But, what has been disturbing me has more to do with law. I am not even referring to the obvious violations of laws and rights, constitutionally guaranteed, that have been literally destroyed during 2020. I am referring to a law that is much more directly related to the specific issue of a “mask.”
Almost all of my professional career has been involved with matters related to the Food, Drug, and Cosmetic Act. Specifically, I have been involved in the areas that are regulated by the Food and Drug Administration (FDA). My first position after the Ph.D. was as a development chemist. I had to learn the regulations concerning Good Manufacturing Practices (GMP) that are specified in the Code of Federal Regulations, Parts 210 and 211.
My experience as a development chemist meant only peripheral contact with the FDA. On a couple of occasions I had to meet and answer technical questions with a FDA inspector.
Later, when I entered Quality Assurance, the role became much more direct. When I rose into management positions, especially at the Director level, I typically was the primary host and liaison when it came to FDA inspections and interactions.
I was mostly involved with drugs and biologics, although I had a brief experience with medical devices. I spent many hours preparing filings, working with inspectors, dealing with quality issues, etc. Besides day-to-day quality assurance activities, dealing with the FDA was a major part of my life and a source of stomach acid production.
Back in March, the first advice was that you do not need to mask (which is scientifically accurate). That soon was lost and the purposes have morphed over time from protecting needed supplies, to protecting the wearer. The shift changed to protecting others (since it was apparent they weren’t protecting the wearer). But here is where the argument turns a little on itself. The idea of a face covering has changed in 2020.
Remember, most face coverings, i.e. “masks” were never intended to deal with infectious disease. They were intended to deal with inert environmental substances, which is the area of occupational health and safety. That is why the N95 has a NIOSH certification. In 2020 that has changed and now it is the idea of protecting oneself or another from an infectious disease. That is disease mitigation, not occupational health and safety.
Let me quote a section from the United States Federal Regulations, that is Section 201(h)) of the Food, Drug, and Cosmetic Act as it defines a Medical Device:
Per Section 201(h) of the Food, Drug, and Cosmetic Act, a device is: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions pursuant to section 520(0).
I submit that any type of face covering that is being used by the general public and is mandated as a part of a public health directive qualifies as a medical device. Since the primary purpose, as stated, of a mask mandate is to prevent transmission of an infectious disease, that is a clear attempt at disease mitigation. As such, these devices have to be approved and regulated by the FDA,
In order to gain FDA approval, the manufacturer has to submit an application, part of which is proof of function, quality control standards, manufacturing specifications, intended usage, stability (i.e. how long or often it can be used), cleaning and disinfecting requirements, etc., amongst other areas.
There is an exemption clause where products that are intended only for promoting a healthy lifestyle are exempted, but they must not meet any of the above definitions. Mandatory mask mandates do not meet that exemption.
What that means is that there must be proof of concept and efficacy if it is to mitigate disease.
So, who would have to comply with that requirement?
- Commercial mask manufacturers for every type of commercial mask that may be used during the mandate.
- Custom manufacturers who are making the “custom/stylish” face covering.
- Any individual who is making their own cloth mask, although conceivably the CDC could set a standard and serve as the surrogate for the millions of people who are doing this and take control of the application process. That would require a “Federally Approved” design.
The thing about the Food, Drug, and Cosmetic Act is that it covers all states and territories of the United States. In other words, individual states cannot get around it by their own mandates.
The Food, Drug, and Cosmetic Act was established, in part, to put forth uniform standards based upon scientific justification for use. There are no uniform standards when it comes to mask mandates, just as there is no scientific justification.
But, since most of the actions that have been taken since March of 2020 have been in violation of the US Constitution itself, why should we expect that to change now?
We are often cynical of regulations, especially over regulation, but sometimes they do serve a purpose. Now may be one such time.
PrintRoger W. Koops
Roger W. Koops holds a Ph.D. in Chemistry from the University of California, Riverside as well as Master and Bachelor degrees from Western Washington University. He worked in the Pharmaceutical and Biotechnology Industry for over 25 years.
Before retiring in 2017, he spent 12 years as a Consultant focused on Quality Assurance/Control and issues related to Regulatory Compliance.
He has authored or co-authored several papers in the areas of pharmaceutical technology and chemistry.
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