FDA WARNING_LETTER - VivioMD Group LLC dba VivioMD - March 01, 2026

The FDA issued a Warning Letter to VivioMD Group LLC, doing business as VivioMD, on June 8, 2026, following a March 2026 review of the company’s website. The investigation revealed significant violations concerning the promotion of compounded drug products, specifically semaglutide and tirzepatide. The central issue identified is that VivioMD’s website and product labels falsely suggest the company is the actual compounder of these drugs. Under the Federal Food, Drug, and Cosmetic Act, a drug is considered misbranded if its labeling or advertising is false or misleading. By representing itself as the manufacturer when it is not, VivioMD violated federal regulations governing the introduction of misbranded products into interstate commerce. This oversight is particularly concerning as compounded medications must adhere to strict safety and transparency standards to remain exempt from certain federal drug approval processes. To resolve these issues, the FDA requires VivioMD to submit a written response within 15 business days detailing the root causes of these violations and the corrective measures implemented. Specific actions include identifying the actual manufacturers of the products, submitting representative samples of accurate labeling, and removing all misleading claims from their website. The FDA warned that failure to comply could result in further legal action, including product seizures or injunctions to stop distribution.