What happened
Original notice title
Mother Earth Minerals, Inc. MARCS-CMS 692527, March 28, 2025
From the archived source record
Based on inspectional findings and review of the product labels collected during the inspection, as well as review of your website [see original source] we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs FDA reviewed your website at the Internet address [see original source] in September 2024 and January 2025 and has determined that you take orders there for the products Calcium, Magnesium, and Silver. Misbranded Drugs A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Calcium, Magnesium, and Silver fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)]. Adulterated Dietary Supplements The inspection of your facility between August 7 and 15, 2024 identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Thus, in addition to being unapproved new drugs and misbranded drugs, your Calcium, Magnesium, and Silver are also adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].] Your significant violations of the dietary supplement CGMP requirements are as follows: 1.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- f532949cbcee
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →