The American Cleaning Institute, Consumer Healthcare Products Association have been calling for the temporary guidance withdrawal, citing quality and safety concerns as well as stabilized supply chains.
The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) praise the U.S. Food and Drug Administration (FDA) for announcing the withdrawal of its temporary guidance for the manufacturing of alcohol-based hand sanitizer products.
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.
“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. “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. Now that supplies have been stabilized, the removal of this temporary guidance will free up FDA’s time to return to its important work.”
In April 2021, ACI and CHPA submitted a joint letter to FDA, recommending that, “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, allowing a reasonable period for manufacturers marketing under the temporary guidance to finish out their pre-existing supply contracts. We further 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.”