Rachael Schmidt
Senior Consultant
ALINC

Rachael Trimpert Schmidt (retired CAPT, USPHS) brings over a decade of experience in regulatory and compliance solutions within the tobacco and nicotine industry. With a distinguished tenure at the FDA, serving as the Assistant Director of Laboratory Compliance & Coordination of the CTP, she spearheaded crucial initiatives to enforce the FSPTCA of 2009.

During her tenure at FDA, CAPT Schmidt played a pivotal role in establishing and coordinating FDA tobacco regulatory laboratories, ensuring rigorous adherence to regulatory standards. Her leadership was instrumental in developing and executing comprehensive tobacco product testing programs, encompassing pre-market application reviews, post-market compliance assessments, adverse event evaluations, and the development of tobacco product standards. Schmidt's expertise extends to fostering collaboration with national and international stakeholders to harmonize tobacco enforcement and policy efforts.

Sessions with Rachael Schmidt

Panel
VA, United States, 22202
Smoke-Free Product Standards
11:50 - 12:50
Baseline product standards, which could take the form of voluntary consensus standards, could streamline the pathway to market for potentially reduced risk products for adults who smoke. FDA uses product standards in its regulation of pharmaceuticals and food, but they have not yet been established for regulating e-cigarettes and other non-combustible nicotine products. Could the establishment of product standards based upon the available scientific, clinical, and public health research provide regulatory and scientific clarity, and ultimately a wide variety of authorized products? Panelists will discuss how product standards might be developed in this space, and the pros and cons of such an approach

Moderators

Speakers