OBJECTIVES: US Food & Drug Administration Center for Tobacco Products’ Premarket Tobacco Product Applications (FDA CTP PMTA) require assessment of the public health impact of New Tobacco Products (NTP) to gain approval via Marketing Granted Orders. PMTA assessment should inform on individuals’ risk perception of NTP. Consumer Reported Outcome Measures (CROMs) are central in generating this evidence-base. The study objective was to evaluate risk perception CROMs for use in real-world evidence (RWE) generation in support of regulatory engagement.

METHODS: Building upon existing literature review, we investigated the development and validation of three risk perception CROMs, (i) the ABOUT – Perceived Risk instrument; (ii) the Perception and Behavioral Intentions (PBI) survey; and (iii) the brief measures of tobacco product health risk perceptions (FDA CTP instrument). We reviewed the reported conceptualization, intended population, item-level matrix, scoring structure, and psychometric performance revealed in empirical studies.

RESULTS: These CROMs assess absolute or relative risk perception, with the PBI and FDA CTP instruments capturing both. With different conceptual coverage, the reviewed CROMs measure domains such as perceived health, addiction, social, practical, and risk to others, in adult population of tobacco products users as well as non-users. Measurement properties in multiple countries/languages, using both modern and classic psychometric validation, were only evaluated for the ABOUT – Perceived Risk instrument.

CONCLUSIONS: Selecting and potentially combining risk perception CROMs for use in assessment studies require considerations of instruments characteristics, including conceptual overlap. Health communication strategies should ensure targeted, effective, non-misleading messaging to empower adults who elect to continue to use nicotine and tobacco products to make informed decision when switching to potentially reduced risk alternatives. Appropriate psychometric CROMs have the potential to capture RWE insights concerning one individual’s journey (stages, moments). Characterizing elements that promote a desired behavioral change, such as accurate risk perception, could further support tobacco harm reduction.