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: Alcobaca Portugal broad beans and fava beans, canned,
at Milford, Ill. (C.D. Ill.); Civil No. 92-2195.
CHARGED 6-30-92: While held for sale after shipment in interstate commerce at the Fremont Company, in Milford, Ill., the articles were adulterated in that they consisted of insects and insect-damaged beans--402(a)(3). The articles were also adulterated in that they were prepared and packed under insanitary conditions whereby they might have become contaminated with filth--402(a)(4).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 66443; S. No. 92-610-596; S.J. No. 1)

PRODUCT: Flounder fillets, frozen, at Newport News, Va. (E.D. Va.); Civil No. 4:95CV00125.
CHARGED 9-6-95: While held for sale after shipment in interstate commerce at Top Quality Seafood, Inc., in Newport News, Va., the articles were adulterated in that they consisted of decomposed fish--402(a)(3).
DISPOSITION: A consent decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67104; S. No. 95-733-868; S.J. No. 2)

PRODUCT: Fresh plate fish, frozen, at Columbus, Ohio (S.D. Ohio); Civil No. C2-89-125.
CHARGED 2-13-89: While held for sale after shipment in interstate commerce at Interstate Cold Storage, Inc., in Columbus, Ohio, the articles were adulterated in that Smooth Oreo Dory was substituted for Orange Roughy--402(b)(2). The articles were misbranded in that they were offered for sale under the name of another food, and labeling failed to bear the common name of the food--403(b) and 403(i). The articles were also misbranded in that their labeling was false because the food was labeled as Orange Roughy when it was Smooth Oreo Dory--403(a)(1).
DISPOSITION: The articles were donated to a charitable organization. (F.D.C. No. 65619; S. No. 89-547-961; S.J. No. 3)

PRODUCT: Raisins, at Selma, Calif. (E.D. Calif.); Civil No. CV-F-94-5689-GEB-SSH.
CHARGED 7-5-94: While held for sale after shipment in interstate commerce at American Raisin Packers, Inc., in Selma, Calif., the articles were adulterated in that they consisted of insects, insect fragments, insect cast skins, and feather barbules--402(a)(3). The articles were misbranded in that they were manufactured from two or more ingredients, and their label failed to bear the common name of each ingredient--402(i)(2).
DISPOSITION: A consent decree ordered the articles destroyed. (F.D.C. No. 66984; S. No. 94-705-349; S.J. No. 4)

PRODUCT: Shrimp, frozen, at Tampa, Fla. (M.D. Fla.); Civil No. 95-1877-Civ-T-23(A).
CHARGED 11-14-94: While held for sale after shipment in interstate commerce at Seaboard Cold Storage, in Tampa, Fla., the articles were adulterated in that they consisted of decomposed shrimp--402(a)(3).
DISPOSITION: A consent decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67111; S. No. 95-713-265; S.J. No. 5)

Drugs/Human Use

PRODUCT: Broncho saline, sterile, at Evansville, Ind. (S.D. Ind.); Civil No. EV-91-83.
CHARGED 6-18-91: While held for sale after shipment in interstate commerce at Blairex Laboratories, Inc., in Evansville, Ind., the articles were adulterated in that they were unapproved new drugs--505(a). The articles were misbranded in that they were represented to be a drug, sodium chloride inhalation solution, which is recognized by the U.S. Pharmacopeia, but they were not packaged and labeled in single-dose containers as required by the U.S. Pharmacopeia--502(g).
DISPOSITION: A consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 66083; S. No. 91-555-243/244; S.J. No. 6)

Medical Devices

PRODUCT: Thor of Genesis I, vibrational sound instrument, at South Euclid, Ohio (N.D. Ohio); Civil No. 1:93CV1724.
CHARGED 8-17-93: While held for sale after shipment in interstate commerce at the Window of Mind Bookstore in South Euclid, Ohio, the article was adulterated in that it was a class III device without an application for premarket approval--501(f)(1)(B). The article was misbranded in that its labeling was false and other information regarding the article was not provided as required--502(a) and (o).
DISPOSITION: The article was destroyed. (F.D.C. No. 66704; S. No. 93-670-674; S.J. No. 7)

INJUNCTION ACTIONS

DEFENDANTS: Big E Industries, Rio Arriba Minerals, Inc., Action Trading Company, Inc., and Harvey L. Earles, at Oklahoma City, Okla. (W.D. Okla.); Civil No. Civ-89-957-W.
CHARGED 5-31-89: The defendants introduced and delivered into interstate commerce adulterated industrial grade/inedible oils and blended feeding fat--301(a). The industrial grade/inedible oils were adulterated in that statements warning of their inferior quality were removed--301(k). The defendants also adulterated blended feeding fat, which is used as an ingredient in animal feeds, in that it was unfit for food and its inferior quality was concealed--402(a)(3) and 402(b)(3).
DISPOSITION: The parties were ordered by the court to enter into an agreement calling for written standard operating procedures. The company subsequently was found to be in compliance with the court's order. (Inj. No. 1207; S. No. 89-527-364/367; S.J. No. 8)

DEFENDANT: Frank Gasper, at Tulare, Calif. (E.D. Calif.); Civil No. 96-5443-REC DLB.
CHARGED 4-29-96: The defendant introduced or caused to be introduced into interstate commerce adulterated calves for slaughter for use as food--301(a). The calves were adulterated in that they contained unsafe new animal drugs--402(a)(2)(D). The calves were also adulterated in that they were held under insanitary conditions whereby they might have been rendered injurious to health--402(a)(4).
DISPOSITION: A consent decree of permanent injunction was filed. The defendant later was found to be in compliance with the decree. (Inj. No. 1392; S. No. 95-753-841; S.J. No. 9)

MISCELLANEOUS ACTIONS

ACTION: Henley v. FDA, at Mineola, N.Y. (2d Cir.); Civil No. CV 93-5389.
CHARGED 11-26-93: Plaintiff-appellant requested that FDA require oral contraceptive manufacturers to include in the labeling of their product the following warning statement: "Estrogen has been shown to cause cancer in animals." FDA denied the petition and a subsequent petition for reconsideration. The district court granted a summary judgment in favor of the defendant and denied the plaintiff's cross-motion for summary judgment.
DISPOSITION: Plaintiff appealed. The appellate court affirmed the district court's ruling. Plaintiff did not file a petition for certiorari. (Misc. No. 1016; S.J. No. 10)

ACTION: Public Citizen, Inc. v. DHHS, et al., at Washington, D.C. (D.D.C.); Civil No. 1:94CV02338.
CHARGED 10-28-94: Plaintiff charged that FDA had unreasonably delayed publishing regulations under the Safe Medical Devices Act of 1990.
DISPOSITION: While in litigation, three of the four regulations the plaintiff was suing over were published--510(k) summary/statement, civil money penalties, and medical device reporting. Plaintiff lost on the remaining claim relating to postmarket surveillance. Plaintiff was awarded a settlement under the Equal Access to Justice Act. (Misc. No. 1075; S.J. No. 11)

Correction:
S.J. No. 5 in the April 1996 FDA Consumer Summaries of Court Actions stated (in the Disposition) that Duramed Pharmaceutical entered into a consent decree of permanent injunction. The consent decree was subsequently dissolved by the U.S. District Court for the District of Maryland on Jan. 2, 1996.

FDA Consumer magazine (October 1996)