FDA WARNING_LETTER - Invisi Smart Technologies UK LTD - June 21, 2021

On August 24, 2021, the FDA issued a Warning Letter to Invisi Smart Mask, specifically addressing Ms. Saba Yussouf, regarding the sale of adulterated and misbranded products related to COVID-19. The FDA reviewed Invisi Smart Mask's websites (invisismart.com, shop.invisismart.com, and Twitter) on June 21, 2021, and found that the ISM5 Invisi Smart Mask, ISM5 Invisi Smart Mask (Black Edition), and ISM30 Invisi Smart Mask were being offered for sale in the United States with claims indicating their use for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h). The FDA determined these devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks approved premarket approval (PMA) or investigational device exemption (IDE) applications. Furthermore, the products are misbranded under section 502(o) of the Act, 21 U.S.C. §