Mask Supply Store

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The 3 ply Surgical Mask, Disposable Protective Mask (which your website indicates is manufactured by “WEIDA Medical apparatus Co., Ltd”), Mask Disposable Protective, and Personal Protective Face Mask are offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, the products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).

Passage 2

In addition, the products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false or misleading.

Passage 3

Stating that the Personal Protective Face Mask is “FDA Approved,” incorporating unauthorized use of FDA’s logo***2*** [https://masksupply.store/]

Passage 4

Unauthorized use of FDA’s logo***2*** displayed in an image of the Mask Disposable Protective’s package [https://masksupply.store/]

Passage 5

Displaying a “Certificate of FDA Registration” also referred to as a “FDA Certificate 3 Ply Mask” (Certificate) issued by “UCL-Reg Service Inc” near information about the products. The Certificate may be viewed by clicking on a link to “View Our Certificates.” The Certificate “certifies that Weida Medical Equipment (Wuxi) Co. Ltd … has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” Although some of the text is illegible, the Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo and an illustration of an eagle with the U.S. flag (or a similar flag) [https://masksupply.store/images/worldofgivingcovid19-certificate.pdf]