Premarket Tobacco Product Applications (PMTA)
Helping you to show your product is appropriate for the protection of public health with Food and Drug Administration (FDA) approval.
Helping you to show your product is appropriate for the protection of public health with Food and Drug Administration (FDA) approval.
On 10 May 2016, the Food and Drug Administration (FDA) introduced legislation for the vaping industry in the United States – the Federal Food, Drug and Cosmetic Act.
Following the PMTA deadline of 9 September 2020, we announced that ADACT had completed over 1,000 submissions on behalf of 20 major brands.
PMTA is an abbreviation of Premarket Tobacco Product Application. It is a regulatory requirement for companies selling electronic cigarette and vaping products in the United States to comply with the new rules.
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.
If you are unsure if your business is affected, contact Adact by calling (786) 706-4316 or emailing [email protected] for a quick answer.
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 provided regulatory compliance services for thousands of companies across the world. We support your company by providing the advice and guidance to keep you ahead of the current regulations in the markets that matter.
Adact delivers an excellent level of service which is still very affordable, making us a true champion for entrepreneurship. We believe in an approach that allows you and your company to grow a successful product range in the US marketplace.
Adact has proven that regulatory compliance is so much more than ticking boxes. It is about creating a platform that builds with you as future regulatory challenges occur for continued accountability and safety.
Adact faces challenges and delivers industry beating results. From our ISO 17025 accredited testing laboratory we deliver world class regulatory compliance services which are further backed up with excellent on-demand custom service.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
We are the trusted regulatory compliance partner of leading e-cigarette and vaping brands around the world. Our proven end to end services help get your products approved and on the market quickly and affordably.
Copyright © ADACT Medical Ltd 2021 All rights reserved Terms & Conditions Privacy Policy Cookie Policy
Adact Medical US LLC is registered in the United States of America L20000054855