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.
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)
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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