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August 17, 2020

Wearing a mask is one of the easiest and most effective ways to slow the spread of COVID-19, but not all masks meet the same safety standards. The U.S. Food and Drug Administration’s Emergency Use Authorization, initially published March 2, 2020, can help American businesses and consumers identify manufacturers that uphold required safety standards and produce masks that are safe, effective and approved for use.

Recent revisions to the Emergency Use Authorization have resulted in the removal of many manufacturers from Appendix A, which outlines the manufacturers and products the FDA has approved for use in the United States. This Appendix A list of approved manufacturers for the KN95 masks is commonly referred to as the “white list.”

What does it mean to be an FDA-whitelisted manufacturer, and how can Appendix A help businesses and consumers make the right choices when purchasing masks?

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A widespread shortage of masks and personal protective equipment led the FDA to enact an Emergency Use Authorization that allowed overseas manufacturers to fabricate KN95 masks for use on U.S. soil.

However, many of these masks lack the approval of the National Institute for Occupational Safety and Health, which is the regulatory body responsible for making recommendations that seek to prevent work-related injuries and illnesses.

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Back in late March, the FDA approved a temporary policy allowing for the use of imported masks to help address supply shortages in the U.S. The following month, the FDA revised its initial policy and issued an Emergency Use Authorization that would allow Americans to use non-NIOSH-approved KN95 respirators manufactured in China in response to growing PPE shortages.

While N95 masks set the U.S. standard for respirator masks, KN95 masks differ in that they set the standard for China. In other words, the two types must meet different certification standards, so they may differ to some degree in terms of effectiveness. Because the United States was experiencing such a severe shortage in N95 masks, the FDA allowed for the importation of Chinese KN95 models even when their manufacturers did not produce verified test reports demonstrating product efficacy or evidence of separate authentication.

Once approved for domestic use, the FDA added specific mask models and manufacturers to Appendix A, a list detailing the fabricators and masks the administration deemed adequate, suitable and safe for use in the United States.

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After realizing that many of the masks making their way to the U.S. did not meet the same quality standards as those produced domestically, the FDA reversed its authorization allowing for the use of non-NIOSH-certified models May 7.

In doing so, it expressed concerns about whether non-NIOSH-certified respirators provided adequate respiratory protection against COVID-19, noting that some models failed to demonstrate a minimum particulate filtration efficiency of 95%, which is the U.S. standard.

Under the initial Emergency Use Authorization, KN95 masks did not have to undergo testing by American regulators, but when NIOSH and other independent bodies tested them for efficacy, results showed that many of them fell below acceptable standards. The FDA then reduced its list to only include manufacturers making respirators with strong test results from independent and recognized laboratories.

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Upon further testing, manufacturers that failed to produce masks that met U.S. standards were removed from Appendix A. The number of approved manufacturers for these masks has decreased substantially as a result, and only manufacturers whitelisted by the FDA remain on it.

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The manufacturers that still appear on Appendix A are those that uphold the most stringent safety standards set by U.S. regulatory bodies.

Certain manufacturers that appear on the revised whitelist, among them Lanshan Shendun Technology, had their masks independently tested to ensure they upheld these strict standards and were appropriate for inclusion on Appendix A. The results of these tests are available for viewing on the Centers for Disease Control and Prevention website. Here is an example of a test report from Lanshan Shendun Technology posted on the CDC website.

Any KN95 masks that come from manufacturers that do not appear on Appendix A may not meet U.S. safety and efficacy standards. Consumers and businesses should exercise extreme caution before using them and also consider conducting their own tests prior to use because there have been some instances of false reporting from certain manufacturers.

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Earlier, we asked what it meant to be an FDA-whitelisted manufacturer. In its simplest terms, it means these manufacturers follow required protocols and fabricate masks that are safe, effective and approved for use by Americans.

We also asked how Appendix A can help businesses and consumers make the right choices when purchasing masks. Before purchasing a particular mask, check to see if the manufacturer and mask model appears on Appendix A. If the manufacturer does not appear on the list, do not take the chance. KN95 masks produced by manufacturers on Appendix A are usually a little more expensive, but the premium is well worth it when the bad outcomes from ineffective masks are considered.

The information provided on Appendix A is subject to change, so check back regularly for the most up-to-date information available.