Mineral BioSciences, LLC(FDA Ref. No.: CMS #724745)

Issuing Office:

Human Foods Program

United States

June 5, 2026

WARNING LETTER

CMS #724745

Dear Mr. Blotsky:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 4050 S Sarival Ave, Goodyear, AZ, on November 12-24, 2025. Based on inspectional findings and subsequent review of your websites https://mineralbiosciences.com/ and https://protectcells.com/, and your Facebook and Instagram social media pages at https://www.facebook.com/ProtectCells/ and https://www.instagram.com/p/BYR6AmlDlx4/, 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 November 24, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your responses dated December 18, 2025, April 13, 2026, April 30, 2026, and May 1, 2026, and we address your responses below.

Unapproved New Drugs

FDA reviewed your websites at the Internet addresses https://mineralbiosciences.com/ and https://protectcells.com/ in May 2026 and determined that you take orders on the website https://protectcells.com/ for your products Totala Fulvic Ionic Mineral Complex and Ionicell. We also reviewed your social media pages on Facebook (https://www.facebook.com/ProtectCells/) and Instagram (https://www.instagram.com/p/BYR6AmlDlx4/) in March 2026, where you direct consumers to your website, https://protectcells.com/, to purchase your products. Claims on your social media webpages establish that your Totala Fulvic Ionic Mineral Complex and Ionicell 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:

• Totala Fulvic Ionic Mineral Complex AND Ionicell
  “Did you know Higher A1C levels are linked to diabetes complications? But did you also know that case reports have shown that Ioniplex can help control post-prandial blood sugar levels?” Note: Ioniplex is an ingredient in both the Totala and Ionicell products. (https://www.facebook.com/ProtectCells/, from a post dated February 24, 2022)

• Totala Fulvic Ionic Mineral Complex AND Ionicell
  “Ioniplex has been clinically shown to repair and stimulate the body at the cellular level, leading to better glucose management.” Note: Ioniplex is an ingredient in both the Totala and Ionicell products. (https://www.facebook.com/ProtectCells/, from a post dated January 29, 2021)

• Totala Fulvic Ionic Mineral Complex
  “[H]as been taking Totala … and has noticed not only a drop in his blood pressure, but less pain in his joints…” (https://www.instagram.com/p/BYR6AmlDlx4/, from a post dated February 23, 2018)

• Ionicell
  “[H]as been taking IoniCell for several weeks and has already noticed a drop in her daily glucose levels and fasting glucose levels.” (https://www.instagram.com/p/BYR6AmlDlx4/, from a post dated February 6, 2018)

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 Totala Fulvic Ionic Mineral Complex and Ionicell 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, Totala Fulvic Ionic Mineral Complex and Ionicell 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 on November 12-24, 2025, 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 Totala Fulvic Ionic Mineral Complex Lemon Lime and Ionicell 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 Totala Fulvic Ionic Mineral Complex Lemon Lime and Ionicell products are also adulterated dietary supplements under section 402(g)(1) of the Act.

Your significant violations of the CGMP requirements are as follows:

1. You failed to meet sanitation requirements that apply to your physical plant and grounds under 21 CFR 111.15. Specifically:

• You failed to maintain your physical plant in a clean and sanitary condition and in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated, as required by 21 CFR 111.15(b). For example, from November 12-13, 2025, our investigator observed insulation hanging from the ceiling, one light casing which appeared to be taped with water leaking from it, two holes in your wall exposing outside elements, and multiple doors, including bay doors, with opening gaps allowing light to shine into your facility.

• You failed to take effective measures to exclude pests from the physical plant and to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests, as required by 21 CFR 111.15(d)(2). For example, on November 13, 2025, our investigator reviewed your pest control records for April 2025 through November 2025 and observed several occasions in which a pest control technician documented interior stations with apparent rodent activity, including inside the (b)(4) room, (b)(4) room where finished products are stored, and in the ambient warehouse. In addition, our investigator observed multiple exit doors propped open to the outside.

During the inspection, you stated that you would create a risk assessment based on your assessment of these observations and that you were already in the process of making certain changes, such as (b)(4). We will evaluate the adequacy of your corrective actions during our next inspection.

2. Your quality control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). Specifically:

• Your component specifications for (b)(4) had not been signed and approved by your quality control personnel.

We have reviewed your responses to the FDA 483, dated December 18, 2025, and April 30, 2026, in which you stated that your raw material specifications will be signed, reviewed, and approved by quality control personnel. However, we are unable to evaluate the adequacy of your response because you did not provide documentation supporting that your quality control personnel have approved your raw material specifications.

3. Your written batch production records (BPRs) did not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b), because they did not include all information required to be in a BPR under 21 CFR 111.260. Specifically, your firm’s BPRs for the dietary supplement products Totala Fulvic Ionic Mineral Complex Lemon Lime and Ionicell did not include the following required information:

• The time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records where this information is retained. [21 CFR 111.260(c)]

• The initials of the person responsible for weighing or measuring each component used in the batch. [21 CFR 111.260(j)(2)(i)]

• The initials of the person responsible for verifying the weight or measure of each component used in the batch. [21 CFR 111.260(j)(2)(ii)]

• The initials of the person responsible for adding the component to the batch. [21 CFR 111.260(j)(2)(iii)]

• The initials of the person responsible for verifying the addition of components to the batch. [21 CFR 111.260(j)(2)(iv)].

We have reviewed your responses to the FDA 483, dated December 18, 2025, and April 30, 2026, in which you stated that the batch production records will be updated. However, we are unable to evaluate the adequacy of your response because you did not provide documentation supporting that your batch production records have been updated.

4. Your firm failed to qualify certain suppliers by establishing the reliability of the suppliers’ certificates of analyses through confirmation of the results of the suppliers’ tests or examinations, in accordance with 21 CFR 111.75(a)(2)(ii)(A). Specifically, your firm relies on certificates of analyses to determine that component specifications for identity, purity, strength, composition, and limits on contamination are met, and you did not conduct testing on your (b)(4) dietary ingredients to establish the reliability of the suppliers’ certificates of analyses before use.

We have reviewed your responses to the FDA 483, dated December 18, 2025, and April 30, 2026, in which you stated, “suppliers will be qualified establishing the reliability of the supplier’s certification of analysis through confirmation of the results of their tests or examinations.” On May 1, 2026, you provided component specification sheets that include instructions to confirm suppliers’ certificates of analyses with testing; however, we are unable to evaluate the adequacy of your response because you did not provide documentation supporting that the relevant suppliers have been qualified.

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.

We also have the following comment:

21 CFR 111.75(a)(2) does not allow firms to rely on a certificate of analysis to confirm the identity of a dietary ingredient. Rather, under 21 CFR 111.75(a)(1)(i), you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to using a component (or submit an exemption petition under 21 CFR 111.75(a)(2)(ii)). However, your component specification sheets submitted on May 1, 2026, for your (b)(4) dietary ingredients state that component identity testing will be conducted (b)(4) instead of every time the component is used.

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 Rebecca Allen, Compliance Officer, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #724745 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.

Sincerely,
/S/

Maria S. Knirk, JD, MBA
Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program