U.S. Food and Drug Administration
FDA Consumer magazine
May-June 2001
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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.
PRODUCT: Black Pills for Arthritis/Chinese Herbal Medication at Biscoe,
Ariz. (D.Ariz.); Civil Action No. 4-00 CV-00-684.
CHARGED 9-12-00: While held for sale after shipment in interstate commerce at
Jewell & Daisy Hall, Biscoe, Ariz., the articles of drug were misbranded within
the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C., Section 352(c)
in that words, statements, or other information required by or under authority
of the Act to appear on the label were not prominently placed thereon with such
conspicuousness and in such terms as to render them likely to be read and understood
in that the label did not appear in the English language--352(c); its labeling
failed to bear adequate directions for use and it was not exempt from such requirement
since the article is an unapproved new drug--352(f)(1); and its labeling failed
to bear such adequate warnings against the use in those pathological conditions
or by children where its use may be dangerous to health, or against unsafe dosage
or methods or duration of administration or application, in such manner and
form as necessary for the protection of users, in that no such warnings were
provided for undeclared prescription drug ingredients--352(f)(2).
DISPOSITION: The articles were destroyed. (FDC No. 67426; S. No. 47843; S.J. No. 1)
PRODUCT: Carbon Dioxide USP at Canton, Mich. (E.D.Mich.); Civil Action
No. 98-73385.
CHARGED 8-6-98: While held for sale after shipment of one or more of their components
in interstate commerce at AGA Gas Inc., Canton, Mich., the articles of drug
were adulterated within the meaning of the Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. Section 351(a)(2)(B) in that the methods used in and the facilities
and controls used for their manufacture, processing, packing and holding did
not confirm to, and were not operated and administered in conformity with, current
good manufacturing practice requirements.
DISPOSITION: The articles were destroyed. (FDC No. 67242; S. No. 98-900-922; S.J. No. 2)
PRODUCT: Oxygen USP at New Hyde Park, N. Y. (D.N.Y.); Civil Action No.
CV-00-6827.
CHARGED 11-15-00: While held for sale after shipment in interstate commerce
at American Industrial Gases, Inc., the articles of drug were adulterated within
the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 351(a)(2)(B),
in that the methods used in, and the facilities and controls used for their
manufacture, processing, packing, and holding did not conform to and were not
operated and administered in conformity with current good manufacturing practices
to ensure that such drugs meet the safety requirements of the Act and have the
identity and strength and meet the quality and purity characteristics which
they purport and are represented to possess; and one or more of their components
were misbranded within the meaning of the Act, 21 U.S.C. Section 352(b)(2),
in that the articles failed to bear an accurate statement of the quantity of
the contents in terms of weight, measure, or numerical count; and complaint
alleges that pursuant to 21 U.S.C. Section 353(b)(4)(A), the articles are prescription
drugs which are misbranded since the labels of these articles fail to bear,
at a minimum, the symbol "Rx only."
DISPOSITION: The articles were seized. (FDC No. 67416; S. No 98-590-900; S.J.
No. 3)
ACTION: Consummated Productivity Co., and Melchor R. Jayme v. United States
of America, FDA, at the District of New Jersey Court of Appeals, (D.N.J.);
Civil Action No. 99-3499.
CHARGED 7-12-00: Melchor Jayme sued the agency and six individual defendants,
Jane Henney, Robert J. Moore, Douglas I. Ellsworth, Ray Abrahams, Diane E. Boucher,
and David Benstein, in their individual and official capacities. The plaintiffs
brought this action after FDA detained 60 boxes of their product, Bio-Normalizer.
The FDA detained the Bio-Normalizer because the plaintiffs were marketing and
distributing it as a drug, although it had not been approved by the FDA. The
plaintiffs sought a declaration that the product is a food, not a drug; injunctive
relief to bar any further FDA seizures of the product; and compensatory relief
for unlawful conversion of their property.
DISPOSITION: On July 12, 2000, U.S. District Judge John Lifland dismissed with
prejudice the plaintiffs' claims as to all of the individual FDA employees and
dismissed without prejudice the plaintiffs' claims against the FDA. The plaintiffs
did not appeal the decision, and the U.S. Attorney's Office in New Jersey has
now officially closed its file. (Misc. 1232; S.J. No. 4)
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