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Latest Posted July 27, 2026

FDA Warns Mineral BioSciences for Drug Claims and Manufacturing Violations

On June 5, 2026, FDA issued a Warning Letter to Mineral BioSciences, LLC of Goodyear, Arizona, following an inspection of the company’s facility that found its Totala Fulvic Ionic Mineral Complex and Ionicell supplements to be adulterated because they were manufactured under conditions that did not meet current Good Manufacturing Practices (cGMP) requirements for dietary supplements.

In addition, a review of the company’s websites and social media pages found statements made about the products to be drug claims, which are not permitted for dietary supplements, such as suggesting the products could help control blood sugar levels after eating.

(See ConsumerLab’s Shilajit Supplements Review for tests of products containing fulvic acid and our Top Picks.)

FDA cited several cGMP violations, including failure to maintain the facility in clean, sanitary, and adequate repair; failure to exclude pests and protect against contamination; failure of quality control personnel to approve certain specifications; incomplete batch production records; and failure to qualify certain suppliers by establishing the reliability of suppliers’ certificates of analysis.

FDA stated that the products are not generally recognized as safe and effective for these uses and are therefore unapproved new drugs. FDA also stated that the products are misbranded because they are intended for treatment or prevention of diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner, making it impossible to write adequate directions for layperson use.

The FDA instructed the company to respond in writing within 15 working days with the steps it had taken to correct the violations and prevent them from recurring.

For more information, use the link below.

FDA Warning Letter: Mineral BioSciences, LLC - 724745 - 06/05/2026

See related recalls and warnings:

FDA Warns Ambaya Gold for Promoting Products for Depression, Cancer, & Arthritis

FDA Warns Seller of Novid NASAL SPRAY for Allergy, Virus, and Cold Claims