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This weight loss provider comparison is independently researched by our editorial team. We compare telehealth services based on publicly available information including pricing, available treatments, service areas, and verified customer reviews.
Not Medical Advice: This comparison is for informational purposes only. We are not healthcare providers. Always consult with a licensed physician before starting any treatment. Read our full medical disclaimer and editorial policy.
FDA Warning Letters and Compounded GLP-1s: What 10 of Our Listed Brands Have in Common (2026)
Checked on August 23, 2026, 10 of the 25 active telehealth brands we track carry an open FDA warning letter. All 10 are for a version of the same underlying problem: what the company's own website said or showed about a compounded GLP-1 weight loss drug (compounded semaglutide or tirzepatide), not a finding that the drug itself is unsafe or ineffective. And this is not a short list. FDA has sent at least three dated batches of telehealth warning letters since September 2025: 58 issued on 2025-09-09, 30 on 2026-02-20, and 25 on 2026-06-08, counted in FDA's own warning-letter index by the date on the letter rather than the later date FDA posted it. That is 113 letters, and fewer than 113 companies, since one parent company can receive one letter per brand. Which is why this page exists. Against a list that long, a warning letter reads as close to standard for a company selling compounded GLP-1s, which makes it context for the 10 brands below rather than a clean bill of health for anyone else. Common is not the same as cleared, and that cuts in both directions. A brand we track that carries no notice on our site has not been cleared either. It means that on one date we searched FDA's records by brand name, by website, and for 24 of the 25 brands by the company's registered legal name as well, and found nothing. A letter filed under a corporate name we never found could still slip past that, and one nearly did here. You should also know who pays us. Of the 10 brands named on this page, 9 pay us a commission when you sign up through our link; Ivim Health is the only one we earn nothing from. It doesn't change a single fact below: every claim here is attributed to FDA's own letters or FDA's own pages, read directly, not recalled or paraphrased from a secondary source.
Step 1: What an FDA Warning Letter Is, and What It Isn't
- A warning letter flags a marketing, labeling, or manufacturing practice FDA believes violates federal law; it is a notice, not a recall or a ban
- None of the 10 letters we read alleges a specific injury or adverse event, and none contains the word recall; they cite what the company's website said and showed, not what its product did to anyone
- The letter does not order a company to stop selling; it demands a written response within fifteen days and warns that seizure or injunction could follow as a separate step
- A close-out letter, issued after FDA accepts the company's response, would close the matter; none of the 10 shows one on FDA's own index, checked August 23, 2026
Step 2: Sameness Claims, Labels, and Two More Objections
- Problem 1: claiming a compounded drug is "the same" as an FDA-approved brand-name drug
- Problem 2: the company's own name on a compounded product's label, representing itself as the compounder under 21 CFR 201.1(h)(2)
- Problem 3: efficacy language for a product with no FDA-reviewed efficacy data, such as the "Clinically studied ingredients" and "Proven to lose weight effectively" phrasing FDA quoted from Maximus's site
- Problem 4: calling a pharmacy or outsourcing facility "FDA-approved" or "FDA-licensed"; FDA's letters state the law creates no such designation for those entities
- Not every letter cites all four; Ivim Health's letter, for example, cites only the labeling issue, with no marketing claim quoted
Step 3: What "Compounded" Means When You're the One Buying
- Compounded = prepared by a licensed pharmacy under a prescription written for you (section 503A) or by an FDA-registered outsourcing facility (section 503B), not mass-manufactured under an FDA-approved application
- Compounded is not the same as FDA-approved: in FDA's own words, compounded drug products "have not been evaluated by FDA for safety, effectiveness, or quality before marketing," and registering a facility with FDA is not approval of it or of what it makes
- Shortage-based mass compounding of semaglutide and tirzepatide lost its legal basis by deadlines in spring 2025 (tirzepatide shortage resolved Dec 2024, semaglutide Feb 2025); today's compounded GLP-1 sales rely on a narrower, individualized basis
- None of this makes a compounded GLP-1 illegal or automatically unsafe; it does mean the safety and quality assurance comes from the pharmacy and your prescriber, not from an FDA review of that specific formulation
Step 4: Four Questions to Ask a Compounded GLP-1 Seller
- Ask directly: is this specific product compounded, or FDA-approved brand-name or generic?
- Ask which pharmacy compounds it and whether that pharmacy is licensed in your state
- If the company has an open letter, ask what changed in response to it
- Ask whether an FDA-approved alternative is available through the same provider, if that matters to you
- This page states what FDA's letters say; it doesn't tell you what to buy. That decision is yours and your provider's
How We Track This, and Why a Brand Not Listed Here Isn't Automatically Cleared
Why We Still List Brands With an Open Letter
Online vs In-Person Treatment Comparison
Understanding the differences between online and in-person treatment helps you choose the right approach for your needs.
| Brand | Warning Letter (MARCS-CMS #, Date) | What FDA's Letter Cites |
|---|---|---|
| Hers | 716825, dated 2025-09-09 (Sept 2025 wave) | Quotes two lines from Hers's own website about its compounded semaglutide: "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients". FDA's stated objection: compounded drug products are not FDA-approved, and those claims imply the product is the same as an approved one when it is not |
| Hims | 716567, dated 2025-09-09 (Sept 2025 wave) | FDA's letter quotes hims.com on its compounded semaglutide: "Same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." FDA's objection is the same one it raised to Hers: compounded products are not FDA-approved, so a sameness claim is misleading. Same corporate parent (Hims & Hers Health, Inc.) as the Hers letter above, issued the same day as a separate letter |
| MyStart Health | 714755, dated 2025-09-09 (Sept 2025 wave) | The cited language is MyStart Health's own, on its compounded semaglutide: "Generic Ozempic" and "Save with generics that offer the same active ingredients and results." FDA's position is that a compounded drug is not a generic of an approved one, so calling it that misleads the buyer |
| Sprout Health | 715879, dated 2025-09-09 (Sept 2025 wave) | One line from Sprout Health's own site, quoted in the letter alongside its compounded semaglutide and tirzepatide: "GLP-1 medications are FDA-approved and backed by extensive clinical research…." FDA's answer in the letter is direct: compounded drug products are not FDA-approved, so the claim implies an approval the products do not have |
| Medvi | 721455, dated 2026-02-20 (published wave 2026-03-03) | Two counts. The "MEDVi" name on the pictured product label, which FDA reads as representing MEDVi as the compounder when it is not. And two quoted website claims: "Same active ingredient as Wegovy® and Ozempic®." "Same active ingredient as Mounjaro® and Zepbound®." FDA's objection: those imply the compounded products were FDA-approved or evaluated for safety and effectiveness when they were not |
| Strut | 721448, dated 2026-02-20 (published wave 2026-03-03) | The "Strut" name on the pictured product label, which FDA reads as representing Strut as the compounder when it is not, plus three quoted website lines: "Generic Zepbound, Mounjaro" "Semaglutide is the active ingredient in the brand medications." "Tirzepatide is the active ingredient in the brand medications Zepbound® and Mounjaro®." FDA's objection is that these imply FDA approval or evaluation the compounded products never had |
| Skinny.Rx | 717989, dated 2026-02-20 (published wave 2026-03-03) | Letter addressed to Lean Rx, Inc. dba SkinnyRx. The "SkinnyRx" name on the pictured label, which FDA reads as representing SkinnyRx as the compounder when it is not, plus three quoted website lines: "from the same family as GLP-1 treatments like Mounjaro® and Zepbound®" "Get access to the same active ingredient as name-brand GLP-1 medications" "It contains the same active ingredient as FDA-approved medications". FDA's objection: they imply approval or evaluation the compounded products do not have |
| Ivim Health | 721816, dated 2026-02-20 (published wave 2026-03-03) | The narrowest letter of the 10. It cites only the "Ivim" name on the pictured product label, which FDA reads as representing Ivim as the compounder when it is not. No marketing claim of any kind is quoted |
| Maximus | 730095, dated 2026-06-08 (published wave 2026-06-16) | No sameness claim and no label count. FDA quotes three efficacy lines from maximustribe.com: "Clinically studied ingredients." "Clinically studied to help patients…." "Proven to lose weight effectively". It also cites the site's description of its sourcing as "FDA approved pharmacies," and states that no "FDA-approved" or "FDA-licensed" designation exists for pharmacies or outsourcing facilities |
| Eden | 728279, dated 2026-06-08 (published wave 2026-06-16) | Two counts, neither of them an efficacy or sameness claim. The "Eden" name on the pictured product label, which FDA reads as representing Eden as the compounder when it is not. And the site's description of its sourcing as "FDA-licensed 503(a) outsourcing facilities," where FDA's answer is that the law creates no "FDA-approved" or "FDA-licensed" designation for such facilities |
Frequently Asked Questions
Does an FDA warning letter mean a company's product hurt someone or is unsafe?
Not based on what these 10 letters say. None of them alleges a specific injury or claims the compounded product caused harm. Nine of the 10 cite language from the company's own website and five cite the product label, with Ivim's resting on the label alone; the concern FDA raises is that what the company said or showed could mislead a buyer about what they're getting (an FDA-approved drug versus a compounded one), not that the drug itself has been shown to be dangerous.
Is it legal to buy a compounded GLP-1 medication?
Compounding itself is lawful under federal law, either by a licensed pharmacy filling a prescription written for you specifically (section 503A) or by a facility registered with FDA as an outsourcing facility (section 503B). What these warning letters are about is what the companies' websites said and showed, not whether compounding is legal. Compounded drugs are still not FDA-approved: in FDA's own words in these letters, they "have not been evaluated by FDA for safety, effectiveness, or quality before marketing," and registering a facility with FDA is not approval of that facility or of what it compounds. That gap is exactly what the cited language blurred.
If a brand on your site doesn't have a notice, does that mean it's been cleared by the FDA?
No. No notice on our site means one thing only: we searched FDA's records on August 23, 2026 and did not find an open warning letter for that brand. It does not mean the brand was formally cleared, or investigated and found clean. We searched by brand name, by website, and, for 24 of the 25 brands we list, by the company's registered legal name too; for the 25th no public record we could reach gave us a legal name to search, which makes that one check weaker than the rest. It also isn't a live FDA feed, and a letter filed under a corporate name we never found could still slip past it. That's not hypothetical. One of the 10 letters on this page (Hims, 716567) surfaced only when we searched FDA's index by corporate parent, after a brand-name search had already missed it.
What happens after a company gets a warning letter like these?
The company is expected to respond in writing describing how it will fix the cited issues, within fifteen days of receiving the letter in all 10 of these cases. If FDA accepts that response, it can issue a close-out letter, which closes the matter. We checked FDA's own index for a close-out or response letter on each of the 10 brands here, and opened each letter page looking for the close-out banner FDA adds to a closed letter; on August 23, 2026 none showed either, meaning each currently reads as open. If FDA is not satisfied, or a company doesn't respond, FDA has further enforcement tools available (like seizure or injunction actions), which would be separate, later steps this letter alone does not represent.
Why do you still list and rank brands that have an open FDA warning letter?
Because delisting a brand would take the letter out of view along with everything else. Each affected brand's own page now carries a dated notice linking to the letter itself, so the fact travels with the brand instead of living only on this page. Keeping all 10 listed is also the only way the scale of it is visible to you: 10 of the 25 brands we currently list are in this position, and a roster with the affected companies quietly missing would read as though far fewer were.
Do you make money from the brands named on this page?
Yes, from 9 of the 10, and all 9 of those currently carry an open FDA warning letter. Ivim Health is the only brand named on this page that pays us nothing. We earn a commission when you sign up with a brand through a link on our site. That's a real conflict of interest, so the useful thing we can hand you is a check that doesn't depend on trusting us: take any MARCS-CMS number in the table above, look it up on FDA's warning-letter index, and read the letter yourself. Nothing on this page was supplied or paid for by a brand.
Sources & References
Our comparisons are informed by official sources and regulatory guidelines. We encourage readers to verify information with authoritative sources.
- FDA Drug InformationGLP-1 medication approvals and safety
- NIH National Institute of DiabetesWeight management research
- CDC Obesity InformationObesity statistics and health impacts
- Obesity Medicine AssociationClinical obesity treatment guidelines
Editorial Note: Researched and edited by our editorial team. AI tools assist with initial research and drafting; all content is fact-checked and edited by humans before publication. Learn more about our editorial standards