FDA WARNING_LETTER - Spartan Enterprises Inc. dba Watershed Wellness Center - July 25, 2022

The FDA inspected Watershed's dietary supplement manufacturing facility in Lansing, MI, from June 29 to July 25, 2022, and reviewed their websites and YouTube channel in December 2022. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.

Several products, including Dr. Bob’s Naturals Spirulina, Magtein, Tulsi-Holy Basil Extract Capsules, Milk Thistle Liver Support, Stone Breaker Powder, Parasite Killer, Yew VeggieCaps, Gingko Magic, Chlorella, and Raw Food World Ashwagandha Extract, are deemed unapproved new drugs and misbranded. This is due to claims on product labels, websites, and YouTube channel that establish their intent for use in the cure, mitigation, treatment, or prevention of disease, making them "new drugs" under section 201(p) of the Act, requiring prior FDA approval. Additionally, some products are misbranded under section 502(f)(1) for lacking adequate directions for layperson use, as they are intended for conditions requiring professional supervision.

The inspection also found serious Current Good Manufacturing Practice (CGMP) violations for dietary supplements, rendering Dr. Bob’s Naturals NootriTonic ULTRA, Parasite Killer, and Raw Food World Sleep Deep Powder adulterated. Violations include: 1. Failure to establish component and