FDA WARNING_LETTER - Mineral BioSciences, LLC. - November 24, 2025

The FDA issued a warning letter to Mineral BioSciences, LLC following an inspection of its Goodyear, Arizona, facility from November 12-24, 2025. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act, specifically concerning the marketing and manufacture of the products Totala Fulvic Ionic Mineral Complex and Ionicell. The FDA determined these products are unapproved new drugs and misbranded because the company marketed them on social media and websites with claims to treat or manage medical conditions such as diabetes, high blood pressure, and joint pain without the necessary regulatory approval or adequate directions for safe use.

Furthermore, the inspection revealed that the products are adulterated dietary supplements due to serious violations of manufacturing regulations. Specific issues included poor facility sanitation involving leaking ceilings and structural holes, inadequate pest control measures, and a lack of quality control oversight for raw materials. The firm also failed to maintain complete batch production records and did not perform required testing to verify the identity and reliability of ingredients provided by suppliers.

Mineral BioSciences must submit a written response within 15 working days detailing the corrective actions taken to address these violations and prevent their recurrence. The FDA emphasized that failing to rectify these issues may lead to legal action, including product seizure or injunctions.