FDA Lacks Jurisdiction to Regulate Tobacco

By Ronald L. Scott
rscott@central.uh.edu

As predicted by Wall Street analysts, the Fourth Circuit Court of Appeals recently held that the Food and Drug Administration (FDA) lacks jurisdiction to regulate tobacco products and invalidated the FDAs August 28, 1996 regulations of tobacco products, principally aimed at restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. See Brown & Williamson Tobacco Corp. v. Food & Drug Admin., --- F.3d ----, 1998 WL 473320 (4th Cir. N.C., Aug 14, 1998).

Although the decision is disappointing from a public-health standpoint, to hold otherwise would have perpetuated the old law school adage that "hard cases make bad law." The FDAs mandate is to ensure that drugs are both safe and effective before being marketed to the public, yet in this instance the FDA not surprisingly found at the outset that tobacco products are "dangerous" and "unsafe." The FDA would certainly not approve for sale and distribution any drug that is dangerous, unsafe, and that lacks any health benefit when used as intended. However, the FDA realized that it would be untenable politically at this time to totally ban the sale and use of tobacco products, so the agency proposed a creative regulation under a statutory provision that requires conditions on sale and distribution which provide a reasonable assurance of safety. The court refused to accept the argument, noting that the FDA is unable to state any health benefit derived from leaving tobacco products on the market.

The court found the FDAs use of the Food and Drug Acts (Act) definitions overly technical and unconvincing. The FDA argued that nicotine is a "drug" which is defined in the Act as "[an] article[s]intended to affect the structure or any function of the body." The FDA asserted that cigarettes are "combination devices." A medical device is defined as "an article which is intended to affect the structure or any function of the bodyand which does not achieve its primary intended purposes through chemical action within. . . the body." Combination devices are products that contain a combination of a drug, device, or biological product. Neither party asserted that tobacco products contain any biological product.

The court below, which had upheld the FDA regulations in part, framed the issue as "whether Congress has evidenced its clear intent to withhold from FDA jurisdiction to regulate tobacco products as customarily marketed." The appellate court found that the court below had fundamentally misconstrued the issue, and restated the question as "whether Congress intended to delegate such jurisdiction to the FDA." Using traditional tools of statutory construction, the court determined that Congress had not intended to delegate such jurisdiction to the FDA. The court first considered the "plain meaning" of the statutory language defining "drugs" and "devices," and requiring that drugs be "safe and effective" before FDA approval could be granted. The court also noted that from 1914 until the 1996 rulemaking attempt, the FDA had consistently stated that tobacco products were outside the scope of its jurisdiction. Also, neither the Act nor its legislative history mentions tobacco. Finally, in a footnote, the court noted with irony that two of the main supporters of the Act were representatives from Kentucky and North Carolina, the two leading tobacco states, and that such representatives would have likely expressed opposition to the Act if there had been any indication that the Act might apply to tobacco products. In 1964, Congress specifically considered (and rejected) expansion of the Act to cover tobacco products by creating a new category of products subject to FDA jurisdiction. The court also noted that Congress has enacted legislation addressing many of the activities the FDA sought to regulate, including the Cigarette Labeling Act, the Smokeless Tobacco Act, and provisions in the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992 that provide financial incentives to states that enact and enforce access restrictions for individuals under age 18.

Nonetheless, the FDAs rulemaking attempt could still serve a useful purpose in advancing the debate about whether additional or different regulations are needed and perhaps even serve as a model for new limited tobacco legislation. As the court noted, this case is not about such substantive issues, but is rather about "who has the power to make this type of major policy decision." The proposed regulations were principally aimed at restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. Although Congress has recently rejected major tobacco legislation, the primary stated grounds for objection has been an unwillingness to raise taxes. Opponents of tobacco legislation might find it more politically difficult to oppose legislative enactment of more limited controls as contained in the FDAs proposed regulations. Further, the proposed FDA regulations benefit from their exposure to the rulemaking process, i.e., publication and public comment, which could further and narrow the public debate.

08/19/98