FDA WARNING_LETTER - Dr. Dhole's Sushanti Homeopathy Clinic - May 05, 2020

The FDA and FTC issued a Warning Letter to www.homeopathyhelps.com on May 4, 2020, following reviews of their website and social media in April and May 2020. The firm was found to be selling "Homeopathic Genus Epidemicus" in the U.S., claiming it could mitigate, prevent, treat, diagnose, or cure COVID-19. This product is deemed 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)). Furthermore, the FTC cited the firm for violating the FTC Act (15 U.S.C. 41 et seq.) by making unsubstantiated claims to prevent, treat, or cure human disease without competent and reliable scientific evidence, particularly for COVID-19. The letter demands immediate cessation of sales for these unapproved products. The firm must email both the FDA and FTC within 48 hours detailing corrective actions. Failure to comply may lead to legal action, including seizure and injunction, and the firm's inclusion on FDA’s public list of non-compliant COVID-19 product sellers. Imported products may also face detention and refusal.