Pineapple Growers Association of Hawaii v. Food and Drug Administration

Pineapple Growers Association of Hawaii (PGAH) petitions for review of an order of the Food and Drug Administration (FDA) overruling without hearing PGAH’s objections to certain amended regulations governing standards of identity for canned pineapple, and confirming the effective date of those regulations.

The regulations were promulgated pursuant to Section 401 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 341 . The procedures for promulgation of such regulations are set forth in 21 U.S.C. § 371 (e).

The United States is a member of the World Health Organization and of the Food and Agriculture Organization of the United Nations. The Codex Alimentarius Commission formed by those organizations adopts recommended standards for food products which member countries are then obliged to consider for adoption. See 37 Fed.Reg. 21102 (1972). In the United States this is done by FDA promulgation of regulations under § 341.

In 1973, the FDA promulgated a regulation providing that “[a]ny interested person may petition [FDA] to adopt a Codex standard ... by proposing a new standard or an appropriate amendment of an existing standard. ...” 21 C.F.R. § 130.6 (1981). Such…