Phuoc Loc Tho Herbals, Inc. – FDA Warning Letter, Sep 1, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to Phuoc Loc Tho Herbals, Inc. on October 26, 2026, following an evaluation of the company"s website conducted in August and September 2026. The FDA determined that the company is marketing several products, including "Toa Cot Than Kinh Cot Thich Hoan," "Gai Cot Hoan," and "Professor’s Pill," as unapproved new drugs. These products are promoted with claims to treat or mitigate serious medical conditions such as acute gout, rheumatism, strokes, and heart failure. Under the Federal Food, Drug, and Cosmetic Act, any product intended for the diagnosis or treatment of disease is classified as a drug and requires agency approval to verify safety and effectiveness before being sold to the public. Furthermore, the FDA raised safety concerns regarding additional products sold by the firm, such as "Notoginseng Formula Special Gout Granule" and "Linsen Double Caulis Plus." The agency noted that previous analyses of similarly named products found hidden pharmaceutical components, which could pose health risks to consumers. Phuoc Loc Tho Herbals, Inc. is responsible for ensuring all its offerings comply with federal regulations. The company has been directed to submit a written response within 15 business days outlining the specific steps taken to correct these violations and prevent their recurrence. Failure to address these concerns adequately may lead to regulatory actions, such as product seizures or legal injunctions.