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Posted December 09, 2021

FDA Warns Seller of Curcumin, Lion's Mane, Quercetin & More

On November 9, 2021, the FDA issued a warning letter to Synaptent, LLC because it found statements on the company's website about its products, including Berberine HCL, Curcumin, Lion's Man, Milk Thistle, Quercetin, Boswellia Serrata Extract, and Garlic Extract to be drug claims, and all products fail to bear adequate directions for intended use.

For example, Berberine HCL was promoted with statements such as "It…was once used as a treatment for diarrhea in diabetics." It has also been promoted as a "Powerful Anti-inflammatory."

See ConsumerLab's Berberine and Goldenseal Supplements Review for tests of related products.

Curcumin was promoted with statements such as "Curcumin is an extremely powerful anti-inflammatory…" and "Powerful Anti-inflammatory." The serving size on the label of this product was also deemed incomplete and therefore misbranded by the FDA.

See ConsumerLab's Turmeric and Curcumin Supplements and Spices Review for tests of related products.

Lion's Mane was advertised as an "anti-inflammatory" and claimed to "reduce inflammation in the brain and protect it from cell degeneration."

See ConsumerLab's answer to the question:  Do lion's mane supplements improve memory or cognitive function in older adults?

Milk Thistle was advertised to "reduce insulin resistance" and the product failed to declare a complete and accurate statement of net quality of contents and was therefore deemed misbranded by the FDA.

See ConsumerLab's Milk Thistle Supplements Review for tests of related products.

Quercetin was advertised as a "powerful anti-inflammatory."

See ConsumerLab's Quercetin Supplements Review for tests of related products.

Boswellia Serrata Extract was misbranded on the product webpage. For example, the product webpage states, "Powerful anti-inflammatory" and the Health section of the company's website states, "Boswellia Serrata…is taken…for its perceived effect in reducing joint pain…"

See ConsumerLab's Joint Health Supplements Review (Glucosamine, Chondrotin, MSM, Boswelia, Collagen and Turmeric) for more information regarding related products.

Garlic Extract was promoted for "preventing and managing bacterial and fungal infections" on the product page and on the Immune page of the company's website.

See ConsumerLab's Garlic Supplements Review for tests of related products.

The FDA advised Synaptent, LLC to notify the agency in writing within 15 days of receipt of the warning letter outlining specific steps it has taken to address these violations.

For more information, use the link below.

Warning Letter: Synaptent, LLC

See related recalls and warnings:

FDA Warns Seller of Reishi Mushroom Supplements

FDA Warns Seller of Fish Oil, Apple Cider Vinegar, Collagen, and Elderberry Supplements

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