Week of May 19 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• FDA and CBP Seize Nearly $34 Million Worth of Illegal E-Cigarettes During Joint Operation - FDA

The U.S. Food and Drug Administration (FDA) today announced the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million. The seizures, which occurred in February of this year in collaboration with U.S. Customs and Border Protection (CBP), were part of a joint federal operation to examine incoming shipments and prevent illegal e-cigarettes from entering the country.

These seizures are another example of coordinated compliance and enforcement actions across federal agencies to curb the distribution and sale of illegal e-cigarettes. In the lead up to this operation, the joint FDA and CBP team identified potentially violative incoming shipments and completed other investigative work. The team was also able to successfully implement several new internal efficiencies and procedures building off previous operations.

• FDA Names Acting Leaders for Inspections, Tobacco Regulation - Bloomberg

US Food and Drug Administration Commissioner Marty Makary named agency veterans to lead tobacco regulation and inspections, two high-profile areas, according to documents seen by Bloomberg.

Elizabeth Miller will serve as the acting associate commissioner for the Office of Inspections and Investigations, and Bret Koplow will be acting director of the Center for Tobacco Products, according to emailed announcements of the appointments. The agency is facing pressure to crack down on illicit e-cigarettes and working to change how it approaches foreign inspections.

Miller has worked at the FDA overseeing inspections of medical products and in the agency’s tobacco division since 2020. She did a prior stint at the agency from 2007 to 2016, according to her LinkedIn profile. Koplow has worked for the agency in various roles since 2011.