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WARNING LETTER

Eniva USA, Inc. MARCS-CMS 706565 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Andrew J Baechler
Recipient Title
CEO
Eniva USA, Inc.

2700 Campus Dr.
Plymouth, MN 55441-2601
United States

andyb@eniva.com
Issuing Office:
Human Foods Program

United States

September 10, 2025

WARNING LETTER

CMS #706565

Dear Mr. Baechler:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 2700 Campus Dr., Plymouth, MN, from November 19, 2024, through January 13, 2025. Based on inspectional findings and review of product labels collected during the inspections, as well as review of your website, www.eniva.com, 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 January 13, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your response on February 5, 2025, and we address your response below.

Adulterated Dietary Supplements

The inspection of your facility from November 19, 2024, through January 13, 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 your Immune Support (previously called Cold Buster) and Ashwagandha Gummies dietary supplements to 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.

Your significant violations of the CGMP requirements are as follows:

1) You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplements, as required by 21 CFR 111.70(e). During the inspection, your Senior Quality Manager stated that your finished product specifications are maintained in the form of blank “(b)(4)” documents. However, your “(b)(4)” documents do not establish product specifications that confirm the identity, purity, strength, and composition of the finished batches of your Cold Buster (now Immune Support) and Ashwagandha Gummies dietary supplements. Specifically:

  • Your “(b)(4)” document for your Cold Buster (now Immune Support) lists appearance, color, odor, conductivity, pH, percent solids, and specific gravity as “(b)(4).” These factors do not constitute unique criteria that can confirm the identity of the Cold Buster product. Additionally, these factors do not—either alone or in conjunction—evaluate the purity, strength, and composition of this finished product.
  • Your “(b)(4)” document for your Ashwaghanda Gummies lists appearance, color, odor, and water activity as “(b)(4).” These factors do not constitute unique criteria that can confirm the identity of the Ashwaghanda Gummies product. Additionally, these factors do not—either alone or in conjunction—evaluate the purity, strength, and composition of this finished product.

We have reviewed your response to the FDA Form 483, received February 5, 2025, and find it does not adequately address the violation. In your response, you stated that you plan to update finished product specification forms for the finished dietary supplement products you manufacture, including Immune Support and Ashwagandha Gummies. However, to date, you have not submitted any evidence of further corrective action.

2) You failed to make and keep documentation of any material review and disposition decision and follow-up, as required by 21 CFR 111.140(b)(3). Specifically, your Senior Quality Manager stated that when “(b)(4)” results had been encountered by your firm since your last inspection for incoming components and outgoing dietary supplements, you failed to document the investigation, findings, material review by quality, and the disposition of affected materials.

We have reviewed your response to the FDA Form 483, received February 5, 2025, and find it does not adequately address the violation. In your response, you stated that you will review and update your SOP QS-009, “(b)(4),” and proceed to document all investigations. However, to date, you have not submitted any evidence of corrective action.

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.

In addition to the above-mentioned violations, we also have the following comment:

We conducted a case assessment and review of your firm’s response regarding observation 1, namely 21 CFR 114.83 for acid foods. Your response to this observation appears inadequate. We request the following be addressed by your firm:

  • Is management able to furnish the supporting documents from the University of Minnesota which support the conclusion that these products are acid foods?
  • Has management made formulation changes to the following original four products: Vibe Original, Vibe 2.0, Vibe Apple and Vibe Kids?
  • Has management fully evaluated the other products, not listed above, to determine if they are acidified or acid food products?
  • Please provide a list of ingredients, pH for all ingredients, formulation, and finished product pH for the Vibe product for review. Does your firm add acid ingredients to shift the product pH? What is the pH of the product before acidulent is added?

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 #706565 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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