Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Latest Posted September 14, 2021
For example, the company's Lion's Mane supplement was promoted with statements such as "Protects Against Ulcers in the Stomach: Goodbye Pain," and "Lion's Mane May Be Effective in Combating Dementia/Alzheimer's Disease." BoomChaga was promoted with statements such as "Data has shown that Chaga could help ward off the following health problems: Diabetes, lrratable [sic] Bowel Syndrome, and viral infections such as Herpes."
The FDA noted that these products "are not generally recognized as safe and effective" for these uses and for this reason are considered to be "new drugs." The company has 15 days to respond the FDA in writing, explaining the steps it has taken to correct these violations.
See ConsumerLab's answer to the question: Do lion's mane supplements improve memory or cognitive function in older adults?
Also see ConsumerLab's Review of Reishi Mushroom Supplements for tests of related products.
For more information, use the link below.
Warning Letter: Brilliant Enterprises LLC
See related recalls and warnings:
FDA Warns Seller of Reishi Mushroom Supplements
FDA Warns Sellers of Prostate, Reishi, Immune Products, and More
Mushroom Supplement Seller Warned for Drug Claims
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please visit the FDA MedWatch website.