Invigorate Med Spa: What the FDA Letter Means for What You Pay

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://invigoratemedspa.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. As described below, your claims concerning compounded semaglutide and tirzepatide products are false or misleading 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)], resulting 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. 1

   ““Semaglutide (Wegovy)””

2. 2

   ““Tirzepatide/B12 (Mounjaro)””

3. 3

   “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are 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)].”

1. 1

   Letter issued

   September 2025

2. 2

   15-working-day response window

   FDA gives the company 15 working days to respond in writing.

3. 3

   Close-out, if issued

   FDA may post one once it is satisfied the cited issues have been corrected.

invigoratemedspa.com returned a live site on 2026-08-09 titled "Medical Spa | InVigorate Med Spa | United States", with a full service menu covering hormone replacement, IV therapy, peptides, aesthetics and a weight-loss section, plus an online store and patient forms — an operating clinic. None of "Mounjaro", "Wegovy", "tirzepatide" or "B12" appeared in the homepage navigation as fetched.

"Tirzepatide/B12 (Mounjaro)" is the most self-defeating claim in this collection, because the slash and the parenthesis contradict each other on the same line. Mounjaro contains tirzepatide and nothing else; a preparation combining tirzepatide with vitamin B12 is by definition a different product, so the bracket is inaccurate even if you grant every argument compounders make about equivalence. This matters beyond the wordplay. Adding B12 is one of the standard ways a compounded GLP-1 is made to look distinct — and, under the rules that governed compounding during the shortage, the addition of another active ingredient was part of how some sellers argued their preparation was a clinically necessary variation rather than a copy. So the same ingredient that justified compounding the product was being papered over by a brand name that does not contain it. For a buyer, the concrete question is what else is in the syringe and at what strength, because a combination product cannot be price-compared against a single-ingredient one on a per-milligram basis at all. FDA's finding is confined to the two product lines and makes no claim about the safety of either preparation. The clinic is still operating and its published menu no longer names the brands.

As of August 2026, 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 Invigorate Med Spa failed to respond.