A company that claimed its miracle hand sanitizers and antiseptic lotions would protect people from all sort of nasty diseases, including Ebola, is now being taken to court by the federal government.
On Wednesday, the Food and Drug Administration announced it was filing a complaint in federal court against Innovative BioDefense, Inc, the makers and distributors of several topical antiseptics sold under the brand name Zylast. The complaint alleges that the California-based company ignored previous warnings to not market and sell Zylast (sold online through its website) as a product that could treat or prevent various diseases, skirting FDA drug labeling regulations.
The agency is seeking a permanent injunction that would keep the company from selling Zylast. The lawsuit, filed by the Department of Justice on behalf of the FDA in the U.S. District Court for the Central District of California, also names Colette Cozean, the company’s president and chief executive officer.
According to the complaint, Innovative BioDefense claimed or strongly implied in its marketing material that its Zylast products could prevent diseases ranging from the stomach bug norovirus to the superbug MRSA to Ebola. The company also claims on its website that Zylast’s non-alcohol based formulation, which instead contains a chemical called benzethonium chloride (BZT), could keep germs away for hours at a time, as opposed to the 15 minutes of protection provided by alcohol-based hand sanitizers.
The FDA, along with the Federal Trade Commission, issued a stern warning letter to Innovative BioDefense for the germ claims in 2015, since products aren’t allowed to say they can treat or prevent disease without going through the FDA’s drug-approval process. But the current lawsuit alleges the company largely ignored their warning, only tweaking their language to state that Zylast’s main ingredient, BZT, was approved as a first aid option and “even considered safe and effective in open wounds by the FDA.”
The problem there, according to the FDA, is that it still hasn’t issued a final verdict regarding the effectiveness of BZT as a first aid treatment or its use in open wounds. Nor has it approved the use of BZT in products like Zylast, the FDA said. Because of that, the FDA is arguing these products are essentially new, unapproved drugs that have been illegally sold from California to Arizona, according to the complaint.
“We’re concerned that people potentially exposed to pathogens may use these products with a false sense of safety,” said FDA chief Scott Gottlieb in a statement. “This may result in infrequent hand washing, or the substitution of these products for protective gloves and clothing or hand washing, which are the principal methods for protecting against the spread of diseases.”
Of course, it should be said that Innovative’s alleged activities aren’t really all that different from what other companies that sell consumer antibacterial-laden soaps and hand rubs do. In reality, these products won’t provide the average person any better protection from germs than a simple scrub at the sink with water and plain soap.
The FDA has already started the process of banning ingredients used in consumer antiseptic washes, not only because of their ineffectiveness but over fears they might be promoting antibacterial resistance. It is also reviewing whether the same should happen with hand sanitizers.