ELR Citation: ELR 20158
No(s). 72-1864 (D.C. Cir. Jan 24, 1974)

In the companion case to Hess & Clark v. FDA (4 ELR 20147), the Court of Appeals for the D.C. Circuit vacates the Food and Drug Administration's withdrawal of approval from New Animal Drug Applications for DES feed premixes. Petitioners were illegally deprived of the opportunity for a hearing since FDA's prior notice did not communicate that withdrawal was contemplated and did not contain the data upon which agency relied in ordering withdrawal. The notice given was therefore inadequate to serve as a basis for summary disposition of the withdrawal question. The court points out that the FDA's action could not be grounded on the Delaney Clause which prohibits any residue of carcinogenic drugs in meat, because the tests that detected DES traces in beef liver were new procedures not yet approved by FDA regulations. The case is remanded to the agency and petitioners are declared free to market DES feed premixes pending these further proceedings.

Counsel for Petitioners
Eugene I. Lambert
Covington & Burling
888 16th Street, NW
Washington, DC 20006

Walter E. Byerley
Wayne K. Hill
Markel, Hill & Byerley
Mansey Building
Washington, DC 20004

Counsel for Respondents
See Hess & Clark v. FDA, 4 ELR 20147.