FDA WARNING_LETTER - US Products - December 02, 2020

On December 10, 2020, the FDA and FTC issued a Warning Letter to Steve Crear of Indigenous Products regarding unapproved and misbranded products related to COVID-19. The FDA observed that Indigenous Products' Facebook page offered mineral products for sale, claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are considered unapproved new drugs under section 505(a) of the FD&C Act and misbranded drugs under section 502.

Examples of violative claims include statements from a March 17, 2020 Facebook post and a linked YouTube video, asserting the product's ability to "eradicate the infection inside of the body" (referring to coronavirus), "kill viruses," and regenerate respiratory tissue. The letter cites specific timestamps from the video detailing these claims and product usage with a nebulizer for breathing problems.

The FDA requires immediate action to cease the sale of these unapproved and unauthorized products. Indigenous Products must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective steps, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and the firm's addition to FDA's public list of non-compliant COVID-19 product sellers. The FTC also requires immediate cessation of unsubstantiated claims, warning of potential legal action and