-cigarettes and related products such as e-liquids (ENDS) must submit a PreMarket Tobacco Application, more commonly known as a PMTA, to the FDA in order to sell your products in the USA. Having submitted close to 400 PMTAs for our clients, here are our top tips to help you to submit a successful PMTA and sell your products in the USA.
Have a plan and be organised
The FDA has provided guidance on the format of PMTAs which closely mirrors the established format of pharmaceutical applications for medicinal products. The Tobacco Technical Document (TTD), which is essentially the PMTA, comprises 7 Modules, shown below.
Understand how much time you will need to prepare, in which order you will be generating the information and plan your time accordingly. We recommend making a list of the information each module will require and starting from there.
Contact your suppliers
Your application doesn’t end with you. If you use external suppliers to make your products, you’ll need to include details about their practices and impact in your PMTA as well, so be prepared to contact your suppliers in order to gather the information you need.
Most suppliers will be happy to provide you with the information you need, and you may already have access to the basics, such as location and company procedures. To make it easier for you and your suppliers, make sure you make exactly what you need from them clear.
Understand what the FDA want and ensure that your application covers it
The purpose of the PMTA is to make sure that your product is safe to be on the US market and does not pose a health risk to the general public.
This means that the FDA will be looking for evidence that you are a responsible manufacturer in your application. Make sure that you consider things such as how you intend to market your products in a way that protects youth and vulnerable people, that the ingredients and packaging are safe and how your products will impact the environment.
Get support from reputable organisations
Submitting a PMTA can be an expensive and extensive task, so you want to ensure that your application is successful and a worthy investment of your time and money. Seeking external help from a reputable regulatory organisation can help you with this.
In order to submit a PMTA, your products will need to be subject to lab analysis and you may also choose to seek help with the generation and submission of your application. Do your research and make sure that you choose a reputable organisation with the right credentials and values to support you with your PMTA.
We’ve submitted 400 PMTAs on behalf of our clients, and whether you’re looking for regulatory guidance, testing or a full PMTA generation and submission service, we can help. Click here to learn more about our PMTA services, or contact email@example.com.