Las Villas Health Care LLC dba Villas Health
FDA issued a warning letter to Las Villas Health Care LLC dba Villas Health (Coral Gables, FL) in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and sildenafil falsely implied equivalence to FDA-approved drugs (Ozempic/Wegovy and Viagra). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease the offending language immediately and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (2)
Sildenafil 2%: the active ingredient in Viagra. Clinically proven to improve outcomes in women with sexual arousal disorder by increasing blood flow to the genitals.
Semaglutide GLP-1 is a once-a-week injection that contains the same active ingredient as Ozempic and Wegovy….
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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