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Posted November 14, 2012

Mushroom Supplement Manufacturer Warned For Drug Claims and Adulteration

On October 18, 2012, the FDA issued a warning letter to Mushroom Wisdom, Inc. following a facility inspection and product label review which found the dietary supplements Amyloban 3399 From Lion's Mane, Grifron Maitake, and Super Shiitake to be promoted as drugs.

Additionally, the company's supplements were found to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices.

Amyloban 3399 From Lion's Mane contains extracts of the mushroom Hericium erinaceum, and was promoted to "support the survival of nerve cells in the presence of toxic amyloid." Excessive amounts of amyloid protein deposits are found in neurological diseases such as Alzheimer's disease.

Grifron Maitake contains extracts of the mushroom Grifola frondosa, and was promoted for immune system support.

Super Shiitake contains whole and extracted shiitake mushrooms, also called Lentinus edodes, and was promoted as being anti-fungal and protective of the liver.

See's Reviews of Ginkgo Supplements and Reishi Mushroom Supplements for tests of related products, and see the answer to the question, Do lion's mane supplements improve memory or cognitive function in older adults?.