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  1. Warning Letters

WARNING LETTER

H2 BEV, LLC and H2 RENU, INC MARCS-CMS 730567 —

Delivery Method:
VIA ELECTRONIC DELIVERY
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Kurt H Ruppman
Recipient Title
Owner
H2 BEV, LLC and H2 RENU, INC

912 Presidio Ct
Allen, TX 75013
United States

kurtsr@h2bev.com
Issuing Office:
Human Foods Program

United States

July 31, 2026

WARNING LETTER

CMS #730567

Dear Mr. Ruppman:

The United States Food and Drug Administration (FDA) conducted inspections of your acidified foods facility, which includes H2 BEV, LLC and H2 RENU, INC, located at 1601 Summit Ave, Ste 100, Plano, TX 75074-8109 US, on December 3, 2025, through January 12, 2026, and January 6 through 12, 2026, respectively. The inspections revealed serious violations of the Emergency Permit Control regulation, Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114).

As an acidified food processor, you are required to comply with the Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108.25, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114.

Based on FDA’s inspectional findings, we have determined your acidified, non-carbonated, hydrogen gas-infused beverages are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You can find the Act and FDA’s regulations through links in FDA’s homepage at www.fda.gov.

At the conclusion of the inspections, a Form FDA 483 (FDA 483), Inspectional Observations, was issued listing the deviations found at your facility. We acknowledge your response received via email on March 10, 2026, which included an employee registration to a Better Process Control School for acidified foods. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.

Furthermore, we have reviewed the claims on your websites, www.h2renu.com and www.h2bev.com, and established that your H2 RENU Oncology Care Beverage product and Hydro Shot Hydrogen Beverage Strawberry, Lemon Lime, and Orange flavored 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.

Acidified Foods Violations (21 CFR Part 108 and 114):

1. Commercial processors of acidified foods must register as a food canning establishment and file Form FDA 2541 (Food Canning Establishment Registration) with the FDA within 10 days after first engaging in the manufacture, processing, or packing, as required by 21 CFR 108.25(c)(1). However, you did not register your firms as food canning establishments.

2. As a commercial processor engaged in the processing of acidified foods, you must no later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes, as required by 21 CFR 108.25(c)(2). This information must include conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size. Specifically, you manufacture acidified, non-carbonated, hydrogen gas-infused beverages including Hydro Shot Hydrogen Beverages in various flavors, Hydro Brew Unsweetened Green Tea, Silver Bullet Green Tea with Zinc, and H2 RENU Oncology Care Beverage, which are acidified food products. However, you have not filed a scheduled process for any of these products. Further, the scheduled process must be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods, as required by 21 CFR 114.83.

Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication "Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format'' available at: https://www.fda.gov/food/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf-paper-submissions.

3. You did not employ appropriate quality control procedures to ensure that finished foods do not present a health hazard, as required by 21 CFR 114.80(a). Specifically, on December 4, 2025, your firm was manufacturing both Strawberry and Lemon Lime flavored 8.4 fluid ounce cans of Hydro Shot Hydrogen Beverages with lot codes "LOT: (b)(4)" and "LOT: (b)(4)," respectively. The FDA investigator reviewed the production logs after the first flavor was filled and packaged and observed no information had been recorded for that day’s production, including the date, product type, pasteurization temperature, and pasteurization time. According to your firm, the production logs are filled out after processing. When the investigator reviewed the production log records for processing between October 1, 2025, and December 4, 2025, the pasteurization temperature was recorded as an identical value each date of processing reviewed (i.e., “(b)(4)”). You stated that the pasteurizer temperature fluctuates, therefore your firm records the minimum temperature (b)(4). This minimum temperature is an (b)(4) temperature; however, you could not provide evidence of a (b)(4) temperature. Additionally, the pasteurization time for each date was not recorded in specific units of time; you recorded “(b)(4)” for all pasteurization times, which was the value the (b)(4) showed. According to your firm, (b)(4). However, you could not provide evidence that the (b)(4) correlates to an actual time, such as (b)(4). As a result, your firm cannot assure the finished product reaches a specific temperature for a set amount of time.

Furthermore, on January 6, 2026, the FDA investigator also reviewed your production logs for the H2 RENU Oncology Care Beverage, packaged in 8.4 fluid ounce cans, processed on October 7, 2025, November 5, 2025, and December 17, 2025. The same deficiencies noted above were observed in these production records.

4. You must have sufficient control, including frequent testing and recording of results, so that the finished equilibrium pH values for acidified foods are not higher than 4.6, as required by 21 CFR 114.80(a)(2). However, your firm did not document pH values across multiple products and production dates. Specifically, on (b)(4), your firm was manufacturing both Strawberry and Lemon Lime flavored 8.4 fluid ounce cans of Hydro Shot Hydrogen Beverages with lot codes "(b)(4)" and "(b)(4)", respectively. The FDA investigator’s review of your manufacturing records revealed that you did not document pH testing results. Additionally, on January 6, 2026, the investigator reviewed your firm’s production logs from October 7, 2025, November 5, 2025, and December 17, 2025, for H2 RENU Oncology Care Beverage, packaged in 8.4 fluid ounce cans, and observed the manufacturing records do not include pH testing results. Your firm’s management confirmed this and stated that your firm tests each batch but does not record the pH results.

We acknowledge your March 10, 2026, response which included employee registration to a Better Process Control School for acidified foods. However, your response does not adequately address the lack of food canning establishment registration and filed scheduled processes, as well as the failure to document pH results and inadequate pasteurization time and temperature monitoring. As of the date of this letter, you have not registered as a food canning establishment or filed scheduled processes with FDA.

Furthermore, in April 2026, we reviewed your websites www.h2renu.com and www.h2bev.com and determined that you take orders there for your H2 RENU Oncology Care Beverage product and Hydro Shot Hydrogen Beverage Strawberry, Lemon Lime, and Orange flavored products.

The claims on your websites, www.h2renu.com and www.h2bev.com, establish that your products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims that provide evidence that your products are intended for use as drugs include:

On your H2 RENU Oncology Care Beverage page https://h2renu.com:

  • “***support your body’s resilience during oncology care”.
  • “Our oncology care drink is uniquely formulated***designed specifically to support oncology patients***that complements treatment and recovery”.
  • “MADE FOR ONCOLOGY PATIENTS”.

On your website for Hydro Shot Hydrogen Beverage Strawberry, Lemon Lime, and Orange flavored https://h2bev.com/collections/hydroshot:

  • "...TBI/Concussion support".
  • "Hydro Shot has been featured in third-party published scientific studies as a potential meaningful adjuvant treatment for TBI's***helps reduce brain swelling***help aid in concussion recovery".

On your about– Compelling Science page https://h2bev.com/pages/about:

  • "Third party studies with Hydro Shot***improvements in***concussions".

Your H2 RENU Oncology Care Beverage product and Hydro Shot Hydrogen Beverage Strawberry, Lemon Lime, and Orange flavored products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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.

This letter is not intended to be an all-inclusive list of violations that may exist at your facility or 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 with 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 Food and Drug Administration via email to HFP-OCE-Labeling@fda.hhs.gov, copying Simone E. Hollis, Compliance Officer, at Simone.Hollis@fda.hhs.gov. If sending a response by mail, address to Food and Drug Administration Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Critical Foods and Dietary Supplement Enforcement HFS-608, 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding any issues in this letter, please contact HFP-OCE-Labeling@fda.hhs.gov, copying Simone E. Hollis at Simone.Hollis@fda.hhs.gov, and include reference #730567 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD, MBA
Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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