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Sunday, May 31, 2020

According to the FDA, that mask the CDC is requiring you to wear isn't protecting you from disease.

The CDC states here we must wear cloth face coverings because they may prevent the spread. It recommends:

 "CDC is additionally advising the use of simple cloth face coverings to slow the spread of the virus and help people who may have the virus and do not know it from transmitting it to others.  Cloth face coverings fashioned from household items or made at home from common materials at low cost can be used as an additional, voluntary public health measure.
The cloth face coverings recommended are not surgical masks or N-95 respirators.  Those are critical supplies that must continue to be reserved for healthcare workers and other medical first responders, as recommended by current CDC guidance."
However, the FDA gives guidance here (here ) for the non-surgical masks which the CDC is telling everyone to wear: 
"Masks for non-medical purposes are not medical devices and are not regulated by the FDA.
Under the policy, the FDA believes face masks not intended to provide liquid barrier protection [i.e. non-medical masks] do not create such an undue risk where:
  • The face masks include labeling that:
    • Accurately describes the product as a face mask (as opposed to a surgical mask or filtering facepiece respirator);
    • Includes a list of body-contacting materials (which does not include any drugs or biologics); and
    • Includes recommendations and general statements that would reduce the risk of use. For example, recommendations against use:
      • In any surgical setting or where significant exposure to liquid, bodily, or other hazardous fluids may be expected;
      • In a clinical setting where the infection risks level through inhalation exposure is high;
      • In the presence of a high intensity heat source or flammable gas;
  • The face masks are not intended for any use that would create such an undue risk. For example, the labeling does not include uses for antimicrobial or antiviral protection, infection prevention or reduction, or related uses, and does not include particulate filtration claims."
In other words, the FDA says that it is okay to manufacture and sell these non-medical masks, but they cannot protect you from infection and must be clear about stating this. So, why is the CDC recommending we all wear them? 

Think about it. If a cloth mask won't protect you from symptomatic transmission, why would anyone, including the CDC, think it would protect you from asymptomatic transmission?

To further muddy the waters, the FDA is now allowing millions of non-surgical (but surgical looking) masks to flood into the country from China. None of these masks protect anyone from disease, but they are being marketed as such because of the CDC guidelines, which imply they do. How many of our healthcare workers are now wearing cloth masks that do not protect them from anything? How many of our healthcare workers are wearing cheap, surgical mask imitations that will not protect them from liquids (i.e. the droplets that transmit the disease). 

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