EA WORKS Limited Liability Company dba Trust Labs
FDA issued a warning letter to EA WORKS LLC dba Trust Labs (operating as coretrustlabs.com) in September 2025 for unlawfully selling unapproved and misbranded compounded drug products — including retatrutide, semaglutide, and tirzepatide — to U.S. consumers via the internet. Compounded retatrutide products were cited as unapproved new drugs and misbranded because retatrutide does not appear on the 503A or 503B bulk drug substances lists and is not a component of any FDA-approved drug. Additionally, website claims implying that compounded semaglutide and tirzepatide are FDA-approved were found to be false or misleading. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (2)
FDA approval: Tirzepatide was approved by the U.S. Food and Drug Administration (FDA) in 2022.
FDA approval: Semaglutide was approved by the U.S. Food and Drug Administration (FDA) in December 2017.
Required actions (3)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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