FDA Warns Purell Marketer For Claims About Ebola, Resistant-Bacteria Protection
GOJO Industries’ online claims for Purell Healthcare Advanced hand sanitizers – including statements about warding off potentially deadly infections – identify its products as unapproved drugs, the FDA asserts in a 17 January warning letter.
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Purell Battling Class Actions Over Disease Claims While World Scrambles To Increase Hand Sanitizer Supplies
Leading chemical firms, beauty and consumer health companies, even distilleries and medical marijuana cultivators are adapting operations to meet global demand for hand sanitizers amid the COVID-19 pandemic. Meanwhile, plaintiff’s attorneys are busy with multiple class actions against Purell manufacturer GOJO Industries for alleged false advertising following a January warning letter to the firm from the US FDA.
Claims that Germstar antiseptic cleanser line treat swine flu, E-coli, salmonella and norovirus are not part of an OTC final monograph or TFM, FDA says in warning letter. The products contain active ingredients FDA deferred from OTC monographs for consumer and health care rubs to await additional data.
The majority of over-the-counter hand sanitizers and wipes on the US market rely on ethyl alcohol, one of three active ingredients for which final rulemaking has been deferred to allow industry to generate additional safety and effectiveness data. FDA's final rule, released April 11, completes a series of related actions pertaining to OTC antiseptic drug products.