FDA WARNING_LETTER - Nuance Health, LLC - June 23, 2020

On June 26, 2020, the FDA and FTC issued a Warning Letter to Nuance Health, LLC, regarding their "Swype Shield" product, marketed on websites (https://swypeshield.com, www.swype-shield.myshopify.com) and social media (https://twitter.com/swypeshield). The agencies reviewed these sites on June 12 and 23, 2020.

The FDA determined that "Swype Shield" is an unapproved new drug, sold in violation of section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 (21 U.S.C. § 352). The product is marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, for which it lacks FDA approval or authorization. Examples of violative claims include tweets suggesting "Use Swype!" for COVID-19 and website statements like "proven to kill > 99.99% of all viral upper respiratory illnesses (VURI), including Coronavirus." Metatags such as "Swype for Corona" also contribute to the intended use.

Furthermore, the product is misbranded because the website falsely states it is "FDA cleared as a product intended to clean the skin."