Premarket Tobacco Applications 101: Your guide to PMTA
The Deeming Regulations that deemed nicotine-containing products as tobacco products created a number of pathways for products on the US market to be granted Market Orders (MOs) by the FDA. The most common pathway for approval for electronic nicotine delivery systems or ENDS is that of the Premarket Tobacco Application (PMTA) pathway. Under this pathway, ENDS manufacturers or importers must submit an application to FDA which contains a broad array of information related to the product in order to determine the appropriateness of the product for the protection of public health (APPH).
It is unusual to think that a product which is considered to be a tobacco product must be shown to be appropriate for the protection of public health, considering the substantive health warnings imposed on tobacco products and the common knowledge that tobacco products do not come without risk to both the consumer and those around them.
The purpose of submitting a pre-marketing application to FDA is to collage and consider the information in a number of key areas that enable the determination of the risk to benefit of the product. It is worth noting that most cigarettes are exempt from the PMTA process due to a ‘grandfathering’ clause in the regulations which means that ENDS products are disproportionately affected by the regulations.
A guide to the PMTA Modules
The PMTA should be constructed through the use of building blocks known as Modules. In total there are 7 distinct Modules required to build a PMTA and within each Module, there are a number of specific requirements set out within FDA guidance.
Here is a brief overview of the modules and their broad requirements:
This module is concerned with the administrative information of the application including the manufacturers/importers details, information on the communication between FDA and the manufacturer/importer, product-specific details such as leaflets and labelling, and information on the marketing plan for the proposed tobacco product.
This section should provide a summary of the information compiled from Modules 3-7 and include additional information on the target demographic for the proposed tobacco product. The integrated summary document contained in the Module may be seen as the pivotal document to make the justification for APPH as mentioned in the introduction and should consider all information both positive and negative with respect to the proposed tobacco product.
Module 3 should contain all the necessary information with respect to the manufacturing of the tobacco product in addition to information on the performance of the product. It is within this section that product shelf life and Harmful and Potentially Harmful Constituents (HPHCs) should be addressed. This topic is somewhat complex and will be addressed in future information blogs on PMTA.
This module should include an assessment of the nonclinical or toxicological impact of the product, inclusive of ingredients and degradants/HPHCs. Assessment of the nonclinical impact of abuse liability should be considered inclusive of abuse, misuse and addiction, and any other risks that may be identified as part of the use of the proposed tobacco product.
Module 5 should contain an assessment of the clinical impact at an individual level of the product. The assessment of the clinical impact of abuse liability should be considered inclusive of abuse, misuse and addiction, and any other risks that may be identified as part of the use of the proposed tobacco product. Consideration of specific risk-groups of populations should also be considered.
This module addresses the clinical particulars and risks associated with the use of the proposed tobacco product at a population level. A population impact assessment should be formed based on population modeling and considering the impact of biomarkers of harm and exposure.
Module 7 contains an environmental impact assessment which must comply with Federal requirements. Deficiencies in this module have been responsible for a large number of FDAs rejection of PMTA submissions to date.
In conclusion, the overall process for PMTA is relatively complex when considered to its European counterpart, the Tobacco Products Directive (TPD) and it is recommended that a 12-18 month period should be anticipated for the compilation and filing of a PMTA. Contact us for more information on our PMTA services and to see how our experienced team and simply the process for you.