FDA WARNING_LETTER - Carahealth - March 27, 2020

On March 26, 2020, the FDA and FTC issued a Warning Letter to Carahealth.com following a March 2020 review of their website and social media (facebook.com/pg/herbaltonics). The FDA determined that Carahealth.com offers "Carahealth Immune" (also "Immune Tonic") for sale in the U.S., claiming to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and misbranded drugs under section 502, 21 U.S.C. § 352. Their 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 action.

Carahealth.com is required to immediately cease selling these unapproved products for COVID-19 related uses. Within 48 hours, they must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions and preventative measures, with supporting documentation. Failure to comply may result in legal action,