Rachael Trimpert Schmidt, CAPT, USPHS (Ret.), is a former senior officer with the U.S. Food and Drug Administration’s Center for Tobacco Products and a regulatory strategy advisor with more than two decades of experience in federal public health, laboratory compliance, and tobacco product regulation. As Assistant Director for Laboratory Compliance and Coordination at FDA, she led national initiatives supporting implementation and enforcement of the Family Smoking Prevention and Tobacco Control Act.

During her tenure at FDA, CAPT Schmidt established and coordinated the agency’s tobacco regulatory laboratory framework and oversaw product testing and compliance programs. Her work spanned premarket application reviews, post-market surveillance, adverse event assessments, and the development of tobacco product standards, requiring continuous coordination across FDA centers, federal agencies, and international regulatory bodies.

Drawing on an extensive professional network developed through years of senior regulatory service, CAPT Schmidt provides strategic advisory support informed by deep institutional knowledge and real-world regulatory insight. She advises a number of organizations navigating complex, high-stakes regulatory, enforcement, and compliance challenges within the tobacco and nicotine sector.