WARNING LETTER
CC Pollen Company MARCS-CMS 714784 —
- Delivery Method:
- Via Email
- Product:
- Dietary Supplements
- Recipient:
- CC Pollen Company
5455 N. 51st Ave Ste 17
Glendale, AZ 85301-7030
United States-
- Bruce@ccpollen.com
- Issuing Office:
- Human Foods Program
United States
January 9, 2026
Warning Letter
CMS #714784
Dear Mr. Brown,
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 5455 N. 51st Ave Ste 17, Glendale, AZ 85301 on April 7, 2025 to April 14, 2025. Based on inspectional findings, we 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 April 14, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We received your written response to those observations on April 25, 2025 and discuss your corrective actions below in relation to each of the noted violations, where applicable.
Adulterated Dietary Supplements
The inspection of your facility on April 7, 2025 through April 14, 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 dietary supplements, Bee Pollen Granules and Royal Jelly capsules 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.
Your significant violations of the CGMP requirements are as follows:
1. You failed to, for each dietary supplement that you manufacture, establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, the label claim for your Bee Pollen product is 3g Bee Pollen, and the label claim for your Royal Jelly product is 268mg Royal Jelly and 99 mg Bee Pollen. However, you did not establish specifications for the identity, purity, strength, and composition of the Bee Pollen Granules 16 oz and Royal Jelly 1000 mg 60ct capsules.
We have reviewed your response dated 4/25/25, in which you state that you will create finished product specifications for Bee Pollen Granules 16 oz and Royal Jelly 1000 mg 60ct capsules; however, we are unable to evaluate the adequacy of your response because you did not provide documentation to support you have established the required product specifications. Additionally, once you have established the required product specifications, you must verify that the established product specifications are met in accordance with 21 CFR 111.75(c).
2. Your quality control personnel failed to approve or reject component specifications that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). For example, you provided the FDA investigator raw ingredient specifications for Domestic Bee Pollen Powder Bulk, Foreign Bee Pollen Powder Bulk, and Foreign Bee Pollen Granules Bulk. However, the specifications did not include documentation to support that your quality unit approved or rejected the specifications.
We have reviewed your response dated 4/25/25, in which you state that you will be training quality control personnel concerning the need to review all documents to ensure there are no missing signatures or dates before items are released. However, we are unable to evaluate the adequacy of your response because you did not provide documentation to support that this training has been conducted.
3. For specifications established under § 111.70(b)(1) that you did not meet, your quality control personnel failed to reject the component and prevent it from being used in manufacturing the dietary supplement, as required by 21 CFR 111.77(b). Specifically, Silica lot (b)(4) was tested by FTIR and obtained a critical match of 80.37, which is below the acceptance criteria of (b)(4) stated in your procedure for FTIR identity testing.
The procedure for FTIR Identity Testing QA-QC 10.180 states “Acceptance criteria (is greater than 85 critical points) or as established by the specification committee will be used as the criteria releasing and distribution of the raw materials or finished products as per SOP QA-QC 10.142.” Silica lot (b)(4) was approved on 10/1/2021 and was used in the manufacture of Royal Jelly (b)(4) mg Capsules Bulk Lot (b)(4), which was used to manufacture Royal Jelly (b)(4) mg Capsules (b)(4)ct finished product Lot (b)(4).
We have reviewed your response dated 4/25/25. However, we are unable to evaluate your response because you did not provide any supporting documentation demonstrating that a corrective action has been implemented.
4. You did not prepare a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufactured, as required by 21 CFR 111.205(a). Specifically, you stated (b)(4).
We have reviewed your response dated 4/25/25, in which you state you (b)(4). However, we are unable to evaluate your proposed corrective action because you did not provide documentation that you have prepared an MMR for this product.
5. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to use in manufacturing, as required by 21 CFR 111.75(a)(1)(i). Specifically, you failed to conduct identity testing of Bee Pollen Lots (b)(4), and (b)(4) prior to use in the manufacture of Bee Pollen Granules dietary supplement Lot (b)(4).
We have reviewed your response dated 4/25/25, in which you state you (b)(4). However, we are unable to evaluate your response because you did not provide any supporting documentation demonstrating that one of these corrective actions has been implemented.
Misbranded Dietary Supplements
In addition, we reviewed your product labels collected during the inspection and have determined the Bee Pollen Granules and Royal Jelly capsules products product you manufacture/distribute are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:
1. Your firm’s CC Pollen Royal Jelly capsules product is misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the label 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). The directions of use suggest the consumer take “1-2 capsules once daily” but the serving size lists 1 capsule. The serving size listed should be two capsules based on the directions of use. The related nutrition information on the label per accurate serving size may need to be revised accordingly.
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 Lauren Crivellone, 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 # 714784 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, J.D., M.B.A.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program