On October 20, 2023, the FDA issued a warning letter to Top Health Manufacturing, LLC, manufacturer of Grandma’s Herbs Kidney supplement, following an inspection of the company’s facility that found its products to be adulterated because they were, packed, labeled or held under conditions that do not meet Current Good Manufacturing Practices (CGMP).

Grandma’s Herbs Kidney contains ingredients such as marshmallow root, juniper, and Yarrow, and is promoted for “strengthening and cleansing” the kidneys. (See ConsumerLab’s articles about supplements and kidney function and kidney stones.)

Violations noted by the FDA include not following written procedures for quality control operations and failure to establish specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement manufactured.

According to the FDA, Grandma’s Herbs Kidney is also misbranded because the label fails to provide information required by federal regulations, including the identity of the part of the plant from which each botanical dietary ingredient is derived. In addition, the product label lists “candelilla wax” as an ingredient, but the batch record reviewed during the FDA’s inspection found that candelilla wax was not added to the product.

Top Health Manufacturing, LLC must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

For more information, use the link below.

Warning: Top Health Manufacturing, LLC

See related recalls and warnings:

West Coast Laboratories Warned for Manufacturing, Labeling Violations

NutraCaps Labs Warned for Unsafe Ingredients and Manufacturing Violations

Seller of Digestion Supplements Warned for Manufacturing Violations

Seller of CoQ10, Resveratrol and More Warned for Manufacturing Violations