AILSA CHANG, HOST:
Surgical masks and other protective equipment remain hard to come by even months into the COVID-19 pandemic. NPR pharmaceuticals correspondent Sydney Lupkin is here to tell us about another complication - certificates from suppliers that imply their products have the Food and Drug Administration's seal of approval. But those certificates don't come from the agency at all.
Hey, Sydney.
SYDNEY LUPKIN, BYLINE: Hey, Ailsa.
CHANG: Hey. So what's going on here? What are these certificates? Like, how are they being used?
LUPKIN: Yeah. So these are bogus certificates. They claim to be certificates of registration, and they usually have the FDA logo on them and a drawing of an eagle. But the FDA doesn't issue them. The certificates are meaningless but give the impression that the company has the FDA's OK to sell a product and that the FDA has inspected a facility. In reality, that's not true. I spoke with Ben England, an attorney and consultant who has dozens of clients that import to the U.S. He says that because of the surge in demand for surgical masks during the COVID-19 pandemic, new manufacturers are entering the market, particularly in China.
BEN ENGLAND: They were making, you know, hats and socks last week and teddy bears. And now they're making masks.
LUPKIN: And they're posting these certificates online and showing them to buyers to make a sale. Even worse, when a mask order arrives at a facility in bad shape - dirty, full of holes, made of the wrong material - sometimes the seller will say, well, I have this FDA certificate.
CHANG: So I mean, how extensively are manufacturers actually using these certificates?
LUPKIN: So the certificates are really popular with manufacturers in China. About 80% of mask imports are coming from China or South Korea according to an NPR analysis of data from importgenius.com. New manufacturers don't know the FDA. But they need to get registered, so they hire third-party companies to handle that for them. Since certificates are kind of expected in China, those third-party companies print one out and hand it over. But registering with the FDA is more like getting in a phone book. It doesn't mean the FDA has OK'd the product or inspected the facility.
On alibaba.com, a giant e-commerce site where manufacturers are selling surgical masks wholesale, we found that about half of their top listings had the certificates. When NPR reached out to Alibaba about it, they took them down and say they're asking sellers to delete confusing information.
CHANG: And what have the FDA had to say about all of this?
LUPKIN: The FDA acknowledges that there is confusion and has posted an FAQ online to help set the record straight. But there's another twist worth noting - right now, because of the pandemic, the agency is letting surgical masks on the market without putting them through its usual review process. But the fact is only the FDA is allowed to use its logo. Here's Attorney Ben England again.
ENGLAND: The obvious implication is that it's an FDA document or the product or the facility to which it relates is somehow approved.
LUPKIN: He says it's a big problem. We found dozens of complaints filed with the FDA about bad masks, including surgical masks, N95s and face shields. And a handful of these added that the seller claimed to have the FDA's OK when it didn't.
CHANG: Well, what about the people who ultimately need to rely on these masks, like health care workers? I mean, how are they getting impacted by this?
LUPKIN: So health care workers like nurses aren't the ones buying things like surgical masks, so they're not seeing the certificates. But they're definitely feeling the effects. Betsy Marville has been a nurse for three decades and is active in the union 1199SEIU. At the start of the pandemic, nurses started complaining to her about what she called hairy masks.
BETSY MARVILLE: They've got some kind of fibers that are shedding off of them when they wear them. And they're irritating their nose and eyes and their respiratory tract.
LUPKIN: She doesn't know where they came from. The box usually says things like a lot number, a manufacturer - not this time. All it said was blue face mask and made in China.
CHANG: That is NPR's Sydney Lupkin.
Thank you, Sydney.
LUPKIN: You bet. Transcript provided by NPR, Copyright NPR.