ACI, CHPA Applaud FDA’s Withdrawal of Temporary Hand Sanitizer Manufacturing Guidance

The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) praise the US Food and Drug Administration (FDA) for announcing the withdrawal of its temporary guidance for the manufacturing of alcohol-based hand sanitizer products.

 

“We applaud the responsible companies that temporarily stepped up to the plate and produced hand sanitizers in accordance with FDA’s guidelines during the early stages of the pandemic,” said Dr. Barbara Kochanowski, senior vice president, regulatory and scientific affairs, CHPA and Dr. James Kim, vice president, science and regulatory Affairs, ACI in a joint statement. “However, we were extremely concerned with ongoing reports of products with dangerous ingredients entering the U.S. market that both jeopardized public health and required significant FDA oversight and resources.”

 

At the beginning of the COVID-19 pandemic, FDA issued a Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), to help meet unprecedented demand, allowing non-traditional sanitizer companies to manufacture FDA-regulated hand sanitizers. While FDA’s temporary guidance provides instructions for developing hand sanitizers, the newer manufacturers were not required to meet FDA’s standard manufacturing quality and safety requirements, which have historically applied to companies that traditionally make the products.

 

In April, ACI and CHPA submitted a joint letter to the FDA, recommending that the FDA promptly withdraw the temporary policy and require alcohol-based hand sanitizer manufacturing that is not in compliance with cGMPs and other applicable requirements to stop. This would allow a reasonable period for manufacturers marketing under the temporary guidance to finish out their pre-existing supply contracts. 

 

The duo also recommend that any product manufactured and placed into interstate commerce prior to the withdrawal of the temporary policy be permitted to remain in distribution to allow distributors time to clear current inventory of temporary hand sanitizer.

 

“Now that supplies have been stabilized, the removal of this temporary guidance will free up FDA’s time to return to its important work,” Kim and Kochanowski said.