FDA WARNING_LETTER - Gaia's Whole Healing Essentials, LLC - March 30, 2020

This Warning Letter, dated April 1, 2020, from the FDA and FTC, addresses Gaia's Whole Healing Essentials regarding unapproved and misbranded colloidal silver products marketed for COVID-19. The agencies reviewed the websites www.gaiaswholehealingessentials.org and www.lovehaswon.org on March 17 and March 30, 2020. The FDA determined that the colloidal silver products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19, making them unapproved new drugs in violation of section 505(a) of the FD&C Act (21 U.S.C. § 355(a)). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act (21 U.S.C. § 352), and their introduction into interstate commerce is prohibited under sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FTC also cited violations of the FTC Act (15 U.S.C. 41 et seq.) for advertising products to prevent, treat, or cure human disease without competent and reliable scientific evidence, which is currently lacking for COVID-19 related claims for these products. The letter emphasizes the ongoing public health emergency due to COVID-19. The firm is required to immediately cease the sale of these unapproved products and send an email to both FDA and FTC within 48 hours detailing corrective actions, including steps to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction, being added to FDA's public list of non-compliant firms, and potential orders to pay back money to consumers by the FTC.