Senator Schumer asking FDA to crackdown on unregulated at-home coronavirus testing kits

National News

(WSYR-TV) — Many people are trying to profit off the COVID-19 crisis by selling at-home coronavirus testing kits, but U.S. Senator Chuck Schumer warns that these kits are unregulated, and is asking the FDA to crackdown on them. 

On Sunday, Senator Schumer demanded the FDA to do more oversight of the marketplace and take cease and desist actions against people selling unregulated tests.

Schumer says he’s seen both unregulated COVID-19 testing kits as well as unregulated antibody testing kits being sold on the internet. 

According to a press release from Schumer’s office, if the FDA does not act quickly, many New Yorkers could fall victim to purchasing these kits that could give them a false sense of security.

Schumer said New Yorkers need to rely on testing that has been proven to be accurate in order to fully return to normal.

The authenticity and accuracy of any at-home testing kits must be paramount at the FDA, because consumers are not only willing to buy them, but they are willing to rely upon them. Shoddy tests could spell disaster for hot spot states like New York because if there is anything New York and other places will require to turn the page on this virus, it’s rooted in testing accuracy, and these unregulated kits pose serious risk to the overall recovery.

Senator Chuck Schumer

According to the press release, below is the full letter Senator Schumer sent to FDA Commissioner Stephen Hahn:

Dear Commissioner Hahn:

The array of misinformation about the coronavirus is a danger to public health and an impediment to a swift and full re-opening of our country. One of the most dangerous elements of this misinformation is the volume of unapproved COVID-19 tests available online, many of them claiming they are able to conduct an authentic test at home. As you very well know, these tests are not currently approved. I have grave concerns that New Yorkers, understandably frustrated and desperate because of the broad testing shortage across the country, are turning to these unapproved tests. If such a test is unreliable or administered incorrectly, and a person falsely believes they do not have COVID-19 or have antibodies, that presents a danger to their family and their community.

I appreciate the work that FDA has done thus far, including in its March 20 announcement, in pushing back against these unauthorized tests. However, more must be done. A simple online search, as well as anecdotal evidence from people in New York City, shows that these tests are still easily available and people are buying them. Given how high the stakes are right now, the administration must use all its resources and authority to immediately get these tests off the market.

I request answers to the following questions:

1.     What is the FDA doing since its March 20 announcement to continue to crackdown on these tests?

2.     Does FDA have sufficient resources to monitor and respond to the availability of these unauthorized tests?

3.     What is FDA doing, in coordination with the White House and its press efforts, to educate the public that authorized tests should not be used?


U.S. Senator Charles Schumer

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