The 37 year history of the Delaney Clause

Exp Toxicol Pathol. 1996 Feb;48(2-3):183-8. doi: 10.1016/S0940-2993(96)80040-6.

Abstract

The Delaney Clause has been part of the US Food, Drug and Cosmetic laws since it was enacted by the Congress in 1958. It states that no cancer-causing agent, as demonstrated in humans or animals, shall be deliberately added to, or found as a contaminant in food. The FDA was charged with enforcing this Clause. Other agencies such as EPA used similar approaches with the avowed aim to prevent cancer. Legal cases have been brought against Agencies who failed to comply with this law to the letter. Since 1958, research has elucidated the main mechanisms whereby chemicals cause cancer. The leading causative factors of the major human cancers are basically known, and include smoking and tobacco use, excessive alcohol, and common dietary practices and nutritional traditions. The etiology of lymphomas, leukemias and cervical cancer may be viruses. The Delaney Clause was designed to protect against these many cancer types. It was based on the hypothesis held in the 1950s that human cancers are due to environmental chemicals. This is clearly not true for the great majority of cancers and therefore, the Delaney Clause as framed has not saved any lives, is obsolete, and should be eliminated.

Publication types

  • Historical Article
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • Animals
  • Carcinogens / history*
  • Food Technology / history*
  • Food Technology / legislation & jurisprudence*
  • History, 20th Century
  • Humans
  • Neoplasms / chemically induced
  • Neoplasms, Experimental / chemically induced
  • United States
  • United States Food and Drug Administration / history
  • United States Food and Drug Administration / legislation & jurisprudence

Substances

  • Carcinogens