Horowitz: Masks are experimental medical devices that must be optional, according to law Emergency Use Authorization

theblaze.com ^ | March 26, 2021 | DANIEL HOROWITZ

[ransomnote]

Just like the COVID vaccines, use of masks (instead of respirators) to block transmission of a virus was only authorized as experimental use. As such, according to law, it must be optional. If we are going to passively allow governors and governments to make this medical device mandatory, what is to stop them from making the vaccine mandatory?

As I've mentioned before, both the FDA and OSHA have made it clear over the years that only respirators, not masks, are considered valid PPE to block transmission of a respiratory virus. Which is why mask manufacturers must continue to place a disclaimer on their labels that the product does not work for airborne viruses. The CDC is lying to the public and giving them a false sense of security by suggesting masks are valid medical devices for COVID. That is why the FDA was forced to use an Emergency Use Authorization – the same process used for the vaccines – to approve masks as medical devices to be used as source control to reduce the spread of COVID on April 24, 2020.

This is also why in the EUA statement, the FDA discloses, "A face mask is a device, with or without a face shield, that covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels." Well, indeed, any industrial hygienist or exposure expert will tell you that anything less than a fit-tested N-95 could not even be considered to meet the filtration efficiency levels. Even then, OSHA's Reparatory Protection Guidance under 29 CFR 1910.134 would require fit testing, training, proper breaks, and a medical exam in order for governments or businesses to demand that people use them in various settings.

All this is to say that with no evidence masks work, and with endless evidence that they failed to stop the spread in a single part of the world for 12 months, this is why masks, according to law, must remain optional.

CDC violating FDA's experimental medical device policies

Federal law governing the conditions of authorization of unapproved emergency medical products (21 U.S.C. §360bbb–3(e)(1)(A)(ii)(III)) requires the secretary of HHS to "ensure that individuals to whom the product is administered are informed," among other things, "of the option to accept or refuse administration of the product."

There it is in plain English. This is the reason, among others, why the federal government or any other actor cannot mandate the COVID vaccines. For the CDC to make masks mandatory on all federal lands and places of travel, and possibly even for states to do it, violates the emergency authorization use of medical device statute that same way it would if they mandate vaccines.

MORE AT LINK

[ransomnote]

Thank you to Greeneyes for providing the link and comments in the following post:

greeneyes to greeneyes; ransomnote; All

STUDIO B JUST READ THIS EXCELLENT OP ED BY HOROWITZ, SO I WENT LOOKING FOR IT.

ICYMI:

Horowitz: Masks are experimental medical devices that must be optional, according to law
OP-ED
Emergency Use Authorization
DANIEL HOROWITZ March 26, 2021

Just like the COVID vaccines, use of masks (instead of respirators) to block transmission of a virus was only authorized as experimental use.

As such, according to law, it must be optional. If we are going to passively allow governors and governments to make this medical device mandatory, what is to stop them from making the vaccine mandatory?

As I’ve mentioned before, both the FDA and OSHA have made it clear over the years that only respirators, not masks, are considered valid PPE to block transmission of a respiratory virus.

Which is why mask manufacturers must continue to place a disclaimer on their labels that the product does not work for airborne viruses.

The CDC is lying to the public and giving them a false sense of security by suggesting masks are valid medical devices for COVID. That is why the FDA was forced to use an Emergency Use Authorization – the same process used for the vaccines – to approve masks as medical devices to be used as source control to reduce the spread of COVID on April 24, 2020. ...SNIP...

https://www.theblaze.com/op-ed/horowitz-masks-are-experimental-medical-devices-that-must-be-optional-according-to-law

[Texas Eagle]

Great point. Mandating mask wearing is dispensing medical advice without seeing the patient. A clear violation.

Herr Doktor Fauscist should have his medical license revoked.

[ifinnegan]

Common masks aren’t medical devices.

[JD_UTDallas]

The governors can make vaccines mandatory they have all the legal constitutional authority to do so. The Supreme Court has already decided that long ago. Open a history book it’s right there. Not that they should but to say they don’t have the authority to do so is false.

But don’t take my word for it just look up the case.

“Jacobson v. Massachusetts, 197 U.S. 11, was a United States Supreme Court case in which the Court upheld the authority of states to enforce compulsory vaccination laws. The Court’s decision articulated the view that individual liberty is not absolute and is subject to the police power of the state. “

All this Kabuki<<spelling? Theater is growing tiresome. Everyone who is trained in bio or chem warfare knows only a respirator will protect the person wearing it. The point of masks was NEVER to protect the person wearing it they keep particles next to the persons mouth that’s it. But Americans are such narcissistic a$$holes if you told the truth that the masks are to keep your mouth funk on your face and not in the air up to 5 meters away the selfish Americans would be F every one else. So we have the kabuki theater instead. In Japan they know full well the masks are part of the social contract and wear them to protect others and not just for covid. Go to Japan during flu season nearly everyone who has so much as a sniffle will be wearing a mask at all times why because the Japanese have a bond with their fellow man and have honor and discipline. I wish Americans could be half has disciplined as the Japanese we would have been over with this like they are 6 months ago.

[SoCal Pubbie]

So masks only block one way transmission, is that what you’re saying?

[Deaf Smith]

Correction:

Respirators prevent reception of hazards in the air, not transmission.

Respirators only filter intake, not expelled air.

My Corp does not understand this as we make our customers feel "safe" by wearing half face respirators.

[greeneyes]

Jacobson v. Massachusetts, 197 U.S. 11 (1905)

The emergency use law which Horowitz refers to was passed after this case:

(June 25, 1938, ch. 675, §564A, as added Pub. L. 113–5, title III, §302(b), Mar. 13, 2013, 127 Stat. 183 ; amended Pub. L. 114–255, div. A, title III, §3088(c), Dec. 13, 2016, 130 Stat. 1149 ; Pub. L. 116–22, title VII, §705(c), June 24, 2019, 133 Stat. 964 .)

And there is a difference from a traditional vaccine that has gone through the required testing and emergency use authorization according to what Horowitz is saying.

The FDA has not approved it. It’s authorized as emergency use-which also requires that there is no known viable treatment.

That’s my understanding of the distinction. So is it ok to require experimental shots? Has that been litigated?

[greeneyes]

Common masks aren’t medical devices.
**************************************************************************

The surgical masks that everyone is pushing on people when they enter without a mask is considered a medical device:

Face mask regulations explained ... - NS Medical Devices
Search domain www.nsmedicaldevices.com/analysis/face-mask-regulations/https://www.nsmedicaldevices.com/analysis/face-mask-regulations/

Respirator masks are considered personal protective equipment (PPE) products by both the European Union and US Food and Drug Administration (FDA), while surgical face masks are classified as a medical device.

Furthermore the Law that Horowitz cites has a very broad definition which they call “eligible product”. It doesn’t address just medical devices.

[Truthoverpower]

Libs love the mask. There’s no doubt about it. Maybe cause they’re ugly

[ImAbelieverinfreep]

Japan does Japan. The United States does THE CONSTITUTION.

[bagster]

Common masks aren’t medical devices.

Just a second, doctor. Consider this;

How to Determine if Your Product is a Medical Device

(excerpt)

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters.

Certain radiation-emitting electronic products that have a medical use or make medical claims are also considered medical devices. Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers.

What say you?

[bagster]

why because the Japanese have a bond with their fellow man and have honor and discipline.

Balderdash.

a.) Masks don't work and have done nothing to stem the spread. You have been fed lies.

b.) The Japanese are used to being subservient to authority, they have been for a thousand years. They have never been free in the way that Americans have. Remember, they didn't 'die for Japan', they 'died for the Emperor'.

Your analogy is flawed and your basic premise false.

[bagster]

Libs love the mask. There’s no doubt about it. Maybe cause they’re ugly.

That's the real reason.

I mandate that Hillary, Whoopie, M. Waters, and Nadler wear a mask in perpetuity.

A more complete list to be submitted by the end of the week.

[ifinnegan]

You like to waste a lot of time on personal grudges I see.

It’s good for you to read, so I’ve done you a service.

Keep reading FDA guidances on medical device approval.