Dr. Gater’s Weight Loss & 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://drgatergetsresults.com in September 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,[sic] is the generic version of Ozempic/Wegovy. The generic version Semiglutide [sic] allows for affordability and accessibility to everyday consumers looking to attain a healthy weight.””

2. 2

   ““While the Brand Ozempic from retail pharmacies is extremely expensive, Dr. Gater has licensed pharmacies that can dispense Brand Ozempic at a much more affordable price. You can purchase Brand Ozempic through our website at a significant cost savings. All prescription medications including generic Semiglutide [sic] and brand Ozempic require a telemedicine visit with a medical provider prior [sic] a prescription being sent to our partner pharmacies.””

3. 3

   ““Compounded Semiglutide [sic] is the generic equivalent of the brand names and pharmacologically similar to Ozempic & Wegovy.””

4. 4

   “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.

The domain resolves, but on 2026-08-09 https://drgatergetsresults.com redirected to /password and returned a Shopify lock screen titled "Dr. Gater's Weight Loss & Wellness" reading "Coming Soon — We are working on the full version of our new site and will be back shortly", with a phone number, (706) 816-9255, for additional help. A password-gated storefront is not a closure: the practice may still be seeing patients by phone, and a Shopify store can be unlocked at any time. Recorded as unknown, not ceased-operations.

This is the one letter in the roster where the money is the point rather than a side effect. Most cited copy claims the compounded drug equals the brand; this site went further and said it could sell you the brand itself, through "licensed pharmacies", at "a significant cost savings" over retail. Those are two very different offers sitting on one page — a compounded product described as "the generic version", and a genuine brand-name product described as cheap — and a shopper moving between them has no way to tell which one a given price belongs to. There is no generic Ozempic; the patents have not expired and FDA has approved no generic semaglutide, so a page that uses the word about a compounded product is not describing a regulatory category that exists. FDA's finding is confined to that copy. It makes no claim about the medication's safety, about the pharmacies involved, or about the clinician's care. The practical takeaway is narrow and useful: when a site offers both a brand and a compounded version, make it say in writing which one your money is buying, at what dose, before you pay. The storefront was password-locked when we checked, so none of that copy is currently readable by a customer.

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 Dr. Gater’s Weight Loss & Wellness failed to respond.