Earlier this month, a federal court in the District of Columbia allowed a lawsuit, filed by Lorillard Tobacco and R.J. Reynolds and challenging the composition of FDA’s Tobacco Products Scientific Advisory Committee (TPSAC), to proceed.

TPSAC advises FDA on issues relating to its regulation of tobacco products.  It is composed of twelve members knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products.  TPSAC is specifically responsible for advising FDA about:  (1) the use of menthol in cigarettes, (2) the impact of dissolvable tobacco products, (3) modified risk applications, and (4) FDA’s list of harmful and potentially harmful tobacco constituents.

The plaintiffs in the litigation have challenged TPSAC’s composition on the principal ground that certain TPSAC members have financial conflicts of interest by virtue of their expert testimony in tobacco litigation and their financial relationships with pharmaceutical companies that make smoking-cessation products.

FDA sought to have the lawsuit dismissed, claiming that the plaintiffs lack standing to sue and that enforcement of conflict of interest requirements is not subject to judicial review.  In essence, FDA claimed that the plaintiffs had no right to challenge that the tobacco industry’s regulators may be tainted by bias.

The federal court rejected FDA’s attempt to have the lawsuit dismissed, which means that the plaintiffs will now have the opportunity to prove their claim that TPSAC is tainted by an unlawful bias.  If the plaintiffs prevail, it could call into question all of TPSAC’s work, most notably on issues pertaining to the use of menthol in cigarettes and FDA’s list of harmful constituents.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.