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Summaries of Court Actions

Summaries of Court Actions are given pursuant to Section 705 of the Federal Food, Drug, and Cosmetic Act. Summaries of Court Actions report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions taken against goods alleged to be in violation, and criminal and injunction proceedings are against firms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, or cosmetics alleged to be adulterated or misbranded or otherwise violative of the law when introduced into and while in interstate commerce.
Summaries of Court Actions are prepared by Food and Drug Division, Office of the General Counsel, HHS, and are published by direction of the Secretary of Health and Human Services.

SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Opilio Crab, at Puyallup, Wash. (W.D. Wash.); Civil Action No. C98-0277WD.
CHARGED 3-5-98: While held for sale after shipment in interstate commerce, in Puyallup, Wash., the article was adulterated in that it was unfit for food due to the presence of the odor and flavor of smoke and burnt plastic--402(a)(3).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67230; S. No. 98-738-122; S.J. No. 1)

INJUNCTION ACTIONS

DEFENDANT: Agro-Ochoa, Inc., a corporation, and Jorge Ochoa Bacallao, Armando Ochoa Villavisanis, and Luis R. Maristany Quinones, individuals, at Guaynabo and Barceloneta, Puerto Rico (D. Puerto Rico); Civil No. 89-01052.
CHARGED 8-7-89: While held for sale after shipment in interstate commerce at various mills, in Guaynabo and Barceloneta, Puerto Rico, the defendant article, medicated feed, was adulterated in that the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and holding of the feed did not conform to and were not operated in conformity with good manufacturing practice requirements (GMP's) of the Food, Drug, and Cosmetic Act--501(a)(2)(B).
DISPOSITION: U.S. District Court entered a default judgment enjoining the defendants from manufacturing, processing, labeling, storing, or distributing any article of medicated feed unless and until the defendants complied with the GMP's. The Court further ordered the defendants to pay all costs. (Inj. No. 1216; S.J. No. 2)

DEFENDANT: Jack G. Tuls, an individual d/b/a Jack Tuls & Sons Dairy, and Arden J. Van Peursem, an individual, at San Jacinto, Calif. (C.D. Calif.); Civil No. 95-7930.
CHARGED 11-20-95: While held for sale after shipment in interstate commerce at Jack Tuls & Sons Dairy, in San Jacinto, Calif., the beef derived from cattle sold or offered for sale by Jack Tuls & Sons Dairy was adulterated in that it contained residues of unsafe new animal drugs--402(a)(2)(D). In addition, the cattle sold for use as human food were adulterated in that they had been held under insanitary conditions whereby their edible tissue may have been rendered injurious to health--402(a)(4). The defendants caused drugs to be adulterated because they used drugs in ways that are inconsistent with the approved conditions for use, thereby rendering the drugs unsafe new animal drugs--510(a)(1).
DISPOSITION: The U.S. District Court granted a consent decree of permanent injunction. The Court further ordered the defendants to pay costs for the investigational expenses incurred. (Inj. No. 1385; S.J. No. 3)

MISCELLANEOUS ACTIONS

ACTION: Professionals and Patients for Customized Care v. Donna Shalala et al., at Houston, Texas (S.D. Texas); Civil Action No. H92-1499.
CHARGED 5-14-92: Professionals and Patients for Customized Care, an organization composed of individuals and entities engaged in the practice of pharmacy, brought suit, claiming that the Food and Drug Administration (FDA) Compliance Policy Guide (CPG) was invalid as a substantive rule issued in violation of the Administrative Procedures Act's (APA) notice and comment requirement.
DISPOSITION: The U.S. District Court ruled for the agency, and the plaintiff appealed. The Court of Appeals held that the guide was not a substantive rule and thus was not subject to APA's notice and comment requirements, and therefore maintained the District Court's decision. (Misc. No. 978; S.J. No. 4)

ACTION: Truth in Labeling Campaign et al. v. Donna Shalala et al., based in Illinois (E.D. Ill.); Civil Action No. 4:95CV1633TCM.
CHARGED 8-29-95: Truth in Labeling Campaign, a nonprofit organization, brought suit disputing the Food and Drug Administration's (FDA's) labeling requirements for monosodium glutamate (MSG). Current regulations require that MSG be identified on a food label when MSG is added to a food in its single-ingredient form but do not require that it be so identified if MSG is a component of a food.
DISPOSITION: The U.S. District Court granted the government's motion for summary judgment. (Misc. No. 1112; S.J. No. 5)

CORRECTION
In the March 1996 issue of FDA Consumer magazine, S.J. No. 4 (regarding Prune Culls, at Cheektowaga, N.Y. (W.D.N.Y.); Civil No. 94-CV-0144) stated that while the article was "held for sale after shipment in interstate commerce at Allied Frozen Storage, Inc., in Cheektowaga, N.Y., the articles were adulterated in that they consisted of insects, insect parts, insect pupae, insect larvae, insect webbing, and insect excreta--342(a)(3). The notice also should have stated:
Although the prune culls were in fact stored at Allied Frozen Storage, Inc., the prune culls were not owned by Allied Frozen Storage, Inc. In fact, the U.S. marshal reimbursed Allied Frozen Storage, Inc., for all storage expenses.

FDA Consumer magazine (November-December 1998)

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