FDA Rule Marks Consumer Antibacterial Soaps An Endangered Category
This article was originally published in The Rose Sheet
FDA’s final rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that benzalkonium chloride, benzethonium chloride and chloroxylenol are safe and effective or risk losing the entire OTC drug category. The rule bars firms from marketing consumer antiseptic wash products containing triclosan, triclocarban and 17 other lesser-used active ingredients.
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The American Cleaning Institute is preparing to submit a healthcare personnel hand wash study to the US FDA pending confidentiality discussions, along with results from a literature review on the topic of antimicrobial resistance. A progress report is due to the agency in October, which could stave off an administrative order under the reformed OTC drug review system.
Kline & Company’s worst-case scenario – which it says is looking more and more likely – has the US cosmetics and personal-care market declining by as much as 8.1% in 2020. However, Kline, Mintel and other market intelligence firms say there are opportunities available to companies struggling to weather the COVID-19 storm.
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.