Last Updated on June 4, 2021 by Ithos Global Regulatory Team
The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) have called on the U.S. Food and Drug Administration (FDA) to withdraw its temporary guidance for the manufacturing of alcohol-based hand sanitizer products.
In an effort to address the COVID-19 pandemic in the spring of 2020, the agency issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products, including the “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”.
In their letter to the agency, the two industry groups call out the numerous quality and safety issues with hand sanitizers manufactured under the temporary policy throughout the pandemic and cite the lack of compliance of certain Current Good Manufacturing Practice requirements (cGMPs) as the likely cause.
Elsewhere in hand sanitizer news, drugstore chain CVS is facing a class action lawsuit over its CVS Health brand hand sanitizer, which it claims kills 99.99% of germs. The plaintiff in the case argues that there are a number of pathogens it cannot kill.
A California’s U.S. District judge approved the certification, which suggests a future class action suit against the company. The suit was first submitted to California state court in May 2020 and moved to the federal court in October.
It is noteworthy that CVS voluntarily recalled hand sanitizers under the brand name “Next Hand Sanitizer” after the FDA added it to its warning list of sanitizers consumers should not use due to contamination.
The outcome of this lawsuit may affect the hand sanitizer market. It is important that appropriate testing to substantiate effectiveness claims are conducted. It will be interesting to observe how current testing protocols are affected.