On August 13, 2024, the FDA issued a Warning Letter to Restorative Botanicals, LLC, following an inspection of the company’s facility found the company’s products, including its My GUT Shrooms Gummies and My IMMUNE Shrooms Capsules, to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP).

(See ConsumerLab’s Reviews of Reishi Mushroom and Lion's Mane and Chaga Supplements for more information and tests on related products.)

Violations noted in the FDA’s warning letter include failure to establish an identity specification for each component used in the manufacture of a dietary supplement and failure to establish product specifications for the identity of the finished batch. The agency stated that the company relied only on the physical characteristics (color, smell, and taste) for identification of certain ingredients in its products, and failed to provide toxic element specifications for each of its mushroom components, and noted that “due to their common growing conditions,” mushroom ingredients “are at high risk for the accumulation of toxic elements.” The FDA also identified labeling violations. For example, the label for My GUT Shrooms Gummies was found to be lacking a Supplement Facts panel.

Restorative Botanicals, LLC is required to notify the FDA in writing the specific steps it has taken to address these violations within 15 working days of receipt of the Warning Letter.

For more information, use the link below.

Warning Letter: Restorative Botanicals, LLC

See related recalls and warnings:

NutraCaps Labs Warned for Unsafe Ingredients and Manufacturing Violations

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Seller of CoQ10, Resveratrol and More Warned for Manufacturing Violations