Premarket Tobacco Product Application (PMTA)

A strategy definition session will map the best approach for obtaining a Marketing Order for your nicotine or tobacco product. This will consider your company’s strategic objectives, product roadmap, and the data required to meet the PMTA submission threshold. From the definition phase, we will define the overall scientific strategy for your PMTA project. We’ll also discuss bridging strategies from previous submissions or consider future submissions to ensure the program gives you the most efficient plan for delivering your longer-term business objectives.

The strategy definition phase is essential for setting your PMTA regulatory project up for success. Having the right scientific strategy will help save time and costs, plus decrease the risk of receiving FDA deficiencies or Refuse to File notifications.

We advise any manufacturer considering a PMTA to engage directly with the FDA before submission. A Broughton senior regulatory consultant can act as your Authorized Representative and work on your behalf to prepare scientific briefing documents, manage communications or conduct meetings with FDA, and help you understand the nuances of the interactions with the agency.

Our consultants have years of experience working with FDA and will ensure your PMTA project is professionally managed throughout. They will be available to lead all contact with FDA and ensure prompt and appropriate communications.

A PMTA submission requires a substantive dossier to be submitted to FDA. Compiling a dossier requires extensive expertise in the PMTA process and multidisciplinary scientific areas such as toxicology, physiology, chemistry, biochemistry, environmental assessment, and psychology.

Our regulatory consultants have deep experience compiling PMTA dossiers and have worked on several projects that received Marketing Orders. They are experienced in using the eTTD format, which reduces time and costs when making amends or future submissions to FDA. Having worked on several successful PMTAs, our scientific and regulatory consultants understand where the threshold has been set by FDA for providing sufficient evidence of Appropriateness for the Protection of Public Health (APPH).

Scientific data from Human Health Studies (HHS) are required to substantiate a PMTA. Our full-service PMTA package includes analytical testing in our UK-based accredited laboratories integrated with expert scientific analysis and regulatory consultancy support. Our team has delivered several successful PMTAs for clients and has extensive nicotine industry experience.

Our full-service PMTA service includes:

• Product Characteristics and Characterization
• Product Safety Testing (devices)
• Product Stability Studies (NGP devices, e-liquids, HTPs, MONPs)
• Harmful and Potentially Harmful Constituents (HPHCs)
• Human Factors Testing
• Clinical Studies (PK/PD, Topography)
• Biomarker of Harm/Exposure Studies 
• Toxicological Risk Assessments 
• Behavioral Studies 
• Environmental Impact Assessment 

Following the submission of a PMTA dossier, FDA may issue a ‘Deficiency Letter’ to request additional information or clarification on the data submitted.  They must be responded to promptly to ensure that the FDA does tno Refuse to File the application. 

Deficiencies may require further scientific data to be submitted within the predefined time frame of 90 days. Our scientific and regulatory experts have extensive experience in responding to deficiency letters. They can offer insightful strategic advice on bridging data gaps or conducting additional studies to ensure an application meets FDA requirements.

The TPMF platform enables raw material manufacturers to share confidential and commercially sensitive information directly with the FDA without sharing it with the manufacturer submitting the PMTA. The TPMF is similar to the Drug Master File for the pharmaceutical industry.

Our regulatory experts are experienced in updating and maintaining the TPMF for PMTA clients and can remove this task from your in-house team.

A manufacturer has a duty of care to ensure all the products they sell are compliant with regulations and safe for consumers. The PMTA regulatory framework recommends that once a Marketing Order has been granted, the manufacturer instigates a program to ensure their product's ongoing stewardship and can evidence its continued Appropriateness for the Protection of Public Health (APPH) status.

Our scientific and regulatory consultants can advise on effective due diligence programs to create a robust post market compliance strategy, including ongoing quality control and stability testing in our in-house laboratories. They will also support the collation and reporting of data to FDA.

You can read more information on post market compliance services. 

A senior scientific consultant with many years of nicotine-related experience will be appointed as a Technical Project Lead, ensuring open communication with your in-house experts to create a common purpose and high-quality outcomes.

The Technical Project Lead will be supported by an experienced Project Manager who will coordinate across your PMTA project, ensuring timely communication, accurate meeting notes, and the project remains on track and within budget.