FDA WARNING_LETTER - www.outoftheboxremedies.com - June 08, 2020

On June 10, 2020, the FDA and FTC issued a Warning Letter to Out of the Box Remedies for selling unapproved and misbranded iodine products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed the company's websites (www.outoftheboxremedies.com, www.outsidetheboxremedies.yolasite.com, www.outoftheboxremedies.net) and Facebook page on June 1 and June 8, 2020.

The FDA determined these products are unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d). The FTC noted a lack of competent and reliable scientific evidence, including clinical studies, to substantiate COVID-19 related claims, violating the FTC Act.

Out of the Box Remedies must immediately cease selling these products and correct all violations. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov and rcleland@ftc.gov detailing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply may result in legal action, including seizure, injunction, and monetary penalties. The firm will be added to FDA's public list of firms selling fraudulent COVID-1