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: Articles of food, at Chicago Heights, Ill. (N.D.Ill.); Civil No. 95C-0452.
CHARGED 1-24-95: While held for sale after shipment in interstate commerce at U.S. Spice, in Chicago Heights, Ill., the articles were adulterated in that they were stored under insanitary conditions whereby they might have been contaminated with filth--402(a)(4).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67057; S. No. 95-741-369; S.J. No. 1)

PRODUCT: Baby Don't Be Bald Medicated Shampoo, Mallard's Tail and Mane Hair and Scalp Treatment, Arthur's Pro-Grow Protein Enriched Conditioning Shampoo Maximum Strength, and other OTC topical preparations, at Mobile, Ala. (S.D.Ala.); Civil No. 95-0339-BH-S.
CHARGED 4-26-95: While held for sale after shipment of one or more of their components in interstate commerce at Mallard Enterprises (a.k.a. Branton Laboratory) and Arthur's Beauty Lab, Inc. (a.k.a. Jessica's Beautee Internationale, Inc.), in Mobile, Ala., the articles 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 requirements--501(a)(2)(B). The articles were unapproved new drugs--505(a). The articles contained unsafe color additives, for coloring purposes only, which were intended for use in drugs--501(a)(4)(A) and (B). The articles were misbranded in that their labeling failed to bear adequate directions for use--502(f)(1).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67039; S. No. 94-679-282; S.J. No. 2)

PRODUCT: Basmati Rice, Lentils, and Mung Beans, at Elk Grove Village, Ill. (N.D.Ill.); Civil No. 93C-6467.
CHARGED 10-22-93: While held for sale after shipment in interstate commerce at the House of Spices, Inc., in Elk Grove Village, Ill., the articles were adulterated in that they were held under insanitary conditions whereby they might have been contaminated with filth--402(a)(4).
DISPOSITION: Claimant entered into a consent decree, and resumed business upon compliance. (F.D.C. No. 66799; S. No. 94-710-287; S.J. No. 3)

Drugs/Human Use

PRODUCT: Hydrosol Medicated Ointment, Hydrosol Hemorrhoidal Ointment, and raw material components, at Miamitown, Ohio (S.D.Ohio); Civil No. C-1-95-007.
CHARGED 1-5-95: While held for sale after shipment of one or more of their components in interstate commerce at Hydrosol Manufacturing Company in Miamitown, Ohio, the articles 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 requirements--501(a)(2)(B).
DISPOSITION: A consent decree of condemnation was entered providing for reconditioning of the seized articles. Some of the articles were released for sale in contradiction to the decree, and a recall was instituted. The reconditioning was completed, and the articles were released. (F.D.C. No. 66966; S. No. 94-670-115; S.J. No. 4)

PRODUCT: Liquid Oxygen, at Bloomsberg, Pa. (M.D.Pa.); Civil No. 4:CV-94-0644.
CHARGED 8-17-94: While held for sale after shipment in interstate commerce at Respiratory Support System, Inc., in Bloomsberg, Penn., the articles 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 requirements--501(a)(2)(B).
DISPOSITION: A consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 66965; S. No. 93-633-774; S.J. No. 5)

PRODUCT: Nifedipine, capsules, at Newark, N.J. (D.N.J.); Civil No. 94-4880 (NHP).
CHARGED 10-14-94: While held for sale after shipment of one or more of their components in interstate commerce at Chase Laboratories in Newark, N.J., the articles 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 requirements--501(a)(2)(B). The articles were also unapproved new drugs introduced into interstate commerce--505(a).
DISPOSITION: A consent decree of condemnation was filed, and all but eight lots of the articles were destroyed. The claimant was permitted to attempt to bring these lots into compliance. Four lots were authorized for release, and the others were destroyed. (F.D.C. No. 66914; S. No. 93-675-794; S.J. No. 6)

Drugs/Veterinary

PRODUCT: Articles of drugs for veterinary use, at Perry, Iowa (C.D.Iowa); Civil No. 4-93-CV-80420.
CHARGED 6-8-93: While held for sale after shipment of one or more of its components in interstate commerce at Immuno-Dynamics, Inc., in Perry, Iowa, the articles were adulterated in that they were unapproved new animal drugs--501(a)(5).
DISPOSITION: The products were seized, and the government filed a motion for summary judgment, which was denied. The district court returned a verdict in favor of the defendants, and the appellate court affirmed the district court's decision. (F.D.C. No. 66672; S. No. 93-636-092; S.J. No. 7)

CRIMINAL ACTIONS

DEFENDANTS: Dr. Leon Silverstone, at Denver, Colo. (D.Colo.); Criminal No. 93-CR-251.
CHARGED 8-3-93: Counts 1 and 2: Defendant Dr. Leon Silverstone submitted used false studies to support a premarket application for an electronic dental anesthesia device made by SION Technology--301(q)(2), 303(a)(1), and 18 U.S.C. Section 2.
DISPOSITION: Guilty plea; ordered to pay a $5,000 fine and sentenced to six months of prison and a year of supervised release. (F.D.C. No. 66510; S.J. No. 8)

INJUNCTION ACTIONS

DEFENDANT: George Plantenga d/b/a Western Sky Dairy, at Corona, Calif. (C.D.Calif.); Civil No. 92-4186-RSWL(EEx).
CHARGED 7-16-92: While held for sale at Western Sky Dairy in Corona, Calif., the defendant introduced adulterated food into interstate commerce--301(a). The food was adulterated in that the cattle sold for slaughter contained unsafe new animal drugs--402(a)(2)(D).
DISPOSITION: The defendant entered into a consent decree of permanent injunction and was authorized to resume business upon compliance. (Inj. No. 1289; S. No. 92-567-555/556; S.J. No. 9)

MISCELLANEOUS ACTIONS

ACTION: Bae v. Shalala, at Chicago, Ill. (7th Cir.); Civil No. 94-1373.
CHARGED 1-4-95: In 1993, FDA debarred the defendant, the former president of a generic drug manufacturer, from providing services in any capacity to a person with an approved or pending drug product application. The defendant was debarred for a felony conviction. The defendant appealed the debarment, alleging the order was punitive and that its retroactive application violated the Constitution.
DISPOSITION: The appellate court rejected the defendant's arguments and held that the debarment was a remedial act intended to safeguard the integrity of the generic drug industry. (Misc. No. 1015; S.J. No. 10)

FDA Consumer magazine (May 1996)