FDA WARNING_LETTER - Ketdaxandrugs / www.ketdaxandrugs.org - February 26, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to Ketdaxandrugs, which operates the website www.ketdaxandrugs.org, following a review conducted on February 26, 2026. The agency found that the company is illegally introducing unapproved and misbranded ketamine products, such as "Ketamine Crystal," into the United States. Under the Federal Food, Drug, and Cosmetic Act, these products are classified as new drugs that require federal approval to ensure they are safe and effective for public use. The FDA highlighted that while certain versions of ketamine are approved for specific medical uses, they are controlled substances that must be administered under strict medical supervision and, in some cases, through restricted safety programs known as Risk Evaluation and Mitigation Strategies (REMS). Ketdaxandrugs violated these standards by selling the drugs without requiring a valid prescription and by failing to provide adequate directions for safe use. The agency warned that such unapproved drugs pose serious health risks, including potential contamination or life-threatening infections like sepsis. To address these violations, Ketdaxandrugs must immediately stop selling unapproved medications to U.S. consumers. The company is required to submit a written response within 15 business days outlining the specific corrective actions taken and their plans to prevent future recurrences. Failure to comply may result in legal consequences, including product seizures or injunctions.