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: Milk, condensed, at Chicago, Ill. (E.D. Ill.); Civil No. 95C-4148.
CHARGED 7-18-95: While held for sale after shipment in interstate commerce at La Bodega, Inc., in Chicago, Ill., the article was misbranded in that the statement of identity, declaration of net quantity of contents, and the statement of ingredients were not in English--403(f). The article was also misbranded in that the name and place of business of the manufacturer, packer or distributor did not appear on the label in the required type size, and the label failed to bear nutrition information--403(f) and 403(q)(1).
DISPOSITION: A default decree of condemnation, forfeiture and destruction ordered the articles destroyed. (F.D.C. No. 67098; S. No. 94-741-379; S.J. No. 1)

PRODUCT: Riga Sprats, at Elizabeth, N.J. (DNJ); Civil No. 95-1148 (AJL).
CHARGED 3-8-95: While held for sale after shipment in interstate commerce at SeaLand Container Service Station, in Elizabeth, N.J., the articles were adulterated in that they were prepared and packed under conditions whereby they might have been rendered injurious to health--402(a)(4).
DISPOSITION: A consent judgment and final order of forfeiture ordered the articles destroyed. (F.D.C. No. 67048; S. No. 95-647-620; S.J. No. 2)

PRODUCT: Similac infant formula, powdered, at Deer Park, N.Y. (E.D.N.Y.); Civil No. CV-96-0938.
CHARGED 3-1-96: While held for sale after shipment in interstate commerce at Krantor Corp., in Deer Park, N.Y., the article was adulterated in that it failed to bear a lot code--412(a)(3). The article was misbranded in that it was represented to be for special dietary use in that the label declared the product as "infant formula." The article lacked nutrient information regarding the product when prepared in accordance with label directions for infant consumption, a statement of the number of fluid ounces supplying 100 kilocalories, and the weight and volume of powdered formula to be reconstituted--403(j).
DISPOSITION: A default decree of condemnation and destruction ordered the article destroyed. (F.D.C. No. 67129; S. No. 96-782-071; S.J. No. 3)

PRODUCT: Tuna, chunk light, at Tampa, Fla. (M.D. Fla.); Civil No. 94-609-CIV-T-23C.
CHARGED 4-12-94: While held for sale after shipment in interstate commerce at Winn Dixie Warehouse, in Tampa, Fla., the article was misbranded in that it failed to meet the standard of fill for canned tuna, and the label did not state that the article was below such standard--403(h)(2).
DISPOSITION: A default judgment ordered the articles donated to a charitable institution. (F.D.C. No. 66934; S. No. 93-681-942; S.J. No. 4)

PRODUCT: Tuna, chunk light, at Pascagoula, Miss. (S.D. Miss.); Civil No. 1:94cv164RR.
CHARGED 3-29-94: While held for sale after shipment in interstate commerce at Starkist Food, Inc., d/b/a Heinz Pet Products, in Pascagoula, Miss., the article was misbranded in that it failed to meet the standard of fill for canned tuna, and the label did not state that the article was below such standard--403(h)(2).
DISPOSITION: A default judgment ordered the articles donated to a charitable institution. (F.D.C. No. 66927; S. No. 93-651-183; S.J. No. 5)

PRODUCT: Tuna, raw, frozen, whole, at Long Beach, Calif. (C.D. Calif.); Civil No. 95-4257 KN.
CHARGED 6-26-95: While held for sale after shipment in interstate commerce at Sea-Land Service, in Long Beach, Calif., the article was adulterated in that it consisted of decomposed tuna--402(a)(3).
DISPOSITION: A default judgment ordered the article destroyed. (F.D.C. No. 67095; S. No. 95-714-095; S.J. No. 6)

Drugs/Human Use

PRODUCT: Exachol, capsules, at Hastings-On-Hudson, N.Y. (S.D.N.Y.); Civil No. 87 Civ. 7779 (RWS).
CHARGED 5-20-88: While held for sale after shipment in interstate commerce at U.S. Health Club, Inc., in Hastings-On-Hudson, N.Y., the articles were adulterated in that they were unapproved new drugs--505(a). The articles were misbranded in that they failed to bear adequate direction for use--502(f)(1).
DISPOSITION: A consent decree ordered the article destroyed. (F.D.C. No. 65277; S. No. 87-459-661; S.J. No. 7)

Medical Devices

PRODUCT: Intraocular lenses, at Azusa, Calif. (C.D. Calif.); Civil No. 93 6928 WDK.
CHARGED 11-18-93: While held for sale after shipment in interstate commerce at Optical Radiation Corp., in Azusa, Calif., the articles were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, packing and storage were not in conformity with current good manufacturing practice requirements--501(h).
DISPOSITION: A consent decree ordered the articles destroyed. During an inspection, it was discovered that the firm destroyed some of the articles without FDA's supervision. The firm agreed to pay the value of the destroyed articles. Consequently, FDA released the firm from the rest of the bond. (F.D.C. No. 66754; S. No. 93-663-878; S.J. No. 8)

PRODUCT: Sharper Image Relaxation Systems, at North Little Rock, Ark. (E.D. Ark.); Civil No. LR-C-94-563.
CHARGED 9-1-94: While held for sale after shipment in interstate commerce at ABF Freight System, Inc., in North Little Rock, Ark., and at The Sharper Image in Little Rock, Ark., the articles were adulterated in that they were class III devices without an application for premarket approval--501(f)(1)(B). The articles were misbranded in that information regarding the articles was not provided as required--502(o).
DISPOSITION: A consent decree of condemnation was filed. The articles were reconditioned as set forth in the consent decree. (F.D.C. No. 67003; S. No. 94-687-982; S.J. No. 9)

PRODUCT: Various Articles of Device, at Seattle, Wash. (W.D. Wash.); Civil No. C94-883R.
CHARGED 6-10-94: While held for sale after shipment in interstate commerce at Synetic Systems, Inc., in Seattle, Wash., the articles were adulterated in that they were class III devices without an application for premarket approval--501(f)(1)(B). The articles were misbranded in that information regarding the devices was not provided as required--502(o).
DISPOSITION: A consent decree of condemnation was filed. The articles were reconditioned as set forth in the consent decree. (F.D.C. No. 66918; S. No. 93-629-464; S.J. No. 10)

PRODUCT: Viro-Gloves, at Pompano Beach, Fla. (S.D. Fla.); Civil No. 94 7224 CIV-HURLEY.
CHARGED 12-19-94: While held for sale after shipment in interstate commerce at Knight Industries, Inc., in Pompano Beach, Fla., 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 current good manufacturing practice requirements--501(a)(2)(B). The articles were misbranded in that they failed to bear adequate directions for use--502(f)(1).
DISPOSITION: A consent decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67000; S. No. 94-682-477; S.J. No. 11)

INJUNCTION ACTIONS

DEFENDANTS: Smith Family Farms and Paul Steven Smith, at Clyde, N.Y. (W.D.N.Y.); Civil No. 94 CV 6260T.
CHARGED 6-2-94: The defendants introduced into interstate commerce adulterated cattle and held the cattle for sale after shipment in interstate commerce--301(a) and 301(k). The cattle were adulterated in that they contained an unsafe new animal drug--402(a)(2)(D). The cattle 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 defendants later were found in compliance with the decree. (Inj. 1350; S. No. 93-543-575; S.J. No. 12)

FDA Consumer magazine (December 1996)