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Posted December 22, 2021

Unauthorized Rapid Antigen Test Gets FDA Warning

On December 1, 2021, the FDA issued a warning letter for DermaCare Biosciences, LTD. following a review of the company's websites and social media, which found the company promoted the sale of the Easy Rapid Now COVID-19 Nasal Swab Antigen Test without marketing approval, clearance, or authorization from the FDA, making the product adulterated and misbranded.

The COVID-19 test was promoted with statements such as, "Mass Surveillance. Protect Classrooms, Workplaces, and Other Populations," and "Rapid detection of SARS-CoV-2 nucleocapsid antigen in less than 15 minute[sic]," confirming the company's COVID-19 Test is intended for screening and diagnosis.

Because this product was sold without approval, clearance, or authorization from the FDA while claiming to mitigate, prevent, treat, diagnose, or cure COVID-19 in people, the FDA has instructed immediate action to cease the sale of unapproved, uncleared, and unauthorized products. The company was also advised to send an email to within 48 hours of receipt of the warning, describing the specific steps it has taken to correct these violations.

See ConsumerLab's reviews of rapid antigen tests, including its Top Pick among these tests.

For more information, use the link below.

Warning Letter: DermaCare Biosciences, LTD.

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