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: Banana Chips, at Chicago, Ill. (N.D. Ill.); Civil Action No. 96-C-6627.
CHARGED 10-10-96: While held for sale after shipment in interstate commerce at Trung Viet Co., Inc., in Chicago, Ill., 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).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67156; S. No. 96-759-222; S.J. No. 1)

PRODUCT: Mushrooms, at New Orleans, La. (E.D. La.); Civil Action No. 93-3623.
CHARGED 11-3-93: While held for sale after shipment in interstate commerce at New Orleans Cold Storage, in New Orleans, La., 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. 66771; S. No. 93-690-604; S.J. No. 2)

PRODUCT: Porcelain Dinnerware, at San Leandro, Calif. (N.D. Calif.); Civil Action No. 96-2688.
CHARGED 7-29-96: While held for sale after shipment in interstate commerce at West Pacific Trading Co., in San Leandro, Calif., the articles were adulterated in that they contained lead, an unsafe food additive--402(a)(2)(C).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67137; S. No. 96-753-709; S.J. No. 3)

PRODUCT: Raisins, at Porterville, Calif. (E.D. Calif.); Civil Action No. CV-F-94-5724-REC.
CHARGED 7-18-94: While held for sale after shipment in interstate commerce at Stephen Pavich & Sons, in Porterville, Calif., the articles were adulterated in that they consisted in part of a filthy substance, specifically insects, insect casts, insect eggs, insect fragments, rat or mouse hair, feather fragments, and cat or dog hair--402(a)(3).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67001; S. No. 94-705-726; S.J. No. 4)

PRODUCT: Shrimp, at Orlando, Fla. (M.D. Fla.); Civil Action No. 96-35-CV-ORL-22.
CHARGED 1-10-96: While held for sale after shipment in interstate commerce at U.S. Cold Storage, in Orlando, Fla., the articles were adulterated in that they consisted in part of a decomposed substance by reason of the presence therein of decomposed shrimp--402(a)(3).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67115; S. No. 96-711-905; S.J. No. 5)

Drugs/Human Use

PRODUCT: Articles of Drug, at Jackson, Miss. (S.D. Miss.); Civil Action No. 3:97CV312WS.
CHARGED 5-11-97: While held for sale after shipment in interstate commerce at Catherx Pharmaceuticals, Inc., in Jackson, Miss., the articles of drug were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practice requirements of the Act--501(a)(2)(B).
DISPOSITION: The articles of drug were destroyed. (F.D.C. No. 67180; S. No. 97-964-027; S.J. No. 6)

PRODUCT: Articles of Drug, at Madison, Miss. (S.D. Miss.); Civil Action No. 3:97CV313LN.
CHARGED 5-11-97: While held for sale after shipment in interstate commerce at Cypress Pharmaceutical, Inc., in Madison, Miss., the articles of drug were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practice requirements of the Act--501(a)(2)(B).
DISPOSITION: The articles of drug were destroyed. (F.D.C. No. 67181; S. No. 97-964-028; S.J. No. 7)

PRODUCT: Bee Pollen, at Naples, Fla. (M.D. Fla.); Civil Action No. 97-307-Civ-FTM-23.
CHARGED 7-11-97: While held for sale after shipment in interstate commerce at Health Better Living, Inc., in Naples, Fla., the articles of drug were misbranded within the meaning of 352(f)(1); and they were unapproved new drugs within the meaning of 355, and thus may not be introduced into interstate commerce.
DISPOSITION: The articles of drug were destroyed. (F.D.C. No. 67197; S. No. 97-683-131; S.J. No. 8)

INJUNCTION ACTIONS

DEFENDANT: Loran Medical Systems, Inc., Bent Formby, and Ernest M. Thomas Jr., M.D., and individuals, at Santa Barbara, Calif. (C.D. Calif.); Civil No. 96-4283.
CHARGED 6-18-96: While held for sale after shipment in interstate commerce at Loran Medical Systems, Inc., in Santa Barbara, Calif., the Cell product was a new drug within the meaning of 301(p), and was neither approved under 501(a) nor exempt from such approval provisions under 505(i) and was in violation of 301(a).
DISPOSITION: The court granted the government's motion for summary judgment and entered a permanent injunction against the defendants' importation, use and sale of the Cell product. (Inj. No. 1400; S.J. No. 9)

FDA Consumer magazine (July-August 1998)

FDA Home Page | How to Subscribe | Back Issues | Table of Contents