FDA WARNING_LETTER - Dongguan City Xinyuan Nonwoven Co., Ltd. - May 19, 2021

On May 27, 2021, the FDA issued a Warning Letter to Dongguan City Xinyuan Nonwoven Co., Ltd. after reviewing their websites, http://xinyuanmask.com/index.php/culture.html and https://dg-xinyuan.en.alibaba.com/?spm=a2700.shop_plser.88.29, on May 19 and May 12, 2021, respectively. The firm offers "Disposable Medical Face Mask," "Wholesale Disposable Medical Protective CE Mask 3 Ply," and "3 Ply Disposable Medical Filter Nonwoven Face Mask Dust" for sale in the U.S.

The FDA determined these products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h), due to claims of medical and protective use, including filtration efficiency, virus isolation, and infection control.

The products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), as the firm lacks required premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act,