FDA WARNING_LETTER - H2 RENU, INC - January 12, 2026

The FDA issued a warning letter to H2 BEV, LLC and H2 RENU, INC following inspections of their Plano, Texas facility conducted between December 3, 2025, and January 12, 2026. The inspections revealed that the companies failed to comply with the Federal Food, Drug, and Cosmetic Act and specific regulations regarding acidified foods (21 CFR Parts 108 and 114). Specifically, the firms failed to register as a food canning establishment or file required scheduled processes for their hydrogen-infused beverages. The FDA also noted serious quality control failures, including the absence of documentation for pH testing and inadequate monitoring of pasteurization times and temperatures, which are essential to ensure products are safe from harmful contamination.

Beyond manufacturing violations, the FDA determined that the companies" websites marketed products such as "Oncology Care" and "Hydro Shot" as treatments for medical conditions including cancer and traumatic brain injuries. These therapeutic claims legally classify the beverages as unapproved new drugs, as they have not been evaluated by the FDA for safety and effectiveness in treating such diseases. To resolve these issues, the companies must provide a written response within 15 working days detailing their corrective actions and plans to prevent future violations. Failure to satisfy these requirements may result in legal action, including product seizures or a court-ordered halt to operations.