FDA Warning Letters – COVID-19 Testing Kits

FDA issues warning letters for many different reasons. These reasons include misbranding and adulterated drugs. A recent category of warning letters are letters for “Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19).” This category includes COVID-19 testing kits.

On March 20, 2019, FDA announced that the agency is actively and aggressively monitoring marketing products that make fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims. The agency stated that FDA is starting to observe unauthorized fraudulent test kits which are being marketed to test for COVID-19 in the home.

As of the date of the release, FDA states that the agency hasn’t authorized any at-home tests kits for testing whether a person has COVID-19 (though, at least one was granted an emergency use authorization after the release date,  Lucira COVID-19 All-In-One Test Kit – Letter of Authorization (fda.gov). FDA does agree that valid trusted COVID-19 test kits will benefit the public but that fraudulent health claims, tests, and produces may be a danger. A leading danger is that some patients may delay getting the medical care that the patient needed because the patient relied on an inaccurate test.

FDA recommends that consumers follow the U.S. Centers for Disease Control and Prevention’s guidelines and speak with their local healthcare provider if the consumer has any COVID-19 symptoms or reasons to believe the consumer might be infected. Medical providers should be able to inform patients about whether the patients need to get tested and how.

The FDA announcement states that the agency will take appropriate actions to help ensure the public isn’t deceived by marketing tests that may risk a patient’s health. These actions include warning letters, seizures, and injunctions. FDA has already identified and issued warning letters to companies found “selling and promoting fraudulent items.” FDA also added that the agency is stepping up enforcement at ports of entry, including International Mail Facilities, to ensure these fraudulent products that originate outside the country do not enter through our borders.

FDA is an agency with the US Department of Health and Human Services. FDA “protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.”

Lucira COVID-19 All-In-One Test Kit – Letter of Authorization (fda.gov)

FDA did approve a COVID-19 test kit in a letter of authorization dated November 17, 2020. The letter identified the product, the company, and the intended use.

The intended use was listed as:

“Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is for prescription home use with self-collected nasal swab specimens in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider.

This test is also authorized for use at the point of care (POC), in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, with self-collected nasal swab specimens in individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC.

This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19.”

Lucira requested that an EUA (Emergency Use Authorization) be granted pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

Based on the dangers of the disease, the HHS Secretary “declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.”

FDA informed Lucira that the agency considered the “totality of scientific information available in authorizing the emergency use of your product for the indication above.”

The authorization summarizes the performance information FDA used in its evaluation (in the Instructions for Use part of the authorization letter). FDA concluded that Lucira did meet the criteria for issuance of this authorization under Section 564(c) of the Act. The test kit was approved as described “in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization.”

The criteria for the issue of authorization are instructive for other companies who seek FDA EUA approval of their COVID-19 test kits:

1. “The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus.
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and
3. There is no adequate, approved, and available alternative to the emergency use of your product.”

FDA warning letters to Avazo-Healthcare, LLCMARCS-CMS 610282

On November 30, 2020, FDA issued a warning letter to a Warminster, PA company going by the name of COVID Test Shop. FDA informed COVID Test shop, which uses the Facebook Social Media site under the name Avazo Detenser that the agency reviewed the company websites, the Facebook account, and the Instagram account for its products. FDA states that the websites offer COVID-19 test kit products and CBD products for sale in America – “and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.”

FDA stated that the Coronavirus Disease 2019 (COVID-19) is a respiratory disease caused by “a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). A public health emergency was announced by the HHS on January 31, 2020. On March 13, 2020, the President, in response to the disease announced a national emergency. The warning letter continues by stating FDA is aggressively working to protect consumers “from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.”

The warning letter then asserts that the company’s products violate this claim structure. FDA states that the company must immediately cease selling the unapproved and unauthorized products.

The Company’s COVID-19 Test Kit Products

The warning letter which focused on the COVID-19 test kit products was based on the following statements on the company’s website (www.covidtests.shop):

The company offers two COVID-19 antigen test kit products for sale:

• “COVID-19 Ag Rapid Test Cassette (Box of 25) for Qualitative Detection of SARS-CoV-2 Antigen in Swabs. CE.”
• “COVID-19 Coronavirus Spike Glycoprotein Antigen Ag Rapid Test Kit by Sputum or Stool. CE. Box of 25.” (Collectively, “COVID-19 antigen tests”).

The violations

FDA review shows that these two products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. For this reason, the products are “devices” under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).

The antigen tests are offered for sale in America – without FDA marketing approval, clearance, or authorization. This means the antigen tests are “adulterated under the ACT – because the company doesn’t have:

• An approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or
• An approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).”

The products are also “misbranded” under section 502(o) of the Act, 21 U.S.C. § 352(o), because the company didn’t notify FDA of its intent to introduce the devices into commercial distribution – which is required by section 510(k) of the Act. Introducing or delivering these products into interstate commerce is prohibited by section 301(a) of the Act. Further, Section 301 (k) prohibits doing “any act with respect to a device while the device is held for sale after shipment in interstate commerce and results in the device being misbranded.”

FDA also studied the company website and saw that the company offers a serology test kit for sale that’s labeled “the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). FDA EUA. Box of 25,”4 and the “FDA EUA CE Approved Coronavirus (COVID-19) IgM/IgG Rapid Test Kit by Assure Tech. Box of 20.” FDA states the EUAs (Emergency Use Authorization) which do authorize use of the Healgen Rapid Test Cassette and the Assure Rapid Test Device – restrict the distribution and use of those products to “authorized laboratories.” Direct sales to consumers are not permitted.

The company was informed that the reply to the warning letter should state the steps the company is taking to ensure that the testing products are only sold to “authorized laboratories,” as required by the EUA.

More information about FDA regulations of COVID-19 devices used to mitigate, prevent, treat, diagnose, or cure the disease can be found on the FDA website – https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-pandemic.

Additional testing information can be found in the FDA guidance document titled – In addition, the guidance titled “Policy for Coronavirus Disease 2019 Tests during the Public Health Emergency (Revised).”

The company was directed to submit any inquiries regarding the COVID-19 test kit products to COVID-19-Task-Force-CDRH@fda.hhs.gov

CBD products that have medical uses for COVID-19

The FDA warning letter discussed additional violations involving CBD products sold by the company which are “intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.” FDA found that the CBD products were unapproved new drugs which were sold in violation of the federal Food, Drug, and Cosmetic Act and that the products were also misbranded in violation of the Act. Introducing the products into interstate commerce also violated the FD&C Act. FDA provided examples of the false claims.

The warning letters advised the company that there may be other violations and that it is the company’s responsibility to show the company is in compliance with the ACT and the implementing regulations. The company was given 48 hours to respond by identifying the corrective steps the company was taking to correct the violations – including steps to prevent further recurring violations. If the company doesn’t make the necessary corrections, FDA informed the company that legal action including seizures and injunctions could follow.

In response to the COVID-19 healthcare pandemic, many companies are developing products and devices to help diagnose, treat, and hopefully cure the disease. These products and devices are monitored by the Food and Drug Administration. FDA has issued a EUA for one at-home self-care product. They’ve issues at least one EUA of a COVID-19 vaccine. A skilled healthcare lawyer can explain FDA compliance issues and how to respond to FDA complaints of noncompliance. Even when FDA grants a EUA, the manufacturer will need to comply with any conditions set forth by FDA in the Emergency Use Authorization.

Medical product and device manufacturers should contact Cohen Healthcare Law Group, PC for legal advice on FDA approval and FDA emergency use authorization for COVID-19 products and any other products. Our experienced healthcare attorneys explain how the FDA approval and EUA process works. We help companies respond to FDA warning letters.