Thesis Abstract

In August of 1996, the Food and Drug Administration (FDA) concluded, after a two-year investigation, that the nicotine found in tobacco products was a drug, and tobacco products were drug delivery devices according to the Food, Drug, and Cosmetic Act of 1938 (FDCA). Consequently, the Agency placed a regulatory ruling on the tobacco industry for the first time in the FDA’s eighty-year existence. Following this regulatory action to control the marketing and sale of manufactured tobacco, R.J. Reynolds Tobacco Corporation and several other industry goliaths filed a lawsuit in the Middle District of North Carolina claiming the FDA had overstepped their authority. Contrary to the predictions of Big Tobacco, this court upheld most of the FDA’s conclusions, only reversing the portion associated with tobacco advertising. In a 2-1 decision, this judgment was reversed in the court of appeals of the Fourth Circuit. The Supreme Court of the United States granted the Agency’s writ of certiorari and, in a close 5-4 verdict, ruled in favor of the tobacco corporations. It is the position of this discussion that the reasoning of the court of appeals in the Fourth Circuit as well as that of the Supreme Court was inherently flawed and skewed by a fear of the political and economic influence held by Big Tobacco. The Food and Drug Administration has every legal, rational, and moral entitlement to regulate the tobacco industry consistent with the FDCA, the interest of public health, and the mandate of Congress.