FDA WARNING_LETTER - Disinfect & Shield - May 05, 2021

On May 6, 2021, the FDA issued a Warning Letter to Ms. Caldwell regarding the sale of "DISINFECT™ & SHIELD HAND SANITIZER" products on disinfectandshield.com. The FDA reviewed the website on May 5, 2021, and found that the products were marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions.

The FDA determined that "DISINFECT™ & SHIELD HAND SANITIZER" is an unapproved new drug, violating section 505(a) of the FD&C Act, 21 U.S.C. § 355(a). The product is also deemed a misbranded drug under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. § 352(a) and (ee). The introduction of such products into interstate commerce is prohibited by section 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

The product is considered a "new drug" because it is not generally recognized as safe and effective (GRASE) for its intended uses, which include claims of efficacy against various pathogens and up to 8 hours of protection against COVID-19.