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: Lobster Tails, at Miami, Fla. (S.D. Fla.); Civil Action No. 94-1351.
CHARGED 6-30-94: While held for sale after shipment in interstate commerce at National Freezers, Inc., in Miami, Fla., the articles were adulterated in that they consisted in whole or in part of decomposed lobster--402(a)(3).
DISPOSITION: Pursuant to a consent decree of condemnation, the articles were reexported under bond. (F.D.C. No. 66960; S. No. 94-682-248; S.J. No. 1)
PRODUCT: Mushrooms, at Jacksonville, Fla. (M.D. Fla.); Civil Action No. 94-435-CIV-J-10.
CHARGED 5-3-94: While held for sale after shipment in interstate commerce at Grimes Distribution Services, in Jacksonville, Fla., the articles were adulterated in that they contained a poisonous or deleterious substance, lead, whereby they might have been rendered injurious to health--402(a)(1). The articles were also adulterated in that they 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 the labeling was false and misleading because it represented and suggested that the articles were grown and packed in Taiwan when in fact they were not--403(a)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66948; S. No. 93-682-693; S.J. No. 2)
PRODUCT: Pollock Fillets, at Chicago, Ill. (E.D. Ill.); Civil Action No. 94C00922.
CHARGED 2-14-94: While held for sale after shipment in interstate commerce at Fulton Market Cold Storage Company, in Chicago, Ill., the articles were adulterated in that they consisted in whole or in part of decomposed seafood--402(a)(3).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66928; S. No. 94-710-338; S.J. No. 3)
PRODUCT: Sauerkraut, at Bear Creek, Wis. (E.D. Wis.); Civil Action No. 94-C 0260.
CHARGED 3-8-94: While held for sale after shipment in interstate commerce at Flanagan Brothers, Inc., in Bear Creek, Wis., the article was misbranded in that its labeling was false and misleading because it represented and suggested that the article was fresh when, in fact, it was not fresh and contained chemical preservatives--403(a)(1). Also, the article was misbranded in that it was fabricated from two or more ingredients, and its label failed to bear the common or usual name of such ingredient--403(i)(2).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 66917; S. No. 93-718-826; S.J. No. 4)
Drugs/Human Use
PRODUCT: Dental Powder, at Simsbury, Conn. (D. Conn.); Civil Action No. 3:94CV287.
CHARGED 2-25-94: While held for sale after shipment in interstate commerce at Dental Clearing House, in Simsbury, Conn., there was an article of drug within the meaning of 201(g) which may not be introduced or delivered for the introduction into interstate commerce pursuant to 505(a), since it was a "new drug" within the meaning of 201(p) and no approval of an application filed pursuant to 505(b) was in effect for such a drug.
DISPOSITION: The articles were destroyed. (F.D.C. No. 66796; S. No. 93-638-093; S.J. No. 5)
PRODUCT: Yeast-X Medicated Cream, at Lynchburg, Va. (W.D. Va.); Civil Action No. 97-0051-L.
CHARGED 7-10-97: While held for sale after shipment in interstate commerce at C.B. Fleet Company, in Lynchburg, Va., there was an article of drug which may not be introduced or delivered for the introduction into interstate commerce pursuant to 505(a), since it was a "new drug" within the meaning of 201(p) and no approval of application filed pursuant to 505(b) was in effect for such drug. The article of drug was misbranded in that its labeling was false or misleading because it suggested that the product was safe and effective in the treatment of vaginal yeast infections, but did not contain any ingredients which were generally recognized as a safe and effective treatment for such use--502(a). Also, the article was misbranded in that its labeling failed to bear adequate directions for use-- 502(f)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67195; S. No. 97-716-108; S.J. No. 6)
Drugs/Veterinary
PRODUCT: Various articles of drug for veterinary use, at Syracuse, N.Y. (N.D. N.Y.); Civil Action No. 94-CV-197(FJS/MJGJD).
CHARGED 2-15-94: While held for sale after shipment in interstate commerce at Nomera Resources Corporation, in Syracuse, N.Y., the articles were adulterated within the meaning of 501(a)(5), in that they were new animal drugs within the meaning of 201(w) which were unsafe within the meaning of 512(a)(1)(A) because no approvals of applications filed pursuant to 512 were in effect with respect to their intended uses. The articles were misbranded in that they were drugs fabricated from two or more ingredients and the label failed to bear the established name and quantity of each active ingredient--502(e)(1)(A)(ii). Also, the articles were misbranded in that the labeling failed to bear adequate directions for their intended use for the treatment of dermatitis--502(f)(1). The articles were further misbranded in that in that they were manufactured in an establishment not duly registered under 21 U.S.C. Section 510 and they were not included in a list required by 21 U.S.C. Section 510(j)--502(o).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66903; S. No. 93-603-143; S.J. No. 7)
MISCELLANEOUS
ACTION: John Copanos v. Food and Drug Administration, at Washington, D.C. (D.D.C.); Civil Action No. 96-1128.
CHARGED 4-22-96: John Copanos ("Petitioner") requested that the court review the Order of the Food and Drug Administration ("FDA"), which denied Petitioner's request for a hearing, and FDA's final Order issued, which permanently debarred Petitioner from providing services in any capacity to a person that has an approved or pending drug product application.
DISPOSITION: The Court of Appeals denied the review because Petitioner waived his retroactivity and constitution arguments by failing to raise them before FDA. The U.S. Supreme Court denied his petition for a writ of certiorari. (Misc. No. 1150; S.J. No. 8)
FDA Consumer magazine (March-April 1998)
