NuPack Inc – FDA Warning Letter, Sep 24, 2025

On March 20, 2026, the FDA issued a warning letter to Nupack Inc. following an inspection of their Elgin, Illinois facility conducted between August 20 and September 24, 2025. The investigation revealed that the company is marketing products such as Diabetech, Cardiag, and MACA with claims that they can treat or prevent serious medical conditions, including diabetes, heart disease, and high blood pressure. Under the Federal Food, Drug, and Cosmetic Act, these therapeutic claims classify the products as unapproved new drugs. Furthermore, because these conditions require professional medical oversight, the products are considered misbranded as they lack safe directions for consumer use. Beyond labeling issues, the FDA identified critical failures in the company’s manufacturing processes. Nupack Inc. failed to meet mandatory quality control standards, including the failure to establish specifications for product identity and purity. The company also lacked essential documentation, such as master manufacturing records and batch production logs, and had no formal procedures for handling returned products. These systemic manufacturing failures led the FDA to classify the supplements as adulterated. Nupack Inc. is required to respond to the FDA within 15 working days, providing a detailed plan and supporting documentation to correct these violations. Failure to take prompt action may result in legal consequences, including product seizures or a court-ordered shutdown of operations.