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On November 8, 1990, President Bush signed into law the Nutrition Labeling and Education Act of 1990 (NLEA). The law embodied an aggressive agenda, dictating a comprehensive overhaul of food labels. The law clarified and enhanced the Food and Drug Administration's (FDA's) authority to require nutrition labels on foods, and established circumstances under which health claims could be made about the nutritional composition or value of foods. Culminating two years of activity on Capitol Hill, the consideration and passage of the bill coincided with a major initiative at the FDA to overhaul food labeling requirements.

The provision of the NLEA that is the focus of this article received little attention during the deliberations on the bill, and in fact might be called a procedural curiosity. The provision--known as the "hammer"--was an innovative instrument used to put teeth into the NLEA's statutory deadlines. Despite its low profile, the hammer had a significant impact on the character of the rule writing process at the FDA. One plausibly could claim, a claim this article will test, that the relative speed--given the enormous nature of the task--with which the NLEA regulations were promulgated was in part attributable to the unique pressures created by the hammer.

This study of the effect of the hammer provision on the regulation writing process reveals that this procedural device had an important impact on the character of the rulemaking. The hammer helped to create a pressured environment in which the regulations were crafted. This environment operated to push the agency toward closure on key issues, and considerably strengthened the hand of an agency--with respect to those who ultimately would be subject to the rules and to those in the executive branch--that wanted to overhaul food labeling rules.


Business and the Law, Education Law, First Amendment, Health

Publication Title

Food and Drug Law Journal

Publication Citation

50 Food & Drug L.J. 149 (1995)