Smoke and mirrors - SAMHSA - Substance Abuse and Mental Health Services Administration, antismoking regulations and FDA's David A. Kessler

National Review, Oct 9, 1995 by Peter Samuel

SAMHSA is hardly one of Washington's best-known acronym agencies. This summer, the Substance Abuse and Mental Health Services Administration was preparing to issue final regulations for a carefully designed plan to combat teenage smoking. Under Section 1926 of the Public Health Act, the Secretary of Health and Human Services (in whose bailiwick SAMHSA is located) has the power to make block grants to the states conditional on the implementation of anti-teen-smoking programs, and SAMHSA had been busy holding hearings with a view to releasing a final program this fall.

Into SAMHSA's jurisdiction jumped Food and Drug Administration czar David Kessler. As the Food & Drug Insider Report newsletter put it: "Like the schoolyard bully elbowing the littler kid aside, David Kessler has pushed his way to the front of the Clinton Administration's anti-tobacco parade." Kessler, the Insider Report notes, has an addiction to media attention, a craving for a more powerful FDA, and "undisguised opportunism." He has been publicly pitching for cigarette regulation for at least a year, and last month President Clinton finally gave him the go-ahead. The FDA simultaneously released a slew of draconian restrictions -- bans on advertising, bans on tobacco-company sponsorships, new warning notices on packages, and a $150-million propaganda campaign financed by the industry but designed and run by Dr. Kessler.

The first result of this power grab will be to jeopardize collaboration between cigarette companies and the Federal Government, of the sort that SAMHSA had developed with Philip Morris in its voluntary campaign against under-age smoking. Kessler's antics also clumsily encouraged the advertising industry to support the tobacco companies in a legal challenge to FDA jurisdiction, which is going to have the agency in the courts for several years.

Cigarettes are not "drugs" in the sense of the pharmaceutical medicines envisioned as objects of FDA regulation. The Food, Drug, and Cosmetic Act, from which the agency derives its authority, speaks of the FDA regulating "drugs [or] devices . . . intended for use in the treatment or prevention of disease in man. . . ." (21 U.S.C. 321 g). And court cases have established that FDA jurisdiction is limited to substances for which a therapeutic claim has been made.

Now, there are studies showing that smoking reduces the incidence of degenerative diseases and reduces stress and high blood pressure. But given that the tobacco companies make no therapeutic claims, selling cigarettes only as a source of pleasure, their products are under the jurisdiction of SAMHSA, not the FDA.

President Clinton knows that the appointment of Dr. Kessler as anti-smoking czar will produce political and legal fireworks, and no action. There won't be any action because of the legal challenges to FDA authority, and because Congress is unlikely to provide the money or the legislation to support it. The new Congress has already killed the 500-acre, $675-million FDA office/laboratory campus proposed for Clarksburg, Maryland, which insiders dubbed the Kessler Kastle. The FDA does not need to be encouraged to spread its mischief further afield.