Color Certification Branch

FDA-certifiable color additives are batch certified by the United States Food and Drug Administration using analytical chemistry methods developed for this purpose by the FDA. The color additive regulations are described in Title 21, Parts 70 to 82, of the United States Code of Federal Regulations (21 CFR Parts 70 to 82). The batch certification process is described in 21 CFR Part 80. Current certification analytical methods are available from the Office of Cosmetics and Colors, Colors Certification Branch (HFS-107), U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740. 

With Dunlap casting the deciding vote, the Board ruled in November that, under the law, other dyes could not and should not be forbidden unless the Bureau of Chemistry (i.e. Hesse) could present evidence that the dyes in question were harmful to human health. Considering the number of dyes on the market, this was tantamount to rejecting mandatory certification. Still, the decision reached was inescapable to one concerned, as McCabe was, with the text of the law as enacted. The statute only expressly prohibited poisonous color in confectionary, and under the general adulteration clause, prohibited any added ingredient which would render a food harmful to health. This was as far as McCabe would go. The question of moral propriety was simply not relevant. It was the duty of the executive branch to enforce the law ns enacted, and not to legislate (59) ... 

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