Early in the COVID-19 pandemic, the U.S. market was flooded with cheap (and often faulty) personal protective equipment (PPE) — mainly from China. As the United States faced a shortage of life-saving PPE, scammers spotted an opportunity to make a quick buck, producing misbranded and defective masks falsely claiming to be N-95 respirators. The Centers for Disease Control and Prevention (CDC) found many of these products failed to meet the safety standards required to protect against the coronavirus. And the FBI warned the health care industry of “an increased potential for fraudulent activity dealing with the purchase of COVID-19-related medical equipment.” To help consumers identify the safest masks and ensure they know what they are buying, the CDC recently stated they are working with industry standards groups to develop minimum filter efficiency standards. In early 2021, products that meet this safety criteria will have a specific label that clearly states so - making it easier to identify effectiveness of a mask prior to purchase.
The right kind of PPE are critical to saving lives. Most types are available without a prescription and sold at pharmacies, medical supply stores, and by online retailers. To the uninformed, navigating this marketplace and avoiding its many pitfalls can be challenging.
The American Mask Company (AMC) was founded to meet the surge in demand for PPE. All of our products are 100 percent U.S.-made — allowing us to guarantee the quality of our products and the reliability of our supply chains. Our team has put together some useful tips to help you navigate the PPE market.
How to Spot Fraud
The Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) are responsible for evaluating and regulating respiratory protective devices in the United States. Such devices must receive NIOSH approval and meet standards and test results specified by 42 Code of Federal Regulations (CFR) Part 84 before they can be used by the public.
NIOSH-approved respirators come with an approval label on or within the packaging of the respirator. 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.
According to the CDC:
“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.”
The CDC offers helpful guidance on how to spot counterfeit PPE.
The CDC lists the following red flags 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
The U.S. government has attempted to address the issue of counterfeit PPE through the Federal Emergency Management Agency’s (FEMA’s) Supply Chain Task Force, tighter regulation by the Food and Drug Administration (FDA), through arrests and prosecutions by the U.S. Department of Justice, and seizures of fraudulent goods by U.S. Customs and Border Protection (CBP).
FEMA advises organizations to report instances of counterfeit or fraudulently labeled PPE, as well as any instances of hoarding or price gouging relating to PPE, to the National Center for Disaster Fraud.
Where is the PPE Manufactured?
In order to better ensure the quality of PPE and avoid supply chain disruptions, the U.S. government is increasingly requiring vendors to provide U.S.-made PPE.
AMC prides itself on manufacturing all of its products in the United States, down to the last molecule. On our website, we have published full details about our manufacturing process; we also provide the locations of our manufacturers and full details about testing and certification so you can have all of this information at your fingertips.
The fact that our products are manufactured in the United States helps us ensure the quality of our products, guarantee the security of our supply chain, and protect against disruptions.
Is the Vendor Up-Front?
AMC is a firm believer in transparency; vendor transparency should be a priority when shopping for a PPE provider. A reliable and legitimate vendor will be up-front about their products and supply chain, easy to communicate with, and ready to provide all necessary information throughout the process — including shipment-tracking numbers, proof of shipment, source of goods, etc.
This bring us to the question of legitimacy.
Is the Vendor Legitimate?
The legitimacy of vendors is critical, especially when you are purchasing products on which your life (literally) depends.
The FBI has helpful guidance on signs of suspicious activity by the vendor. This includes:
- Unusual payment terms (e.g., supplier asking for up-front payments)
- Last-minute price changes
- Last-minute excuses for delay in shipment (e.g., claims that the equipment was seized at port or stuck in customs)
- Unexplained source of bulk supply
The FBI has some recommendations for ensuring the legitimacy of the PPE vendor. These include:
- Verify NIOSH approval. Consult the CDC NIOSH website to view a list of all NIOSH-approved manufacturers of N95 respirator masks and validate approval and certification numbers.
- Verify the URL and web address. When ordering PPE from online retailers, always verify the URL and confirm “https” is in the web address — a lack of security certification (“https”) may be an indicator that the site is insecure or compromised. The Federal Trade Commission (FTC) warns that there are also countless fraudulent new websites claiming to sell PPE.
- Confirm the approval status and certification numbers. If the product claims N95 respirator mask approval, confirm the status and certification numbers using the NIOSH flyer, the NIOSH website, or the CDC website, which includes examples of identified counterfeit or unapproved N95 respirators.
- Consult the manufacturer for authenticity. If procuring other categories of PPE such as gowns, gloves, goggles, and face shields, consult the manufacturer to verify authenticity and availability.
- Be cautious. Be wary of unprompted solicitations to purchase large quantities of PPE and do not provide usernames, passwords, personal identifying information (PII) such as social security number and date of birth, or financial information in response to an email or robocall.
Tests and Certifications
The FDA has established Quality Systems Regulations and Good Manufacturing Practices to ensure PPE are safe and effective. Manufacturers are expected to abide by these regulations and practices. “For PPE, these standards may include for fluid resistance, leak protection, filtering capacity, or resistance to tears and snags,” according to the FDA.
It is important to understand what tests the PPE you are purchasing has undergone and what certifications it has received. AMC’s face shields are regulated by the FDA under 21 CFR 878.4040—surgical apparel. Face shields are Class I devices and are exempt from premarket notification requirements under 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Our surgical masks have been tested to the ASTM Level 1 standard by Intertek undergoing rigorous testing that covered filtration efficiency, fluid resistance, and breathability. And our half mask respirators have undergone rigorous pre-certification testing at the U.S. Army Combat Capabilities Development Command (CCDC) Chemical Biological Center at Aberdeen Proving Ground, Maryland. Once completed, they will go to NIOSH for certification.
Pay Attention to the Price Tag
Finally, while low-cost PPE may seem attractive, it often comes at the cost of quality. If the price of a product sounds too good to be true, it probably isn’t.
On the other hand, demand for PPE has sent prices skyrocketing and unscrupulous persons have indulged in hoarding and price gouging.