WARNING LETTER
Mother Earth Minerals, Inc. MARCS-CMS 692527 —
- Delivery Method:
- Via Email
- Product:
- Drugs
Food & Beverages
- Recipient:
-
Recipient NameJoan C. Ott
-
Recipient TitleOwner
- Mother Earth Minerals, Inc.
1260 S. 1200 W. Ste 3
Ogden, UT 84404-5412
United States
- Issuing Office:
- Human Foods Program
United States
March 28, 2025
WARNING LETTER
CMS #692527
Dear Ms. Ott:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1260 S. 1200 W. Ste. 3 Ogden, UT between August 7 and 15, 2024. Based on inspectional findings and review of the product labels collected during the inspection, as well as review of your website https://www.meminerals.com/, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
At the conclusion of the inspection on August 15, 2024, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your response dated August 23, 2024, and we address your response below.
Unapproved New Drugs
FDA reviewed your website at the Internet address https://www.meminerals.com/ in September 2024 and January 2025 and has determined that you take orders there for the products Calcium, Magnesium, and Silver. FDA also reviewed product labels for your products Calcium, Magnesium, and Silver following the inspection of your facility between August 7 and 15, 2024. The claims on your website and product labels establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
Your “Applications” Online Catalog Search webpage at https://www.meminerals.com/applications/states “Applications are certain combinations of minerals that have been found lacking in the body with each different disease state. These combinations of minerals may help your body in recovering from disease.” The drop-down menu on this page provides links to Applications webpages for specific diseases, including Cancer, Multiple sclerosis, and Diabetes – Hypoglycemia Applications webpages (discussed further below).
From your webpage: https://www.meminerals.com/recommended/cancer/
- “Recommended Package: Cancer . . . This package contains the following products . . . Calcium 2 OZ Bottle . . . Magnesium 2 OZ Bottle . . . Silver 2 OZ Bottle”
- “Cancer … is directly caused by a malfunction in the cellular DNA. Because Cancer is actually one's own cells misbehaving, there truly can never be any "cure" for the condition - only PREVENTION and REGENERATION! Cancer does not kill as all cancer really is your very own cells that have somehow started to mutate ... This protocol is designed to increase inter-cellular "communication" cycles, and help repair and regenerate "damaged" DNA. Once this happens, cancer cells often return to their "normal" state of existence. This "miracle" is known as "spontaneous regression" - and happens quite often.”
From your webpage: https://www.meminerals.com/catalog/ApplicationsResults.asp under the Applications drop-down menu search result for Cancer
- “Disease: Cancer . . . Applications: Any of various malignant neoplasms characterized by the proliferation of anplastic[sic] cells that tend to invade surrounding tissue and metastasize to new body sites. . . .
- Calcium - 2 dpfl. ... Magnesium - 4 dpfl. ... Silver - 4 dpfl. a.m. and p.m. . . . Cancer forms when the pH of body is low. In addition to the treatment listed here . . . .”
From your webpage: https://www.meminerals.com/recommended/multiple-sclerosis/
- “Recommended Package: Multiple Sclerosis . . . Package comes with the following products. . . Calcium 2 oz. Bottle . . . Magnesium 2 OZ Bottle . . . Silver 2 OZ Bottle . . . ”
From your webpage: https://www.memineraIs.com/catalog/ApplicationsResuIts.asp under the Applications drop-down menu search result for Multiple Sclerosis:
- “Disease: MULTIPLE SCLEROSIS . . . ”
- A chronic degenerative disease of the central nervous system in which gradual destruction of myelin occurs in patches throughout the brain or spinal cord or both, interfering with the nerve pathways and causing muscular weakness, loss of coordination, and speech and visual disturbances. It is thought to be caused by a defect in the immune system that may be genetic or viral in origin. . . . Calcium - 2 drprful ... Magnesium - 4 drprful ... “Silver - 4 drprful 4X daily for two weeks; thereafter, 2 drprful a.m. & p.m.”
From your webpage: https://www.meminerals.com/recommended/diabetes-hypoglycemia/
- “Recommended Package: Diabetes – Hypoglycemia”
- “Type II Diabetes (non insulin-dependent) typically responds very favorably to this mineral protocol within 3-6 months. . . Hypoglycemia – An abnormally low concentration of glucose in the blood. Often hypoglycemia progresses into diabetes. . . Package contains the following products . . . Calcium 2 OZ Bottle . . . Magnesium 2 OZ Bottle . . .”
From your webpage: https://www.meminerals.com/catalog/ApplicationsResults.asp under the Applications drop-down menu search result for Diabetes - Hypoglycemia:
- “Disease: DIABETES – HYPOGLYCEMIA . . . Applications: ... Calcium – 1 drpfl.... Magnesium 2 drplfs....”
From your webpage: https://www.meminerals.com/catalog/magnesium-8-oz/ under “Additional product details”, which shows a copy of the product label for your Magnesium, 8oz, supplement:
- “Deficiencies of Magnesium produce symptoms of frequent migraine headaches...”
- “Readily bio-available magnesium as provided by Mother Earth Minerals is essential in keeping the heart muscle healthy and happy. Magnesium deficiency has been linked to potentially life-threatening heart arrhythmias and palpitations. Heart disease is still the #1 killer in America, and is possibly linked to magnesium-deficient diets and lifestyle.”
- “Vital for prevention of migraine headaches, osteoporosis, and constipation.”
On the product label for Magnesium, 8 oz:
- “Vital for prevention of migraine headaches, osteoporosis, and constipation.”
From your webpage: https://www.meminerals.com/catalog/silver-8-oz/
- “Silver is a potent natural antibacterial, antiviral, and antifungal. Silver kills bacteria...”
- “Unlike modern antibiotic prescriptions Silver doesn't create resistance or immunity in the organisms that are killed by it.”
Under “Additional product details”:
- “Silver is a potent natural antibiotic...”
In the drop-down menu under “Applications”
- “For more product details, browse our knowledgebase on applications use.”
“AIDS (AUTO IMMUNE DEFICIENCY SYNDROME)”
“ALLERGIES”
“ANTHRAX”
“ATHLETE'S FOOT”
“BELL'S PALSY”
“BLADDER INFECTION”
“CANCER”
“CANDIDIASIS”
“CANKER SORES (acid condition)”
“CAVITIES”
“COLDS/FLU (ANAEROBIC VIRUSES & BACTERIA)”
“E COLI”
“ECZEMA”
“EPSTEIN BARR VIRUS”
On the product label for Silver, 8oz:
- “Silver is a potent natural antibacterial, antiviral, and antifungal.”
- “Silver kills bacteria...”
- “Natural Antibacterial, Antiviral, and Antifungal.”
- “Wound Care ... Pink Eye ... Ear Infections.”
- “Anti-inflammatory, Speed Healing...”
On the product label for Calcium, 8oz:
- “[L]ower blood pressure”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
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). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your products Calcium, Magnesium, and Silver are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. 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. You failed to establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70. Specifically:
- You failed to establish an identity specification for each component that you use in the manufacture of a dietary supplement as required by 21 CFR 111.70(b)(1). For example, during the inspection, your management explained to the FDA investigator that you have not established identity specifications for the calcium used to manufacture your Calcium supplement, the magnesium used to manufacture your Magnesium supplement, or any other components used to manufacture your dietary supplement products.
- You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). For example, during the inspection, your management explained to the FDA investigator that you have not established component specifications for the dietary ingredients calcium and magnesium that are necessary to ensure the specifications for the purity, strength, and composition of the Calcium and Magnesium supplements manufactured using these ingredients are met, or for any other components used to manufacture your dietary supplements.
- You failed to establish component specifications that establish the limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by21 CFR 111.70(b)(3). For example, during the inspection, your management explained to the FDA investigator that you have not established limits for contaminants for the calcium used in the manufacture of the Calcium supplement and the magnesium used in the manufacture of the Magnesium supplement, or for any other components used to manufacture your dietary supplements.
- You failed to establish specifications for dietary supplement labels (labeling specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR 111.70(d). For example, during the inspection, your management explained to the FDA investigator that you have not established packaging and label specifications for your Calcium and Magnesium supplement packaging and labels, or any of your other dietary supplements.
- You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement and for limits on those types of contaminants that may adulterate or lead to the adulteration of the finished batch of the dietary supplement for each dietary supplement that you manufacture, to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). For example, during the inspection, your management explained to the FDA investigator that you had not created finished product specifications for your Calcium and Magnesium supplements, or any of your other dietary supplements.
We note that, in addition to establishing these specifications, you must determine whether such specifications are met, in accordance with 21 CFR 111.73 and 111.75.
2. You failed to prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection, your management explained that master manufacturing records had not been created for your Calcium or Magnesium supplements, or any of your other dietary supplements.
3. Your batch production record failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your batch production records for your Calcium and Magnesium products fail to include the following required information:
- the batch, lot, or control number;
- the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained;
- the identity and weight or measure of each component used;
- a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;
- the initials of the person responsible for weighing or measuring each component used in the batch;
- the initials of the person responsible for verifying the weight or measure of each component used in the batch;
- the initials of the person responsible for adding the component to the batch;
- the initials of the person responsible for verifying the addition of components to the batch;
- an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record;
- documentation at the time of performance that quality control personnel approved and released, or rejected, the batch for distribution, including any reprocessed batch; and
- documentation at the time of performance that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement.
4. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection, your management stated that you did not have written procedures for quality control operations. Additionally, your management could not provide any documentation that you are performing any quality control operations during the manufacture of your dietary supplements, including approving and releasing product for distribution.
We note that, in addition to establishing the required written procedures for the responsibilities of quality control operations, you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65.
5. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83. Specifically, during the inspection, your management stated that you do not collect and hold reserve samples for any of the finished dietary supplements you distribute, including your Calcium and Magnesium supplements.
We reviewed your response, received August 23, 2024, in which you state you will:
- create product and raw material specifications for the identity, purity, strength, composition, and contamination limits, and will develop label and packaging specifications,
- create master manufacturing records for each product,
- revise your batch production records to include all required information,
- establish written procedures for quality control operations, and
- begin collecting and holding reserve samples of your products.
Your response states you are aiming to complete all corrective actions within six months. We have been unable to verify the adequacy of your corrective actions because you did not provide records or other information demonstrating that the requirements outlined above are met.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Sara Dent Acosta via email at HFP-OCEDietarySupplements@fda.hhs.gov. Please reference CMS #692527 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCEDietarySupplements@fda.hhs.gov.
Sincerely,
/S/
Laura Akowuah, JD, MPH
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program