FDA WARNING_LETTER - Homeomart Indibuy - March 30, 2020

On April 1, 2020, the FDA and FTC issued a Warning Letter to Homeomart (www.homeomart.com, www.homeomart.net) for selling unapproved and misbranded homeopathic drug products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. This violates sections 505(a) and 502 of the FD&C Act, and is prohibited under sections 301(a) and (d).

The FDA initiated urgent measures due to the COVID-19 public health emergency and national emergency declarations. Homeomart's websites made claims establishing intended use for COVID-19 treatment/prevention. The letter demands immediate cessation of sales for these unapproved products.

Homeomart must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of non-compliant firms.

The FTC also cited violations of the FTC Act, stating that advertising products to prevent, treat, or cure human disease requires competent and reliable scientific evidence, which is lacking for Homeomart's COVID-19 claims. Homeomart must cease all such claims and email rcleland@ftc.gov within 48