676 F.2d 338 (8th Cir. 1982), 81-1291, International Nutrition, Inc. v. United States Dept. of Health and Human Services

Docket Nº:81-1291.
Citation:676 F.2d 338
Party Name:INTERNATIONAL NUTRITION, INC., Petitioner, v. UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; Richard S. Schweiker, Secretary of the Department of Health and Human Services; Food and Drug Administration; Mark Novitch, Acting Commissioner of Food and Drugs; Joseph P. Hile, Associate Commissioner for Regulatory Affairs, Respondents.
Case Date:April 28, 1982
Court:United States Courts of Appeals, Court of Appeals for the Eighth Circuit

Page 338

676 F.2d 338 (8th Cir. 1982)

INTERNATIONAL NUTRITION, INC., Petitioner,

v.

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES;

Richard S. Schweiker, Secretary of the Department of Health

and Human Services; Food and Drug Administration; Mark

Novitch, Acting Commissioner of Food and Drugs; Joseph P.

Hile, Associate Commissioner for Regulatory Affairs, Respondents.

No. 81-1291.

United States Court of Appeals, Eighth Circuit

April 28, 1982

Submitted Oct. 16, 1981.

Page 339

William F. Baxter, Asst. Atty. Gen., Robert B. Nicholson, Mark C. Del Bianco, Dept. of Justice, Washington, D. C., for U. S. Dept. of Justice; Richard E. Geyer, Associate Chief Counsel for Veterinary Medicine, Elizabeth M. April, Asst. Chief Counsel for Veterinary Medicine Food and Drug Administration, Rockville, Md., of counsel.

Robert H. Becker, Kinsey S. Reagan, Kleinfeld, Kaplan & Becker, Washington, D. C., D. Jeff. Lance, Armstrong, Teasdale, Kramer & Vaughan, St. Louis, Mo., for Intern. Nutrition, Inc.

Before LAY, Chief Judge, McMILLIAN, Circuit Judge, and HUNTER, [*] Senior District Judge.

McMILLIAN, Circuit Judge.

International Nutrition, Inc. (International) appeals from an order of the Commissioner of Food and Drugs denying International's request for approval of Pig Ration Ban-250, a medicated animal feed. The Commissioner denied his approval because International had failed to follow proper agency procedure in seeking approval for the feed, which it produces. International appeals the Commissioner's decision arguing that (1) the safety and effectiveness of its feed is established and undisputed; (2) the Federal Food, Drug and Cosmetic Act provides for reference to more than one regulation in seeking approval for the use of more than one animal drug in animal feed; (3) the Food and Drug Administration's (FDA) interpretation of the relevant statute is contrary to the statute's purpose; and (4) this court should grant the requested approval rather than remand the case to the FDA. For the reasons set forth below, we affirm the decision of the Commissioner.

The Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 301 et seq., sets out a two-step process for approving medicated animal feeds. The first step involves obtaining approval of a generally unrecognized or "new animal drug" or pre-mix. 1 The FDA decides whether to approve the new drug or pre-mix based upon a review of the New Animal Drug Application which is required to be filed under 21 U.S.C. § 360b(b). The application must contain data showing the safety and effectiveness of the new drug or pre-mix. The new drug or pre-mix can neither be manufactured nor marketed in interstate commerce without this approval. The new drug or pre-mix cannot be added to the feed then manufactured and marketed in interstate commerce in the absence of approval. The publication

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by the FDA of the regulation is "proof" of the safety and effectiveness of the new drug or pre-mix for use in medicated animal feeds.

The second step involves obtaining approval of the feed containing the new drug or pre-mix. The animal feed may not be manufactured or marketed in interstate commerce until the feed mixer 2 applies for and receives approval to do so from the FDA under 21 U.S.C. § 360b(m)(1). An application submitted under § 360b(m)(1) must contain "an identification of the regulation or regulations (relating to the new animal drug or drugs to be used in such feed), published pursuant to subsection (i) of this section, on which he relies as a basis for approval of his application ...." § 360b(m)(1)(B).

After the application is filed, the FDA must either approve it or give the applicant notice of opportunity for a hearing regarding the denial within ninety days. 21 U.S.C. § 360b(m)(2).

In June 1976, International filed an application under § 360b(m)(1) for pre-marketing approval of its animal feed, Pig Ration Ban-250. The feed contains two drugs-Aureo SP-250 and Banminth. The former protects swine against worm infestation; the latter improves their weight gain and feed efficiency, and fights bacterial diseases. International seeks to manufacture and market swine feed containing the combination, arguing that it is more convenient for swine producers to use a feed containing both drugs rather than choose between feeds containing one drug or the other. Each of the drugs has been approved separately by the FDA for use in swine feed under § 360b(b). Regulations embodying the approval were published by the FDA according to statutory procedure.

In its application International referred to the two regulations approving each drug as, it argues, is possible under § 360b(m)(1)(B). International included with its application information to show that the combination of Aureo SP-250 and Banminth is safe and effective.

In July 1976, the FDA returned International's application, stating that there was no published regulation approving the combination of the two drugs which could support International's application. In November 1976, International resubmitted its application, supplementing it with extended arguments for approval based on the two regulations.

The FDA's Director of Veterinary Medicine gave notice that he proposed to deny the application because no regulation was in effect which would provide a basis for approving the use of the drugs in...

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