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: Flour, at Chicago, Ill. (N.D. Ill.); Civil Action No. 97 C 6405.
CHARGED 9-11-97: While held for sale after shipment in interstate commerce at Don & Johnson Trucking, Inc., in Chicago, Ill., the article was adulterated in that it consisted in part of a filthy substance because it was rodent-gnawed and contained rodent hair--402(a)(3). The article was also adulterated in that it had been shipped and held under insanitary conditions whereby it might have been rendered injurious to health--402(a)(4).
DISPOSITION: The article was destroyed. (F.D.C. No. 67206; S. No. 97-760-407; S.J. No. 1)

PRODUCT: Mushrooms, at Anaheim, Calif. (C.D. Calif.); Civil Action No. 97-4682-ABC(JGx).
CHARGED 6-25-97: While held for sale after shipment in interstate commerce at Harapan International, Inc., in Anaheim, Calif., the articles were adulterated in that they had been shipped and held under insanitary conditions whereby they might have been rendered injurious to health--402(a)(4). The articles were misbranded in that their labeling was false and misleading because it contained a fictitious can code which falsely represented and suggested that the articles were packed by General Canned Food Factory in Zhangzhou, People's Republic of China--403(a)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67194; S. No. 97-480-213; S.J. No. 2)

PRODUCT: Mushrooms, at Miami, Fla. (S.D. Fla.); Civil Action No. 94-166.
CHARGED 1-27-94: While held for sale after shipment in interstate commerce at Smith Terminal Distribution Systems, in Miami, Fla., the articles were adulterated in that they contained an added poisonous and deleterious substance, staphylococcal enterotoxin, which might render them injurious to health--402(a)(1); and the articles had been shipped and held under insanitary conditions whereby they might have been rendered injurious to health--402(a)(4). The articles were misbranded in that their labeling was false and misleading because it represented and suggested that the articles were grown and packed in Taiwan--403(a)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66792; S. No. 93-594-119; S.J. No. 3)

PRODUCT: Mushrooms, at Tampa, Fla. (M.D. Fla.); Civil Action No. 94-51-CIV-T-25.
CHARGED 1-11-94: While held for sale after shipment in interstate commerce at Winn-Dixie Warehouse, in Tampa, Fla., the articles were adulterated in that they contained an added poisonous and deleterious substance, staphylococcal enterotoxin, which might render them injurious to health--402(a)(1); and the articles had been shipped and held under insanitary conditions whereby they might have been rendered injurious to health--402(a)(4). The articles were misbranded in that their labeling was false and misleading because it represented and suggested that the articles were grown and packed in Taiwan--403(a)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66793; S. No. 93-681-640; S.J. No. 4)

PRODUCT: Mushrooms, at Miami, Fla. (S.D. Fla.); Civil Action No. 94-165-CIV-HOEVELER.
CHARGED 1-27-94: While held for sale after shipment in interstate commerce at Hammersmith, Inc., in Miami, Fla., the articles were adulterated in that they had been shipped and held under insanitary conditions whereby they might have been rendered injurious to health--402(a)(4). The articles were misbranded in that their labeling was false and misleading because it represented and suggested that the articles were packed in Thailand, which was contrary to the fact--403(a)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66794; S. No. 93-594-934; S.J. No. 5)

Medical Devices

PRODUCT: Article of device, at Las Vegas, Nev. (D. Nev.); Civil Action No. CV-S-91-886-PMP
CHARGED 11-18-91: While held for sale after shipment in interstate commerce at Paradise Pain Clinic, in Las Vegas, Nev., the articles were adulterated in that they were a class III device without an application for premarket approval--501(f)(1)(B). The articles were misbranded in that their labeling represented and suggested that the devices were safe and effective for the treatment of cancer, AIDS, and other diseases, which was contrary to the fact--502(a). Also, the articles were misbranded in that their labeling failed to bear adequate directions for use--502(f)(1). Further, the articles were misbranded because no notices or other information regarding the devices was provided to the Food and Drug Administration as required under 510(k).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66322; S. No. 91-624-082; S.J. No. 6) PRODUCT: Electrode Cream, at Joliet, Ill. (N.D. Ill.); Civil Action No. 97 C 5236.
CHARGED 7-24-97: While held for sale after shipment in interstate commerce at Med-Tek Corporation, in Joliet, Ill., the articles were adulterated within the meaning of 501(h), in that the methods used in, and the facilities and controls used for, their manufacture, packing, storage, and installation were not in conformity with good manufacturing practice for devices, as set forth in 21 C.F.R. Part 820. The articles were misbranded in that their labeling contained statements which represented or suggested that the devices were adequate and effective because they were formulated from pure USP grade ingredients when in fact they were not--502(a). The articles were further misbranded in that their labeling was false or misleading because it bore an expiration date which was not substantiated by adequate testing results--502(a).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67201; S. No. 97-661-784; S.J. No. 7)

Cosmetics

PRODUCT: Glow in the dark cream make-up, at Freeport, N.Y. (E.D. N.Y.); Civil Action No. CV 97 1596.
CHARGED 4-2-97: While held for sale after shipment in interstate commerce at Zauder Brothers, Inc., in Freeport, N.Y., the article was adulterated within the meaning of 601(e), in that it was not a hair dye; and the article contained zinc sulfide, a color additive which is unsafe within the meaning of 721(e) because there is not in effect a regulation issued under 731e(b) listing it for use as a colorant in cosmetic products.
DISPOSITION: The article was destroyed. (F.D.C. No. 67169; S. No. 96-753-347; S.J. No. 8)

FDA Consumer magazine (May-June 1998)