The Legal Authority of the United States Food and Drug Administration to Regulate Tobacco: Calling on Congress

Article excerpt

Smoking has plagued America for generations, but the issue has never received more scrutiny than in the past decade. The rise of teen smoking' and the long-term deleterious effects of nicotine addiction2 prompted a national outcry for change.3 As a result, the United States Federal Food and Drug Administration (FDA) has asserted jurisdiction over the regulation of tobacco products.4

The FDA, as one of the chief health regulatory agencies of the United States, is determined to take action to curb the nation's leading preventable killer.5 Due to the large number of adults addicted to cigarettes, however, an outright ban on tobacco would be both impractical and unrealistic.6 Therefore, acting on the findings of several major health organizations, the FDA determined the best way to curb the United States' addiction to nicotine was to stop it before it began.7 The resulting tobacco initiative included the regulation of the sale of tobacco products to minors, advertisement, and teen education cataloging the dangers of tobacco addiction.8

The FDA's controversial regulatory scheme has prompted more public comment than any other agency-proposed regulation.9 Specific legislation granting the FDA authority to regulate tobacco products, however, has not occurred.10 Thus, the final words regarding the regulation of tobacco will now emanate from Congress.11

The FDA based its jurisdiction over tobacco products on the Federal Drug and Cosmetic Act's (FDCA) definitions of "drug"12 and "device."13 This article explores the ramifications of the FDA's assertion of jurisdiction. First, it reviews why the FDA has asserted jurisdiction over such products in the past and the judicial decisions reviewing its action. Second, it provides an indepth analysis as to the Middle District of North Carolina's opinion in Coyne Beam, Inc. v. FDA,14 which allowed FDA jurisdiction, and the subsequent reversal by the Fourth Circuit in Brown & Williamson Tobacco Corp. v. FDA, which the United States Supreme Court has recently affirmed.15 It focuses on the different approaches taken by each court in interpreting whether tobacco products are a "drug" or "device" under the FDCA. This timely analysis is crucial as the case was recently decided by the United States Supreme Court.

I. BACKGROUND ON FDA TOBACCO REGULATION: THE WAFFLE EFFECT AND THE FOOD AND DRUG ADMINISTRATION'S CHANGE IN POLICY ASSERTING JURISDICTION

An indication that tobacco products posed a serious threat to human health surfaced in 1964,16 when the Surgeon General reported that smoking caused cancer in men and could also affect women in the same way.17 Congress acted swiftly in response to the report by passing the Federal Cigarette Labeling and Advertising Act in 1965, requiring warning labels on all cigarette packages.18 Soon thereafter, Congress banned cigarette advertising on television and radio.19

The Surgeon General then began issuing new, more detailed warnings,20 which prompted the Federal Trade Commission to refine their labeling criteria to specifically reflect warnings about health consequences.21 The war on smoking evolved into a fullscale attack when several states enacted indoor clean air laws,22 such as Pennsylvania's Clean Indoor Air Act,23 to combat secondhand smoking's adverse effects.

The findings concerning the dangers of smoking were so alarming that major health organizations declared war on cigarette smoking.24 The FDA entered the battle several times by asserting jurisdiction over tobacco products that promised increased health benefits associated with their use.25 For example, in United States v. 354 Bulk Cartons,26 the FDA asserted jurisdiction over cigarettes that promised appetite reduction and subsequent weight loss.27 The district court found that jurisdiction had been properly asserted where the manufacturer's promises were based upon such weight reduction.28 The manufacturer intended the cigarettes to be used for therapeutic purposes. …