FDA WARNING_LETTER - Captain's Cloth LLC - June 10, 2021

On July 2, 2021, the FDA issued a Warning Letter to Brian Eckert regarding the sale of "KN95 Face Mask" on the website https://captainscloth.com/ and its associated Facebook page. The FDA reviewed these sites on June 10, 2021.

The FDA determined that the "KN95 Face Mask" is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act") due to its intended use for disease prevention and affecting body function. The product is considered adulterated under section 501(f)(1)(B) of the Act because it is offered for sale without required marketing approval, clearance, or authorization (PMA or IDE).

Furthermore, the product is misbranded under section 502(o) of the Act because the firm failed to provide the required 510(k) premarket notification. It is also misbranded under section 502(a) of the Act because its labeling is false or misleading, specifically by displaying the FDA logo and making statements implying FDA approval or endorsement, which is prohibited.

The letter requires a written response within fifteen business days detailing corrective actions, a plan to prevent recurrence, and supporting documentation. The response should be sent to CDRHWarningLetterResponses@fda.hhs.gov or via mail to the specified FDA address, referencing CMS Case