Facts

Defendant Innovative BioDefense, Inc. manufactures and distributes over the counter topical drug products under the name "Zylast." These products include antiseptics lotions and antiseptic foaming soap. The Department of Justice filed a complaint on behalf of plaintiff, the United States of America against defendants Innovative BioDefense and its president, Collete Cozean for violation of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Section 301.

PLAINTIFF'S CONTENTIONS: Plaintiff contended that defendants distributed its "Zylast" products to various consumers claiming that these products were effective against the norovirus, rhinovirus, rotavirus, the flu virus, Methicillin-Resistant Staphylococcus Aureus bacteria and Ebola even though defendants did not have proof that the "Zylast" products were in fact effective for these viruses nor were these products safe for use. Plaintiff also contended that defendants did not have an approved new drug application or an abbreviated new drug application as required by the Act.

DEFENDANTS' CONTENTIONS: Defendants denied plaintiff's contentions.

Result

The district court issued an order for permanent injunction permanently enjoining defendants from manufacturing and distributing "Zylast" products to consumers until defendants remove the labels stating the false claims about its effectiveness for various viruses and until defendants obtain an approve new drug applicant and an abbreviated new drug application from the Food and Drug Administration.