US SUPREME COURT DECISIONS

Under § 406(b) of the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration, in 1969, certified as "harmless and suitable for use in food" a coal tar color which has been used for many years in coloring oranges. After new tests in 1951-1953 had shown that the color had toxic effects on animals, and after public notice and hearings, the Secretary of Health, Education, and Welfare, in 1955, ordered the color removed from the certified list. Under §§ 301 and 402(c) of the Act, this had the effect of making it unlawful to ship in interstate commerce any food bearing or containing such color. The Secretary did not determine that the color was harmful for human consumption in the amounts used in coloring oranges, but only that the color itself was not "harmless and suitable for use in food" within the meaning of § 406(b), and he took the position that he had no authority to determine whether it was "required in the production" of food within the meaning of § 406(a) or to promulgate thereunder a safe tolerance for its use on oranges. In a review proceeding under § 701(f), the Court of Appeals set aside the order insofar as it removed the certification of that color as harmless and suitable for use as external coloring on oranges.

Held: the Secretary's order was lawful, and it must be sustained. Pp. 358 U. S. 160-165.

(a) In §§ 402(c) and 406(b), dealing specifically with coal tar colors, Congress carefully outlined the special treatment to be given to coal tar colors: the test of certification provided concentrates on the color substance itself; it is to be certified only if it is harmless. Pp. 358 U. S. 160-162.

(b) This special method of dealing with coal tar colors relieves the Secretary from showing in such case that a food containing chanrobles.com-red

Page 358 U. S. 154

them raises a possibility of injury to health; and it makes no requirement that the colors be tested by experimental feeding in the proportions in which they are used in specific food products. Pp. 358 U. S. 162-164.

(c) The evidence justified the Secretary's finding that the color here involved was poisonous. P. 164, n 13.

(d) In forbidding the use of coal tar colors, in foods, the Secretary is not required to restrict his prohibition to specific food uses in whish the color is shown to have a deleterious effect. Pp. 358 U. S. 164-165.

2. The Secretary is not authorized by § 406(a) to permit the use of harmful coal tar colors in specific foods through a system of tolerances, since that section does not apply to § 402(c)'s flat prohibition against the use of uncertified coal tar colors. Pp. 358 U. S. 165-176.

3. That special legislation has permitted the use of the color here involved solely in application to the skin of oranges for a temporary period ending March 1, 1959, does not render this case moot, or prevent respondents from being persons "adversely affected" by the Secretary's order within the meaning of § 701(f). Pp. 358 U. S. 167-168.

246 F.2d 850 reversed.