About ARAC

Our Team

Our Services

Paid Studies

Case Studies

Contact Us

Contact Us

Contact Us

A Proven Track Record

From the first flavored ENDS authorization by a small manufacturer to Module 6 programs for the world's largest, our team has delivered the behavioral and regulatory evidence behind successful FDA outcomes.


01

Switching Study for 1st Flavored ENDS PMTA Authorization in the U.S.

ARAC had four months to design a switching study, secure IRB approval, develop surveys, recruit exclusive heavy smokers, execute a three-month study, analyze the data, and report results to FDA. We delivered. Our randomized actual use study provided the product use and switching behavior evidence central to FDA's APPH determination, alongside the device access restrictions FDA called a potential game changer for preventing youth use.

RCT

Flavored ENDS

DAR APPH

Switching Study

Module 6

Deficiency Letter

Deficiency Letter

MGO

PMTA

MGO

PMTA

08

Programs

M5 + M6

Modules

PMTA | MRTPA

Pathways

Completion of Module 6 Program Supporting Large Multinational Manufacturer

02

ARAC has designed, executed, and managed the entire Module 6 research program, from protocol design, study executions, through final reporting:

  • Tobacco Product Perceptions, Intentions, & Comprehension Study

  • Label Comprehension and Human Factors (Usability) Assessment

  • Switching Study

Pre-PMTA Submission Meetings: Success with FDA

03

ARAC has led numerous pre-PMTA engagement meetings with FDA on Module 5 and Module 6 study design for ENDS, HTPs, and Oral Nicotine Pouch products, aligning clients' research plans with CTP expectations ahead of their submissions.

  • Prepared and led FDA Pre-Submission meetings for 3 manufacturers in 2026: 2 international companies new to market, and 1 U.S. sponsor.

  • Scientist-to-scientist engagement gave clients direct insight into FDA research expectations and standards.

FDA Engagement

Pre-Submission Meetings

Regulatory Guidance

Population Modeling

04

Every successful PMTA or MRTPA depends on product-specific modeling that assesses the net public health impact of authorizing a new product. ARAC leads these modeling efforts across every tobacco and nicotine category. So why are they critical to commercial success?

  • Formal Population Modeling, aligned with CORESTA working group standards, is the only way to project mortality and prevalence estimates with and without the new product or its reduced risk/exposure claim.

  • It combines evidence across PMTA/MRTPA modules, analyzing candidate-specific data on initiation, switching and cessation, dual- and poly-product use, ECDR rates, and HPHC exposure.

International Behavioral Evidence & Category Expansion

05

ARAC generated behavioral evidence supporting a large multinational manufacturer's international product application and category expansion.

  • Systematic Literature Review

  • Assessment of evidence against the country's regulatory requirements and standards

  • Authored Final Report of findings







ARAC generated behavioral evidence supporting a large multinational manufacturer's international product application and category expansion.

  • Systematic Literature Review

  • Assessment of evidence against the country's regulatory requirements and standards

  • Authored Final Report of findings

06

Other Wins

Within the U.S., and around the world, ARAC supports small independents. Contract research organizations and multinational manufacturers bring an array of products to the market in compliance with regional, national, and international regulation. Our unwavering commitment to scientific rigor allows ARAC to keep consumer behavior at the center of decision-making, wherever you are commissioning.

  • Consumer research to inform product development strategy or develop evidence for a regulatory submission

  • Regulator-mandated studies in support of a marketing application

  • The design of a post-market surveillance strategy or study.


Within the U.S., and around the world, ARAC supports small independents. Contract research organizations and multinational manufacturers bring an array of products to the market in compliance with regional, national, and international regulation. Our unwavering commitment to scientific rigor allows ARAC to keep consumer behavior at the center of decision-making, wherever you are commissioning.

  • Consumer research to inform product development strategy or develop evidence for a regulatory submission

  • Regulator-mandated studies in support of a marketing application

  • The design of a post-market surveillance strategy or study.

Principal Investigator for TPPI - Verve PMTA Authorization

07

ARAC’s Chief Research Officer, Dr Jessica Zdinak led the Tobacco Product Perceptions & Intentions (TPPI) study behind Verve's oral tobacco products, which received a marketing granted order (MGO) from the FDA in 2021.

TPPI

Oral Tobacco

PMTA MGO

Stay current on the regulatory science landscape — from FDA developments and industry news to event updates and insights from the ARAC team.

Stay current on the regulatory science landscape — from FDA developments and industry news to event updates and insights from the ARAC team.

FDA TPSAC Experience

ARAC's Chief Research Officer, Dr. Jessica Zdinak, supported the Altria Regulatory Science team in preparing extensive scientific evidence and documentation to present at FDA TPSAC meeting for Copenhagen Fine-Cut MST, which ultimately received Modified Risk Granted Order from the FDA.

ARAC's Chief Research Officer, Dr. Jessica Zdinak, supported the Altria Regulatory Science team in preparing extensive scientific evidence and documentation to present at FDA TPSAC meeting for Copenhagen Fine-Cut MST, which ultimately received Modified Risk Granted Order from the FDA.

08

MRTPA

TPSAC

Behavioral Science