2C2K Photography via Flickr

Masks Sold by Former White House Official to Navajo Hospitals Don’t Meet FDA Standards

New information from the Indian Health Service calls into question why the agency purchased expensive medical gear that it now cannot use as intended.

The Indian Health Service acknowledged on Wednesday that 1 million respirator masks it purchased from a former Trump White House official do not meet Food and Drug Administration standards for “use in healthcare settings by health care providers.”

The IHS statement calls into question why the agency purchased expensive medical gear that it now cannot use as intended. The masks were purchased as part of a frantic agency push to supply Navajo hospitals with desperately needed protective equipment in the midst of the coronavirus pandemic.

ProPublica revealed last week that Zach Fuentes, President Donald Trump’s former deputy chief of staff, formed a company in early April and 11 days later won a $3 million contract with IHS to provide specialized respirator masks to the agency for use in Navajo hospitals. The contract was granted with limited competitive bidding.

IHS said its Navajo office “has used every available avenue to purchase more supplies and keep up with the demand.”

The masks provided by Fuentes “are not approved by the FDA or covered by an Emergency Use Authorization for use in healthcare settings by health care providers,” the agency said.

In addition, some of the masks have packaging stating that the product is a “non-medical device.” “These masks will not be used in a clinical setting,” the agency said.

Until now, it was unclear who had manufactured the masks that Fuentes’ firm had provided to IHS and thus impossible to know if they met FDA certifications. Contract data shows that IHS asked for KN95 respirator masks, a Chinese version of specialized N95 masks, which provide far greater protection from viruses than ordinary masks.

On Wednesday, IHS told ProPublica the masks sold by Fuentes were made by four Chinese manufacturers and are registered in an FDA database, but have not met the regulator’s relaxed pandemic-era standards for Chinese-made masks.

Fuentes charged the government $3.24 per mask, which is higher than the pre-pandemic rates for respirator masks and far higher than prices charged for masks that can’t be used in hospital settings.

The agency did not respond to follow-up questions asking why it was keeping the masks if they did not meet standards and whether it would ask Fuentes for a refund.

IHS said it purchased the masks from Fuentes “under urgent and compelling authority to meet program needs. At the time, the IHS Navajo Area determined there was no availability of masks in the US, and limited vendors who could supply the masks. IHS solicited quotes from available vendors to determine a fair and reasonable price.”

Facing an acute shortage of specialized N95 masks, the FDA in April issued emergency rules allowing for the import of Chinese-made masks, in line with certain specifications.

But the FDA later tightened those rules when testing by the Centers for Disease Control and Prevention revealed that some of the Chinese masks let in too many fine particles.

Fuentes’ company told the government that the masks it provided were made by four firms: Rich Resource Global Supply Chain (Guangzhou) Co. Ltd.; Guangdong Jin Jun Lian Medical Technology Co. Ltd.; Zhejiang Jufeng Drilling Decoration Co. Ltd.; and Qingdao Opis Commodity Co. Ltd.

Those four companies, all based in China, are registered with the FDA, but the registry only serves as a phone book of sorts for the sprawling global medical supply industry and does not mean the FDA has certified the company or its products.

“Registration and Listing does not denote approval or clearance of a firm or their devices,” the FDA says on its website.

None of the companies appear on federal government lists of approved foreign-made respirator masks. U.S.-based representatives of the companies listed in FDA records did not respond to emails and phone calls on Wednesday.

An FDA spokesperson said because the companies do not appear on an approved list of Chinese manufacturers, “their products cannot be marketed or distributed in the U.S. as respirators.”

In an interview with ProPublica last week, Sia N. Ashok, a consultant for Fuentes’ company who helped find masks abroad, said the company had “provided all the FDA certificates, all the documentation” to IHS. She declined at the time to name the manufacturers of the masks, saying it could violate the company’s contract, but she sent a ProPublica reporter a picture of a single mask in its packaging, which said the manufacturer was “Rich Resource Global Supply Chain(GuangZhou)CO.,LTD.”

Ashok and Fuentes did not immediately respond to requests for comment.

Fuentes’ deal sparked demands for investigations from Democratic members of Congress.

On Wednesday, Democratic senators and representatives from New Mexico and Arizona sent a letter to the head of the IHS asking for more information on Fuentes’ contract and the masks he provided, as well as the agency’s protocols in obtaining medical protective equipment.

Also on Wednesday, three Democratic representatives — Ruben Gallego and Raul Grijalva of Arizona, and Deb Haaland of New Mexico — asked the Government Accountability Office to open its own investigation into the contract. A GAO spokesman, Chuck Young, said the office goes through an “internal review process” for every new congressional request before it decides on an investigation, which usually takes a couple weeks.

On Tuesday, Rep. Gerry Connolly, a Democrat from Virginia, asked an official in the inspector general’s office at the Department of Health and Human Services to look into the Fuentes contract.

During a call on Saturday with Trump administration officials including IHS Director Rear Adm. Michael Weahkee and HHS Deputy Secretary Eric Hargan, Sen. Tom Udall of New Mexico and other lawmakers pressed officials for contract details, a Democratic aide said on the condition of anonymity.

Officials told the lawmakers that IHS is identifying which portions of the shipments contain “substandard masks” so they are not delivered to IHS facilities for use, the aide said.

Do you have access to information about federal contracts that should be public? Email Yeganeh.Torbati@propublica.org or derek.willis@propublica.org. Here’s how to send tips and documents to ProPublica securely.

This article was originally published in ProPublica. It has been republished under the Creative Commons license.  ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for their newsletter.

X
This website uses cookies to enhance user experience and to analyze performance and traffic on our website. We also share information about your use of our site with our social media, advertising and analytics partners. Learn More / Do Not Sell My Personal Information
Accept Cookies
X
Cookie Preferences Cookie List

Do Not Sell My Personal Information

When you visit our website, we store cookies on your browser to collect information. The information collected might relate to you, your preferences or your device, and is mostly used to make the site work as you expect it to and to provide a more personalized web experience. However, you can choose not to allow certain types of cookies, which may impact your experience of the site and the services we are able to offer. Click on the different category headings to find out more and change our default settings according to your preference. You cannot opt-out of our First Party Strictly Necessary Cookies as they are deployed in order to ensure the proper functioning of our website (such as prompting the cookie banner and remembering your settings, to log into your account, to redirect you when you log out, etc.). For more information about the First and Third Party Cookies used please follow this link.

Allow All Cookies

Manage Consent Preferences

Strictly Necessary Cookies - Always Active

We do not allow you to opt-out of our certain cookies, as they are necessary to ensure the proper functioning of our website (such as prompting our cookie banner and remembering your privacy choices) and/or to monitor site performance. These cookies are not used in a way that constitutes a “sale” of your data under the CCPA. You can set your browser to block or alert you about these cookies, but some parts of the site will not work as intended if you do so. You can usually find these settings in the Options or Preferences menu of your browser. Visit www.allaboutcookies.org to learn more.

Sale of Personal Data, Targeting & Social Media Cookies

Under the California Consumer Privacy Act, you have the right to opt-out of the sale of your personal information to third parties. These cookies collect information for analytics and to personalize your experience with targeted ads. You may exercise your right to opt out of the sale of personal information by using this toggle switch. If you opt out we will not be able to offer you personalised ads and will not hand over your personal information to any third parties. Additionally, you may contact our legal department for further clarification about your rights as a California consumer by using this Exercise My Rights link

If you have enabled privacy controls on your browser (such as a plugin), we have to take that as a valid request to opt-out. Therefore we would not be able to track your activity through the web. This may affect our ability to personalize ads according to your preferences.

Targeting cookies may be set through our site by our advertising partners. They may be used by those companies to build a profile of your interests and show you relevant adverts on other sites. They do not store directly personal information, but are based on uniquely identifying your browser and internet device. If you do not allow these cookies, you will experience less targeted advertising.

Social media cookies are set by a range of social media services that we have added to the site to enable you to share our content with your friends and networks. They are capable of tracking your browser across other sites and building up a profile of your interests. This may impact the content and messages you see on other websites you visit. If you do not allow these cookies you may not be able to use or see these sharing tools.

If you want to opt out of all of our lead reports and lists, please submit a privacy request at our Do Not Sell page.

Save Settings
Cookie Preferences Cookie List

Cookie List

A cookie is a small piece of data (text file) that a website – when visited by a user – asks your browser to store on your device in order to remember information about you, such as your language preference or login information. Those cookies are set by us and called first-party cookies. We also use third-party cookies – which are cookies from a domain different than the domain of the website you are visiting – for our advertising and marketing efforts. More specifically, we use cookies and other tracking technologies for the following purposes:

Strictly Necessary Cookies

We do not allow you to opt-out of our certain cookies, as they are necessary to ensure the proper functioning of our website (such as prompting our cookie banner and remembering your privacy choices) and/or to monitor site performance. These cookies are not used in a way that constitutes a “sale” of your data under the CCPA. You can set your browser to block or alert you about these cookies, but some parts of the site will not work as intended if you do so. You can usually find these settings in the Options or Preferences menu of your browser. Visit www.allaboutcookies.org to learn more.

Functional Cookies

We do not allow you to opt-out of our certain cookies, as they are necessary to ensure the proper functioning of our website (such as prompting our cookie banner and remembering your privacy choices) and/or to monitor site performance. These cookies are not used in a way that constitutes a “sale” of your data under the CCPA. You can set your browser to block or alert you about these cookies, but some parts of the site will not work as intended if you do so. You can usually find these settings in the Options or Preferences menu of your browser. Visit www.allaboutcookies.org to learn more.

Performance Cookies

We do not allow you to opt-out of our certain cookies, as they are necessary to ensure the proper functioning of our website (such as prompting our cookie banner and remembering your privacy choices) and/or to monitor site performance. These cookies are not used in a way that constitutes a “sale” of your data under the CCPA. You can set your browser to block or alert you about these cookies, but some parts of the site will not work as intended if you do so. You can usually find these settings in the Options or Preferences menu of your browser. Visit www.allaboutcookies.org to learn more.

Sale of Personal Data

We also use cookies to personalize your experience on our websites, including by determining the most relevant content and advertisements to show you, and to monitor site traffic and performance, so that we may improve our websites and your experience. You may opt out of our use of such cookies (and the associated “sale” of your Personal Information) by using this toggle switch. You will still see some advertising, regardless of your selection. Because we do not track you across different devices, browsers and GEMG properties, your selection will take effect only on this browser, this device and this website.

Social Media Cookies

We also use cookies to personalize your experience on our websites, including by determining the most relevant content and advertisements to show you, and to monitor site traffic and performance, so that we may improve our websites and your experience. You may opt out of our use of such cookies (and the associated “sale” of your Personal Information) by using this toggle switch. You will still see some advertising, regardless of your selection. Because we do not track you across different devices, browsers and GEMG properties, your selection will take effect only on this browser, this device and this website.

Targeting Cookies

We also use cookies to personalize your experience on our websites, including by determining the most relevant content and advertisements to show you, and to monitor site traffic and performance, so that we may improve our websites and your experience. You may opt out of our use of such cookies (and the associated “sale” of your Personal Information) by using this toggle switch. You will still see some advertising, regardless of your selection. Because we do not track you across different devices, browsers and GEMG properties, your selection will take effect only on this browser, this device and this website.