CHAPTER: Food and Drug Administration *: THE DELANEY CLAUSE: STILL NO "DE MINIMIS" EXCEPTION. Skip over navigation
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Copyright (c) 1989 The George Washington Law Review
The George Washington Law Review


* This Chapter was developed by Sherry Booth Mastrostefano.

MAY, 1989

57 Geo. Wash. L. Rev. 1306


The Food and Drug Administration (FDA), a subdivision of the Department of Health and Human Services (HHS), enforces the Food, Drug & Cosmetic Act (FDCA). 1 The FDCA provides guidelines for regulating adulterated and misbranded foods and drugs. The FDA has authority to regulate dangerous foods, drugs, cosmetics, food additives, color additives, and animal drugs pursuant to general safety provisions that are contained in each respective section of the FDCA. 2 FDA policy usually provides that in order for a substance to be safe under the general safety clauses, it cannot pose greater than a one-in-a-million lifetime chance of harming an individual. 3 The food and color additive provisions and the animal drug provisions also contain a Delaney Clause, 4 requiring that food and color additives and animal drugs be tested and banned if they are found to be carcinogenic. 5 Thus, food and color additives and animal drugs are measured against the general safety provisions and Delaney Clauses of their respective sections.

The Delaney Clause is a strict legislative pronouncement -- if a substance is found to be carcinogenic, the substance must be prohibited. 6 Congress enacted the Delaney Clause in response to widespread public fear of cancer. 7 Since the enactment of the Delaney Clause, however, advances in technology have provided the capability to detect even the minutest traces of carcinogens that many believe do not pose a significant risk to the public. 8 If the Delaney Clause is applied ...
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