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Administrative Law Keyed to Mawshaw
Public Citizen v. Young
Citation:
831 F.2d 1108 (1987)Facts
In 1986, the FDA approved Orange No. 17 and Red No. 19 for use in externally applied cosmetics. The FDA acknowledged that both dyes induced cancer when tested in laboratory animals but conducted quantitative risk assessments to determine the actual risk to humans. For Orange No. 17, the lifetime cancer risk was calculated as one in 19 billion at worst, and for Red No. 19, one in 9 million at worst. The FDA characterized these risks as “so trivial as to be effectively no risk” and concluded that the dyes were safe. The FDA acknowledged that its safety findings represented a departure from past agency practice, as a strictly literal application of the Delaney Clause would prohibit listing these dyes. However, the agency declared that it had “inherent authority” under the de minimis doctrine to list them despite the Delaney Clause’s language. In a separate case, Public Citizen challenged the FDA’s continued provisional listing of several color additives, including Red Nos. 3, 33, and 36, which were still undergoing safety testing.
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