FDA Pulls the Plug on a Lot of China PPE


According to press reports, the U.S. Food & Drug Administration (FDA) has withdrawn its authorization for dozens of China-made respirators, “after government testing found many didn’t work properly.” This is reflected in the FDA’s own thinning list of China-made respirators covered by the  relevant Emergency Use Authorization (EUA), the current iteration of which lists only 14 manufacturers, down from a peak of around 60. The EUA was originally issued on April 3, 2020, but was reissued yesterday, May 7, 2020:

In response to questions and concerns that have been received by FDA since
issuance of the [original EUA] and having concluded that revising the April 3, 2020 EUA is appropriate to protect the public health or safety . . . FDA is reissuing the April 3, 2020 letter with certain revisions. Specifically, FDA has revised the April 3, 2020 EUA for clarity and to address concerns about sub-standard products, which includes revising the third criterion for eligibility and adding a process for removal from Appendix A.

Regarding that third criterion, under the updated EUA, a China-made respirator is eligible for authorization if

it was previously listed in Appendix A under the April 3, 2020 letter of authorization as
an authorized respirator because it demonstrated acceptable performance to applicable
standards as documented by test reports, has had particulate filtration efficiency assessed
by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEBAPR-STP-0059 within 45 calendar days of the date of issuance of this EUA, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent.

The language of the original EUA was much vaguer, giving much more leeway as to what test reports had to show.

To be clear, this decision only affects respirators “intended for use by health care personnel in healthcare settings.” Masks intended for use by the general public are outside the purview of the FDA. This means that respirators manufactured by the companies  removed from the authorized list can still be imported for use by, say, painters and others dealing with smoke or fumes. Whether valved respirators are suitable for use in everyday settings is a different question, which we will leave to the experts.

It is also worth clarifying that China-made respirators that meet regular FDA standards are A-OK. What the EUA sought to do was open the market to the large universe of China-made respirators manufactured for use within China and/or third countries, recognizing that at least some of them might be of sufficient quality.

In addition to the obvious relevance for those who were planning to import and/or use respirators on the basis of the EUA, there are three general takeaways here:

One, everything about China PPE, both at the China and U.S. ends, is in constant flux. As we stress every time we talk about the subject (for example, during our recent webinar), it is important to check all relevant regulation and appended lists constantly, because they are changing constantly . Back in April, in China PPE: Just When You Thought it Might be Safe to Go into the Water, we noted that, when “advising clients on importing face masks and other PPE products from China, our PPE team advises that one of the biggest risks is that the export/import rules constantly change.”

Two, with regard to the FDA’s authorizations, as their name indicates, they have been issued in the context of an emergency. As that emergency subsides, it is to be expected that the government restores normal standards. After all, there are reasons why the respirators covered by the EUAs were not authorized for use in health care settings before the COVID-19 emergency. Moreover, even if the underlying public health situation remains fraught, increased domestic production could also allow the FDA to restore normal standards.

As I recently have been writing to clients:

It is important to keep in mind that this is a fluid situation, which is likely to change as the emergency subsides and/or domestic production ramps up. It is fair to expect that the FDA will begin to curtail the scope of the EUAs as respirators that meet its normal standards come to market and/or are provided by the government.

Finally, this is yet another reminder of the continuing quality problems with Chinese products. As we pointed out in Fighting Fake and Bad Quality PPE with QC Inspections, “bad quality PPE is everywhere in China; even in FDA-certified factories.” As the author of the post, Sajag Agarwal of Movley explained

We routinely see QC issues with [PPE], whether they are standard civilian grade or medical items. For example, we recently inspected Class II FDA (Product Code: MSH) KN95 masks, and found over 7% had holes in them large enough to easily see with the naked eye. Just because a supplier is FDA-registered does not mean their product quality is good.

COVID-19 has changed a lot, but as far as shoddy and counterfeit products coming from China go, it’s business as usual.

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