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

Source: https://www.keypedia.com/records/warning_letter/spartan-enterprises-inc-dba-watershed-wellness-center/ceb2f507-56c2-4984-a33c-51951c19ca09

> FDA WARNING_LETTER for Spartan Enterprises Inc. dba Watershed Wellness Center on October 28, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Spartan Enterprises Inc. dba Watershed Wellness Center
- Inspection Date: 2020-10-28
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/spartan-enterprises-inc-dba-watershed-wellness-center/e673d747-da3f-45a5-861c-0630a86039d9

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c