FDA Errs in Removing Highly Qualified Scientists from Tobacco Advisory Committee – Decision Is Based on Misguided Court Ruling

WASHINGTON, DC – It is deeply troubling that the FDA today removed several extraordinarily qualified members of its Tobacco Products Scientific Advisory Committee (TPSAC) based on a misguided and overreaching court ruling that is under appeal. The FDA’s action demonstrates that the court decision and FDA’s overly cautious interpretation of that decision will deprive the agency of advice from many of the nation’s foremost and most credible scientific experts and undermine the FDA’s ability to do its job. It is essential that the FDA both aggressively pursue its appeal of the court decision in question and, in the interim, apply that ruling in a way that does not impair its tobacco advisory committee.

In July 2014, U.S. District Court Judge Richard Leon ruled that three members of TPSAC had conflicts of interest – or just the appearance of conflicts of interest – and barred the FDA from using a March 2011 report on menthol cigarettes issued by the committee. If allowed to stand, this ruling will not only deprive the tobacco advisory committee of the best scientific minds available, but could also impact the FDA’s broader ability to carry out its mission and protect public health. The scientists named in the lawsuit are individuals of unquestioned integrity, and the tobacco advisory committee has operated in a transparent, open manner consistent with all U.S. laws (two of the scientists mentioned in the lawsuit have previously left TPSAC).

The FDA’s advisory committee was constituted and acted in accordance with the 2009 law that granted the FDA authority over tobacco products, as well as other relevant federal laws. Judge Leon’s ruling is inconsistent with these laws and would deprive the FDA of critical advice from the nation’s foremost experts in reducing tobacco use. In fact, that is precisely the goal of the Lorillard and R.J. Reynolds tobacco companies, which filed this lawsuit

Even as this ruling is appealed, the FDA can and should move forward to ban the sale of menthol cigarettes based on the conclusions of its own, independent scientific review of the public health impact of menthol cigarettes. The FDA’s report, issued in July 2013, concluded that menthol cigarettes pose a greater public health risk than regular cigarettes because they lead to increased youth initiation. The FDA does not need TPSAC’s report to take action on menthol, but it is important to note that TPSAC’s report was prepared with great integrity and is a sound scientific document. The FDA has an obligation to act on this scientific evidence and ban menthol cigarettes in the U.S.