- The Washington Times - Sunday, March 26, 2000

The law cherishes the reliance upon reasonable expectations. The Food and Drug Administration and Congress acted and spoke for more than 50 years on the assumption the regulation of tobacco products was outside the agency's jurisdiction. Then in 1996, like Paul on the road to Damascus, the FDA received an epiphany to the contrary, but more likely from the White House than from the heavens.

Under its newly minted interpretation of the Food, Drug and Cosmetic Act, the agency insisted nicotine is an unsafe and dangerous "drug" and that cigarettes and smokeless tobacco are "drug delivery devices" within its domain. Accordingly, the FDA by rule fastened a marketing albatross on the tobacco industry calculated to slash the incidence of smoking among youths.

Last Tuesday, the U.S. Supreme Court arrested the agency's double-cross by a razor-thin 5-4 margin in FDA vs. Brown & Williamson Tobacco Corp. (March 21, 2000), speaking through Justice Sandra Day O'Connor. What was at stake was less the future of the tobacco industry in the United States (that seems bleak at best) than the honoring of customary rules of discourse between Congress and executive agencies aimed at protecting both congressional prerogatives and the reasonable investment expectations of private industry.

The FDCA empowers the FDA to regulate both "drugs" and "devices." The former is defined to include non-food articles "intended to affect the structure or any function of the body," and the latter to include any drug delivery contrivance. Undisputed was the fact nicotine carries significant and well-known pharmacological effects: It exerts psychoactive, or mood-altering, effects on the brain that foster addiction and it tranquilizes, stimulates and controls weight. Further uncontested was the fact that cigarettes and smokeless tobacco deliver nicotine to the body. Read in isolation, the FDCA definitions made a strong case for the agency's claimed jurisdiction.

But provisions of regulatory charters are presumptively intended to live more as a harmonious extended family than like the clashing Montagues and Capulets on the streets of Verona. If the FDA's annexation of tobacco products to its domain was authorized, the FDCA would require an absolute ban on the sale of cigarettes, not simply marketing restrictions, raising the specter of a second but unimproved edition of Prohibition. The law explicitly directs the agency to purge from the marketplace any drug or device that is unsafe or dangerous to health when used as intended and without offsetting therapeutic benefits.

Under that standard, cigarettes are guilty beyond a reasonable doubt. The FDA found that "[m]ore than 400,000 people die each year from tobacco-related illnesses, such as cancer, respiratory illnesses, and heart disease," and that "[t]obacco alone kills more people each year in the United States than … AIDS, car accidents, alcohol, homicides, illegal drugs, suicides, and fires combined." And the consumption of tobacco products is not therapeutic.

Thus, then FDA Commissioner Charles Edwards in 1964 informed Congress that an extension of agency jurisdiction to reach cigarettes would compel their exclusion from the market. Congress, however, has all but expressly withheld that jurisdictional gambit.

On six occasions since 1965 and amidst commonplace knowledge of the health hazards of tobacco products, Congress has embraced a non-FDA regulatory scheme confined to advertising, labeling and health warnings to consumers, and erected a no-trespass regulatory sign for all would-be agency poachers. It rejected several bills to crown the FDA as a tobacco czar. As prologue to these actions, the surgeon general told Congress in 1964 that the FDA lacked authority under existing laws to control tobacco advertising. Like the lesson King Canute administered his flatterers when he sat on the seashore and forbade the tide to come in, that modesty was exhibited again the following year, when FDA Deputy Commissioner Winton Rankin testified that "[t]he Food and Drug Administration has no jurisdiction under the Food, Drug and Cosmetic Act over tobacco, unless it bears drug claims." Indeed, that was the consistent refrain of the agency for decades through both Democrat and Republican administrations until the volte-face under President William Jefferson Clinton, an addict to the idea that consistency is the hobgoblin of small minds.

Also telling was the atypically swift action of Congress to overturn a lower court decision in 1975 ordering the Consumer Product Safety Commission to exercise jurisdiction over cigarettes under the Hazardous Substances Act. Congress adopted legislation unambiguously eliminating such authority, and an accompanying Senate Report explained its purpose was to "unmistakably reaffirm the clear mandate of Congress that the basic regulation of tobacco and tobacco products is governed by the legislation dealing with the subject, … and that any further regulation in this sensitive and complex area must be reserved for specific congressional action."

Canons of construction characteristically sport equal and opposite canons. One teaches that agency interpretations of charter statutes should generally be respected out of an assumed expertise. Another preaches against novel interpretations with revolutionary regulatory implications that would flabbergast Congress and crush an immense industry reasonably believed legal. Wasn't the latter decisively more convincing in Brown & Williamson?



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