FDA WARNING_LETTER - Mask Supply Store - March 12, 2021

On May 21, 2021, the FDA issued a Warning Letter to Masksupply.store following a website review on March 12, 2021. The FDA found that the company was offering "3 ply Surgical Mask," "Disposable Protective Mask," "Mask Disposable Protective," and "Personal Protective Face Mask" for sale in the U.S. These products are considered devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”) due to their intended use in disease diagnosis, cure, mitigation, treatment, or prevention, or to affect body structure/function. The "Personal Protective Face Mask" was specifically noted for its intended use against COVID-19.

The products were found to be adulterated under section 501(f)(1)(B) of the Act because they lacked required marketing approval, clearance, or authorization (PMA or IDE). They were also misbranded under section 502(o) for failure to notify the FDA of intent to introduce devices into commercial distribution (510(k) requirement). Furthermore, the products were misbranded under section 502(a) due to false or misleading labeling, including unauthorized use of the FDA logo and a misleading "Certificate" implying FDA approval, clearance, or endorsement. The FDA emphasized that registration does not denote approval and that such representations are misleading.

Given the COVID-19