Ong Tien USA LLC – FDA Warning Letter, Oct 1, 2026

On October 26, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Ong Tien USA LLC following a review of the company’s website conducted in April 2026. The FDA identified that the firm is distributing unapproved and misbranded drug products, including Sâm Xương Khớp Ông Tiên and Cao Đông Trùng Hạ Thảo Tế Bào Gốc Linh Chi. These products were marketed with claims to treat or prevent serious medical conditions such as arthritis, gout, and cancer without having the necessary FDA approval or scientific evidence of safety and effectiveness. A significant safety violation was identified regarding the product Sâm Xương Khớp Ông Tiên. Laboratory testing confirmed the presence of hidden, undeclared pharmaceutical ingredients: piroxicam (a non-steroidal anti-inflammatory drug) and dexamethasone (a steroid). These substances can cause life-threatening side effects, including heart failure, stomach ulcers, and immune system suppression, yet were omitted from the product label. These actions violate the Federal Food, Drug, and Cosmetic Act. The FDA has directed Ong Tien USA LLC to immediately correct these violations and investigate the root causes to prevent future issues. The company is required to provide a written response within 15 business days outlining their corrective actions and plans for sustained compliance. Failure to address these concerns may lead to regulatory actions such as product seizures or legal injunctions.