FDA WARNING_LETTER - MantroForce - May 01, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to MantroForce, a Hong Kong-based company, following a review of its website in May 2026. The agency identified several products, including Passion Pro Endurance Delay Spray, Complex Men’s Nasal Inhaler, ErectBoost Vitality Spray for Men, Prostate Care Gel, and Prostate Patches, as unapproved new drugs. The primary violation stems from the company marketing these products with specific claims to treat, mitigate, or prevent medical conditions. Specifically, the website promoted the items as solutions for premature ejaculation, impotence, and various prostate-related urinary issues. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, any product intended to diagnose or treat a disease or affect the body"s structure is classified as a drug. Because MantroForce has not obtained official FDA approval or demonstrated that these products are generally recognized as safe and effective, distributing them in the United States is illegal. The FDA requires MantroForce to respond within 15 business days, detailing the corrective steps taken to address these violations and the measures implemented to prevent their recurrence. Failure to rectify these issues promptly may result in legal action, including product seizures or injunctions.