“Quality and Safety” Concerns Should Lead FDA to Withdraw Temporary Hand Sanitizer Manufacturing Guidance

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  • American Cleaning Institute, Consumer Healthcare Products Association Say Pandemic-Inspired Policy is No Longer Needed
  • Long-time Sanitizer Manufacturers Have Secured Supply Chains, Are Able to Meet Product Demand, Groups Say

Washington, D.C. — The American Cleaning Institute (ACI) and the Consumer Healthcare Products Association (CHPA) 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 the early days of the COVID-19 pandemic, FDA issued its 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 these FDA-regulated products. While FDA’s temporary guidance provides instructions for developing hand sanitizers, the newer manufacturers were not required to meet FDA’s typical manufacturing requirements which have historically applied to companies that traditionally make the products to ensure quality and safety.

“FDA issued this temporary policy in the early days of the COVID-19 pandemic in order to meet the huge increase in market demand for hand sanitizers to help address the COVID-19 public health emergency,” wrote ACI and CHPA in a letter to FDA. “We appreciate the actions of all manufacturers to provide hand sanitizer products to support peak consumer and health system demand during the pandemic.”

“We note that FDA has had to address ongoing quality and safety issues associated with many of the products manufactured under the temporary policy, likely due to lack of compliance with Current Good Manufacturing Practice requirements (cGMPs). We believe that it is now appropriate to withdraw the guidance and return to manufacturing only by those firms in full compliance with applicable requirements, including cGMPs.” 

The groups added that the hand sanitizer supply has now stabilized to meet demand and the market has now “become oversaturated with hand sanitizers manufactured under FDA’s temporary policy.”

“ACI and CHPA recommend 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 www.chpa.org.