FDA’s Contradictory Decisions Related to the Delaney Clause

Abstract

This paper will focus on FDA regulation under the Delaney Clause, and particularly regulations that have led to contradictory results. It first will examine the history and basic requirements of the Delaney Clause. It next will discuss cancer: statistics regarding the frequency, types, and causes of cancer. Then it will examine some foods and food additives that have been associated with some level of carcinogenicity and how FDA has handled them. It will conclude by discussing the inherent problems that the Delaney Clause presents in establishing a uniform system of regulation and, finally, by proposing some potential alternative ways in which FDA might better use its power to help the public avoid excessive exposure to carcinogenic food substances.