LAKE FOREST (CBSLA) — A federal court ordered a Lake Forest company to stop distributing hand sanitizer products it touts as being able to fight specific diseases.
Innovative BioDefense Inc. of Lake Forest was ordered Monday to stop distributing its Zylast hand sanitizer products until it obtains FDA approval or removes removes disease-specific claims from its product labeling, according to the U.S. Department of Justice.
The Zylast product line — which includes a broad spectrum antimicrobial antiseptic, an antiseptic lotion and an antiseptic foaming soap — is sold by Innovative BioDefense online, directly to consumers. According to a 2018 federal complaint, the company marketed their products as being effective against pathogens such as norovirus, rhinovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aerus bacteria and Ebola.
The court found a "lack of proof" of the products' safety and effectiveness for such uses and no approval from the FDA. The court also found that Innovative BioDefense's violations of the Federal Food, Drug and Cosmetic Act, or FDCA, were persistent and recurrent.
The order was the result of an eight-day trial and while it coincides with the coronavirus pandemic and a severe shortage of hand sanitizer in stores, COVID-19 was not one of the diseases that Zylast claimed to be effective against.
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