FDA WARNING_LETTER - AusarHerbs - January 27, 2021

On January 12, 2021, the FDA and FTC issued a Warning Letter to Ausar Herbs following website reviews on December 17 and 21, 2020. The company was found to be selling "Corona Destroyer Tea" (in "Prevention" and "Reversal" options) with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined this product is an unapproved new drug, violating 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 FTC noted that advertising claims for preventing, treating, or curing human disease require competent and reliable scientific evidence, which is lacking for this product regarding COVID-19.

Ausar Herbs must immediately cease selling all unapproved and unauthorized COVID-19 related products. Within 48 hours, the company must email COVID-19-Task-Force-CFSAN@fda.hhs.gov and rcleland@ftc.gov, detailing corrective actions, steps to prevent recurrence, and supporting