FDA WARNING_LETTER - 123Herbals - November 30, 2025

The FDA issued a Warning Letter to 123Herbals on November 13, 2025, following a review of their website, www.123herbals.com, conducted from July to November 2025. The agency identified several significant violations concerning the company"s drug products. Specifically, six products – “SILINTAN,” “Ganoderma Huo Luo Dan,” “Hong Kong Vail Bon Tong,” “SAM NHUNG BO THAN,” “TDCARE,” and “Vall Boon Antacid” – are considered unapproved new drugs. These products are marketed with therapeutic claims for various ailments, such as arthritis, gout, coughs, kidney issues, diabetes, and digestive problems, but lack the necessary FDA approval for sale in the United States. Furthermore, the "SILINTAN" product was found to be misbranded. Laboratory analysis confirmed it contains undeclared meloxicam, a non-steroidal anti-inflammatory drug (NSAID). This hidden ingredient poses serious health risks, including potential cardiovascular and gastrointestinal damage, and dangerous interactions with other medications, especially since consumers are unaware of its presence. The letter also noted a prior instance where 123Herbals sold another product with undeclared drug ingredients. Under federal law, 123Herbals is required to immediately investigate and correct these violations, ensure all products comply with FDA regulations, and prevent future recurrences. Failure to adequately address these concerns could lead to further regulatory action, including product seizure or injunctions.