Califf Orders External Review of FDA Tobacco Regulation Office


The review of the Center for Tobacco Products comes after the heavily criticized handling of Premarket Tobacco Product Application (PMTA) review process and more specifically the issuing of a Marketing Denial Order (MDO)–and rescinding of that same order–for JUUL Labs [read more here]. In a separate case, the FDA’s handling of premium cigar regulation was also questioned in court in what was viewed by many as a major win for those businesses operating in the premium cigar industry [read more here]. Some member of Congress are highly critical of the FDA’s handling of e-cigarette regulation in particular, taking issue with the fact that some e-cigarette products remain on the market while the FDA continues to review their associated PMTAs.

Califf commented on the situation faced by the Center for Tobacco Products, he stated: “Challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health.”

According to reporting from Politico, it will take approximately 60 days for the Reagan-Udall Foundation to complete its initial evaluation. Califf has indicated that it will take time to implement any recommended changes but that he’s committed to addressing any issues that are identified during the process and communicating necessary changes to the public in “a timely manner.”