After tweeting about this unintended consequence of the wording used by the FDA the day before to Donald Trump, with a link to the following — it seems the issue was complete resolved by that afternoon the same day! The FDA changed it’s position in allowing hospitals to support the use KN95! Well done Mr. Trump!
Publish April 3, 2020 5:28 AM
A new bottle-neck in the importation of N95 mask for the American people happened overnight. As the US government relaxed its customs enforcement yesterday saying it would allow shipments of KN95 mask into the USA. What-else the FDA said just made it much harder to get quality KN95 mask than it was two days ago when they were illegal to import.
Forbidding medical supplies into the USA sounds crazy in a time like this. So allowing KN95 mask into the country sounds logical to protect the American people, except…. The FDA couldn’t leave it at that!
It only took one statement made by Anand Shah, who is the FDA’s deputy commissioner for medical and scientific affairs that had an overnight effect on the willingness of the larger and much more reputable mask manufactures in China to sell bulk to America because they fear they will get hit with lawsuits over the lack of Government FDA Emergency Approval.
“The FDA is not blocking KN95 mask importations,” said Anand Shah, the agency’s deputy commissioner for medical and scientific affairs in an interview.
But…..always has to be a butt that changes it all, he added that even though the agency will allow importers to bring the equipment into the country, they would be doing so at their own risk. Unlike normally certified devices, or those authorized on an emergency basis, KN95 masks would have none of the legal protections or other support provided by the federal government.
The importers, and the manufactures in China must take on the risk for government agencies because the FDA is not taking this serious enough.
AMERICANS NEED PROTECTION NOW!
Anand Shah statement over liability claims changed everything overnight as to which manufactures will import KN95 mask into the USA. Largest manufactures won’t take the risk now, leaving only the smaller, “more profit and less quality” driven manufactures to supply KN95 mask to the USA.
This is a real problem where the USA needs to accept the KN95 standard which is the same as the N95 standard or else America will risk being sent the poorest quality mask that China produces at crazy prices.
Chinese-certified KN95 mask are designed to almost the exact same standard as the N95 — which is certified by the National Institute for Occupational Safety and Health — yet is currently cheaper and far more abundant. Prices for 3M N95s have seen prices rise to $12 or more per mask, while KN95 masks are available for less than $2, according to importers and manufacturers’ marketing materials.
Until now, the FDA didn’t allow for importing KN95 masks, and importers risked their shipment getting stopped before getting through US customs.
A little more than a week ago, the regulator authorized use of a variety of foreign-certified respirators as a substitute for scarce N95 masks on an emergency basis. That authorization came amid a growing public outcry over doctors and nurses forced to reuse respirators or even fashion masks from bandanas.
The unintended consequences of the FDA’s statement can only ensure America’s wholesale pricing of the KN 95 mask will skyrocket in price and quality will go down as these smaller factories will control the prices with the larger ones happier to sell to countries not openly claiming them as liable in a lawsuit for exporting supplies that were not FDA approved for importing.
According to manufacturers, suppliers, and importers, as much as 80% of the world’s supply of all respirator masks of all types are manufactured in China, including US-certified N95 masks and those certified under European Union and other national standards.
Now that many of the larger mask manufactures fear litigation these masks will be entering the US market from smaller mask manufactures making it more important than ever to know how to spot counterfeits of the KN95 standard being imported from China. They have knock-offs of their own products too, so importers need to beware.
We are lucky to have decades long relationships with many professionals in China’s manufacturing hub. Our advice is that you should only import using trusted sources in China that you have an established relationship of trust, who are knowledgeable in the manufacturing of mask or you should deal directly with the factory in China. Here is a list of every FDA approved mask factories to help find trusted sources for KN95 directly from China
Below you will find links to information WarOnFlu provided before the FDA finally changed it’s position on allowing the import of KN95 Mask today. It is more important than ever that companies importing KN95 mask, and the consumers in America buying them understand what they are buying and from who as we depend on these patches of fiber strung around our heads to protect us!
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