FDA WARNING_LETTER - Ketamine Troche Store / www.ketaminetrochestore.com - February 26, 2026

On June 23, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Ketamine Store (www.ketaminestore.org) following a website review conducted on February 26, 2026. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act, specifically involving the distribution of unapproved and misbranded ketamine products. These products, which include liquid ketamine, troches, and nasal sprays, are marketed for conditions like depression and anxiety but have not received the necessary FDA approval to ensure they are safe and effective for public use.

The FDA emphasized that because ketamine is a potent drug capable of causing serious side effects—such as respiratory distress and sedation—it must only be used under the supervision of a licensed healthcare professional. The company"s products are considered misbranded because they are sold without a prescription and lack adequate instructions for safe use by a layperson. Furthermore, the agency noted that the company"s operations do not qualify for the legal exemptions typically granted to licensed compounding pharmacies.

To address these violations, Ketamine Store is required to immediately stop selling these unapproved drugs to U.S. consumers and investigate the underlying causes of the non-compliance. The company must provide a written response to the FDA within 15 business days outlining the specific steps taken to correct the issues and prevent their recurrence. Failure to comply may lead to regulatory actions, including product seizures or legal injunctions.