Y1 (tobacco) - Legal Controversy

Legal Controversy

Beginning in 1990, the United States Food and Drug Administration (FDA), under Commissioner David Kessler, conducted an investigation into the tobacco industry, including charges that cigarette manufacturers intentionally manipulated nicotine levels in cigarettes to keep their customers addicted. In early 1994, B&W told the FDA that there was an agreement among US cigarette manufacturers not to manipulate nicotine levels in tobacco. However, FDA investigators discovered a Brazilian patent describing a tobacco plant with an unusually high nicotine content, which led them to B&W and Y1. In testimony before Congress on June 21, 1994, Dr. Kessler accused B&W of knowingly manipulating nicotine levels in some of its cigarettes. B&W chairman Thomas Sandefur rejected the claim, stating that "the brands that use Y1 deliver essentially the same nicotine as the products they replaced" and accusing Dr. Kessler of "grandstanding" for political purposes. Several members of Congress suggested that this proved that tobacco executives had committed perjury when they denied knowing smoking was addictive in their April 1994 testimony before Congress.

Y1 became an important piece of evidence in FDA v. Brown & Williamson Tobacco Corp., a lawsuit in which the FDA attempted to exert its authority under the Federal Food, Drug, and Cosmetic Act to regulate tobacco products. Dr. Kessler argued that because Y1 had been raised for its higher nicotine level, it was subject to FDA regulation as a pharmacological product, and therefore its importation and sale in the US without the proper FDA approval was illegal. The FDA also targeted DNA Plant Technology, charging that it had illegally smuggled the Y1 seeds out of the United States. The Justice Department charged DNA Plant Technology with one misdemeanor count of conspiracy to violate the Tobacco Seed Export law, prohibiting the export of tobacco seeds without a permit (a law which was repealed in 1991). DNA Plant Technology pled guilty in 1998 and agreed to cooperate with further investigations of B&W. However, the Supreme Court eventually ruled in March 2000 that the FDA did not have the authority to regulate tobacco as a drug.

The discovery of Y1 fueled allegations that B&W intentionally used Y1 tobacco to increase the addictiveness of its products, resulting in a number of lawsuits. The state of Minnesota heavily referred to Y1 tobacco in its 1997 trial against the American tobacco industry (State of Minnesota et al. v. Philip Morris, Inc., et al.), a trial which took place prior to the inception of the Tobacco Master Settlement Agreement in November 1998.