0.3 - FDA's Regulation Enforcement Transcends Industry





We all know that the Farm Bill defines hemp as containing .0.3% THC on a dry weight basis. But did you know that 0.3 is also the number the FDA uses to regulate Face Masks? Both are some of the most important health products on earth. While the actual correlation may be sheer coincidence, it is worth looking into.... it could be a signal of a larger, 'plandemic' type conspiracy... [ sarcasm]. Conspiracy or not, the FDA is continuing to restrict life saving medical supplies from those that need it most. Is FDA restricting supply or saving lives?? The number 0.3 may have the answers.


In the definition of hemp, 0.3% is often criticized as arbitrary and too low for high quality CBD production, It was the lowest number possible for certified varieties of fiber and seed throughout Europe over the past two decades, and in France they managed to shave another tenth of a percent (0.2) to protect certain seed companies. With a precedent to stand on and and dangerously thin margin of error for most farmers, many countries, as well as activists, are pushing for a higher limit. I would love to discuss this in more detail, and push for 1% at the Federal level. But in 2020, there are bigger fish to fry.


The FDA, has a lot of fish to fry. And by fish, I mean manufacturers of health products. The FDA never considered CBD for human consumption as a dietary supplement, and now, the FDA is retracting their authorization from the vast majority of mask manufacturers. FDA is focused on the this vital medical equipment , AKA Personal Protective Equipment AKA PPE. While this includes dozens of products from gowns to gloves, it is very important in Face Masks Respirators, most famously, the N95.


The N95 mask is the gold standard, and offers a very high level of protection for hospital workers. The N95 is safety protocol that describes the testing measurements of particles that are blocked. And this is where we find the magic number 0.3 . 0.3 Microns is the particle size regulated by the FDA. Technically, and tragically, the Coronavirus particle, is so infinitesimal and incomprehensibly small, that its diameter can be less than 0.06 microns. In this case, the FDA's job is absolutely important, to regulate these masks, because of how dangerous and tiny these particles are.


The N95 Mask is proven to filter 95% of particles that are 0.3 microns. 0.3 is the magic number. N95 is a certification system used in the U.S. by FDA and CDC. Throughout the world, similar masks are graded using different systems and designations. In China, these masks are KN95. In Korea, these masks are KF94. In Europe they may go by FFP2. There are different certifications that a factory can receive that are commonly used in the U.S.: CE, the European standard, FDA certified, and also NIOSH, which is the Occupational Safety department under Health and Human Services.


This is all relevant, because there has been a massive shortage of N95 masks, for months. And now that Hemp is legal, I have to keep myself busy while solving the world's greatest problems, so I have become a full time mask broker. In early March DROZgroup drafted memo suggesting a policy proposal to alleviate the severe mask shortage. Just a week later, the FDA issued a guidance aligned with the proposal - to allow for the import and use of KN95 respirators, in lieu of N95s. This was a huge benefit to reduce the shortage of lifesaving PPE.


But China is well known to make and ship counterfeit goods (bads?) - across the board for years. Think of all the cheap-fake designer products from Chinatown. Face-masks, like health supplements, unfortunately can be very easy to fake . Unless you are testing the product with special equipment, you won't even be able to spot it. Case in point - FDA has protected consumers from fraudulent CBD products with several warning letters. FDA is trying to do the right thing here.


With masks - the difference can, very tragically, sometimes be the difference between life death. So last week, on May 7, the FDA and CDC released new guidance, removing 65 mask suppliers from a list 80, leaving just 15 suppliers for KN95 masks. This means that there is another major shortage of authorized respirator masks.


Is the FDA making things overly complicated and restricting supply needlessly? Or is FDA providing a lifesaving role in protecting consumers from fraudulent products? I have gone back-and-forth on my views of the FDA over the years, over the months, and over the weeks. Last week's action creates a major shortage of respirator masks for hospitals and governments in the U.S., and will certainly lead to higher prices for the limited supply. But in a global shortage, it will allow KN95s to be sent to other countries and simply mean that hospitals, part of a multi-billion dollar industry, will simply have to pay a few cents more per mask. Is FDA a gift or a curse? Let us know in the comments below!



#N95 #Coronavirus #KN95#KF94 #NIOSH #PPE


Links:


DROZgroup Memo on KN95 Masks

https://www.linkedin.com/posts/bendroz_memo-face-masks-executive-order-activity-6648617559107133440-wo2m


In March, FDA decided to allow KN95 masks

https://www.washingtonpost.com/health/2020/03/10/face-mask-shortage-prompts-cdc-loosen-coronavirus-guidance/


On May 7, FDA and CDC removed 65 of 80 manufacturers from the approved list

https://www.nytimes.com/2020/05/07/health/masks-banned-n95-coronavirus.html



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