In July 2022, the Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, released a public statement saying the agency “has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations.” As such, Commissioner Califf was “prompt[ed] . . . to take a closer look at how [FDA does] business.” To this end, Commissioner Califf commissioned external agency experts to conduct a comprehensive evaluation of the Agency’s Center for Tobacco Products (CTP), given the growing concerns from a chorus of industry and public health stakeholders about CTP’s approach to the regulation and enforcement of tobacco products. In Commissioner Califf’s statement, he noted that CTP has “greater challenges . . . ahead as we . . . navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health.”
FDA Files Civil Money Penalty Complaints Against Four Small Vape Shops for Alleged Premarket Review Violations
In response to the complaints, the companies must now either pay the penalty, enter into a settlement agreement, request an extension of time to file
