Pre-Market Tobacco Product Applications (PMTA)
Accorto is the industry leader in PMTA submissions, remediations, and refilings.
“Tobacco Products”: More Than Just Tobacco
In the US, tobacco products have recently been redefined as products containing nicotine “from any source”, giving the FDA regulatory oversight over all existing and new nicotine products, including products made from synthetic nicotine or nicotine that has been derived from another source other than tobacco.
If you are planning to sell a tobacco product (or a device to be used with a tobacco product) in the United States, you will need to submit a Premarket Tobacco Product Application (PMTA) to the US Food and Drug Administration (FDA) prior to bringing your products to market. Manufacturers and distributors that bring products to market without an application risk enforcement action by the agency including product seizure, monetary fines, and in extreme cases, incarceration.
Your Expert PMTA Submission Team
Accorto Regulatory Solutions is the industry leader in PMTA submissions, remediations, and re-filings. Our robust team of expert scientists, researchers, project managers, and regulatory specialists have been working in the regulated nicotine products industry since 2016 and have submitted applications for over 800 traditional and synthetic nicotine products to date, with our applications being part of the less than 0.1% of all applications to hold up to agency scrutiny and currently remain in the review process.
Industry
Experts
Our team has been involved in ENDS regulation since the beginning, having been integral in the development of the initial PMTA regulatory framework. With a wide range of industry experts on staff, including former employees of both FDA and JUUL, our team brings an unparalleled depth of knowledge and expertise to your PMTA submission.
Quality Applications with a Track Record of Success
Of the over 26 million PMTA applications submitted to the agency for review since 2020, Accorto’s applications are among the less than .1% to have NOT received a marketing denial order and remain in the review process.
Custom Tailored
Solutions
We recognize the unique needs of each client, which is why we customize our approaches to fit your budget and timeline. Our personalized strategies ensure your application will meet FDA’s strict requirements without compromising on your specific goals and resources.
Solutions for Every Product at Every Stage
Our team specializes in developing customized programs to best assist our clients when and where they need us most throughout the PMTA process. Whether you’re looking for full turnkey PMTA support, or simply need assistance in one of the many steps along the way, our team is ready to help.
We support applications for a wide range of tobacco harm reduction products, including:
- ENDS Devices
- E-liquids
- Nicotine Pouches
- Heat-Not-Burn
- Novel Technologies
Speak to An Expert
Full PMTA Development & Submission
Accorto Regulatory Solutions is the industry leader in PMTA submissions, working with clients across a variety of product types to develop comprehensive applications that not only meet, but exceed, the agency’s ever evolving requirements. Our team of regulatory experts offer end-to-end support throughout the entire process, from initial strategy development, to document creation and publishing, to amending your submitted application to address changes in agency requirements post-submission.
Tobacco Product Master Files (TPMF)
A Tobacco Product Master File is a comprehensive document developed for manufacturers that contains detailed information about a nicotine product or collection of nicotine products, including information on manufacturing processes, quality control procedures, and product formulations. These documents are confidential, only accessible by the regulatory agency and those who have been personally granted access by the manufacturer. This document provides the opportunity for manufacturers to keep their proprietary information confidential, while still providing the FDA the information necessary to properly review their products. With Accorto’s comprehensive TPMF services, nicotine product manufacturers can confidently streamline their regulatory submissions, demonstrate compliance, and expedite their regulatory approval processes.
Tobacco Product Manufacturing Practices Compliance (TPMP)
The FDA recently released draft guidance outlining the proposed regulations for tobacco product manufacturing facilities. Manufacturers who proactively address compliance issues and start preparing their facilities for regulation now could gain a competitive advantage in the industry when regulations are officially enacted.
Our quality and compliance team offers assistance in:
- TPMP Gap Analysis
- Standard Operating Procedures (SOP) Development
- Quality Management System (QMS) Design, Implementation and Harmonization
- Validation and Qualification Support Services
- TPMP Internal Audit and Facility Audit Preparation
- Corrective and Preventive Action (CAPA) Management
- Supplier Qualification and Audits
- Training of Key Personnel
Longitudinal and Switching Efficacy Studies
The agency has made it clear that for an organization to achieve market authorization for their flavored ENDS products, the applicant must provide data from Randomized Control Trials and/or Longitudinal Cohort Studies measuring the effectiveness of these products over an extended period of time. In addition, the Agency has asked for a comparative efficacy measurement that addresses the increased effectiveness of ENDS products that use flavors other than tobacco to demonstrate those products’ benefits to adult users outweigh the risk of youth uptake.
At Accorto Regulatory Solutions, we have collaborated with one of the worlds’ leading Consumer Research Organizations to develop a series of studies which provide clear data demonstrating the effectiveness of ENDS products in assisting adult smokers in transitioning away from combustible cigarettes and meet the Agency’s current requirements.
Our Study Includes
- Randomized Control Study
- Quitters/Switchers Survey
- Flavor Ban Study
- Product Attraction Study
- Longitudinal Cohort Study
- Bridging
Contact us today to discuss conducting longitudinal and switching efficacy studies for your brand and how we can manage the amendment of your current application to include data from these studies in your current in-process application.
Deficiency Letter Response
Deficiency letters, the FDA’s formal request for additional information they need to complete the review process of an application, is a critical step in the Substantive Scientific Review phase of the PMTA process. Applicants typically have 90 days to address any deficiencies identified and provide additional data to supplement informational gaps. Applicants who fail to address these deficiencies properly are likely to receive a Marketing Denial Order (MDO) for their application.
Pre-Deficiency Letter Strategy
Is your application in review but has not yet received a deficiency letter? Now is the best time to act. Our team of experts will conduct a gap analysis on your existing application and identify possible areas of deficiency prior to receiving your letter from the FDA. By addressing deficiencies early, our team will have the time to perform supplemental studies to fortify your application, giving you the best chance at achieving market authorization.
Post-Deficiency Letter Response
Already received a letter from the FDA? Don’t wait! Applicants that fail to properly address deficiencies are likely to receive a Marketing Denial Order (MDO) for their application and be removed from market. Contact our dedicated regulatory support staff today to review your deficiency letter and develop a comprehensive strategy to best address your application deficiencies within the response window.
Audit Preparation and Live Audit Support
Our team will help you achieve and maintain compliance with the standards and regulations of the nicotine industry, making sure your company is prepared at any time for unannounced FDA facility audits. And when the day comes for the agency to arrive on at your door? Our team is on-call to help you manage the audit process start to finish.
Our Audit Preparation and Support Services Include:
- Gap Analysis and Action Plan to Achieve Compliance
- Training of Key Personnel
- Project Management of Action Plan Implementation
- Live Audit Support
