FDA WARNING_LETTER - Databazaar.com - August 17, 2021

The FDA issued a Warning Letter to Databazaar on September 3, 2021, following a website review on August 17, 2021. The letter addresses the sale of "KN95 Mask" products on databazaar.com, which are marketed with claims related to the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, thus classifying them as devices under the Federal Food, Drug, and Cosmetic Act.

The KN95 Masks are deemed adulterated under section 501(f)(1)(B) of the Act because Databazaar lacks the required premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k). Furthermore, the products are misbranded under section 502(a) due to false or misleading labeling, specifically, false claims of FDA approval and misleading use of the FDA logo implying endorsement.

The FDA emphasizes the public health concern given the ongoing COVID-19 pandemic and the reliance of consumers on accurate product information. Databazaar is required to immediately cease the sale of these adulterated and misbranded products. The company must respond in writing within 15 business days, detailing corrective actions taken, plans to prevent recurrence, and supporting documentation. The letter