Addressing Cardiovascular Toxicity Risk of Electronic Nicotine Delivery Systems in the Twenty-First Century: "What...

Area of Science:

• Toxicology
• Cardiovascular Science
• Regulatory Science

Background:

• Cigarette smoking is a known risk factor for cardiovascular disease (CVD).
• Long-term cardiovascular health consequences of electronic nicotine delivery systems (ENDS) use are uncertain.
• New Approach Methodologies (NAMs) offer rapid hazard prediction, considering biological factors like sex and race/ethnicity.

Purpose of the Study:

• To evaluate current approaches for assessing ENDS cardiovascular toxicity.
• To propose systems biology strategies to bridge knowledge gaps in ENDS risk assessment.
• To inform regulatory policy for protecting public health from ENDS-related cardiovascular risks.

Main Methods:

• Review of existing methods for evaluating tobacco product cardiovascular impacts.
• Exploration of NAMs as alternatives to traditional animal testing for toxicity prediction.
• Identification of data gaps and proposal of systems biology approaches.

Main Results:

• Current methodologies for assessing ENDS cardiovascular toxicity are insufficient for regulatory decision-making.
• NAMs show promise but have limitations in predicting complex human health outcomes.
• A significant knowledge gap exists between traditional toxicological models and NAMs for ENDS.

Conclusions:

• Standardized NAMs are needed to accurately predict ENDS cardiovascular toxicity.
• Systems biology approaches can integrate data from various sources to enhance risk assessment.
• Timely regulatory action requires robust data from validated NAMs to protect public health.