FDA WARNING_LETTER - Joi and Blokes dba Joi + Blokes - March 01, 2026

On June 8, 2026, the FDA issued a warning letter to Joi and Blokes dba Joi + Blokes following a March 2026 review of the company"s website. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act concerning the marketing of compounded semaglutide and tirzepatide products. The primary violations involve false and misleading claims that suggest these compounded drugs are FDA-approved or equivalent in safety and effectiveness to brand-name medications like Ozempic and Wegovy. The FDA highlighted that describing these products as "bioidentical" alternatives is deceptive because compounded drugs do not undergo the same evaluation process as approved brands. Additionally, the company"s labeling incorrectly identified Joi + Blokes as the manufacturer, resulting in the products being misbranded. To comply with federal law, Joi + Blokes is required to investigate the root causes of these violations and implement corrective actions. Necessary steps include identifying the actual manufacturers of the drugs, providing sample labeling to the FDA, and removing or modifying misleading website content. The company must provide a written response within 15 business days detailing its plan to prevent recurrence. Failure to address these issues promptly may lead to legal action, including product seizures or injunctions.