Spartan Enterprises Inc. dba Watershed Wellness Center

Warning LetterOpen

Robert F. McCauley President/Owner Spartan Enterprises Inc. dba Watershed Wellness Center 16280 National Parkway Lansing , MI 48906 United StatesFEI 3012141366Issued Mar 8, 2023Division of Human and Animal Food Operations East VI

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012141366.

Letter Details

Firm: Spartan Enterprises Inc. dba Watershed Wellness Center
Location: Robert F. McCauley President/Owner Spartan Enterprises Inc. dba Watershed Wellness Center 16280 National Parkway Lansing , MI 48906 United States
FEI Number: 3012141366
Country: United States
Issue Date: March 08, 2023
Issuing Office: Division of Human and Animal Food Operations East VI
Product Type: Drugs
Status: Open

Summary

Spartan Enterprises Inc. dba Watershed Wellness Center was cited for marketing unapproved new drugs and misbranded products, including multiple formulations under the Dr. Bob's Naturals brand (such as Spirulina, Magtein, Parasite Killer, and Milk Thistle Liver Support) and Raw Food World Ashwagandha Extract. The company violated the Federal Food, Drug, and Cosmetic Act by making disease claims on product labels, websites (www.shop.watershed.net and www.watershed.net), and a YouTube channel that established these products as drugs intended for the cure, mitigation, treatment, or prevention of disease without FDA approval. The violations were identified during an FDA inspection of the company's dietary supplement manufacturing facility in Michigan from June 29 through July 25, 2022, and confirmed through subsequent website and social media review in December 2022.

Spartan Enterprises Inc. dba Watershed Wellness Center FDA Warning Letter, March 8, 2023