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Nature's Distributing and its related entities were selling KN95 and 3-ply masks through their website without FDA approval, marketing them as medical devices intended to prevent coronavirus transmission by claiming filtration rates exceeding 95% and representing them for use by medical professionals and facilities. The products violated the Federal Food, Drug, and Cosmetic Act by being adulterated under section 501(f)(1)(B), as the company lacked the required premarket approval (PMA) or clearance before distributing these COVID-19 mitigation devices in the United States. The FDA identified the violations during a website review conducted on April 22, 2021, noting specific marketing claims that established the masks' intended use for coronavirus prevention.