FDA WARNING_LETTER - Ket Plug / ketaminelab.org and buyketaminepowderonline.com

On June 23, 2026, the FDA issued a warning letter to the company Ket Plug, which operates the websites ketaminelab.org and buyketaminepowderonline.com, following a regulatory review in April 2026. The FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the distribution of ketamine powder. Specifically, the agency found that the company is marketing an unapproved new drug and distributing misbranded drug products in interstate commerce. Although the company labeled the products for "research" and "non-clinical" use, the FDA determined their intended use was for the treatment of human diseases and mood disorders, which classifies them as drugs under the law. The product is considered misbranded because it lacks adequate directions for safe use by a layperson. Furthermore, because ketamine is a prescription substance with high risks of toxicity and adverse events, it cannot be safely administered without professional medical supervision and, in some cases, a Risk Evaluation and Mitigation Strategy (REMS). The FDA warned that these unapproved products lack safety assurances and may be contaminated or counterfeit. Ket Plug is required to immediately cease the sale of these illegal products and must submit a written response to the FDA within 15 business days. This response must detail the specific steps taken to correct the violations and the measures implemented to prevent future recurrences.