WARNING LETTER
C R Supplements, LLC
MARCS-CMS 624651 —
April 20, 2022
Delivery Method:
Overnight Delivery
Product:
Drugs
Recipient:
Recipient Name
Susan E. Hull
Recipient Title
Vice President and Owner
C R Supplements, LLC
102 North Main Street #445
Kooskia
,
ID
83539
United States
Issuing Office:
Office of Human and Animal Food Operations – West Division 6
United States
April 20, 2022
In reply, refer to CMS 624651
WARNING LETTER
Dear Ms. Hull:
The U.S. Food and Drug Administration (FDA) inspected your facility, located at 102 North Main Street #445, Kooskia, Idaho, from December 6, 2021, to December 10, 2021. In March and April 2022, we also reviewed your website at the Internet address www.crsupplements.com and your Facebook page at www.facebook.com/pages/ category/Health---Wellness-Website/C-R-Supplements-857713577610642. Based on inspectional findings and a review of your website and Facebook page, we have identified serious 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 the FDA’s home page at
www.fda.gov.
Unapproved New Drugs/Misbranded Drugs
FDA reviewed your website at the Internet address www.crsupplements.com in March and April 2022, and has determined that you take orders there for your products Calcium, 4X Calcium 4X, Copper, Molybdenum, Potassium, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost Pack. FDA also reviewed your Facebook page at www.facebook.com/pages/category/Health---WellnessWebsitem/C-R-Supplements-857713577610642 in March 2022, which offers a direct link to your website, www.crsupplements.com. The claims on your website and Facebook page establish that your Calcium, 4X Calcium 4X, Copper, Molybdenum, Potassium, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost Pack 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 on your website, www.crsupplements.com, that provide evidence that your products are intended for use as drugs include:
Calcium
“[Calcium] helps keep your blood stream and other body liquids alkaline, countering body acidity. Harmful bacteria, virus and other disease causers do not thrive in an alkaline environment.”
4X Calcium 4X
“… [C]ountering body acidity. As a result of good body pH, … Bad Bacteria will decline.”
Copper
“[Copper] influences how your body perceives pain because it is a necessary part of enkephalin production.”
Molybdenum
“Molybdenum is essential to the enzymes that change the sulfites into sulfates so they can safely and easily move out of the body. … Sulfites accumulate and can build up to toxic levels. When sulfites reach toxic levels:
o Allergy responses like itching, hives, and fainting can happen.
o Trouble breathing is another possible sulfite response. Respiratory problems can range from wheezing to a full-blown asthma attack.”
“Your liver requires Molybdenum to neutralize harmful by-products of candida and mold exposure.”
Potassium
“A lack of Potassium … can result in muscle cramps.”
Selenium
“Replacing damaged … cells in the body with healthy ones depends on adequate amounts of available Selenium.”
Additionally, the webpage for your Immune Boost Pack product at www.crsupplements. com website and your Facebook social media account at www.facebook.com/857713577610642/photos/pb.857 713577610642.-2207520000../1548660671849259/?type=3&theater contain the following claim, pertaining to your products Silver, Calcium, Magnesium, Zinc, Copper, Selenium, Alkalize-U, and CR-Oxy+:
“Sorry, No Flu Shots Here! Try These Instead … Natural Flu Shots” [followed by an image of Silver, Calcium, Magnesium, Zinc, Copper, Selenium, Alkalize-U, and CR-Oxy+].
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.
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, Copper, Molybdenum, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost Pack are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment 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, Copper, Molybdenum, Selenium, Silver, Magnesium, Zinc, Alkalize-U, CR-Oxy+, and Immune Boost Pack 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 from December 6, 2021, to December 10, 2021, revealed 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). Based on these violations, even if your Silver and Magnesium products were not unapproved new drugs and misbranded drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
The violations include the following:
1. Your firm failed to establish a specification for every point, step, or stage 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 (MMR), as required by 21 CFR 111.70(a). Specifically, you have not established any written specifications for the components you use in your dietary supplement products. As required by 21 CFR 111.70, you must (among other requirements):
a. Establish specifications for each component you use in the manufacture of a dietary supplement [21 CFR 111.70(b)];
b. Establish in-process production specifications for any point, step, or stage in the MMR where control is necessary to ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements [21 CFR 111.70(c)(1)];
c. Establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications) [21 CFR 111.70(d)];
d. Establish specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement, and for 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 [21 CFR 111.70(e)];
e. Establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure the specified packaging is used with the specified label [21 CFR 111.70(g)].
Once you have established the aforementioned specifications, you must determine whether those specifications have been met, as required by 21 CFR 111.73 and 21 CFR 111.75, and you must make and keep records for established specifications, as required by 21 CFR 111.95.
We received your January 4, 2022, response. Your response did not include evidence of any implemented corrective actions relating to this issue.
2. You failed to establish and follow written procedures for the responsibilities of 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 and 111.140(b)(1). Specifically, during the inspection of your facility, your firm’s Laboratory Technician and Co-Owner stated that you do not have written procedures for the responsibilities of quality control operations. Additionally, you do not make and keep written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements by recording the date that the review, approval, or rejection was performed and the signature of the person performing the review, approval, or rejection; and documentation of any material review and disposition and follow-up, as required by 21 CFR 111.140(b)(2) and (b)(3) for the below:
a. Regarding your Silver product, Batch
(b)(4)
, which was used in your Silver, Batch
(b)(4)
, your percent yield, as calculated based on the actual and theoretical weights reported on your batch production record (BPR), is outside of your listed acceptable range of
(b)(4)
. Your MMR identifies that if the percent yield is outside of your acceptable range, a reason for the excessive difference will be provided in the “Events table”; and if a reasonable explanation cannot be provided, an area Supervisor/Designee will be notified, and an investigation will be
referenced in the “Events table”. However, no reason or investigation was recorded in the “Events table”. Additionally, your BPR contains quality assurance verification signatures, despite containing incomplete records, as described further below.
b. Your BPR for your Magnesium product, Batch
(b)(4)
, used in your Magnesium product, Batch
(b)(4)
, contains incomplete records, as described further below, and lacks quality assurance verification signatures.
Once you have established quality control written procedures, you must implement quality control operations into your manufacturing, packaging, labeling, and holding operations, as required by 21 CFR 111.65; including a system of production and process controls to ensure the quality of the dietary supplement, and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.55. Quality control personnel must also ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.105, and you must have documentation, at the time of performance, for the quality control personnel review and approval of release or rejection for any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.127(h) and 111.140(b).
We received your January 4, 2022, response. Your response did not include evidence of any implemented corrective actions related to this issue. Although you provide an MMR and BPR containing quality assurance verification signatures for your Magnesium, Batch
(b)(4)
, no written procedures establishing the responsibilities of quality control operations was provided. Additionally, your MMR and BPR are missing significant elements related to quality control operations, described in greater detail below.
3. You failed to prepare and follow a written 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, the MMRs for your Silver and Magnesium products address only certain portions of the manufacturing process and do not address bottling into individual units for end consumption. The MMRs associated with your Silver and Magnesium products provided to our investigators also have multiple production runs associated with them and do not provide for a determined batch size.
Under 21 CFR 111.205, you must prepare an MMR that (1) identifies specifications for the 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, and (2) establishes controls and procedures to ensure that each batch of dietary supplement that you manufacture meets these specifications [21 CFR 111.205(b)(1) and (b)(2)]. In addition, each MMR must conform to the requirements as described in 21 CFR 111.210. Specifically, your MMRs for your Silver and Magnesium products fail to include:
a. 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)];
b. A statement of any intentional overage amount of a dietary ingredient [21 CFR 111.210(e)];
c. 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)];
d. Written instructions as required by 21 CFR 111.210(h), including the following:
i. Specifications for each point, step, or stage 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 [CFR 111.210(h)(1)];
ii. Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];
iii. 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)];
iv. Special notations and precautions to be followed [21 CFR 111.210(h)(4)].
We received your January 4, 2022, response. Your response included an MMR/BPR for your Magnesium product, Batch
(b)(4)
. This same MMR/BPR was also provided to our investigators during the inspection. The version of this MMR/BPR that was provided in your response continues to exclude requirements under 21 CFR 111.210, including specific items pertaining to 21 CFR 111.210(h).
4. You failed to prepare a BPR every time you manufactured a batch of dietary supplements and to prepare a BPR that includes all required information, as required by 21 CFR 111.255(a) and 21 CFR 111.260. Specifically, you provided our investigator BPRs that were used for multiple production runs of dietary supplements, rather than for individual batches. Additionally, your BPRs, which you stated to our investigator also function as the subject products’ MMRs, provided for your Silver, Batch
(b)(4)
, and Magnesium, Batch
(b)(4)
, include only limited information relating to the manufacture of bulk ingredients for these products. Your BPR’s for your Silver, Batch
(b)(4)
, and Magnesium, Batch
(b)(4)
, products are missing the following required information:
a. 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 [21 CFR 111.260(c)];
b. The unique identifier that you assigned to each component (or, when applicable, to a product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used [21 CFR 111.260(d)];
c. The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
d. Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)];
e. Documentation, at the time of performance, of the manufacture of the batch, including:
i. The date on which each step of the MMR was performed [21 CFR 111.260(j)(1)];
ii. The initials of the persons performing each step, including:
A. The initials of the person responsible for weighing or measuring each component used in the batch [21 CFR 111.260(j)(2)(i)];
B. 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)];
C. The initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)];
D. The initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)].
f. Documentation, at the time of performance, of packaging and labeling operations, including:
i. 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)];
ii. 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)];
iii. 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)].
g. Documentation at the time of performance that quality control personnel:
i. Reviewed the BPR, including:
A. Review of any monitoring operation required under 21 CFR 111 subpart E [21 CFR 111.260(l)(1)(i)];
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)].
ii. Approved or rejected any reprocessing or repackaging [21 CFR 111.260(l)(2)];
iii. Approved and released, or rejected, the batch for distribution, including any reprocessed batch [21 CFR 111.260(l)(3)];
iv. Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)(4)].
h. Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)];
i. Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)].
We received your January 4, 2022, response. Your response included an MMR/BPR for your Magnesium product, Batch
(b)(4)
. This same MMR/BPR was also provided to our investigators during the inspection. The version of this MMR/BPR which was provided in your response continues to exclude requirements under 21 CFR 111.260 including specific items pertaining to 21 CFR 111.260(j), 21 CFR 111.260(k), and 21 CFR 111.260(l).
Misbranded Dietary Supplements
In addition, even if your Silver and Magnesium products were not unapproved new and misbranded drugs, these products would be misbranded under section 403 of the Act because they do not comply with the labeling requirements for dietary supplements.
Specifically, we identified the following:
1. Your Silver and Magnesium products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g., Supplement Facts label) is not in a correct format, as required by 21 CFR 101.9. Foods, other than infant formula, represented or purported to be specifically for children one (1) through three (3) years of age shall bear nutrition labeling for those age groups, as required by 21 CFR 101.9(j)(5). Your Silver and Magnesium products do not provide nutrition information for children between one (1) year and three (3) years of age. There are specific requirements for children under four (4) years of age and under two (2) years of age, per 21 CFR 101.9(j)(5).
In addition, the product labels fail to list the serving size for each of the age groups indicated on the label, which includes 1 teaspoon (5 mL) daily for adults, and children under 4 years of age ¼-½ tsp. (1.2-2.5 mL), respectively. The products are for persons within two different groups, and the quantitative amount and percent of Daily Value for each group shall be presented in separate columns, as required by 21 CFR 101.36(b)(2)(iii)(E).
2. Your Silver and Magnesium products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343(q)(5)(F)) in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36 and 21 CFR 101.9. For example:
a. Your Magnesium product label declares magnesium at a quantitative weight of 1.75 milligrams (mg) per serving and at <1% of the Daily Value. However, if magnesium 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).
b. Your Silver and Magnesium product labels lists the “Other ingredients” above the Supplement Facts label. The “Ingredients” or “Other Ingredients” must be listed immediately following the Supplement Facts label, as required by 21 CFR 101.4(g).
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.
Please send your reply to the U. S. Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Glynn at 425-302-0411.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
Office of Human and Animal Food
Operations – West Division 6
Content current as of:
05/03/2022
Regulated Product(s)
Drugs