FDA WARNING_LETTER - Tonic Therapeutic Herb Shop & Elixir Bar - September 28, 2020

On September 29, 2020, the FDA and FTC issued a Warning Letter to Tonic Herb Shop regarding unapproved and misbranded products related to COVID-19. The agencies reviewed the company's website, tonicherbshop.com, on September 17 and 28, 2020, and found that it offered various herbal products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are considered unapproved new drugs under 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). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). The letter emphasizes the public health emergency declared for COVID-19.

Tonic Herb Shop is required to immediately cease selling these unapproved and unauthorized products. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The