FDA WARNING_LETTER - Genesis 2 Church - March 31, 2020

The FDA and FTC issued a Warning Letter on April 8, 2020, to Genesis II Church of Health and Healing after reviewing their websites (e.g., genesis2church.ch, newg2sacraments.org) between March 27-31, 2020. The agencies found the firm was selling Miracle Mineral Solution (MMS), also known as chlorine dioxide, with unproven claims to cure, mitigate, treat, or prevent Coronavirus Disease 2019 (COVID-19) during a declared public health emergency. The letter identifies MMS as an unapproved new drug under 21 U.S.C. § 355(a) and a misbranded drug under 21 U.S.C. § 352(f)(1). Its introduction into interstate commerce is prohibited under 21 U.S.C. §§ 331(a) and (d), and misbranding while held for sale is prohibited under 21 U.S.C. § 331(k). Additionally, the FTC found the firm's COVID-19 treatment claims to be unsubstantiated by competent and reliable scientific evidence, violating the FTC Act, 15 U.S.C. § 41 et seq. The FDA has previously warned consumers about MMS's dangerous side effects. The firm must immediately cease selling these unapproved products and review all promotional materials. Within 48 hours, they must email both FDA and FTC, detailing corrective actions taken, steps to prevent recurrence, and supporting documentation. Failure to comply may lead to legal action, including seizure, injunctions, being added to FDA's public fraud list, and potential consumer restitution for FTC violations. Products are also subject to import detention.