This section contains the nature of the case and procedural background.

The Delaney Clause of the Color Additive Amendments provided that a color additive was to be deemed unsafe if that additive was found to induce cancer in man or animal. The FDA found that Orange No. 17 and Red No. 19 induce cancer when tested in laboratory animals. The issue, in this case, was whether the FDA could allow an exemption from the literal language of the Delaney Clause for trivial or de minimis risks.

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