Spartan Enterprises Inc. dba Watershed Wellness Center
FDA issued a warning letter to Spartan Enterprises Inc. dba Watershed Wellness Center (Lansing, MI), a dietary supplement manufacturer, after inspecting its facility and reviewing its websites and YouTube channel. The company's products — including Dr. Bob's Naturals Yew VeggieCaps, Parasite Killer, Magtein, Ginkgo Magic, and others — bore claims that cancer treatment, Alzheimer's, kidney stone removal, parasite killing, and blood sugar regulation, rendering them unapproved new drugs and misbranded drugs under the FD&C Act. The facility also had serious CGMP violations including missing specifications, inadequate batch records, and unsanitary conditions. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure and injunction.
Flagged claims (28)
Ginkgo is an anti-inflammatory
Very powerful anti-cancer properties…used in conjunction with chemotherapy and other cancer treatments, but not only does it have anti-cancer properties it also has a lot of other properties as well…the way that Taxane works in the body to fight cancer is it causes cell apoptosis in cancer cells. So it doesn't allow the cancer cell to replicate….
Dr. Bob's Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and antibacterial ingredients with the intention of killing everything in the digestive tract.
Taxane a chemical substance derived from a yew tree of the Pacific Coast: used yew tree experimentally as a drug in the treatment of cancer. It is derived from Yew trees – Taxus Brevafolia – and bushes and used to kill dividing cells, especially tumor cells.
Fights Anemia
Anti-Inflammatory Properties
Helps fight Fibromyalgia
Six Products that kill viruses, bacteria, yeast, mold, and fungus in the bloodstream and digestive tract. Silver: Kills viruses, bacteria, yeast, mold, and fungus in the bloodstream. (16 oz) Bismuth: Kills bacteria in the digestive tract. (16 oz) Papaya Seed Powder: Parasite removal. Parasite Killer BlendTM: Kills viruses, bacteria, yeast, mold, and fungus in the digestive tract. Dissolve Bioactive Silicate: Removes biofilm and nano-bacteria from the arteries and body. Proferment [sic].
Asthma Support
Dr. Bob's Naturals Ginkgo Magic, Dr. Bob's Naturals NootriTonic ULTRA, and The Raw Food World Sleep Deep Powder are each misbranded withing the meaning of section 403(r)(6) [21 U.S.C. § 343(r)(6)] in that the products make structure function claims but fail to bear the required dietary supplement disclaimer
It's used for Alzheimer's, memory loss ….Good for…ADHD ….It also helps with…arthritis….It also helps with…asthma…it is opening up those bronchial tubes and increasing circulation to the lungs….gingko biloba world's most famous herb use for all your…fibromyalgia…increasing that circulation to relieve that pain…be good for MS [multiple sclerosis] as well for that reason….
Helps Balance Blood Sugar
6 grams (2 tsp or 12 capsules) per day if you have memory issues or DEMENTIA
Reduces Cholesterol
The Yew tree (taxus brevifolia) contains a substance called taxane. Taxanes . . . prevent harmful cells from entering mitosis. Taxane has been used in chemotherapy for many years.
Stone Breaker (Chanca Piedra) has been used by the indigenous peoples of the Amazon Forests for centuries to treat and remove of [sic] kidney and gall stones. It helps dissolve the stones so they can be eliminated from the body. Chanca Piedra interferes with stone formation by relaxing urinary passages so small stones are more easily passed. It can be used in conjunction with lithotripsy, a shock wave procedure that fragments stones
Magnesium repairs the damaged synapses of the brain.
Magnesium repairs the damaged synapses of the brain, which is the cause of the various types of neurological and brain-related diseases.
Reduces Risk for Dementia/Alzheimer's
Lowers LDL and Triglyceride Levels
Dr. Bob's Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral and anti-bacterial ingredients with the intention of killing everything in the digestive tract.
Contains Antibacterial, Antifungal Properties
It is commonly used to relieve…pain, skin, joint, digestive issues asn [sic] well as neurological issues.
Gall and Kidney Stone Removal
The taxanes are mitotic inhibitors, meaning that they inhibit tumors primarily by preventing cells from entering mitosis, a process of cell division. The taxanes accomplish this by inhibiting microtubule polymerization. In addition, taxanes appear to stimulate apoptosis, or programmed cell death, which is often inhibited in cancer cells.
Regulates Insulin Levels to Help Balance Blood Sugar
Reduces Insulin Resistance
Tulsi, or Holy Basil…. regulates insulin helping balance blood sugar levels in the body. It also contains antibacterial, antifungal, and anti-inflammatory properties.
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to do so may result in legal action including, without limitation, seizure and injunction.
Failure to do so may result in legal action including, without limitation, seizure and injunction.
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