FDA WARNING_LETTER - EA WORKS Limited Liability Company dba Trust Labs - August 31, 2025

The FDA issued a warning letter to Trust Labs, located at 30 N Gould St Ste R, Sheridan, WY, on September 9, 2025, following a review of their website in August 2025. The FDA identified significant violations concerning the marketing and labeling of compounded drug products, specifically retatrutide, semaglutide, and tirzepatide.

Key violations include the introduction of unapproved new drugs and misbranded drugs into interstate commerce, contravening sections 505(a), 502(f)(1), 301(a), and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA). Trust Labs" compounded retatrutide products do not meet the conditions for exemptions under sections 503A and 503B of the FDCA, as retatrutide is not listed on the required bulk drug substances lists and lacks FDA approval.

Furthermore, the website"s claims about semaglutide and tirzepatide are misleading. Although these substances have FDA-approved versions, the compounded products offered by Trust Labs are not FDA-approved, leading to misbranding under sections 502(a) and 502(bb) of the FDCA.

The FDA requires Trust Labs to cease the distribution of these products until compliance with FDA regulations is achieved. The company must address these violations promptly to avoid further regulatory actions.