August 17, 2018

FDA Seeks Injunction Against Company Selling Unapproved Hand Sanitizers

One part of food safety is keeping your hands clean. That’s why food safety experts tell consumers to wash their hands before they prepare food or before they eat. That can be difficult when you are away from home. That’s why hand sanitizers are so popular.

Hand Sanitizers

But one company is selling unapproved hand sanitizers that claim to prevent infections from many different pathogens, so the FDA is seeking a permanent injunction against that company. The company is BioDefense Inc. of Lake Forest, California. The product is Zylast topical antiseptics.

The company claims that the hand sanitizer is effective against pathogens such as norovirus, rotavirus, flu virus, Methicillin-Resistant Staphylococcus Aureus (MRSA), and Ebola. These are drug claims, and so the product is regulated by FDA as a drug. The press release states, “These products from Innovative BioDefense, Inc. have not been proven to be safe and effective for these uses and are not approved by the FDA.”

FDA Commissioner Scott Gottlieb said in a statement, “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. We’re concerned that people potentially exposed to pathogens may use these products with a false sense of safety. 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.”

The Zylast products include antiseptic lotions, hand washes, and hand sanitizers. They are unapproved new drugs and misbranded drugs, in violation of the Federal Food, Drug, and Cosmetic Act. The company received a warning letter sent jointly by the FDA and the Federal Trade Commission in June 2015.

The action was brought before the court by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the Central District of California.

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