FDA WARNING_LETTER - Zhejiang Xichen Medical Technology Co., Ltd. - March 23, 2021

On June 4, 2021, the FDA issued a Warning Letter to Zhejiang Xichen Medical Technology Co. Ltd. (China) regarding their website, xichen-med.com, reviewed on March 23, 2021. The FDA found that the "FFP2 NR 5-Layer KN95 Face Mask," "Medical Face Mask," and "Sterile Surgical Mask" were offered for sale in the U.S. and marketed with claims indicating their use in disease diagnosis, cure, mitigation, treatment, or prevention, or to affect body structure/function, classifying them as devices under the Federal Food, Drug, and Cosmetic Act.

Specifically, the FFP2 NR 5-Layer KN95 Face Mask was marketed as a "COVID-19 Respirator" with "effective antibacterial" properties to "prevent…bacteria, droplets," and "filter germs." The Medical Face Mask was advertised to "prevent infection," "protect patients...from pathogenic microorganisms," and boasted a "bacterial filtration efficiency [of] > 98%." The Sterile Surgical Mask was promoted as "antibacterial" with "BFE above 95%" to "prevent the spread of body fluids...and isolate dust, particle, alcohol, blood, bacteria, and virus invading."

These products are considered adulterated under section 501(f)(1)(B) of the Act because they lack FDA marketing approval, clearance,