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  5. Valentine Enterprises, Inc. - 705119 - 07/17/2025
  1. Warning Letters

WARNING LETTER

Valentine Enterprises, Inc. MARCS-CMS 705119 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Alan W. Smith
Recipient Title
President/CEO
Valentine Enterprises, Inc.

1291 Progress Center Ave
Lawrenceville, GA 30043-4801
United States

awsmith@veiusa.com
Issuing Office:
Human Foods Program

United States

July 17, 2025

WARNING LETTER

CMS # 705119

Dear Mr. Smith:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1291 Progress Center Ave., Lawrenceville, GA 30043-4801 from October 8 – 24, 2024. Based on inspectional findings and review of the product documents collected during the inspection, 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 October 24, 2024, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your written responses dated November 7, and December 5, 2024, and January 31, February 28, March 31, 2025, May 30, and June 30, 2025, and we address your responses below.

Adulterated Dietary Supplements

The inspection of your facility from October 8 through October 24, 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 product, Vibrant Health Green Vibrance (“VH Green Vibrance”), 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 it has 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. Your firm failed to, for each dietary supplement that you manufacture, establish product specifications for the identity, purity, strength, composition and limits on contamination of the finished batch of the dietary supplement as required in 21 CFR 111.70(e).

Specifically, your document, “(b)(4)” for your product VH Green Vibrance, does not establish an identity specification that includes a test method that will adequately identify the finished product. Your “(b)(4)” sheet purports to use organoleptic attributes (taste, texture, aroma and color), with a specification that states “(b)(4)” for identity testing. However, this does not provide sufficient detail for your firm to be able to confirm the identity of a multi-ingredient finished product in powder form, and it does not ensure that you can distinguish one product from any other mix of powdered substances. Additionally:

- Only eighteen of the dietary ingredients in VH Green Vibrance are listed to be tested on a rotating basis, which is not adequate to establish identity for each batch of the dietary supplement, and there is no acceptance criteria written on the specification form.

Your responses dated 12/06/24, 1/31/25, 2/28/25, 3/31/25, 5/30/25, and 6/30/25 include updated finished product specifications for VH Green Vibrance. They include methods for some of the ingredients, however, the frequency of first lot/annually or rotating is not supported by a scientific rationale as to how this confirms the identity specifications of every lot. Additionally, some of the test methods are from private labs or internal, so we are unable to evaluate if they are adequate for the intended target.

Additionally, for VH Green Vibrance, the label lists probiotic bacteria ingredients and respective quantities, but you state (b)(4). We understand you are in discussions with the client about taking corrective action on this issue. We will evaluate the adequacy of your corrective action at the next inspection.

We note that in addition to establishing the required specifications, your firm must determine whether such specifications are met, in accordance with 21 CFR 111.73 and 111.75.

2. You failed to verify that the laboratory examination and testing methodologies are appropriate for their intended use, as required by 21 CFR 111.320(a).

Specifically, you rely on a third-party laboratory to conduct your pathogen testing for finished products. Your third-party laboratory said they did not determine the suitability of the following methods for testing VH Green Vibrance:

  • BAM chapter 12 for testing for presence of S. aureus;
  • AOAC 991.14 for testing for presence of E. coli;
  • AOAC-RI 121501 for testing for the presence of Salmonella.

Your responses dated 12/06/24, 1/31/25, 2/28/25, 3/31/25, 5/30/25, and 6/30/25, include updated finished product microbial testing specifications and you state you (b)(4) for pathogen testing for finished products. However, we are unable to evaluate the adequacy of your response because you did not provide supporting documentation demonstrating that you have verified that such tests are appropriate for their intended use in your products.

3. Your firm failed to include complete information in your batch production records relating to the production and control of each batch, as required by 21 CFR 111.255(b) and in accordance with 21 CFR 111.260.

Specifically, for VH Green Vibrance, your BPRs did not include:

a. The date and time of 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, as required by 21 CFR 111.260(c).
b. The results of any testing or examination performed during the batch production, or a cross-reference to such results, as required by 21 CFR 111.260(h).

Your responses dated 12/06/24, 1/31/25, 2/28/25, 3/31/25, 5/30/25, and 6/30/25 include updated procedures and you reference updated MMRs which you state (b)(4). We will evaluate the adequacy of your corrective actions at the next inspection.

Misbranded Dietary Supplements

In addition, we reviewed your product labels collected during the inspection and have determined the MuscleTech EuphoriQ Pre-Workout Watermelon Candy, VH Green Vibrance, Vibrant Health Joint Vibrance, and Premium Green Superfood Cytogreens products you manufacture 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.

1. The products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically,

- For MuscleTech EuphoriQ Pre-Workout Watermelon Candy you declare the dietary ingredient “(b)(4)” 10 mcg. Your MMRs’ “(b)(4)” identifies the ingredient as “(b)(4).” Your raw material specification 88-517 provided in your 2/28/25 response describes the ingredient as “(b)(4).” It appears that you add an extract of (b)(4), but the label does not mention the extract.

- For VH Green Vibrance – you declare as “(b)(4) natural flavor, which is not a common or usual name.

- For Vibrant Health Joint Vibrance and Premium Green Superfood Cytogreens – the “(b)(4) is not a common or usual name.

2. The products are 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 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) Table 2. Specifically:

- For Vibrant Health Joint Vibrance - the product’s label declares serving size as 1 scoop. The directions state to take one to two (1 to 2) scoops.

- For products 8 Greens Super Greens Powder and Premium Green Superfood Cytogreens - the serving size needs to be expressed using the term that is appropriate for the form of the supplement, such as “tablets,” “capsules,” “packets,” or “teaspoonfuls,” as required by 21 CFR 101.36(b)(1)(i). The appropriate term would be “1 Scoop (x g)” as stated in the directions for use.

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:

On the label of 8 Greens Super Greens Powder, you compare the amounts of vitamins and zinc to what is contained in fruits and vegetables. Please note all information on the product label must be truthful and not misleading.

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 J. Dent Acosta, 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 #705119 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
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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