Electronic Nicotine Delivery System Toxicological Studies

The Food and Drug Administration is seeking to procure toxicological studies for Electronic Nicotine Delivery Systems (ENDS) through a sole-source contract focused on completing data analysis, interim reports, and final reports for previously initiated e-cigarette studies. The agency requires comprehensive evaluation of long-term toxicological effects of e-cigarettes in rodents, specifically involving repeated dose inhalation studies of ENDS aerosols in Sprague Dawley rats to understand potential health risks associated with e-cigarette use. This research supports the FDA's regulatory mission by providing scientific data for premarket tobacco product applications (PMTAs) and informing tobacco product regulations to protect public health. The contract will be awarded as a sole-source procurement due to the unique qualifications of the selected contractor, who has already conducted the initial in-life experiments, making it impractical and scientifically compromised to change contractors mid-study. The solicitation response deadline was September 30, 2025, following a pre-solicitation notice posted on July 18, 2025, with no competitive responses received.

This procurement carries no set-aside designation and will be awarded to Lovelace Biomedical Research Institute as the sole-source contractor, building upon their previous work under contract 75F40119C10161. The contract value is established at $7,080,013.25 as a firm-fixed-price arrangement, representing a significant investment in continuing research that has already cost over $25 million in initial experiments. The performance period spans two years from September 30, 2025, to September 29, 2027, allowing sufficient time for comprehensive data analysis and report generation. The work will be performed in the United States under NAICS code 541380 for Testing Laboratories and Services, with the research aimed at finalizing studies that evaluate the toxicological profile of electronic cigarettes. The FDA justified the sole-source approach by emphasizing that repeating the experiments with a different contractor would compromise scientific integrity, waste taxpayer resources, and potentially undermine peer review standards for this critical public health research.