We’ve all heard of fake brand-name handbags and some of us have sported counterfeit leather goods on occasion without so much as a blush. But fake face masks — is that even a thing? It turns out that the Food and Drug Administration (FDA) has set certain standards for face masks that are used by the public to prevent the wearer from transmitting virus. This type of preventive measure is called source control.
As far as the FDA is concerned, face masks used for this purpose are considered medical devices and are thus regulated by the FDA. But many masks don’t meet these requirements — and worse, they may be making unsubstantiated claims about their protective abilities.
So what do you need to know about fake face masks to keep yourself safe? Here, we break it down.
What is an FDA Approved Face Mask?
An FDA approved face mask has a label that does the following:
- Accurately describes the product as a face mask and includes a list of the materials that come into contact with the body. These materials do not include drugs or biological agents.
- Does not claim that it should be used as a surgical mask or as a liquid barrier protection (resistant to fluids).
- Recommends against use in clinical settings where the risk of infection through inhalation is high or in which aerosols will be generated (e.g., surgical procedures).
- Does not indicate that the mask can be used for anything other than its intended use (source control). For example, the label cannot state or suggest that the mask offers antiviral protection or that it prevents or reduces infection.
- Does not claim to be a respiratory protective device or that it is suitable for particulate filtration.
Face masks that meet these requirements are approved by the FDA under an Emergency Use Authorization to prevent the spread of the virus causing COVID-19.
What are Some Signs of a Fake Mask or Protective Gear?
Face masks with no labels or with labels that do not meet the above requirements are not approved by the FDA. Although not required for FDA approval, the World Health Organization recommends that face masks have at least three layers of fabric: an innermost layer made of cotton or cotton blend fabric; an outermost layer made of polypropylene, polyester or blends of these materials; and a middle layer of synthetic non-woven material such as polypropylene or cotton. Fake face masks may not have these layers.
Respirators such as N95 respirators are regulated by the National Institute for Occupational Safety and Health (NIOSH). Genuine respirators have an approval label on the box or in the instructions, as well as a brief version of the approval. They have one of the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100. Fake respirators lack markings and approval numbers on the filtering facepiece, feature ear loops rather than headbands, and may be ornamented by decorations such as rhinestones or sequins.
Beware the Fake Face Mask
Face masks and respirators that are fake, or not approved by government regulatory bodies, are becoming more common. Knowing the requirements for genuine masks and respirators and what to look out for in fake ones helps in selecting proper protective wear.
Instead, look to brands you can trust like Boomer Naturals. Boomer Multi-Use Protective Face Masks adhere to all FDA and WHO guidelines, and feature cutting-edge anti-microbial Nano-Silver technology designed to help you stay as healthy as possible. Try one today!