FDA WARNING_LETTER - Santiste Labs LLC - April 23, 2020

On April 27, 2020, the FDA and FTC issued a Warning Letter to the company operating defendpatch.com for selling the "DefendTM Patch," a transdermal patch with botanical oils, claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA reviewed the website on April 16 and April 23, 2020.

The botanical oil component of the product is deemed an unapproved new drug under 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). Its introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency and national emergency declarations for COVID-19 as context for urgent FDA action. The company is ordered to immediately cease selling the unapproved and unauthorized product for COVID-19 related claims.

The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction