CRITICALGLP-1 / Weight LossFDA Warning Letter · September 9, 2025

GLP-1 Solution

Atlas ID: 2025-09-fda-glp-1-solution-mjghmb

FDA issued a warning letter to GLP-1 Solution, a Germany-based online retailer, for selling unapproved and misbranded compounded drug products — including retatrutide, semaglutide, and tirzepatide — to U.S. consumers via its website glp1solution.store. Retatrutide products were cited as unapproved new drugs because retatrutide is not on the 503A or 503B bulks lists and is not an FDA-approved drug component. Claims on the site implied compounded semaglutide and tirzepatide were equivalent to FDA-approved branded products (Ozempic, Wegovy, Mounjaro), rendering those products misbranded under FDCA sections 502(a) and 502(bb). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure, injunction, or import detention.

Flagged claims (2)

MOUNJARO

FDA trademark misuse · branded-drug-name-equivalence

Semaglutide is the generic drug delivered in Ozempic (injectable) and Rybelsus (oral) diabetes control medications, and Wegovy (injectable) weight loss medication.

Other · false-equivalence-to-fda-approved-product

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).

Claim removal

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.

Response required · 15 days

Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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