Regulation

FDA clears Iowa sanitizer maker of making false claims about COVID-19

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The U.S. Food and Drug Administration cleared an Iowa hand sanitizer company of making misleading claims about its product’s ability to “mitigate, prevent, treat, diagnose, or cure COVID-19.” Prefense LLC, of Muscatine, faced an April 23 FDA complaint that made the company the nation’s first manufacturer to get an FDA warning letter claiming the firm marketed a hand sanitizer with unproven COVID-19-related claims.

Fighting COVID-19 in Iowa

We didn’t do it, says first U.S. hand sanitizer maker accused of false claims to treat, cure COVID-19

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An Iowa-based hand sanitizer manufacturer the Food and Drug Administration cited in April for saying its products could “mitigate, prevent, treat, diagnose, or cure COVID-19” says the federal agency is wrong. An attorney for Prefense LLC, of Muscatine, also said the company told the FDA that before the agency announced its April 23 complaint against the firm on April 27, and that the FDA hasn’t acknowledged that response.