FDA WARNING_LETTER - Genesis Health International Inc. dba Genesis - March 01, 2026

On June 8, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to Eden Health International Inc., doing business as Eden, following a March 2026 review of the company"s website. The FDA identified significant violations regarding the marketing and labeling of compounded drug products, specifically semaglutide and tirzepatide. The primary issues involve false or misleading claims that result in the products being classified as misbranded under the Federal Food, Drug, and Cosmetic (FD&C) Act. Specifically, the company’s website featured labels suggesting Eden was the actual manufacturer of the drugs when it was not. Additionally, the company falsely claimed its products were sourced from "FDA-licensed" or "FDA-approved" facilities. The FDA emphasized that it does not license or approve compounding pharmacies or their specific products, making such designations deceptive to consumers. These actions violate sections 502(a), 502(bb), and 301(a) of the FD&C Act, which prohibit the introduction of misbranded drugs into interstate commerce. Eden is required to respond within fifteen business days with a detailed plan to correct these violations and prevent their recurrence. The response must include proof of modified website claims, representative samples of corrected labeling, and identification of the actual entities producing the compounded drugs. Failure to comply may lead to legal actions, including product seizure or injunctions.