FDA WARNING_LETTER - Med Shop Inc / www.medshopinc.com - February 27, 2026

In a warning letter dated June 23, 2026, the U.S. Food and Drug Administration (FDA) notified Med Shop Inc, a Netherlands-based company operating www.medshopinc.com, of significant legal violations. These issues were identified during a regulatory review of the company’s website conducted on February 27, 2026. The FDA determined that Med Shop Inc is illegally selling unapproved and misbranded drug products, specifically ketamine nasal sprays, to consumers in the United States. Under the Federal Food, Drug, and Cosmetic Act, these products are considered "new drugs" that have not undergone the required FDA approval process to ensure they are safe and effective. The agency highlighted that ketamine is a controlled substance with significant risks, including respiratory depression and potential for abuse. While an approved version of esketamine nasal spray exists in the U.S., it is strictly controlled through a safety program that requires medical supervision. Med Shop"s products bypass these safeguards and lack adequate professional labeling, posing a severe health risk to the public. The FDA has ordered the company to immediately stop offering these unapproved drugs for sale to U.S. customers. Med Shop Inc must provide a written response within 15 business days detailing the corrective actions taken to address these violations and prevent them from happening again. Failure to comply may lead to legal actions such as the seizure of products or an injunction.