International Nutrition, Inc. v. U.S. Dept. of Health and Human Services

• Decision Date: 28 April 1982
• Docket Number: No. 81-1291,81-1291
• Citation: 676 F.2d 338
• Parties: 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.
• Court: U.S. Court of Appeals — Eighth Circuit

Page 338

676 F.2d 338

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.

Submitted Oct. 16, 1981.

Decided April 28, 1982.

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 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 combination. International filed additional safety and effectiveness data with the FDA, and requested that the formal hearing to which it was entitled be dispensed with because no material facts were at issue. In January 1981, the FDA again refused to approve International's application because of the lack of a regulation upon which to base approval of the drug combination.

International appealed the Commissioner's decision under 21 U.S.C. §§ 360b(h) and 355(h), which provide for direct appeal to a United States Court of Appeals.

The central issue raised by International concerns the interpretation to be given § 360b(m)(1)(B), the section which provides that reference can be made to existing published regulations in an application for approval of animal feed. International argues that the plain meaning of the statute allows it to cite the two regulations which approve Aureo SP-250 and Banminth; the FDA argues that International is required to refer to one regulation which approves the combination of the two drugs.

In determining which interpretation of the statute to follow, we must consider its legislative purpose, statutory language, and the proper weight to be accorded the FDA's interpretation.

International has claimed that the FDA's interpretation of § 360b(m)(1)(B) is contrary to the purpose of the statute. The provision, as International correctly points out, is designed to avoid having feed manufacturers duplicate the drug manufacturers' experimental efforts. The feed manufacturer essentially incorporates the drug manufacturer's results and data in its application for approval for its feed under § 360b(m)(1). International argues that the purpose of § 360b(m)(1)(B) is achieved by allowing it to refer to more than one regulation because it thereby avoids duplicating drug manufacturers' efforts.

The FDA claims that International's interpretation frustrates the legislative purpose of the Act, which seeks to protect the public health. United States v. Nova Scotia Food Products Corp., 568 F.2d 240, 246 (2d Cir. 1977). The application guidelines are designed to set up appropriate and consistent procedures to safeguard against potentially dangerous substances.

An animal drug is "new" if it is...