FDA WARNING_LETTER - ketaminetroches.com - February 25, 2026

On June 23, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to ketaminetroches.com following a review of their website conducted on February 25, 2026. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act, specifically the sale of unapproved and misbranded ketamine products. The company marketed "Ketamine Troches" for treating mental health conditions such as anxiety and depression without the necessary clinical approvals or evidence of safety and effectiveness. The FDA highlighted that while certain ketamine-based medications are approved for specific uses, they are strictly regulated as controlled substances and often require a Risk Evaluation and Mitigation Strategy (REMS) to ensure patient safety. By selling these products directly to consumers without professional medical oversight or adequate usage directions, the company bypassed critical safeguards against serious risks like sedation, respiratory depression, and abuse. To resolve these issues, the FDA requires ketaminetroches.com to immediately cease the sale of these unapproved drugs. The company must provide a written response within 15 business days detailing the specific corrective actions taken to address the violations and the steps implemented to prevent future recurrences. Failure to comply may result in legal consequences, including product seizure or injunction.