Playing Cat and Mouse: Contests over Regulatory Categorization of Dietary Supplements in the United States
研究了美国膳食补充剂企业如何通过策略互动,先于1976年从药品类别转入食品类别,再于1994年创建全新类别,从而推动市场爆炸性增长,揭示了监管分类是企业与监管机构之间的博弈过程。
Regulatory categorization can be a matter of life and death to firms, as it sets legal limitations on the production and sales of their product. In this paper we set out to uncover this critical process, for which there is only anecdotal information in extant literature, by asking how regulatory categories are determined through the strategies and interaction of firms, regulators, and other category audiences. We use extensive archival data to examine how U.S. dietary supplement makers first moved from the drug to the food category in 1976, and, when faced with resistance from the Food and Drug Administration, created an entirely new category in 1994, which then fueled their explosive market growth. Our findings show that regulatory categorization is a contest between firms and the regulator, where firms try to disrupt unfavorable regulation by overpowering the regulator through hard power imposed by other state actors, which is achieved through pressure from another category audience—consumers—who are themselves won over through soft power.