Volume 1

The tobacco industry and the health risks of smoking : second report / Health Committee.

  • Great Britain. Parliament. House of Commons. Health Committee.
Date:
2000
Catalogue details

Licence: Open Government Licence

Credit: The tobacco industry and the health risks of smoking : second report / Health Committee. Source: Wellcome Collection.

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    30. Normally the FDA regulated drugs which manufacturers wanted to put on the market, that is to say manufacturers themselves sought regulation. The cigarette companies, however, strenuously resisted regulation and mounted a legal challenge to the FDA. Provision existed in statute to allow the FDA to take into account the intent of the manufacturer (so that the FDA merely needed to prove that the cigarette companies intended to deliver a “pharmacologic effect” for it to claim jurisdiction over tobacco products).°? The FDA felt that this evidence was not clear in 1994 so they mounted a lengthy investigation into the use of nicotine in tobacco products. Following this investigation the FDA concluded that cigarettes “were delivery devices for the drug nicotine”.~* 31. During their investigations the FDA learnt precisely how the US cigarette companies had blended tobacco products. One company’s handbook on leaf blending was anonymously submitted and from that the agency “learned that tobacco companies used chemical additives to affect the delivery of nicotine”.** The actual blending allowed the companies to achieve fine tuning over the levels of the nicotine delivered. The former director of applied research at Philip Morris told the agency that “product developers and blend and leaf specialists at Philip Morris were responsible for manipulating and controlling the design and production of cigarettes in order to satisfy the customer’s need for nicotine”.* 32. The Supreme Court rejected the FDA’s case on 21 March 2000. It determined that the statute setting up the FDA, the Food Drugs and Cosmetic Act, excluded tobacco which Congress had sought to control by means of other measures.”° 33. We believe that the publication of the recent RCP report Nicotine Addiction in Britain should have as much impact on the public health debate on smoking as the seminal studies relating to lung cancer and heart disease of the 1950s and early 1960s. The RCP reviewed an enormous amount diagnostic criteria for addiction, a point we pursued with the companies. They listed the two most widely recognized diagnostic criteria for substance dependence - the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria and the World Health Organization International Classification of Diseases ICD-10 criteria: Summary of Diagnostic and Statistical Manual of Mental Disorders, DSM-IV and International Classification of Diseases ICD-10 criteria for substance dependence.” DSM-IV ICD-10 At least 3 of: A cluster of behavioural cognitive and physiological phenomena that develop after repeated substance use and that typically include: Substance often taken in larger amounts or A strong desire to take the drug over a longer period than intended Persistent desire or unsuccessful efforts to cut Difficulty controlling use down or ‘control use A great deal of time spent in activities necessary to obtain the substance, use the substance or recover from its effects Important social, occupational or recreational A higher priority given to drug use than to other activities given up or reduced because of activities and obligations substance abuse *? David A Kessler et al., “The Food and Drug Administration’s Regulation of Tobacco Products”, The New England Journal of Medicine, 1996:335, p.988. 3 ibid., p.991. 4 ibid., p.990. f °° ibid., p.990. © The Times, 22.3.00. The text of the judgment can be found at www.cornell.edu/supct. Nicotine Addiction in Britain, p.85.