New Green Nutrition Inc. – FDA Warning Letter, Sep 1, 2026

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to New Green Nutrition Inc. on October 26, 2026, following a September 2026 review of the company"s website and product samples. The investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act regarding several products, including "Qu Feng Huo Luo Dan," "Pearl Eye Drops," "Japan Reishi Mushroom Powder," and "Shu Jin Huo Xue Wan." The FDA identified these items as unapproved new drugs because they are marketed with claims to treat or prevent medical conditions—such as rheumatism, arthritis, and insomnia—without having undergone the required federal approval process to ensure safety and effectiveness. A major safety concern was identified in "Qu Feng Huo Luo Dan," which laboratory testing confirmed contains dexamethasone, a potent corticosteroid not disclosed on the label. This omission renders the product misbranded and poses serious health risks to consumers, including a weakened immune system and high blood sugar. To resolve these issues, the company must submit a written response within 15 business days detailing the specific steps taken to correct the violations and their plan to prevent future recurrences. Failure to provide adequate corrections may result in legal action, including product seizures or injunctions.