FDA WARNING_LETTER - Spartan Enterprises Inc. dba Watershed Wellness Center - October 28, 2020

On October 30, 2020, the FDA and FTC issued a Warning Letter to Watershed Wellness regarding the sale of "Dissolve BioActive Silicate" and silver-containing products on their website, https://watershed.net, and social media, https://www.facebook.com/WatershedWellness and https://www.youtube.com/user/watershed11. The agencies reviewed these sites on October 7 and October 28, 2020.

The products are marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, making them unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and misbranded drugs under section 502, 21 U.S.C. § 352. The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d), 21 U.S.C. § 331(a) and (d).

The letter highlights the ongoing COVID-19 public health emergency and national emergency declarations. Watershed Wellness is required to immediately cease selling these unapproved and unauthorized products for COVID-19 related uses. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.h