Judge orders O.C. company to stop selling unapproved hand sanitizer products, FDA warns competitor

A judge ordered a Lake Forest hand sanitizer company to stop claiming its products can protect against specific diseases without federal approval after the owners of Purell filed a complaint, but he also slammed the multi-national brand for similar conduct during a trial that ended Monday, May  4.

Innovative BioDefense Inc. (IBD), the firm’s CEO Colette Cozean and distributor Hotan Barough must cease the sale of the company’s “Zylast” line of products until they remove statements from packaging that they can prevent infection by certain pathogens. They were marketed as effective against the flu, Ebola, norovirus and a host of other contagions, but those statements had not been approved by the Food and Drug Administration, officials from the U.S. Justice Department said Wednesday in a news release.

“We are happy to comply with Judge Carter’s order,” attorney for IBD, Kirby Behre said of the decision handed down by U.S. District Judge David Carter of the Central District of California . “And we appreciate the care and attention he gave to our concerns.”

The Zylast product line includes Zylast Broad Spectrum Antimicrobial Antiseptic, Zylast XP (Extended Protection) Antiseptic Lotion and Zylast XP Antiseptic Foaming Soap, government attorneys said. Those were sold directly to customers through the internet. Zylast and competing brands were marketed as disinfectants consisting of at least 70 percent alcohol.

Representatives for Purrell maker Gojo filed a complaint against IBD alleging that the Orange County  company violated the Food Drug and Cosmetic Act, according to court documents. The makers of Zylast were then sued by the Justice Department in 2018 on behalf of the FDA.

“American consumers rely on the FDA to ensure that their drugs are safe and effective,” Stacy Amin, chief counsel for the FDA, said in a statement. “Products with fraudulent claims to prevent or treat serious or life-threatening diseases puts consumers health at risk.”

Attorneys for the government said during their closing arguments on March 2 that IBD’s “false promises of protection could hurt someone.” Carter agreed. However, he went on to acknowledge that advertising and packaging for Gojo’s products made practically identical claims and were also not vetted by the FDA.

“You’ve got an  800-pound gorilla called ‘Purell’ that has a small competitor, a small niche,” Carter said during the trial. “And Purell makes these allegations. Wouldn’t we kind of worry about a monopoly here?”

Carter also suggested that the larger company, Gojo, had the capacity to distribute false advertising to far more people than IBD, thereby causing harm on a much wider scale than the lesser-known Orange County sanitizer maker. He went on to say that the FDA’s “disparity in enforcement creates a perception of favoritism,” while ruling in favor of the government’s case and ordering an injunction against the manufacturers and distributors of Zylast.

“He exposed Purell’s misconduct in trying to put a small business out of business,” Behre said of Carter’s decision. “Now everyone, big and small, can compete fairly.”

The FDA issued a warning letter to Gojo instructing the company to remove disease specific claims from its advertising on Jan.17. The company was voluntarily working to comply, U.S. attorneys said during trial in March.