All American Wellness: 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://all-american-wellness.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.

1. 1

   “The following claims concerning compounded semaglutide and tirzepatide products appear on your website:”

2. 2

   “• “Mounjaro’s compounded version- Tirzepatide Prescription” • “Ozempic’s compounded version- Semaglutide””

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.

all-american-wellness.com returned a live site on 2026-08-09 titled "All American Wellness | Health & Wellness Center in Fishers", presenting an Indiana bricks-and-mortar practice — "All American Wellness Weightloss & Hormone Therapy Services, Cicero, Indiana" — with a published phone number (317) 922-7298, a booking flow, a prescriptions section and a notice that "All prescription refills need to be placed when you take your third shot." That is a check of whether the site is up and what it says; it is not a check of anything the letter alleges.

An apostrophe is doing something here that "same active ingredient as" never does. To say a product is Mounjaro's compounded version is not to compare two things — it is to say the brand HAS one, and that this is it. Read that way, the buyer is not choosing an alternative to the approved drug; they are choosing a variant of it, offered at a lower price, presumably by arrangement. No such arrangement exists. Neither Eli Lilly nor Novo Nordisk issues a compounded edition of anything, and a compounded product is prepared by a third-party pharmacy that the brand has no relationship with, does not supervise and did not test. That is the whole gap the possessive closes for free, which is why it is worth flagging separately from the ordinary equivalence claim: it does not overstate a similarity, it invents a lineage. The practical check is to ask who the seller says makes the product, and then to notice whether the answer is a company you could look up — a named pharmacy with a state licence — or a brand that has been borrowed. Nothing in the letter concerns quality, contents or manufacturing, and FDA has not closed it out.

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 All American Wellness failed to respond.