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A PMTA (Premarket tobacco application) is a regulatory requirement to allow any tobacco product or product derived from tobacco substances to be marketed in the US. This includes Electronic Nicotine Delivery Systems (ENDS).

Fundamentally these regulations are designed to answer three questions:

  • What is in your product? (Manufacturing controls, Product testing and analysis)
  • How hazardous is it? (Non - clinical studies)
  • What reaches the consumer? (Clinical studies)

The FDA is concerned with regulating ENDS to ensure the protection of public health. This covers the users of ENDS products, third parties exposed to the products and potential new users (especially children).

Products on the market after August 8th, 2016 require a PMTA before launch. Deemed ENDS products (those on the market after February 15th, 2007) will require a PMTA to be submitted by August 8th, 2022 to allow them to remain on the market.

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How We Deliver

Successful delivery of PMTA requires regulatory expertise to ensure the project is aligned with regulatory needs. Our combination of scientific knowledge and analytical skills deliver an effective testing strategy for your PMTA process.

You will have a dedicated Project Manager who manages the whole process of your PMTA project covering regulatory, scientific and analytical activities. 

Diagram 1 represents an overview of the various data submissions required for PMTA.

D1-PMTA-Overview1

Diagram 1. PMTA Overview

Whilst our core competence sits with the Product Analysis element of PMTA, we have a network of trusted, specialist partners who can be introduced to your project to deliver an end to end service where required. By working with Broughton Nicotine Services we will optimise your regulatory submission while ensuring cost is kept under control.

Product Analysis

A successful PMTA Product Analysis strategy can only be delivered following an effective planning stage.

At Broughton Nicotine Services we follow a four-step process and engage regularly with FDA.

US PMTA - D2-Product Analysis Process 

  

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Resources

Brochure

Download our brochure to read how Broughton Nicotine Services can help you comply with regulations requiring HPHC testing.

White Paper

Download our free white paper to get further information on the FDA’s Guidance for Industry on PMTA for Electronic Nicotine Delivery Systems (ENDS).

Brochure

Download our brochure for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.