September 2014

The Department of Justice, on behalf of the Food and Drug Administration, has filed an appeals motion in Lorillard v. FDA. In response to a report issued by the Tobacco Products Scientific Advisory Committee on the effects of menthol cigarettes, tobacco giant Lorillard sued FDA claiming that three members of TPSAC had conflicts of interested and should be barred from serving on the advisory panel.

Circuit Court Justice Leon agreed with Lorillard and found that FDA erred in allowing three tobacco control experts to serve on the FDA Tobacco Products Scientific Advisory Committee. In his decision, Justice Leon determined that FDA had failed to comply with the Federal Advisory Committee Act – federal law to ensure open and unbiased operations of federal advisory panels – by allowing three tobacco control experts to serve on the TPSAC. Justice Leon noted that three of the experts challenged by Lorillard had testified in court cases against the tobacco industry and that they had all accepted scientific funding from pharmaceutical companies that make smoking cessation products. Justice Leon ruled that all these potential conflicts, which were fully disclosed with FDA in advance of service on TPSAC, should have caused FDA disqualify these experts from serving on TPSAC.

If allowed to stand, the ruling would both prevent FDA from using the TPSAC report on menthol tobacco products for any further rule making and would set a new standard requiring scientists to be free of any industry support to be able serve on federal advisory panels.