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For now - and for the foreseeable future - our best protection against COVID-19 are NPIs - Non-pharmaceutical Interventions - like social distancing, rigorous hand hygiene, and the wearing of face covers and/or masks (see Two Studies (The Lancet & EID Journal) On The Impact Of NPIs On COVID-19 Spread).
Unfortunately, for months we've seen numerous reports of fake and/or counterfeit N95 respirators flooding the market, which endanger not only the Health Care Workers who wear them, but potentially anyone they come in contact with.
In early June the FDA issued a letter to healthcare providers warning:
Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection
While some Chinese manufacturers appear to be producing reasonably reliable products, others are clearly not. On June 9th the FDA issued a letter listing 66 manufacturers of N95/KN95 masks that are no long authorized by the EUA.
We last visited the NIOSH website in early August, where we saw the names and pictures of dozens of fake and/or counterfeit N95 respirators being sold as `NIOSH Approved', complete with bogus NIOSH certification numbers.
Since then NIOSH has updated their page, adding newly reported `fake' or substandard N95 respirators to their list. While these masks are arguably `better than nothing', those who use them in high-risk environments need to be aware of their limitations.
Counterfeit Respirators / Misrepresentation of NIOSH-Approval
Updated September 22, 2020
Counterfeit respirators are products that are falsely marketed and sold as being NIOSH-approved and may not be capable of providing appropriate respiratory protection to workers.
When NIOSH becomes aware of counterfeit respirators or those misrepresenting NIOSH approval on the market, we will post them here to alert users, purchasers, and manufacturers.
How to identify a NIOSH-approved respirator:
NIOSH-approved respirators have an approval label on or within the packaging of the respirator (i.e. on the box itself and/or within the users’ instructions). Additionally, an abbreviated approval is on the FFR itself. You can verify the approval number on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page to determine if the respirator has been approved by NIOSH. NIOSH-approved FFRs will always have one the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.
Signs that a respirator may be counterfeit:
- No markings at all on the filtering facepiece respirator
- No approval (TC) number on filtering facepiece respirator or headband
- No NIOSH markings
- NIOSH spelled incorrectly
- Presence of decorative fabric or other decorative add-ons (e.g., sequins)
- Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children)
- Filtering facepiece respirator has ear loops instead of headbands
Additional Tips for Spotting Counterfeit Respirators Before You Buy
Of perhaps even greater concern to the general public, scores of brands of hand sanitizer being sold in the United States have been found to contain dangerous levels of methanol (see CDC HAN #00434: Serious Adverse Health Events Associated with Methanol-based Hand Sanitizers).
Methanol (wood alcohol) has a long, and tragic history of being used to fortify bootleg liquor, and when ingested even in small quantities converts to formic acid, which can cause permanent blindness or even death. It has legitimate industrial uses (as solvents, pesticides, and alternative fuel sources), but is not meant to be ingested.
As we go into the winter respiratory season it wouldn't hurt to check any hand sanitizer you have on hand against the list, regardless of where you purchased it. And check back every couple of weeks, since additional brands may be added over time.
