FDA WARNING_LETTER - Keta Med Lab / www.ketamedlab.com - February 26, 2026

On June 23, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Keta Med Lab regarding its website, www.ketamedlab.com. This action follows a February 2026 review that identified the sale of unapproved and misbranded ketamine products, including liquid forms, troches, and nasal sprays, to customers in the United States. The FDA found that the company is marketing these products for serious conditions like depression and anesthesia without the necessary federal approvals. Under the Federal Food, Drug, and Cosmetic Act, these products are considered "new drugs" that have not been evaluated for safety or effectiveness. Furthermore, because ketamine is a controlled substance that carries significant health risks—such as respiratory depression and sedation—it must only be used under strict medical supervision. The FDA highlighted that certain approved versions of these drugs are subject to a safety program (REMS) to protect patients, which this company’s sales model bypasses. The products are also deemed misbranded because they lack professional labeling with safe usage instructions and are sold without requiring a valid prescription. This poses a severe risk to public health, as injectable and unapproved drugs can be contaminated or contain incorrect ingredients. The FDA has ordered Keta Med Lab to immediately stop selling these unapproved drugs. The company must provide a written response within 15 business days detailing the corrective actions taken and their plan to prevent future violations. Failure to address these issues promptly may result in legal consequences, such as the seizure of products or court-ordered injunctions.