FDA WARNING_LETTER - Mother Earth Minerals, Inc. - August 15, 2024

The FDA conducted an inspection of Me Minerals' facility from August 7-15, 2024, and reviewed product labels and the company's website (meminerals.com). The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act.

The products Calcium, Magnesium, and Silver are deemed unapproved new drugs because website and label claims indicate they are intended for disease treatment, cure, mitigation, or prevention (e.g., Cancer, Multiple Sclerosis, Diabetes, migraines, heart disease, infections). These products are not generally recognized as safe and effective for these uses and lack FDA approval.

Furthermore, these products are misbranded drugs under 21 U.S.C. 352(f)(1) as they lack adequate directions for layperson use, being intended for conditions requiring professional supervision.

The inspection also identified serious Current Good Manufacturing Practice (CGMP) violations for dietary supplements (21 CFR Part 111), rendering the products adulterated. Violations include: 1. Failure to establish specifications for components (identity, purity, strength, composition, contamination limits), labels, packaging, and finished products. 2. Failure to prepare written master manufacturing records for each unique formulation and batch size. 3. Incomplete batch production records, lacking critical information like batch numbers, equipment cleaning dates, component weights, actual yields, and quality control approvals. 4. Failure to establish and follow written