Reprinted with permission from ProPublica.
In scrambling to buy protective equipment for the coronavirus pandemic, federal agencies purchased up to $11 million worth of Chinese-made masks, often with little attention to manufacturing details or rapidly evolving regulatory guidance about safety or quality, a ProPublica review shows.
Some agencies cannot say who made their masks at a time when thousands of foreign-made respirators appeared on the market, some falsely claiming approval or certification by the Food and Drug Administration. Some agencies bought the masks, known as KN95s, from companies that share a U.S. representative with another firm recently accused of fraud by the Justice Department.
The contracts reflect the intense pressure federal agencies were under to procure protective equipment as the pandemic surfaced and rapidly spread in the U.S. Now, some experts worry that the products could remain in circulation long past the crisis and be used by unsuspecting federal employees who believe they have legitimate respirator masks.
Agencies have relaxed procurement standards, including granting many contracts without competitive bidding, and have been tripped up by shifting FDA standards, the flood of foreign companies entering the U.S. market and a limited domestic supply of respirators made for medical use.
“I'm so glad we didn't get involved in this KN95 market," said Andy Mitchell, a vice president at Mallory Safety and Supply, which supplies N95 masks. “This isn't right what's happening here."
ProPublica reported last month that the Indian Health Service had purchased $3 million of Chinese-made respirator masks from a company started by a former White House official, and that the masks did not meet FDA standards. A House of Representatives committee plans to hold a hearing on Thursday examining the IHS' response to the COVID-19 pandemic.
ProPublica reviewed 21 contracts awarded by 11 federal agencies that specifically mentioned procuring KN95 masks, a Chinese version of N95 respirator masks. Five agencies — the Bureau of Prisons, the Department of Veterans Affairs, the U.S. Marshals Service, the U.S. Mint and the U.S. Forest Service — could not say who manufactured their masks or did not respond to questions. The total spent on the 21 contracts was more than $11 million, but some of the deals also involved other items such as ear loop face masks and hand sanitizer.
Foreign-made masks have come under increasing scrutiny from federal regulators. The FDA issued an emergency use authorization for some Chinese-made masks in health care settings in April, but it narrowed the authorization after some masks were found to let through far more particles than advertised.
In many cases, the agencies buying the masks are not directly involved in health care provision, and are thus beyond the scope of the FDA authorization, although the Indian Health Service and the National Institutes of Health were among the purchasers. Some agencies told ProPublica they would use the masks they purchased only in nonmedical settings, a recognition of the lesser protection they may provide.
But experts said the purchase of such products at all still poses a risk to employees. Dr. Meghan Dierks, a Harvard Medical School professor who previously worked at the FDA on medical device shortage issues, said she is concerned about “all of these potentially inferior products remaining in circulation, remaining on shelves" after the current crisis passes, whether used in medical or nonmedical settings.
“If you're in charge of procuring a product that you expect to confer some level of safety or protection to your workers, there's responsibility there for knowing what's the basic performance criteria and what's the regulatory authority in the United States that monitors this," Dierks said.
The FDA tightened its April emergency rules rules a month later, after testing by the Centers for Disease Control and Prevention revealed that some Chinese masks let in too many fine particles. Dozens of Chinese manufacturers that had initially appeared on an approved FDA list were removed, tripping up buyers who had purchased masks just weeks earlier.
Dr. Suzanne Schwartz, deputy director of the Office of Strategic Partnerships and Technology Innovation at the FDA's Center for Devices and Radiological Health, said the agency has “encouraged importers and distributors to do their own due diligence and take the appropriate steps to verify the product's authenticity prior to importing, particularly those products not authorized by the FDA."
Typically, the FDA moves slowly when issuing rules and regulations, but it quickened its pace during the pandemic, said Michael Abrams, a co-founder of Numerof & Associates, which advises hospitals, pharmaceutical companies, financial institutions and others on health care issues.
“They've been forced to make decisions that they sometimes need to go back on," he said. “Certainly that makes it more difficult for anyone who's relying on what these regulatory entities have to say."
That includes the rest of the federal government. On May 1, the Department of the Interior purchased $114,400 worth of KN95 masks from Red River Resources LLC, a California vendor. The manufacturer was Guangdong ZhiZhen Biological Medicine Co. Ltd., according to the agency.
“At the time of purchase, the respirators were on the list of approved products," Andrea Antunes, an Interior spokeswoman, wrote in an email. “Subsequently, they were removed from the approved list and will not be purchased again."
Antunes did not respond to questions about what the agency would do with the purchased masks.
The website of Guangdong ZhiZhen Biological Medicine displays a mask it labeled “FDA approved FFP2 KN95 Mask." Phone calls and emails sent to CCTC Service Inc., the company's U.S.-based agent, were not returned. CCTC, based in Delaware, is named as the representative for nearly 1,600 devices listed with the FDA this year, including KN95 masks manufactured by two firms used by Zach Fuentes, a former White House deputy chief of staff, to fulfill the contract with the Indian Health Service.
In a federal court complaint filed June 5 against another Chinese mask manufacturer, King Year Printing and Packaging Co. Ltd., by the Justice Department, an FDA special agent said that there is “probable cause to believe CCTC is a fictitious corporation." FDA records list a residential address for the company, the complaint said, and the house's occupant and owners said they had no knowledge of or connection to CCTC. The Wall Street Journal first reported the federal complaint against King Year.
In the complaint, the government alleges that King Year falsely labeled its respirators with the logo of the National Institute for Occupational Safety and Health, which conducts medical device testing, and included “a test report showing compliance with the N95 standard despite the respirators not meeting the minimum standard for N95 respirators."
Since a national emergency was declared in the U.S. on March 13, more than 3,600 Chinese-made products categorized as “surgical respirators" have been listed with the FDA, a ProPublica analysis of government data shows. In all of 2019, the total number of surgical respirators registered with the FDA was five.
“There are a lot of people producing face masks who are not necessarily reputable suppliers or historic suppliers of this product," said Phil Farinelli, vice president at Government Scientific Source, a Northern Virginia supplier that sold KN95s to the National Institutes for Health. “I probably get 10 emails a day from people trying to sell me face masks from China."
The NIH, the agency responsible for public health research, signed a separate contract worth nearly $700,000 for respirator masks in March with Missouri-based Phoenix Textile Corp., federal data shows.
The original contract was for N95 masks, the agency said in a statement to ProPublica. But because those were unavailable, Phoenix Textile proposed KN95s as an alternative.
“When NIH received the order and learned that the masks were not FDA-approved, NIH tested the products using the FDA standards for respirators and the product had failed," the agency said.
NIH requested a refund for the masks it had already received, will not pay for any more and plans to return the masks to Phoenix Textile. Executives with Phoenix Textile did not respond to an email and voicemail requesting comment.
Tests of some imported respirator masks are finding that they often do not provide the level of protection they advertise. Evan Floyd, a professor at the University of Oklahoma's Health Sciences Center, has been testing the filtration capability of KN95 masks purchased by the state of Oklahoma and private businesses.
Around one-third of the approximately 70 brands he has tested thus far do not meet the 95% filtration standard, Floyd said.
Dr. John Howard, the director of NIOSH, said in an FDA webinar on Tuesday that the agency recently had tested over 130 international respirator models and found that more than half were “substandard."
The Indian Health Service purchased 4,000 KN95 masks manufactured by a Chinese firm, ZhangJiaGang ShineYa Sanitary Products Co. Ltd., in an April 9 contract, an IHS spokesman said. The contract is separate from the Fuentes deal. The masks were sent to the IHS office in Bemidji, Minnesota, which serves tribes in Illinois, Indiana, Michigan, Minnesota and Wisconsin.
ZhangJiaGang ShineYa does not appear on the FDA approved list of Chinese manufacturers.
Half of the masks are still in the Bemidji area office and “will not be distributed to health care personnel," an IHS spokesman said. The other 2,000 masks are being used by IHS environmental health officers “and are being used in non-health care settings," he said.
The company's listed U.S. agent, John Flair, did not respond to a request for comment. The U.S. vendor that supplied IHS with the masks, California-based West Coast Business Products Inc., also did not respond.
The U.S. Marshals Service purchased $77,500 worth of KN95 masks in April from Knock-Out Specialties, a Texas firm that recently began selling PPE. The masks were made in China and “the products or vendors have been registered or certified by FDA," said Drew J. Wade, a Marshals Service spokesman, in an email. They are being used in “non-medical, law enforcement situations."
But “registration" with the FDA does not mean that the FDA approves the manufacturer or its products, a fact prominently mentioned on the FDA website. FDA's registration and listing database serves merely to provide a public, central listing of companies that may sell certain medical equipment.
When asked to clarify if the masks were just registered with the FDA or had some further certification, Wade responded: “I'm not sure I can sufficiently answer that question at this time. USMS holds certificates that appeared to denote some sort of FDA approval."
John Bottone, the owner of Knock-Out Specialties, did not respond to a phone call and email seeking comment.
One agency that kept up with the FDA's shifting rules was the Department of Energy's National Nuclear Security Administration. In a contract with a Georgia-based vendor, American Dream Builders, the agency purchased over $400,000 worth of KN95 masks. An NNSA spokeswoman identified the masks' manufacturer as “Guangzhou Powecom Labor Insurance Supplies Company LTD," which does appear on the FDA-approved list.
Another manufacturer was originally supposed to fulfill the order, spokeswoman Kate Hewitt said. But when the FDA updated its criteria and the original manufacturer fell off the approved list, the purchase order for the mask contract was modified on May 18 to change to “an FDA-approved manufacturer," Hewitt said.
The Federal Emergency Management Agency also appears to have purchased KN95 masks from Guangzhou Powecom, although FEMA provided ProPublica with a slightly different manufacturer name when asked about a $4 million contract for KN95 masks it signed in May.
FEMA's vendor was Osirius Group, an automotive manufacturing firm based in Birmingham, Michigan. Timothy Smith, Osirius Group's CEO, said in an email that “they are the same company." Osirius' first shipment to FEMA was set to arrive this week.
Guangzhou Powecom and other firms with the FDA's endorsement are being inundated with orders, Smith said.
“The FDA list has become a bible of sorts and any one on that list gets overrun," he said via email. He said his firm has been doing business in China since 1992.
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