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Latest Posted September 14, 2021

Seller of Lion's Mane, Other Mushroom Supplements Warned by FDA

On July 20, 2021, the FDA issued a warning letter to Brilliant Enterprises LLC because it found statements made on the company's website and social media about mushroom supplements, including Lion's Mane, BoomChaga, CordaCex, and LVL:MAX to be drug claims.

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