A California-based company is facing a civil complaint from the federal government for selling hand sanitizers that have not been approved by the FDA.
The Justice Department announced today that it has filed a complaint against Innovative BioDefense, Inc., of Lake Forest, California and its President and Chief Executive Officer, Colette Cozean, for distributing unapproved new drugs.
The company’s Zylast products, which include Zylast Broad Spectrum Antimicrobial Antiseptic, Zylast XP (Extended Protection) Antiseptic Lotion and Zylast XP (Extended Protection) Antiseptic Foaming Soap, are marketed as being effective against various pathogens, including the norovirus, rhinovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus bacteria and Ebola virus.
However, the FDA has not approved the safety and effectiveness of these products for such uses, and the company is making false and misleading claims about them on its website.
The complaint was filed in U.S. District Court for the Central District of California on June 6, 2018, and seeks to enjoin the defendants from distributing the unapproved new drugs.
The case is being handled by Trial Attorney Douglas Ross of the Civil Division’s Consumer Protection Branch, with the assistance of the U.S. Attorney’s Office for the Central District of California and Associate Chief Counsel for Enforcement Yen Hoang of FDA’s Office of the Chief Counsel.
Defendant: Innovative BioDefense, Inc.
Criminal Charges: Selling Unapproved New Drugs
City and State: Lake Forest, California
Exact Date: June 6, 2018
Sentence or Outcome: Ongoing litigation
Key Facts
- State: California
- Category: Drug Trafficking|Fraud & Financial Crimes|Violent Crime
- Source: DOJ Press Release â†â€â€
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