Elite Health Center: 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://eliterapidfatloss.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. As described below, your claim concerning compounded semaglutide products is 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

   “The following claim concerning compounded semaglutide products appears on your website:”

2. 2

   ““Compounded semaglutide was first introduced and patented in 2016, and FDA approved as a type 2 diabetes treatment in 2017. It wasn’t until 2021 that compounded semaglutide was approved as a treatment for obesity!””

3. 3

   “Compounded drug products are not FDA-approved. Your claim implies that your products are the same as an FDA-approved product when they are not. As a result, this claim is 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.

eliterapidfatloss.com returned a live commerce site on 2026-08-09 titled "Elite Health Center NJ - Medical Weight Loss, Semaglutide, Lose Weight Fast", running two dated promotions (a $100 first-program discount and a save-$100-plus-free-shipping offer stated as August 3–10) with a working checkout — an operating seller. The cited history does not appear on the page as fetched; the current copy instead carries the line "These medications are compounded and not FDA-approved."

Every other seller in this roster leans on a brand name to imply approval. This one skipped the borrowing and simply narrated an approval that never happened, complete with years. That is worth noticing because dates read as research: 2016, 2017, 2021 sound like someone checked. What the dates actually describe is the approval history of Ozempic and Wegovy — brand-name semaglutide made by a manufacturer under an approved application — and the sentence quietly moves the word "compounded" in front of each of them. A compounded drug is prepared for a patient outside that process, which is the whole reason it can be sold at a different price. So the copy was, in effect, charging for the thing that makes compounding cheaper while describing the thing that makes brands expensive. The letter says nothing about the medication's safety or how it was made. The useful follow-up is not "is this approved" but "what exactly am I being sent, and at what dose" — a question that a page willing to invent an approval date is unlikely to answer well. The site as fetched no longer runs the cited line, and now states plainly that its medications are compounded and not FDA-approved.

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 Elite Health Center failed to respond.