TAGS: Toiletries
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.
FDA issued its Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), first in March 2020 and last updated on 10 February 2021.
Guidance Issued to Meet Demand
The guidance was issued 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.
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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,” wrote ACI and CHPA in a letter to FDA.
Support Production of cGMP Compliant Products
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.”
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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,” wrote ACI and CHPA in a letter to FDA.
Source: Consumer Healthcare Products Association (CHPA)