California Hand Sanitizer Company Ordered to Stop Marketing Unapproved New Drugs

A federal court ordered a California company to stop distributing hand sanitizer products that are unapproved new drugs, the Justice Department announced today.

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.

“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 for 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, www.zylast.com, 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, www.zylastpro.com, also contained disease-specific claims.

“American consumers rely on the FDA to ensure that their drugs are safe and effective. Products with fraudulent claims to prevent or treat serious or life-threatening diseases puts consumers health at risk,” said Stacy Amin, FDA Chief Counsel.  “When we cannot achieve voluntary compliance, we are fully committed to working with the Department of Justice to take appropriate action against those that subvert FDA requirements and jeopardize the health of Americans.”

The case was handled by Trial Attorneys Jason Lee, Jim Nelson, Douglas Ross, Claude Scott, and Sarah Williams 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 and James Fraser of FDA’s Office of the Chief Counsel.

For more information about the Consumer Protection Branch and its enforcement efforts, visit its website at https://www.justice.gov/civil/consumer-protection-branch.