What is the Delaney Clause in the FDCA of 1938 and What Does it Stipulate?
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3 min read
Though often mistakenly associated with the original 1938 law, the Delaney Clause was actually a 1958 amendment to the Federal Food, Drug, and Cosmetic Act (FDCA). This provision mandated that the U.S. Food and Drug Administration (FDA) prohibit the approval of any food additive if it was found to cause cancer in humans or animals. The clause became a landmark, albeit controversial, feature of American food safety regulation for decades.
