Trade Groups Push US FDA To Close Window On Loosened OTC Sanitizer Production Standards
Latest Contaminant Found In Sanitizers From Soap And Candle Business New To Space
A day after FDA posted Scentsational’s recall announcement due to presence of benzene and acetaldehyde as well as methanol, American Cleaning Institute and Consumer Healthcare Products Association submit a letter urging FDA to restore order to OTC alcohol-based sanitizer market.
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FDA should recall dozens of hand sanitizers found to contain benzene, a known human carcinogen, says Valisure, the compounding pharmacy that raised initial alarm about ranitidine in OTC heartburn drugs, leading eventually to withdrawals of the products.
Widespread findings in the US of methanol in OTC hand sanitizers labeled as containing ethyl or isopropyl alcohol are not without precedent as adulteration affecting a specific type of product. But surging sales hand sanitizers, sub-potent formulations as well as methanol-contaminated, prompted more immediate and comprehensive responses from FDA.
The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.