The FDA sent a warning letter to the maker of Purell for inappropriately marketing the hand sanitizer as a way to prevent an array of diseases.
The U.S. Food and Drug Administration sent a warning letter to the maker of Purell this month for inappropriately marketing the hand sanitizer as a way to prevent an array of diseases.
The FDA says GOJO Industries, Purell's parent company, made a series of unverified claims suggesting that over-the-counter hand sanitizer is an effective way of preventing Ebola, MRSA, VRE, norovirus, flu and Candida auris, according to"FDA is currently not aware of any adequate and well-controlled studies demonstrating that killing or decreasing the number of bacteria or viruses on the skin by a certain magnitude produces a corresponding clinical reduction in infection or disease...
On one webpage, GOJO says studies found that Purell reduced student absenteeism by 51% and teacher absenteeism by 10%. The FDA says it is"unaware of any adequate and well-controlled clinical trials in the published literature that" supported this conclusion. "The claims on your product websites … that PURELL® Healthcare Advanced Hand Sanitizers are effective in reducing illness or disease-related student and teacher absenteeism also go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings," the letter says.
The letter says GOJO is responsible for investigating these violations. It requires GOJO to notify the FDA in writing of specific steps it has taken to correct the violations within 15 working days of receiving the letter."GOJO took immediate action to respond to FDA claim requirements. … We have begun updating relevant website and other digital content as directed by the FDA and are taking steps to prevent a recurrence," the statement says.
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