FDA sues soap company that claims to protect against Ebola
The Department of Justice has filed a civil complaint against a hand soap and sanitizer company for claiming that its products will protect customers from diseases.
The move, filed on behalf of the Food and Drug Administration, seeks to block California-based Innovative BioDefense Inc. from selling its Zylast products, which include not just hand sanitizers but lotions and handwashes as well. The complaint, which was filed in the U.S. District Court for the Central District of California, also cites Colette Cozean, the company’s president and CEO.
FDA is going after the company on the grounds that it has falsely claimed that its products can protect from deadly illnesses including the flu, Ebola, and norovirus.
BioDefense says Zylast starts killing germs 15 minutes after use and that the protection lasts for six hours. The product also appeared in a 2018 list of hand-sanitizing measures by Becker's Hospital Review, a leading trade publication for the industry.
Federal law prohibits companies from selling products that falsely market medical benefits or that market benefits without showing regulators that their products work. Several steps are involved in allowing regulators to put a stop to the practice. The FDA and the Federal Trade Commission first sent a warning letter to the company in June 2015, under the Obama administration, but BioDefense continued to sell its products.
"Despite being warned by the FDA about their unproven claims, this company has continued to market their products as a tool for preventing infection from serious disease-related pathogens, without adequate evidence to support these uses," FDA Commissioner Scott Gottlieb said. "We’re concerned that people potentially exposed to pathogens may use these products with a false sense of safety."
People may wash their hands less or protect less against infection as a result of using the products, he said.
If the court grants a permanent injunction, the company would need to go through FDA approval to sell its products again. BioDefense would have to receive certification that the products protect against the illnesses that it claims in its marketing materials.
https:// www.washingtonexaminer.com/policy/healthcare/fda-sues-soap-company-that-claims-to-protect-against-ebola