FDA WARNING_LETTER - Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com - February 27, 2026

On June 23, 2026, the FDA issued a warning letter to Pure Arylcyclohexylamine Store (www.arylcyclohexylamine.com) following a regulatory review of their website conducted on February 27, 2026. The agency identified that the company is selling unapproved and misbranded ketamine drug products, including liquid injectables and sublingual tablets (troches), to U.S. consumers. These activities violate the Federal Food, Drug, and Cosmetic Act, which prohibits the sale of new drugs that have not undergone the required safety and effectiveness reviews.

The FDA expressed significant concern regarding the safety risks of these unauthorized products. Ketamine is a controlled substance that generally requires a prescription and, for certain versions, strict medical supervision under a Risk Evaluation and Mitigation Strategy (REMS) due to risks of sedation and respiratory depression. Because the company’s products are sold without professional oversight and lack adequate directions for safe use, they are considered misbranded. The agency noted that injectable drugs are particularly dangerous if they are not manufactured under strict regulatory standards, as they can lead to life-threatening infections.

To achieve compliance, Pure Arylcyclohexylamine Store must immediately stop offering these unapproved medications for sale. The company is required to submit a written response within 15 business days outlining the specific steps they have taken to correct these violations and prevent them from happening again. Failure to resolve these issues may result in legal actions, including product seizures or court injunctions.