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

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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.”

The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit

The American Cleaning Institute® (ACI – is the Home of the U.S. Cleaning Products Industry® and represents the $60 billion U.S. cleaning product supply chain. ACI members include the manufacturers and formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and chemical distributors. ACI serves the growth and innovation of the U.S. cleaning products industry by advancing the health and quality of life of people and protecting our planet. ACI achieves this through a continuous commitment to sound science and being a credible voice for the cleaning products industry.