Fair Price Labs, Inc. – FDA Warning Letter, Jul 21, 2020

On July 24, 2020, the FDA issued a Warning Letter to FairPriceMD Inc. after reviewing their websites (www.fairpricelabs.com, www.fairpricemd.com) and social media pages on July 21, 2020. The letter addresses the sale of an at-home sample collection kit, referred to as the "covid-19 home test kit" or "DROPTM SARS-CoV-2 virus ELISA IgG and IgM Self-Collection Test Kit," intended for COVID-19 serology testing.

The FDA determined this product is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h), due to its intended use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The product is deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because FairPriceMD Inc. lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), as the firm failed