Harriet S.MeyerMD, Contributing EditorDavid H.MorseMS, Journal Review EditorRobertHoganMD, adviser for new media
In his new book, A Question of Intent, former Food and Drug Administration (FDA) Commissioner David Kessler weaves a richly detailed history of the FDA battle to assume authority over tobacco products and the drug nicotine. Beginning with his arrival at the FDA and early battles with the processed food industry over nutritional labeling, Dr Kessler shows how his regulatory agenda for the agency broke new ground.
In the case of tobacco, the FDA was responding to a series of petitions from the health community asking that the agency regulate tobacco products. In response, a small internal work group began to look at the issue and was having difficulty finding a rationale for placing tobacco products under FDA jurisdiction. In the fall of 1992, one of his staff pointed out that nicotine is a constituent of cigarettes that could be manipulated. "Cigarette manufacturers can take the nicotine out, but they leave it in. That goes to the question of intent," David Adams remarked. That insight propelled the agency to proceed with an effort that would consume Kessler, the health community, and the tobacco industry for a number of years.
Tobacco and the FDAA Question of Intent: A Great American Battle With a Deadly Industry. JAMA. 2001;285(13):1770-1771. doi:10.1001/jama.285.13.1770