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Certified Color Mfrs. Ass'n v. Mathews

Citation: 6 ELR 20629
No. No. 76-1120, 543 F.2d 284/(D.C. Cir., 07/06/1976)

The court of appeals affirms the district court's dismissal of this challenge to the Food and Drug Administration's termination of provisional approval of color additive Red No. 2. Originally approved in 1910, Red No. 2 received provisional approval under the Color additive Amendments of 1960, which reversed the burden of proof of color additive safety but authorized continued provisional approval pending completion of testing. The Food and Drug Administration (FDA) postponed the "closing date" for Red No. 2's interim approval 15 times between the initial stipulated date of early 1963 and early 1976. In February 1976, on the basis of Soviet studies finding Red No. 2 carcinogenic to rodents and a flawed FDA study that could not prove the color's safety, the FDA Commissioner terminated the latest postponement of its closing date and its provisional approval. The Commissioner's action was not arbitrary or capricious given the breadth of his discretion under the Federal Food, Drug and Cosmetic Act applicable provision authorizing such action whenever he judges it "necessary to protect the public health." This language sets a broader standard than, e.g., the hazard terminology of the Federal Inseciticide, Fungicide and Rodenticide Act's suspension provision. Moreover, "[c]ourts have traditionally recognized a special judicial interest in protecting the public health, particularly where the matter involved is as sensitive and fright-laden as cancer." The court also points out that plaintiffs will have another round of judicial review since the FDA has terminated industry's long-pending petition for permanent approval of Red No. 2. There is no merit to the claim that the Administrative Procedure Act required the FDA to give plaintiffs an opportunity for notice and comment prior to the Commissioner's summary terminations at issue.

Counsel for Plaintiffs
William E. Appler
Daniel R. Thompson
Bonner, Thompson, Kaplan & O'Connell
900 17th St., NW
Washington DC 20006
(202) 659-4660

Counsel for Defendants
Charles R. McConachie, Acting Chief
Consumer Affairs Section
Richard A. Merrill, Chief Counsel
Donald Beers
Food and Drug Administration (GCF-1)
5600 Fishers Lane
Rockville MD 20852
(301) 443-1186

Colin R.C. Dyer
Department of Justice
Washington DC 20530
(202) 739-4118

Counsel for Amicus Curiae Health Research Group
Anita Johnson
Larry P. Ellsworth
Health Research Group
2000 P. St., NW
Washington DC 20036
(202) 872-0320

Before: LEVENTHAL, ROBINSON and WILKEY, Circuit Judges.