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  5. Morningstar Minerals LLC - 599745 - 06/01/2020
  1. Warning Letters

WARNING LETTER

Morningstar Minerals LLC MARCS-CMS 599745 —

Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Norman Geoffrey McMahon
Recipient Title
President and Owner
Morningstar Minerals LLC

22 County Road 3957
Farmington, NM 87401-7985
United States

Issuing Office:
Division of Human and Animal Food Operations West IV

United States

June 1, 2020

WARNING LETTER

Ref: # HAFW4-20-04-WL

Dear Mr. McMahon:

From November 19 to November 21, 2019, the U.S. Food and Drug Administration (FDA or we) inspected your facilities located at 22 Country Road 3957, Farmington, New Mexico and 44 County Road 3697, Aztec, New Mexico. This inspection was conducted as a follow-up to the regulatory meeting held with your firm on April 3, 2019. Based on our inspection and subsequent review of your firm’s website at www.msminerals.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Unapproved New Drugs/Misbranded Drugs

FDA reviewed your website at www.msminerals.com in April 2020 and has determined that you take orders there for the products Got Arginine? and Energy Boost 70. The claims on your website establish that these 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 observed on your website that provide evidence that these products are intended for use as drugs including the following:

Got Arginine?, product page
• “Promoting wound healing by reparing [sic] tissue…”
• “[C]an improve cardiovascular health and lessen symptoms related to strokes.”

Energy Boost 70, product page
• “Energy Boost 70’S [sic] Minerals mineral complexes are the world’s finest electrolyte, which . . . reduces high blood pressure . . . and helps rebuild the immune system.”

Your Got Arginine? and Energy Boost 70 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)]. 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.

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 Got Arginine? and Energy Boost 70 products are intended for treatment of one or more diseases that are not amendable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use this product safely for the intended purposes. Accordingly, your Got Arginine? And Energy Boost 70 products fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Adulterated Dietary Supplements

Your Silver Boost and (b)(4) dietary supplement products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMP) regulations, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Following the November 2019 inspection of your facility, FDA issued a Form FDA 483, Inspectional Observations, addressing the violations discussed below. We acknowledge receipt on December 9, 2019, of your undated response to the Form FDA-483, Inspectional Observations, issued on November 7, 2019, and we address your response below.

1. You failed to verify that your finished batch of the dietary supplement meets product specifications for strength for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), as required by 21 CFR 111.75(c). Specifically, during the inspection, your production and quality control staff stated that they have been unable to find a testing method to accurately confirm the strength of the silver in your Silver Boost product.

Note that you must ensure that any tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 11.75(h)(1), and you must make and keep records of the specifications, in accordance with 21 CFR 111.95.

We acknowledge receipt of your response on December 9, 2019, which states that you have updated your master manufacturing record (MMR) to an established strength of (b)(4)ppm. Your updated MMR further provides that you will “[g]et third party testing for silver ppm testing. (b)(4)ppm-(b)(4)ppm.” However, your response does not provide evidence this testing is being performed.

2. You failed to prepare and follow an MMR for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection, you stated that batch 30419A of your (b)(4) product was manufactured without an MMR. In addition, your MMR for “Bulk Silver Boost” failed to include all required information, in accordance with 21 CFR 111.210. Specifically, the MMR fails to include the following information:

• The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement [21 CFR 111.210(d)];
• A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g);
• Written instructions [21 CFR 111.210(h)], including the following:
o Specific actions necessary to perform and verify 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 MMR [21 CFR 111.210(h)(3)].

1) Such specific actions must include verifying the weight or measure of any component and verifying the addition of any component [21 CFR 111.210(h)(3)(i)]; and

2) For manual operations, such specific actions must include [21 CFR 111.210(h)(3)(ii)]:

A. One person weighing or measuring a component and another person verifying the weight or measure [21 CFR 111.210(h)(3)(ii)(A)]; and
B. One person adding the component and another person verifying the addition [21 CFR 111.210(h)(3)(ii)(B)].

We have received your response on December 9, 2019, in which you provided revised MMRs for your “Bulk Silver Boost,” “Bulk Humic Minerals,” “Bulk Fulvic Minerals,” “(b)(4),” and “(b)(4).” However, it appears that these documents have not been reviewed and approved by your quality control unit. In addition, the revised MMRs fail to include all necessary components of the MMR as required by 21 CFR 111.210 including:

• The identity and weight or measurement of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement [21 CFR 111.210(d)].
• A description of packaging and representative label, or cross-reference to the physical location of the actual or representative label [21 CFR 111.210(g)].
• Written procedure for sampling and cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)].
• Written instructions for specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement including, for manual operations one person weighing or measuring a component and another person verifying the weight or measure [21 CFR 111.210(h)(3)(ii)(A)].

3. You failed to establish a batch production record (BPR) that satisfies the requirements of 21 CFR 111.255 and 111.260. Specifically:

• Your BPR fails to accurately follow the appropriate MMR, as required by 21 CFR 111.255(c). You provided an MMR titled “Master Manufacturing Record For Bulk Silver Boost,” which states, “This procedure should yield (b)(4) Gallons of (b)(4)ppm Colloidal Silver.” However, the BPRs related to the MMR you provided to our investigator for Silver Boost Colloidal Silver batch numbers 10719A, 20519A, and 22719A show the respective batches produced (b)(4) gallons in (b)(4) eight-ounce units, (b)(4) gallons in (b)(4) eight-ounce units, and (b)(4) gallons in (b)(4) eight-ounce units.

• Your BPRs for Silver Boost 8 oz (batches 10719A, 20519A, and 22719A) failed to include:
o The unique identifier that you assigned to each component and label [21 CFR 111.260(d)]. For your colloidal silver batches 10719A, 20519A, and 22719A, your BPRs fail to contain a unique identifier for (b)(4) silver and labels;
o Documentation, at the time of performance, of packaging and labeling operations, including:

1) The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels [21 CFR 111.260(k)(1)];
2) An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR [21 CFR 111.260(k)(2)]; and
3) The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)(3)];

o Documentation at the time of performance that quality control personnel:

1) Reviewed the BPR, including:

A. Review of any monitoring operation required under subpart E of this part [21 CFR 111.260(l)(1)(i)]; and
B. Review of the results of any tests and examinations, including tests and examinations conducted on components, in-process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements [21 CFR 111.260(l)(1)(ii)];

2) Approved or rejected any reprocessing or repackaging [21 CFR 111.260(l)(2)];

3) Approved and released, or rejected, the batch for distribution, including any reprocessed batch [21 CFR 111.260(l)(3)]; and

4) Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)].

o Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)].
o Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)].

You also informed our investigator you did not complete the BPRs used in the manufacturing, packing, and labeling of these products during the time of actual performance and production.

We acknowledge receipt of your response on December 9, 2019, which provides an updated MMR reflecting the change in your operations to produce (b)(4)-gallon batches of bulk silver instead of the (b)(4)-gallon batches that were observed during the inspection. However, you did not provide BPRs demonstrating that the changes in operations have been carried forward into your actual operations. In addition, you indicated that you would be providing additional training, but you failed to provide a timeline of when the training would be completed, nor did you explain how such training would specifically address this deviation or prevent it from recurring.

Misbranded Dietary Supplements

In addition, your (b)(4), (b)(4), Energy Boost 70, and Silver Boost products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101 as follows:

1. Your Energy Boost 70 product in 1 fluid gallon (1 fl. gallon) (3.785 liter) and 4 fl. ounce (oz) units and (b)(4) each appears to be misbranded within the meaning of sections 403(s)(2)(A) and 403(q)(5)(F) of the Act [21 U.S.C. §§343(s)(2)(A) and 343(q)(5)(F)] in that the label fails to list the name of each dietary ingredient of the supplements that are described in section 201(ff) and the quantity of each such dietary ingredient, as required by 21 CFR 101.36. For example, your labels suggest that the product contains several dietary ingredients. However, these dietary ingredients and their quantitative amounts by weight per serving are not listed in the Supplement Facts label in accordance with 21 CFR 101.36(b)(3).

2. Your Energy Boost 70 product in 1 fl. gallon (3.785 liter) and 4 fl. oz units are each misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions states: “For other needs up to 2 oz (60 ml)…three times a day or as directed by your health care professional” but the serving size is listed as “1 oz.” The serving size should be “2 oz (60 ml).”

In addition, your Silver Boost Colloidal Silver 4 fl oz and 8 fl oz products are each misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size of “1 tbsp” declared in the Supplement Facts label is not consistent with the label statement of “…hold 1 teaspoon under tongue for 1 minute then swallow …”

Also, your (b)(4) product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the Supplement Facts label fails to declare the serving size in the equivalent metric quantity in milliliters.

3. Your Energy Boost 70 1 fl. gallon and 4 fl. Oz., (b)(4), and (b)(4) products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36 and 101.9. For example,

• The labels declare Calories and Calories from fat but does not provide a quantitative weight or percent Daily Value (DV) as required by 21 CFR 101.36(b)(2). However, if calories and saturated fat is not present or in an amount that can be declared as zero in 21 CFR 101.9(c), it shall not be declared in accordance with 21 CFR 101.36(b)(2)(i).
• The labels for your Energy Boost 70 products do not meet the requirement of 21 CFR 101.36(b)(2)(i)(A) in that the “Amount per serving” heading is not centered over a column of quantitative amounts. Furthermore, a light bar fails to be placed below the heading “Amount per Serving” and “% DV” (21 CFR 101.36(e)(7)).
• The labels for your Energy Boost 70 products, (b)(4), and (b)(4) product bear the title, “Supplement Facts,” in an incorrect format. The title, “Supplement Facts,” shall be set in a type size larger than all other print size in the nutrition label and, unless impractical, shall be set full width of the nutrition labels as required by 21 CFR 101.36(e)(1).
• The labels for your Energy Boost 70 products fail to include a heavy bar beneath the last (b)(2) - dietary ingredient and beneath the last (b)(3) – dietary ingredient (other dietary ingredient), as required by 21 CFR 101.36(e)(6)(ii) and (iii).
• The labels for your Energy Boost 70 products lists the “Other ingredients” in the (b)(3)-dietary ingredient section within the Supplement Facts label. The “Ingredients” or “Other Ingredients” must be listed outside and immediately following the Supplement Facts label as required by 21 CFR 101.4(g).
• The labels for your Energy Boost 70 products fail to place a “*” following the quantitative amount of the “fulvic minerals 100% in solution” as required by 21 CFR 101.36(b)(3)(iv).

4. Your Silver Boost Colloidal Silver 4 oz product is misbranded within the meaning of Section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the number of servings is incorrect.

5. Your (b)(4) and (b)(4) product labels are each misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that each fails to declare the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

6. Your (b)(4) product label is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4 and 21 CFR 101.36.

The product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct all the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

We also offer the following comments:

1. The Silver Boost Colloidal Silver 4 oz product incorrectly declares “This 8 fl oz bottle makes 320 fl oz of 5 ppm product.” This the same statement that appears on the Silver Boost Colloidal Silver 8 oz product.

2. The Silver Boost Colloidal Silver 4 oz and 8 oz product labels bear “Directions: Mix ½ fl oz with 20 fl oz …” We suggest the term “½ fl oz” should be consistent with the serving size declared in the Supplement Facts label, e.g., 1 TBSP (1/2 fl oz)(15 ml).

3. The Silver Boost Colloidal Silver 4 oz and 8 oz, (b)(4), and (b)(4) labels declare “Percent Daily Values are based on a 2,000 calorie diet. We note this statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).

4. The (b)(4) Supplement Facts label contains intervening material in addition to the name of (b)(3)-dietary ingredients which is not in accordance with 21 CFR 101.2(d).

5. The Energy Boost 70 and (b)(4) product labels contain the FDA disclaimer statement but not in accordance with 21 CFR 101.93(b)-(d). Intervening material should not be included within the FDA disclaimer. In addition, the symbol that links the disclaimer does not appear elsewhere on the label with a section 403(r)(6) of the Act statement.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation, such as photographs, corrective actions taken to date, or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.

Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the inspection and assessing and collecting the inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at hanna.potter@fda.hhs.gov. You may reach Ms. Potter at (303) 236-3094 if you have any questions about this matter.

Sincerely,
/S/

LaTonya M. Mitchell, PhD
Denver District Director
Program Division Director
Office of Human and Animal Food Operations –
Division IV West

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