Recalls & Warnings
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Posted April 17, 2021
Previously-Recalled Goldenseal Product Warned by FDA for Microbial Contamination
On April 1, 2020, the FDA issued a warning letter to Maison Terre, LLC, following laboratory testing which found the company's product Goldenseal Root Powder Organic to be adulterated because it was prepared, packed, or held under conditions that violate Current Good Manufacturing Practices (cGMP) for dietary supplements.
According to the FDA's warning, Goldenseal Root Powder Organic was produced under conditions that may have led to possible contamination with filth. For example, the company's drug manufacturing area is a residential kitchen and living room, with no proper controls to ensure cleanliness and purity of the product. FDA lab testing revealed aerobic microbial growth, yeast, and mold all present in the Goldenseal product, including bacteria that may cause pneumonia, meningitis, urinary tract infections, and other illnesses. Additional cGMP violations cited by the FDA include failure to test the drug products for microbiological contamination, failure to establish quality control protocols, and failure to keep inventory or distribution records, as required by federal regulations.
Maison Terre recalled all lots of Goldenseal Root Powder Organic in August 2020 for bacterial contamination. According to the recall announcement, the company received a report of one infant death association with the use of this product.
In addition, statements made about Goldenseal Root Powder Organic and two other products, Orange (Sweet) Essential Oil 15ml and Ylang Ylang 3 Essential Oil 15 ml, were found to be drug claims. For example, the goldenseal product was promoted with statements such as "The herb has been found to be effective against a number of disease-causing organisms, including Staphylococcus, Chlamydia, and Streptococcus species, E. coli, Entamoeba histolytica, Salmonella typhi, and many others. Berberine and related alkaloids in the plant have been recognized with its antimicrobial effects."
See ConsumerLab's Review of Berberine and Goldenseal Supplements for tests of related products.
The essential oil products were promoted with statements such as "Common Uses:... antidepressant... high blood pressure." The FDA letter also stated that the products were also misbranded because the labels did not contain adequate directions for use.
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