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.

HPHC Testing

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. The result is the optimum chance of approval and the best value for your spend.

You will have a dedicated Project Manager who manages the whole process of your PMTA project covering regulatory, scientific and analytical activities. In addition, we may introduce our network of trusted, specialist partners where required.

Resources

Brochure

Download this brochure to learn more about the e-cigarette and e-liquid testing services we offer for PMTA.

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.