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FDA Tobacco Litigation Tracker

The process of regulating the tobacco industry has not been an easy one.  When the U.S. Food and Drug Administration first attempted to regulate tobacco products in the 1990s, a legal challenge from the industry resulted in 5-4 U.S. Supreme Court decision overturning the FDA’s assertion of regulatory authority absent a direct grant of such authority by Congress.  With the Family Smoking Prevention and Tobacco Control Act of  2009, FDA now has the requisite authority to regulate tobacco products.  However, each effort to meaningfully regulate the tobacco industry by FDA is met by a legal challenge.

Here we will track and monitor litigation bearing on the FDA’s regulation of tobacco products.

Updated July 13, 2016

1. Lorillard Inc., v. United States Food and Drug Administration – While the FDA’s Tobacco Products Scientific Advisory Committee was developing its report on the public health impact of mentholated cigarettes in 2011, Lorillard, the menthol market leader sued the FDA primarily on the basis that some Committee members had potential conflicts of interest that barred their participation under federal law.  The members challenged were among the more prolific scholars of peer-reviewed scientific literature involving tobacco products (Neil Benowitz, Jack Henningfield, and Jon Samet, the Committee’s Chair).  This challenge may well have contributed to the agency’s decision to engage in a time-consuming discretionary second scientific review. On July 21, 2014, Judge Richard Leon granted Lorillard’s Motion for Summary Judgment to bar the Committee’s menthol report from consideration and orders the agency to reconstitute the Committee. The U.S. Court of Appeals for the DC Circuit reversed Judge Leon for lack of jurisdiction and permitted the FDA to use the report on mentholated cigarettes issued by its Tobacco Products Scientific Advisory Committee.

2. R.J. Reynolds Tobacco Co. v. Food & Drug Admin. – This case successfully challenged the specific graphic warnings that the FDA had approved for use on cigarette packaging and advertisements.  Graphic warnings are required under the Family Smoking Prevention and Tobacco Control Act and the process of selecting effective warnings that do not present fatal First Amendment issues lies ahead for FDA.

3.  Disc. Tobacco City & Lottery, Inc. v. United States –  FDA’s authority was broadly attacked less than three months after President Obama signed the Family Smoking Prevention and Tobacco Control Act (“FSPTCA”) into law.  This lawsuit challenged several provisions of the law.  While a federal district court in Kentucky issued a mostly-favorable decision for the agency which was upheld on appeal, this was just the first of several obstacles placed in the path of regulatory progress by the industry.

4.   Sottera, Inc. v. Food & Drug Admin. – This e-cigarette  (electronic cigarette) case was brought by an e-cigarette company when the FDA stopped the importation of these products under the Food Drug and Cosmetics Act.  Ultimately, the FDA was required to regulate these products primarily through its Center for Tobacco Products rather than its general authority over drugs and drug delivery devices.

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