The HCG Institute: 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://thehcginstitute.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. As described below, your claims concerning compounded semaglutide 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)].

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   “The following claims concerning compounded semaglutide products appear on your website: • “Clinically proven to reduce appetite, lower food cravings, improve food intake regulation and glycemic control.” • “Compounded Generic Semaglutide is a revolutionary FDA-inspected medication for rapid weight loss that is given once weekly.” • “All of that said, we recognize that due to American drug marketing, many people only know of semaglutide either as ‘a GLP-1’ or ‘Ozempic’ rather than by the actual name or the preferred brand name. ‘Generic’ or compounded semaglutide, like what we sell here at the HCG Institute, are the same medication, as well.””

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   “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)].”

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   Letter issued

   September 2025

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   15-working-day response window

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

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   Close-out, if issued

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

thehcginstitute.com returned a live storefront on 2026-08-09 titled "Buy hCG Injections Online - The HCG Institute", with a patient portal, a published phone number and a catalogue spanning B12 and lipotropic injections, "GLP-1 Therapy" and "GLP-1 + GIP Therapy", sexual-health and hormone products — an operating seller. Neither "FDA-inspected" nor the word "semaglutide" appeared in the homepage as fetched; the GLP-1 categories are now named by drug class rather than by molecule.

"FDA-inspected" is the phrase to take away from this one. It is not a thing a medication can be. FDA inspects facilities — it registers and inspects outsourcing facilities and, at times, pharmacies — and it approves drugs; there is no inspection that a compounded vial passes and is then labelled with. The phrase works precisely because it sounds like a lesser, more modest version of "FDA-approved", which makes it read as honest restraint rather than as a claim. The same letter shows why that matters: the third quoted passage is a small essay about how American drug marketing teaches people to say "Ozempic" when they mean semaglutide — an accurate observation — and it ends by telling the reader the compounded version is "the same medication, as well". Naming the confusion and then trading on it is a more sophisticated move than any of the one-line claims elsewhere in this roster. For anyone comparing prices, the operative rule is simple: a compounded product has no FDA status to cite, so any phrase pairing "FDA" with the product is worth reading twice. The letter makes no finding about safety, potency, or how the product was made, and the site is still trading today.

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 The HCG Institute failed to respond.