Dyclonine

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 or while held for sale after shipment in interstate commerce.

Summaries of Court Actions are prepared by the Office of the Chief Counsel, Food and Drug Administration.

Published by direction of the Secretary of Health and Human Services.

SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Cases of Canned Straw Mushrooms at San Francisco, Calif. (N.D.Cal.); Civil Action No. 99-3733.

CHARGED 8-5-99: While held for sale after shipment in interstate commerce at Superhuck Co., San Francisco, Calif., the article of food was misbranded in that its labeling was false and misleading because the invoice falsely represented that it had been packed by Kepper Food Processor Co.--343(a)(1). The article of food was adulterated in that it had been prepared and packed under conditions whereby it may have been rendered injurious to health because of inadequate processing-342(a)(4).

DISPOSITION: The article was destroyed. (F.D.C. No. 67275; S. No. D53-0029148-6; S.J. No. 1)

Drugs/Human Use

PRODUCT: Dyclonine HCL HSP 19/25 Kilogram Drums, more or less, at Titusville, Fla. (M.D.Fla.); Civil Action No. 99-415.

CHARGED 4-7-99: While held for sale after shipment in interstate commerce at Pharmco Laboratories, Inc., in Titusville, Fla., the articles of drug were adulterated in that the methods used for their manufacture, processing, packing, and holding did not conform to, and were not operated and administered in conformity with, good manufacturing practice to assure that such drugs met the safety requirements of the Food, Drug, and Cosmetic Act and had the identity and strength and met the quality and purity characteristics which they purported, and were represented to possess--501(a)(2)(B).

DISPOSITION: The articles were destroyed. (F.D.C. No. 67263; S. No. 37132; S.J. No. 2)

PRODUCT: Oxygen, U.S.P., at Cincinnati, Ohio (S.D. Ohio); Civil Action No. 99-1083.

CHARGED 2-7-00: While held for sale after shipment of one or more of their components in interstate commerce at Wright Brothers, Inc., Cincinnati, Ohio, in that methods used in, and the facilities and controls used for, their manufacture, processing, and packing do not conform to and are not operated or administered in conformity with current good manufacturing practice to assure that such articles of drug meet the safety requirements of the Food, Drug, and Cosmetic Act, and have the identity and strength and meet the quality and purity characteristics which they purport and are represented to possess-351(a)(2)(B).

DISPOSITION: The articles were destroyed. (F.D.C. No. 67279; S. No. 98-796-236; S.J. No. 3)

PRODUCT: Phenylbutazone Powder at Jackson, N. J. (D.N.J.); Civil Action No. 98-4218.

CHARGED 8-5-98: The articles of drug were misbranded at A&G Pharmaceuticals, Inc., Jackson, N.J. The phenylbutazone was an unapproved new drug and, therefore, the defendant articles of drug were subject to forfeiture and condemnation pursuant to 21 U.S.C. [sections] 334, and having noted that, the United States Marshals Service seized the defendant articles.

DISPOSITION: The articles were destroyed. (F.D.C. No. 67245; S. No. 98-087-136; S.J. No. 4)

INJUNCTION ACTIONS

DEFENDANT: Stewart Sandwiches, Inc., at Norfolk, Va. (E.D. Va.); Civil Action No. 90-1344-N.

CHARGED 7-10-97: United States notified America's Foods, Inc. (AFI) in early 1997 that firm was successor and assign of Stewart Sandwiches, Inc. (Stewart) and operating out of compliance with consent decree. In July 1997, AFl agreed file together with United States, a Joint Motion to Grant Permissive Joiner and To Modify Consent Decree of Permanent Injunction.

DISPOSITION: Modified consent decree was entered on July 15, 1997. Thereafter, the sandwiches were destroyed, the firm shut down, and all assets were sold in bankruptcy. (Inj. No. 1233; S.J. No. 5)

MISCELLANEOUS ACTIONS

ACTION: Satish R. Shah v. FDA, at the District of Columbia Court of Appeals, DC (D.C. Cir); Civil Action No. 99-1191.

CHARGED 7-9-99: Satish R. Shah was debarred in 1994 following his felony convictions for conspiracy and making a false statement to a federal agency. In 1997 and 1998, Shah applied to the agency for special termination of his debarment, contending that he had provided substantial assistance in the investigation of other offenses within FDA's jurisdiction. FDA denied his petition because, based on the record before FDA, the agency could not find that Shah had provided such substantial assistance. The agency is statutorily required to make a determination of substantial assistance prior to granting an application for special termination of permanent debarment.

DISPOSITION: On Nov. 19, 1999, a three-judge panel of the Court of Appeals for the District of Columbia Circuit denied Shah's Application For Special Termination of his permanent debarment. The court found that FDA's denial of Shah's application was reasonable and supported by the record and, therefore, was not arbitrary and capricious. (Misc. 1230; S.J. No. 6)

Statement of Ownership, Management, and Circulation (Required by 39 U.S.C. 3685)

FDA Consumer, ISSN 0362-1332; owner and publisher: Food and Drug Administration (HFI-40), 5600 Fishers Lane, Rockville, MD 20857; editor: Larry Thompson.

Date of filing: October 2000, issued 6 times annually (bi-monthly); annual subscription price $12 ($15 foreign).

I certify that the statements made by me above are correct and complete.

Larry Thompson, editor

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