Amicus brief filed against tobacco companies' lawsuit challenging FDA tobacco regulation law

Today, eleven public health and consumer advocacy organizations filed a friend of the court (amicus) brief asking a federal court to reject a lawsuit by R.J. Reynolds, Lorillard and other tobacco companies that seeks to block key provisions of the new federal law regulating tobacco products. The immediate issue before the court is the industry's challenge of a provision that requires FDA approval before tobacco companies can make claims about "modified risk tobacco products."

The tobacco companies have also challenged other marketing restrictions in the Family Smoking Prevention and Tobacco Control Act, which authorizes the U.S. Food and Drug Administration (FDA) to regulate the manufacturing, marketing and sale of tobacco products.

The friend of the court brief argues that the modified risk provision of the law is narrowly tailored to satisfy First Amendment constitutional requirements and prior court rulings and is designed to end decades of false health claims that have misled millions of smokers. The brief also argues that the new law's requirements are consistent with FDA's long history of pre-approval of drug, food, and device labeling and promotion as a check against unproven and misleading health claims.

The public health groups contend that legal arguments in this case cannot be considered in isolation from the tobacco industry's long history of making deceptive health claims, especially about "light" and "low-tar" cigarettes, and the devastating consequences for public health. As the brief states, "The tobacco industry has long made unsubstantiated claims that certain tobacco products were less harmful than others. Not only were the claims proved false, but the industry long knew they were false. These unsubstantiated claims misled millions of tobacco users and were responsible for millions of preventable diseases and premature deaths."

"Based on the industry's history of misrepresentations ... Congress expressly found that the only way to effectively protect the public from the dangers of unsubstantiated reduced-risk claims is to create a system of pre-market review, to ensure that the evidence to support such claims is verifiable. On this motion for a preliminary injunction, the Tobacco Companies' First Amendment challenge fails on the basis of this lengthy history of industry deceit and the tragic public health consequences that resulted from the industry's purposely misleading marketing," the brief argues.

The brief was filed today in the United States District Court for the Western District of Kentucky, where the tobacco companies filed their lawsuit. It was filed on behalf of the Campaign for Tobacco-Free Kids, American Cancer Society, American Cancer Society Cancer Action Network, American Heart Association, American Legacy Foundation, American Lung Association, American Medical Association, American Public Health Association, Kentucky Medical Association, Oncology Nursing Society and Public Citizen.

The groups are represented by Allison M. Zieve and Gregory A. Beck of Public Citizen, Washington D.C., and Jennifer A. Moore of Grossman and Moore, Louisville, Kentucky.

The brief can be found at: http://www.tobaccofreekids.org/pressoffice/fda_amicus_092009.pdf.