Premarket Tobacco Application (PMTA) Support

US Pre-Market Tobacco Application (PMTA) & Article 20 within European Tobacco Products Directive (TDP)
E-Liquid products produced after August 8th, 2016 must cohere to the FDA Pre-Market Tobacco Application (PMTA).  The PMTA is a multifaceted submission process that through a series of scientifically accurate tests determines key statistics about the e liquid products for sale within the US market. The intent of these new regulations is to provide accurate information to customers so they can be educated in their choices as well as to develop industry minimum standards for development and manufacturing to ensure the quality and safety of all vape products.  This process must be completed under Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).

The PMTA submission period to the FDA typically takes between 18-24 months and is required by law before an ELiquid product can be marketed.  As a result, the compliance periods are staggered to allow completion of the complex applications that must be submitted.  If a company does not comply with the FDA registration, they are subject to penalties and enforcement procedures from the FDA.

 
Requirement Deadline for Manufacturers
 Free sample ban, age restriction, photo-ID check, use of  modified/reduced risk claims and descriptors, adulteration and  misbranding prohibitions  August 8, 2016
 Introduction of new, deemed products without FDA premarket  authorization (products on the market before this date are subject  to the new compliance policy deadlines)  August 8, 2016
 Registration of U.S. manufacturing establishments and  submission  of List of Products manufactured in such  establishments [does not  apply to foreign establishments]  September 30, 2017
 Submission of Health Document Notification  February 8, 2017
 Submission of Ingredient Listing Reports  November 8, 2017
 Submission of Harmful and Potentially Harmful Constituents  (HPHCs) reports  November 8, 2019
 Nicotine Addiction Warning on Labels and Advertisements  August 10, 2018 (distribution of products without the required  warning must cease by September 10, 2018)
 PMTA or SE Report for deemed combustible products  (e.g. cigars or hookah) on market on August 8, 2016  August 8, 2021
 Premarket Tobacco Application (PMTA) or SE Report for deemed  non-combustible products (e.g., vapor products) on August 8,  2016   August 8, 2022

 

Although e-cigarettes do not contain tobacco, judges ruled in 2010 that vape products are considered tobacco products.  Because the FDA now has jurisdiction over tobacco products, if e-cigarette products are to remain on the market after August 2018 they will have to be in compliance with or in process of complying with the PMTA requirements.

What is the FDA seeking?

The chemical and physical identity and quantitative levels of the emission of aerosols under a range of operating conditions (e.g., various temperature, voltage, wattage settings) and use patterns (e.g., use conditions by light users, typical users, and heavy users) within which consumers are likely to use the new tobacco product.

What can Avomeen do for you?

Avomeen can help you complete the non-clinical portion of the PMTA process by providing a thorough chemical analysis on your product, helping you navigate the FDA regulatory guidelines, and conducting a thorough review of the literature and relevant product data.  Avomeen is FDA-Registered, DEA-Licensed, GLP-Compliant, cGMP-Compliant, and ISO-17025 Accredited and is intimately familiar with registering a variety of consumer goods with the FDA.

More specifically, Avomeen can provide the following services:

  • CMC & GMP Testing for:
    • Components
    • Ingredients & Additives
      • GMP characterization & production analysis
    • Properties
      • Storage & stability study
      • Emissions testing
      • Packaging compatibility analysis
        • Extractables & Leachables (E&L) study
      • Principle(s) of operation
        • Hazards risk assessment
        • Development of specifications
      • DMF preparation
    • Health assessment (showing the relative risks of the new tobacco product for both users and nonusers compared to other tobacco products on the market)
      • Assessment of abuse liability
      • Assessment of user topography
      • Toxicology assessment
      • Non-clinical & animal studies
      • Clinical Studies & Site Selection
      • Environmental impact analysis
    • Document submission, filing, and representation with the FDA
    • Other E-Liquid services such as:
      • Product reverse engineering & emulation
      • Nicotine dose consistency testing
      • Batch & Quality control testing
      • Harmful ingredient screen

Don’t wait!

Contact Avomeen today to ensure PMTA compliance and mitigate your risk of financial penalties and potential loss of market share.  To request a quote: