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Posted April 27, 2023

Seller of Magtein, Veggie Caps, & More Warned for Drug Claims, Manufacturing Violations

On March 8, 2023, the FDA issued a warning letter to Spartan Enterprises Inc., dba Watershed Wellness Center, after a review of the company’s website found statements about its Dr. Bob’s Naturals Spirulina, Dr. Bob’s Naturals Magtein, Dr. Bob’s Naturals Tulsi-Holy Basil Extract Capsules, Dr. Bob’s Naturals Milk Thistle Liver Support, Dr. Bob’s Naturals Stone Breaker Powder, Dr. Bob’s Parasite Killer, Dr. Bob’s Naturals Parasite Killer Bundle, Dr. Bob’s Naturals Parasite Killer Bundle MINI, Dr. Bob’s Naturals Yew VeggieCaps, Dr. Bob’s Naturals Gingko Magic, and Dr. Bob’s Naturals Chlorella, and Raw Food World Ashwagandha Extract products to be drug claims.

For example, Dr. Bob’s Naturals Magtein products were promoted with statements such as, “Magnesium repairs the damaged synapses of the brain, which is the cause of the various types of neurological and brain-related diseases.”

(See ConsumerLab’s Review of Magnesium Supplements for details about the clinical evidence for Magtein, and our tests and Top Picks among magnesium supplements.)

Dr. Bob’s Naturals Yew VeggieCaps were promoted with statements such as, “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.”

See ConsumerLab’s Review of Fruits, Veggies, Other Greens Supplements and our tests and Top Picks among fruit, veggie, and other green supplements.)

Dr. Bob’s Naturals Tulsi-Holy Basil Extract Capsules were promoted with statements such as, “Regulates Insulin Levels to Help Balance Blood Sugar” and “Contains Antibacterial, Antifungal Properties.”

(See ConsumerLab’s Review of Holy Basil Extract Supplements for tests of related products.)

In addition, an FDA inspection of the company’s facility found products to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). These violations included failure to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, and failure to maintain the physical plant in a clean and sanitary condition.

The agency also found some of the company’s products to be misbranded because they do not comply with labeling requirements for dietary supplements.

Spartan Enterprises Inc. must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

See ConsumerLab’s answers to the following questions:

Do magnesium supplements, like Magtein, help memory or protect against Alzheimer's disease?

Do any supplements, foods or lifestyle modifications help with brain function, like memory and cognition?

Are Balance of Nature products good dietary supplements?

Which supplements and foods can help lower or control blood sugar?

For more information, use the link below.

Warning: Spartan Enterprises Inc. dba Watershed Wellness Center

See related recalls and warnings:

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

FDA Warns Seller of Vision, Calcium & Magnesium Supplements and More

Seller of Protein Powder, Spirulina & Other Products Warned for Manufacturing Violations

FDA Warns Seller of Turmeric, Ashwagandha, Glucosamine, and More