FDA warning letter · #721447
Deluxe IV and Aesthetics: What the FDA Letter Means for What You Pay
Legal name: Deluxe IV Aesthetics PLLC
Unknown
marketing / labeling
February 2026
Not logged
Primary source
Read the original letter on fda.gov →
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/deluxe-iv-aesthetics-pllc-dba-deluxe-iv-and-aesthetics-721447-02202026
What FDA cited
Quoted verbatim from the letter dated
Read the full letter →This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://deluxeivaesthetics.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].
- 1
“The compounded semaglutide and tirzepatide products displayed on your website identify “Deluxe IV and Aesthetics” on the pictured label, suggesting Deluxe IV and Aesthetics is the compounder of those drugs when in fact it is not. Accordingly, the representations on your website that Deluxe IV and Aesthetics is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].”
- 2
““Semaglutide is the active pharmaceutical ingredient in Ozempic®*, Rybelsus®*, and Wegovy®*””
- 3
““Tirzepatide is the active pharmaceutical ingredient in Mounjaro®* and Zepbound®*.””
- 4
“Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].”
Process
How a warning letter proceeds
- 1
Letter issued
February 2026
- 2
15-working-day response window
FDA gives the company 15 working days to respond in writing.
- 3
Close-out, if issued
FDA may post one once it is satisfied the cited issues have been corrected.
Is Deluxe IV and Aesthetics still operating?
deluxeivaesthetics.com did not resolve on 2026-08-09 — DNS returned no A record for either the apex or the www host — and a WHOIS query to the .com registry (whois.verisign-grs.com) returned "No match for domain DELUXEIVAESTHETICS.COM", meaning the domain is not currently registered. The same query run against mintmed.com as a control returned a full record with a 2030 expiry, so the "no match" is a real result and not a failed lookup. An unregistered domain is not proof a clinic has closed — the Las Vegas practice may operate under another name — so this is recorded as unknown.
What this means for what you pay
The asterisks are the tell. Someone at this business knew the trademarks belonged to other companies, marked them, and pointed the reader at a disclaimer — and FDA cited the claims all the same. That is the single most useful thing this letter teaches, because asterisked brand names are everywhere in compounded GLP-1 marketing and they are widely read as a sign that a seller is being careful. What the footnote can do is disclaim ownership of a trademark. What it cannot do is unsay the sentence it is attached to: "Semaglutide is the active pharmaceutical ingredient in Ozempic®*, Rybelsus®*, and Wegovy®*" is a true statement about those three approved products, placed on a page selling a fourth thing that is none of them, and the implication survives any small print underneath. Read the two findings together and the pattern is complete — the label said the seller made the drug, and the copy said the drug was what the brands are. Neither of those is about safety, and FDA alleges nothing about the product's quality. The practical version: an asterisk beside a brand name tells you the seller has thought about trademarks, not that the comparison beneath it holds. The domain on the letter is no longer registered.
Has Deluxe IV and Aesthetics responded?
As of , FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence Deluxe IV and Aesthetics failed to respond.
Sources
Other letters in this index
VivioMD
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DrMedHealth
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D&H Medical Services
marketing / labeling · Issued June 2026
Mint Med
marketing / labeling · Issued June 2026
Altru Telehealth
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Medica Weight Loss
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Editorial disclaimer: An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.