The N95 mask is no longer a rare commodity thanks to the return of Chinese imports and a resurgence in U.S. domestic production.
Good luck buying them online or at a big box store.
The lack of testing by the U.S. regulators makes it difficult for vendors to sell fake or poorly made N95 masks, which are often marketed as an N95 equivalent.
The FDA revoked the emergency use authorization for imported masks that lack approval from the CDC last July, and that's why the masks are being sold on Amazon and other retailers.
Boncare, Yotu, and ChiSip are brands produced by companies that have failed federal testing standards, while Chengde Technology is the manufacturer of ChiSip.
According to an analysis of sales data published by Jungle Scout, all but a few of the 50 best-selling KN95 masks on Amazon are plagued by similar problems. Almost $34 million was sold by companies that make or sell masks of questionable quality last month.
Anne Miller is the executive director of Project N95, a nonprofit that connects people to personal protective equipment.
All high-filtration masks sold on the site must pass a rigorous review process, according to a statement on Monday. Before listing N95 and KN95 masks in our store, we verify that they are from a trusted manufacturer by reviewing product packing, product description and invoices to trace the inventory, and we verify that the mask is not listed on the C.D.C.'s counterfeit mask list.
Even with rising vaccination rates, experts say masks still matter. The United States is heading into winter and the holiday travel season with increasing case numbers. The discovery of a new variant, Omicron, is a reminder of the dangers of being too confident. Polls show that a third of elementary-school-age children will likely remain unvaccinated in the near future, as communities in Colorado, New York and California have reimposed mask mandates. Millions of people with weakened immune systems rely on masks for protection.
There are a lot of things that can be done to prevent Covid-19, but wearing a high-quality mask is the most important thing that people can do to protect themselves.
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The company scrambled this summer to rehire workers who had been fired in the months before the Delta variant prompted an increase in sales.
More than a year and a half into the Pandemic, the United States is still awash in counterfeit masks, a problem that underscores the need for a more muscular federal role in regulating consumer products.
American companies have been accused of making exaggerated claims about the level of protection in face coverings that they sell.
A San Diego manufacturer sells a children's mask that it describes as a M95c, while a Staten Island start-up sells an N95 mask that it says is approved by the FDA. The agency called the claims "misleading."
Chinese mask producers have been found to be especially egregious.
They say that the fake and poorly made masks are a threat to public health because they give people a false sense of security, increasing the likelihood that someone might be exposed to the virus while attending class, a music concert or when traveling by plane.
Consumer advocates say that Amazon is the biggest source of masks for consumers, even though brick-and-mortar retailers have also been selling masks of poor quality.
Many KN95s sold on Amazon are promoted by fake reviews, a problem not just confined to masks, according to Saoud Khalifah, founder of Fakespot, a web browser extension that helps consumers detect fraudulent vendors. The F.D.A. says it is trying to stop the rise of counterfeits. The agency revoked its authorization for Chinese-made KN95s, as well as issuing import alert for fraudulent products. Customs officials have been working to stop banned imports, and have seized 34 million counterfeit masks from China.
Judith McMeekin, the F.D.A.'s associate commissioner for regulatory affairs, encouraged the public to report websites and individuals they suspect of selling fraudulent or unauthorized products.
The efforts have had little effect on the platforms where American consumers shop. Senator Elizabeth Warren, Democrat of Massachusetts, said that Amazon has ignored her pleas to ban vendors from selling counterfeit masks and modify the algorithms that lure consumers away from the best respirators. She said that the Department of Justice and Federal Trade Commission must act if the failures continue.
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Various masks of Mr. Collins, who is sharing his findings on the internet.
The problem is amplified by online sites that participate in Amazon's affiliate marketing program, which gives publications a share of online sales for products they recommend to their readers.
The survival of an industry born in the early months of the H1N1 epidemic when Beijing cut off supplies and health care workers scrambled to find face masks, disposable gloves and other items is at risk because of the resurgence of Chinese imports.
The domestic industry has problems beyond the consumer mask market. Medical supply giants that serve the country's large hospital systems have resumed buying protective equipment from overseas.
The Biden administration has been lobbying to retain the exemption on imported protective gear that was put in place earlier in the Pandemic. The American Hospital Association and others are pushing for the continued tax exemption on Chinese masks.
Many American companies have been struggling to find institutional buyers as hospital systems increasingly turn to Chinese imports, according to opponents. The price difference is enough to sway cost-conscience bulk buyers.
The issue was framed as a matter of national security by a dozen Senate Democrats. We should support our domestic manufacturers so they can provide U.S. health systems and other essential workers with the high-quality P.P.E. and vital supplies they need to manage the Covid-19 epidemic.
The tariffs will be reimposed on Nov. 30.
The new infrastructure bill strengthens existing rules that require federal agencies to purchase domestically made medical equipment.
According to the American Mask Manufacturers Association, nearly half of the group's members have stopped making masks in the last few months because of the resurgence of Chinese imports.
The chief executive of Protective Health Gear, a N95 start up in Passaic, N.J., that last summer scrambled to rehire dozens of workers, said that the deck is really stacked against them.
To win approval from the National Institute for Occupational Safety and Health, mask-makers must navigate a rigorous testing regimen.
Chinese KN95s are overseen by the Chinese government, but they are not subjected to the same regulatory vetting. The standards for N95s are more stringent than the ones for KN95s, which are meant to filter out 95 percent of airborne particles. The N95s use a headband, which creates a snug fit, while the KN95s use ear loops.
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Project N95 has a director of government affairs. She said that it doesn't seem unreasonable for the F.D.A. to say that if you failed testing, you can't sell your masks in this market.
Some masks are not problematic. The European Union's respirator standards earn high marks from industry experts, and South Korea produces a N95 equivalent known as a KF94, which experts praise for its consistent quality.
The regulatory vacuum in the United States for imports has inspired a number of amateur mask-testing sleuths, among them Mr. Collins, the mechanical engineer from Minneapolis, who broadcasts his findings on YouTube.
Kelly Carothers, the director of government affairs at Project N95, has spent the past few months gathering a database of problematic masks. Chengde Technology, a Chinese company, is responsible for nearly a third of all mask purchases on Amazon, with 15 million monthly sales. The company sells masks under a number of brand names. Chengde had its emergency authorization status revoked by the F.D.A. and was cited by the C.D.C. for claiming its WWDoll masks were approved by NIOSH.
If the F.D.A. were to do better vetting of Chinese KN95s, American mask makers wouldn't need to be propped up by the government. It would save lives.
An employee of Chengde in China tried to dispute the failing test results but refused to provide further details.
Mr. Armbrust said his company began producing its own KN95s in October, after giving up trying to get Amazon or government regulators to review them.
The masks are almost the same as his N95s, but consumers have been programmed to favor the KN95. He said you can't unring a bell.
He began selling the masks last month and within a week they were outselling the N95s. He said, "If you can't beat them, join them."
