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Unless and until a safe and effective COVID-19 vaccine can be developed, our best protection against infection 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 ProtectionWhile 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.
Since then, we've twice visited the NIOSH website which listed 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 July 27, 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.Additional Tips for Spotting Counterfeit Respirators Before You Buy
- 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
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.
Methanol is toxic in very low doses, and the CDC warns :
Every once in awhile we hear of mass poisonings (see Methanol contamination in traditionally fermented alcoholic beverages) - often involving scores or even hundreds of people - who consumed improperly distilled spirits.
Methanol is toxic in very low doses, and the CDC warns :
METHODS OF DISSEMINATION:
- Indoor Air: Methanol can be released into indoor air as a liquid spray (aerosol).
- Water: Methanol can be used to contaminate water.
- Food: Methanol may be used to contaminate food.
- Outdoor Air: Methanol can be released into outdoor air as a liquid spray (aerosol).
- Agricultural: If methanol is released into the air as a liquid spray (aerosol), it has the potential to contaminate agricultural products.
ROUTES OF EXPOSURE: Methanol can be absorbed into the body by inhalation, ingestion, skin contact, or eye contact. Ingestion is an important route of exposure.
On Friday the FDA updated their growing list of methanol-contaminated products, and added warnings about some hand sanitizers that - despite the claims on their labels - don't contain enough active ingredient to effectively kill viruses.
7/31/2020: UPDATE - FDA continues to find issues with certain hand sanitizer products.
[7/31/2020] FDA continues to find issues with certain hand sanitizer products. FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products. The agency urges consumers not to use these subpotent products and has expanded its list to include subpotent hand sanitizers, in addition to hand sanitizers that are or may be contaminated with methanol
The agency continues to add certain hand sanitizers to import alert to stop these products from legally entering the U.S. market.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
Additionally, FDA reminds consumers that no drugs, including hand sanitizers, are approved to prevent the spread of COVID-19.
FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
Complete and submit the report online; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178
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.
