Tobacco use continues to be the leading preventable cause of disease and death in the United States, claiming nearly 500,000 lives annually. In response to this public health crisis, Congress granted the Food and Drug Administration (FDA) the authority to regulate tobacco products in 2009. Over the past 15 years, the FDA has focused on preventing youth tobacco use, assisting individuals in quitting, and mitigating the harm associated with tobacco consumption.

The FDA's comprehensive strategy includes the review of new tobacco products before they can be marketed. In recent years, the agency has processed over 26 million premarket tobacco applications, marking an unprecedented level of regulatory activity. This effort underscores the FDA's commitment to addressing the significant health burdens posed by tobacco use and highlights the ongoing challenges in curbing its prevalence in society.