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: Mushrooms, at Brooklyn, N.Y. (E.D.N.Y.); Civil Action No. CV-95-0324.
CHARGED 1-23-95: While held for sale after shipment in interstate commerce at Good World Trading Co., in Brooklyn, N.Y., the articles were adulterated in that they contained an added poisonous and deleterious substance which might render them injurious to health--402(a)(1). The articles were also adulterated in that they were prepared and packed under conditions whereby they might have been rendered injurious to health--402(a)(4). The articles were misbranded in that their labeling falsely represented that they were grown and packed in Taiwan and that they were sliced mushrooms--403(a)(1).
DISPOSITION: A decree of forfeiture and order of final delivery ordered the articles destroyed. (F.D.C. No. 67040; S. No. 94-725-854; S.J. No. 1)

Drugs/Human Use

PRODUCT: IKB gel, at Miami Lakes, Fla. (S.D. Fla.); Civil Action No. 96-1281-CIV-KING.
CHARGED 5-13-96: While held for sale after shipment in interstate commerce at Tex International, Inc., in Miami Lakes, Fla., the articles were adulterated in that their strength differs from and their quality falls below that which they were represented to possess--501(c). The articles were misbranded in that their labeling falsely represented that they contained halcinonide and neomycin sulfate, and the information required to appear on the label did not appear in the English language--502(a) and 502(c). The articles were also misbranded in that they were not duly listed as required, and their labeling failed to bear the statement "Caution: Federal law prohibits dispensing without a prescription."--502(o) and 503(b)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67141; S. No. 96-711-338; S.J. No. 2)

Medical Devices

PRODUCT: Dilapan hygroscopic cervical dilators, at Middlesex, N.J. (DNJ); Civil Action No. 92-1894(DRD).
CHARGED 5-7-92: While held for sale after shipment in interstate commerce at Gynotech, Inc., in Middlesex, N.J., the articles were adulterated in that they were class III devices without an application for premarket approval--501(f)(1)(B). The articles were also 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). The articles were misbranded in that their labeling failed to bear adequate directions for use, and the information required to be submitted to the agency was not submitted--502(f)(1) and 502(t)(2).
DISPOSITION: The court enjoined the firm and its owner from distributing the articles in interstate commerce. Subsequently, an inspection of the firm revealed that it had ceased manufacturing and distributing the articles. (F.D.C. No. 66325; S. No. 91-612-926; S.J. No. 3)

PRODUCT: Synchro tech relaxman, at Cleveland, Ohio (N.D. Ohio); Civil Action No. 1:93CV1577.
CHARGED 7-28-93: While held for sale after shipment in interstate commerce at Meta Brain/Mind Biomedical Research Foundation in Cleveland, 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 falsely represented that it was adequate and effective for pain reduction, efficient digestion, waste elimination, better sexual functioning, and healthful physical energy levels--502(a). The article's labeling failed to bear adequate directions for use, and it lacked adequate warnings against use in those pathological conditions where its use might be dangerous to health--502(f)(1) and 502(f)(2). The article was also misbranded in that its use is a danger to health when used in the dosage or manner and with the frequency suggested on the labeling, and notice was not provided to the agency prior to the article's release into interstate commerce--502(j) and 502(o).
DISPOSITION: The article was destroyed. (F.D.C. No. 66662; S. No. 93-670-602; S.J. No. 4)

CRIMINAL ACTIONS

DEFENDANT: W.W. Hurt d/b/a New River Livestock Company, at Blacksburg, Va. (W.D. Va.); Criminal No. 93-00122.
CHARGED 7-23-93: Count 1: The defendant willfully conspired to defraud FDA by impeding its efforts to prevent adulterated meat intended for human consumption from entering interstate commerce and to defraud the Packers and Stockyards Administration (PSA) by impeding its efforts to ensure fair practices among livestock dealers and to protect consumers and members of the livestock and meat industries--18 U.S.C. sections 371 and 2. The defendant also devised a scheme using the telephone to defraud FDA and PSA--18 U.S.C. section 1343.
Count 2: The defendant, with the intent to defraud, willfully conspired to introduce into interstate commerce adulterated food which contained unsafe new animal drugs--18 U.S.C. sections 371 and 2.
Count 3: The defendant, with the intent to defraud, delivered to slaughterhouses for slaughter and human consumption cows whose tissues contained unsafe new animal drugs--301(a) and 303(a)(2).
Count 4: The defendant delivered cows to a slaughterhouse that were infected with a poisonous and deleterious substance that might render the food injurious to health--301(a) and 303(a)(2).
Count 5: The defendant knowingly made a false statement to an FDA investigator that he was employed as a truck driver by the New River Livestock Company (NRLC) when, in fact, he controlled NRLC--18 U.S.C. section 1001.
Count 6: The defendant knowingly made a false statement to an investigator that he did not ask producers whether animals were medicated, when, in fact, he frequently asked producers for this information--18 U.S.C. section 1001.
Count 7: The defendant, for purposes of executing the scheme to defraud, used the telephone to conduct the business of NRLC by placing calls and receiving telephone wire communications from other cattle farmers and producers regarding the availability of cows for sale, and for making arrangements for transporting and purchasing these cows--18 U.S.C. section 1343.
DISPOSITION: The defendant pleaded guilty to count three. He was sentenced to six months of imprisonment and 12 months of supervised release. He was also ordered to pay a $2,500 fine and a $50 assessment. (F.D.C. No. 66105; S. No. 91-662-441; S.J. No. 5)

INJUNCTION ACTIONS

DEFENDANTS: Roy H. Bowersox, at Winfield, Pa. (M.D. Pa.); Civil Action No. 1:CV-93-0545.
CHARGED 4-13-93: The defendant delivered into interstate commerce adulterated cattle--301(a). The cattle were adulterated in that they contained an unsafe new animal drug--402(a)(2)(D).
DISPOSITION: A consent decree of permanent injunction was filed. A follow-up inspection revealed the defendant had not changed operating practices. Subsequently, Mr. Bowersox attested that he no longer sells or delivers cows, and he intended to refrain from doing so in the future. (Inj. No. 1295; S. No. 92-632-209; S.J. No. 6)

DEFENDANTS: Novie Iceland and Barry Karch, at Miami, Fla. (S.D. Fla.); Civil Action No. 95-1005.
CHARGED 5-15-95: The defendants introduced into interstate commerce adulterated ready-to-eat smoked and unsmoked fish products. The fish products were adulterated in that they were prepared, packed or held under insanitary conditions whereby they might have become contaminated with filth--402(a)(4).
DISPOSITION: The firm filed for Chapter 11 under the U.S. Bankruptcy Code. Subsequently, the bankruptcy case was converted to a Chapter 7 liquidation. (Inj. No. 1368; S. No. 91-594-341; S.J. No. 7)

MISCELLANEOUS ACTIONS

ACTION: Kimball v. Clausnitzer, et al., at Tampa, Fla. (M.D. Fla.); Civil Action No. 95-1399-Civ-T-24E.
CHARGED 8-23-95: The plaintiff alleged that various federal officials deprived him of his fourth, fifth, ninth, and 14th Amendment rights. The allegations arose from an FDA investigation into the manufacture and distribution of unapproved cancer and AIDS drugs.
DISPOSITION: The court found that the plaintiff failed to state any constitutionally based claim upon which relief could be granted. The court gave the plaintiff 11 days to amend the complaint. Subsequently, the court denied the plaintiff's motion for leave to amend the complaint and add parties. The court also granted a defendant's motion for award of attorney's fees and costs. (Misc. No. 1111; S.J. No. 8)

FDA Consumer magazine (January-February 1997)