Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics
FDA issued a warning letter to Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics (Las Vegas, NV) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The company's website falsely implied it was the compounder of these drugs by displaying its name on product labels, and made claims linking its compounded products to FDA-approved brand-name drugs (Ozempic®, Mounjaro®, Wegovy®, Rybelsus®, Zepbound®), thereby misleadingly implying FDA approval or evaluation for safety and effectiveness. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (4)
Deluxe IV and Aesthetics
Semaglutide is the active pharmaceutical ingredient in Ozempic®*, Rybelsus®*, and Wegovy®*
Same active pharmaceutical ingredient in Ozempic® and Mounjaro®.
Tirzepatide is the active pharmaceutical ingredient in Mounjaro®* and Zepbound®*.
Required actions (5)
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.
Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
Identifying the entities that produce the compounded products offered on your website;
Providing a representative sample of labeling for such products;
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your site against every entry in this Atlas. Most glp-1 / weight loss sites match 3-6 patterns.
Run my free site audit