FDA WARNING_LETTER - Legit Ketamine Suppliers / www.legitketaminesuppliers.com - February 26, 2026

The U.S. Food and Drug Administration (FDA) issued a warning letter to Legit Ketamine Suppliers (www.legitketaminesuppliers.com) following a website review conducted on February 26, 2026. The agency found that the company is marketing unapproved and misbranded ketamine drug products, including injectable forms and nasal sprays, to U.S. consumers. These actions violate the Federal Food, Drug, and Cosmetic Act, which governs the safety and labeling of medications in interstate commerce. The primary violations involve selling prescription-only drugs without a valid prescription and without required FDA approval. The FDA noted that these products lack adequate directions for safe use and bypass critical safety protocols, such as the Risk Evaluation and Mitigation Strategy (REMS) required for approved versions. The agency emphasized that using ketamine without professional medical supervision poses severe risks, including sedation, respiratory depression, and potential abuse. Furthermore, unverified injectable drugs carry the risk of life-threatening infections like sepsis. Legit Ketamine Suppliers is required to immediately stop selling these unapproved products. The company must submit a written response within 15 business days outlining the specific steps taken to correct the violations and prevent their recurrence. Failure to comply may lead to regulatory actions such as product seizure or legal injunctions.