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Innovative BioDefense ordered to stop marketing unapproved new drugs

Christian Fernsby ▼ | May 7, 2020
A federal court ordered a California company to stop distributing hand sanitizer products that are unapproved new drugs, the Justice Department announced.
Zylast
Innovative BioDefense   Zylast
In an order entered on May 4, 2020, U.S. District Judge David O. Carter of the Central District of California enjoined Innovative BioDefense Inc., of Lake Forest, California, along with company CEO Colette Cozean and distributor Hotan Barough, from distributing “Zylast” hand sanitizer products until the company obtains U.S. Food and Drug Administration (FDA) approval or removes disease-specific claims from its product labeling. Judge Carter entered his order following eight days of trial.

Topics: Innovative BioDefense

“Consumers are entitled to drug labeling that complies with the law,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice works closely with the FDA to ensure that manufacturers lawfully comply with the drug approval process.”

In a 2018 complaint, the United States alleged that the defendants distributed Zylast products in violation of the Federal Food, Drug, and Cosmetic Act

FDCA). According to the complaint, the defendants marketed their products as being effective against infection by pathogens such as the norovirus, rhinovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus bacteria and Ebola virus, despite a lack of proof of the products’ safety and effectiveness

or such uses and no approval from the FDA. The court found that the defendants’ violations of the FDCA were persistent and recurrent.

The Zylast product line includes Zylast Broad Spectrum Antimicrobial Antiseptic, Zylast XP (Extended Protection) Antiseptic Lotion and Zylast XP (Extended Protection) Antiseptic Foaming Soap.

The defendants distributed their Zylast products through the internet directly to consumers. According to the complaint, the Zylast website featured a “Buy Now” button that linked consumers to a second website, zylastdirect.com, where customers could purchase the products. Along with these websites, the court also found that a new webpage that IBD launched during trial also contained disease-specific claims.


 

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