FDA WARNING_LETTER - EA WORKS Limited Liability Company dba Trust Labs - August 01, 2025

On September 9, 2025, the FDA issued a warning letter to EA WORKS LLC, operating as Trust Labs, following an investigation of its website in August 2025. The company, based in Sheridan, Wyoming, was found to be marketing compounded drug products—specifically retatrutide, semaglutide, and tirzepatide—in violation of the Federal Food, Drug, and Cosmetic Act. The FDA identified retatrutide as an unapproved new drug that is being sold illegally. Because retatrutide is not a component of an FDA-approved drug and does not appear on official lists for bulk drug substances, it does not qualify for the legal exemptions typically granted to compounded medications. Additionally, the product is considered misbranded because it lacks adequate instructions for safe use by a layperson. Furthermore, the FDA cited the company for making false and misleading claims regarding its semaglutide and tirzepatide products. Trust Labs" website implied these compounded drugs were FDA-approved by referencing the approval dates of existing brand-name medications. However, the FDA emphasized that compounded drug products themselves are not FDA-approved. To resolve these issues, Trust Labs must take immediate corrective actions to address the violations and prevent their recurrence. The company is required to submit a written response to the FDA within 15 working days, outlining the steps taken to ensure compliance with federal law. Failure to satisfy these requirements may result in further legal action, including product seizure or an injunction.