Judge Richard Leon, who has consistently ruled against the FDA on everything related to tobacco, is at it again, ruling that the FDA Tobacco Products Scientific Advisory Committee is flawed. (Why does every tobacco case on the FDA end up in front of the same hostile judge?)



The opinion basically concludes that because the challenged members acted as consultants to companies selling cessation products (or in the case of Henningfield an ownership interest in a cessation product), they would have a conflict because banning Menthol might generate consulting fees. The judge also concludes that the challenged members would have a conflict because they would want to protect their past expert testimony on tobacco (and in one case menthol) issues and would want plaintiff lawyers to hire them in the future.



This is truly amazing to disqualify scientists for something they might do in the future. Perhaps Judge Leon has a time machine to observe the future.



You can read Judge Leon's ruling at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2011cv0440-82



TFK put out the following statement, which I completely agree with:



Court Ruling on FDA’s Tobacco Advisory Committee Is Misguided and Must Be Appealed



FDA Should Move Forward in Banning Menthol Cigarettes Based on Conclusions of Its Own Independent Review



Statement of Matthew L. Myers

President, Campaign for Tobacco-Free Kids



WASHINGTON, DC – The Justice Department should immediately appeal today’s misguided ruling by a federal judge that concluded three members of the FDA’s Tobacco Products Scientific Advisory Committee (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.



This ruling by U.S. District Court Judge Richard Leon would 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 three 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.



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’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 clearly 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. The companies, which stand to gain the most from selling more menthol cigarettes, are once again putting their profits ahead of lives and health.



Today’s decision should not slow FDA’s progress in addressing the problem of menthol cigarettes. FDA’s own independent review found that menthol cigarettes lead to 1) increased smoking initiation among youth and young adults; 2) greater addiction; and 3) decreased success in quitting smoking. “These findings, combined with the evidence indicating that menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes,” the FDA’s report concluded



The FDA has an obligation to act on this scientific evidence and ban menthol cigarettes in the U.S. The FDA’s own report provides more than adequate scientific evidence for the FDA to take immediate action.



Vince Willmore

Vice President, Communications

Campaign for Tobacco-Free Kids

1400 I Street NW, Suite 1200

Washington, DC 20005

PH: 202-296-5469

FX: 202-296-5427

http://www.tobaccofreekids.org

http://global.tobaccofreekids.org



