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  1. Home
  2. Compare
  3. Medvi vs Maximus
Ben KowalskiWritten by Ben KowalskiStaff Writer
Updated onOctober 06, 2026
Medvi telehealth platform
Medvi
VS
Maximus telehealth platform
Maximus
Visit MedviVisit Maximus

Medvi vs Maximus

Complete 2026 Comparison for Erectile Dysfunction

Erectile Dysfunction

Our Verdict

Maximus ED plans start at $35.99 a month as of 2026-09-10; MEDVi starts at $114.00 a month as of 2026-09-06, a gap of $78.01 at the floor. Maximus prescribes sildenafil and tadalafil as single FDA-approved medications, from $49.99 and $53.99 a month respectively, and offers a compounded combination as an option. MEDVi sells only the compounded Quad formula, which is not FDA approved or reviewed. Maximus takes HSA and FSA funds. Both companies hold open FDA warning letters citing misbranding, Maximus from June 8, 2026 and MEDVi from February 20, 2026.

Pick Medvi if

the single-dose combination format is the specific thing you want and you are willing to pay about three times the Maximus entry price for it, $114.00 a month as of 2026-09-06. In its favor: a consultation included, a decision inside 24 hours, no charge if you do not qualify, and free rush shipping in plain packaging. Against it: a compounded four-ingredient formula outside FDA review, no single-molecule option in our records, and an open FDA warning letter citing misbranding from February 20, 2026.

Pick Maximus if

price is why you are reading this, if you would rather start on one prescription molecule that holds its own FDA approval and adjust from there, or if you want to pay with HSA or FSA funds. Plans start at $35.99 a month as of 2026-09-10, with sildenafil from $49.99 and tadalafil from $53.99. You are accepting a company with an open FDA warning letter citing misbranding from June 8, 2026 over its own claims language.

Maximus wins this one on everything we can actually verify. It is $78.01 a month cheaper at the floor, it accepts HSA and FSA funds, and it will prescribe a single FDA-approved generic rather than a compounded four-ingredient formula. MEDVi's case is the one-dose format and a no-charge-unless-approved policy. Both carry open FDA warning letters citing misbranding.

Quick Answer

Best overallMedvi

Medvi is our overall pick for erectile dysfunction, based on our rating and feature coverage.

Top Erectile Dysfunction Providers

Our Top Choice
1
Strut logo

Start for Free - Daily Tadalafil & Custom ED Formulas

  • FDA-approved generic Tadalafil and Sildenafil prescribed online by U.S.-licensed physicians
  • Once-daily Tadalafil dosing available for always-ready spontaneity
  • Strut Mojo: oral Enclomiphene + Tadalafil combo (compounded, not FDA-approved)
  • Optional at-home test kit measures Testosterone, DHEA-S, Estradiol, Cortisol and SHBG
Strut displays LegitScript certificate 11142478, checked September 19, 2026Cert. 11142478September 19, 2026
9.4
OutstandingScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
★★★★★
See PricingRead full review
Best Value
2
Taurus Meds logo

NEW Charge™ Liquid ED - Just $12.99/Dose or Less

  • Charge™ liquid ED treatment from $12.99 per dose, a compounded four-drug formula the FDA has not approved or reviewed for safety, effectiveness, or quality
  • Charge™ blends sildenafil, tadalafil and vardenafil with apomorphine, whose US approvals are all for Parkinson's disease rather than ED
  • 100% online - prescribed and monitored by licensed clinicians, then shipped to you
  • Part of a full men's health platform: TRT, peptides and hair regrowth
Taurus Meds displays LegitScript certificate 44265708, checked September 19, 2026Cert. 44265708September 19, 2026
9.6
ExceptionalScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
★★★★★
See PricingRead full review
Most Popular
3
Hims logo

ED Treatment From $22/mo - Sildenafil or Tadalafil Chews From $30/mo

  • Generic sildenafil and tadalafil plus prescription-strength flavored chews (compounded, not FDA-approved)
  • Combo plans: Sex Rx + Hair Health from $35/mo, Sex Rx + Climax Control from $39/mo
  • Daily options available so you're never caught off guard
  • 100% online consultation, free and discreet shipping
9.4
OutstandingScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
★★★★★
See PricingRead full review

Provider Overview

Medvi logo
9.2

Our editorial rating 9.2/10Trustpilot: 4.3/5 from 14,726 reviews, checked Sep 11, 2026

Medvi prescribes compounded GLP-1 weight loss medications through licensed US providers, bundling dietician visits and care coaching into a flat monthly price. Compounded drugs are not FDA-approved and have not been reviewed by the FDA for safety, effectiveness, or quality.

Rating9.2/10
Free ConsultationYes
Free ShippingYes
HSA/FSAYes
Founded2023
HQUnited States
Visit MedviRead Full Review
Maximus logo
9.2

Our editorial rating 9.2/10Trustpilot: 4.4/5 from 1,067 reviews, checked Sep 11, 2026

Maximus specializes in testosterone replacement therapy and erectile dysfunction treatment for men, offering injectable TRT, enclomiphene, and ED medications through a streamlined telehealth platform.

Rating9.2/10
Free ConsultationNo
Free ShippingYes
HSA/FSAYes
Founded2021
HQAustin, TX
Visit MaximusRead Full Review
VS

Feature Comparison

Feature comparison between Medvi and Maximus
FeatureMedviMedviMaximusMaximus
Rating9.2/109.2/10
Founded20232021
Free ConsultationYesNo
Free ShippingYesYes
Accepts InsuranceNoNo
HSA/FSA AcceptedYesYes
Mobile AppNoNo
Consultation TypeVideo, AsynchronousVideo, Asynchronous
Shipping Time3-5 business days3-5 business days

Pricing Comparison

Pricing comparison between Medvi and Maximus across treatment categories
TreatmentMedviMaximus
Erectile Dysfunction$114/month$35.99/month

Prices shown are starting costs. Actual pricing varies by treatment plan and medication.

Pros and Cons

Medvi

Pros

  • Introductory pricing at $179 first month
  • Free dietician visits included
  • Ongoing care coaching between refills
  • All-inclusive cash pricing
  • Simple 3-step onboarding flow

Cons

  • Price increases to $299/month after first month
  • Does not accept insurance
  • Newer company with limited reviews
  • Weight loss only focus
Maximus

Pros

  • Multiple TRT options (injectable, oral, gel)
  • Free medication shipping
  • HSA/FSA accepted
  • At-home testosterone testing

Cons

  • No insurance accepted
  • Initial assessment fee ($49)
  • Limited to men's health
  • No mobile app

Which Should You Choose?

MedviChoose Medvi if you:
  • Patients seeking complete GLP-1 program
  • Those wanting metabolic insights
  • Patients preferring personalized coaching
  • First-time GLP-1 users wanting guidance
Visit Medvi
MaximusChoose Maximus if you:
  • Men with low testosterone symptoms
  • Those seeking multiple TRT delivery options
  • Patients wanting at-home testing convenience
  • Men looking for combined TRT + ED treatment
Visit Maximus

Who This Is For

This is for
  • Men seeking ED medication who want to compare costs and options across multiple online providers before committing.
  • Men comparing prescription availability, pricing, and dosage options across telehealth services in their state.
  • Men who want a licensed prescriber and pharmacy, but prefer an independent comparison over going direct to one brand.
Not for
  • If you take nitrates for heart conditions, online ED treatment is not safe - see a cardiologist first.
  • Sudden or unexplained ED alongside chest pain or shortness of breath needs in-person cardiac evaluation, not telehealth.
  • An erection lasting over 4 hours requires emergency care, not an online consultation.

These notes are not a medical screening: a licensed provider decides after an intake review whether a treatment is appropriate for you.

About This Comparison

Our Editorial Standards

This medvi vs maximus provider comparison is independently researched by our editorial team. We compare telehealth services based on publicly available information including pricing, available treatments, and service areas. Our ratings are editorial judgments, not tallies of reviews.

Independent Research: We do not accept payment for rankings or favorable reviews
Affiliate Disclosure: We may earn commissions from qualifying purchases at no extra cost to you
Regular Updates: Content is reviewed and updated monthly for accuracy
Licensed Providers Only: All listed services employ US-licensed healthcare providers

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.

Independent ResearchNo paid placements
Fact-Checked InformationVerified against official sources
Regularly UpdatedLast updated October 6, 2026
Licensed Providers OnlyAll listed services are US-licensed

MEDVi or Maximus: One Combination Formula Against the Cheapest Entry Price

Ben KowalskiWritten by Ben KowalskiStaff Writer
11 min readUpdated October 6, 2026

Table of Contents

Start with the number, because the number is most of the story. Maximus lists ED plans from $35.99 a month and MEDVi lists its ED formula from $114.00 a month. That is roughly three times the price for a product that is built on a different idea: Maximus will sell you one prescription molecule at a time, each FDA-approved in its own right, while MEDVi sells a single compounded formula that puts four ingredients into one dose. Below the price, the two companies have one uncomfortable thing in common. Both are carrying an open FDA warning letter, for entirely different reasons.

Read the entry price carefully before you compare it

Maximus ED starts at $35.99 a month, verified as of 2026-09-10. MEDVi starts at $114.00 a month, verified as of 2026-09-06. The gap at the floor is $78.01 a month.
Here is the catch, and Maximus is open about it in its own feature copy. That figure is where plans start. The named medications sit above it: prescription sildenafil from $49.99 a month and tadalafil from $53.99 a month. So the entry price buys a plan rather than a specific prescription, and the medication you are actually prescribed may price higher. Neither is what you will pay.
Even taking the higher Maximus figures at face value, $53.99 against $114.00 is still a gap of about $60 a month, which is roughly $700 across a year. On a comparison where neither side can show you an outcome, a gap that size deserves to carry real weight.
  • Maximus: plans from $35.99/mo as of 2026-09-10. Sildenafil from $49.99/mo, tadalafil from $53.99/mo.
  • MEDVi: from $114.00/mo as of 2026-09-06, for the Quad combination formula.
  • Floor to floor: $78.01 a month. Named-medication to formula: about $60 a month.
  • Unverified at both: renewal pricing after month one, refund terms, state coverage.

One drug at a time, or four in one dose

This is the structural difference and it survives any change in price. Maximus sells prescription sildenafil and prescription tadalafil as individual medications. Each of those molecules is FDA-approved on its own. Maximus also offers a compounded vardenafil plus tadalafil combination, and its own copy states that while the three molecules are FDA-approved individually, combining two of them into one formula is not something the FDA has approved or reviewed.
MEDVi sells one ED product: Quad, described as tadalafil, sildenafil, vardenafil and L-Citrulline in a single dose. It is compounded, which means it has not been approved or reviewed by the FDA for safety, effectiveness or quality. There is no single-molecule option in the MEDVi ED listing we hold.
What that means in practice is that Maximus lets a clinician start you on one thing and change it, while MEDVi asks you to accept four ingredients at once from the start. Maximus says its ED line suits you if you want to try sildenafil, tadalafil or vardenafil to find the right fit, and that is exactly what a one-at-a-time menu is for. We hold no equivalent suitability statement for MEDVi's ED line, which on a four-ingredient product is a gap worth noticing.
Maximus also publishes who its ED line is not for: anyone whose ED came on suddenly or alongside chest pain, who should see a doctor immediately; anyone taking nitrates for a heart condition, which FDA labeling for these medications contraindicates; and anyone who needs an in-person exam or lives outside the United States. Our records contain no such list for MEDVi's ED product.

Two open FDA letters, about two different problems

Neither company has a clean regulatory record in our data, and the letters are not about the same thing, so it is worth separating them.
Maximus Health, Inc. received warning letter MARCS-CMS 730095 on June 8, 2026, following a May 2026 FDA review of maximustribe.com. The agency quoted site language about ingredients being clinically studied and about weight-loss results, and separately took issue with the site describing the pharmacies behind its compounded products as FDA approved. On that last point the FDA was explicit: no FDA-approved or FDA-licensed designation exists for compounding pharmacies or outsourcing facilities at all, so describing one that way is misleading. Both findings were cited as misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. We checked FDA's warning letter index for MARCS-CMS 730095 on October 6, 2026: it listed no response letter and no close-out letter, so the letter has not been closed out.
MEDVi, LLC received warning letter MARCS-CMS 721455 on February 20, 2026, after a December 2025 review of medvi.io. The FDA said labels bearing the MEDVi name implied MEDVi compounds the drugs when it does not, and that two sameness claims equating its compounded drug with brand-name products implied an FDA approval compounded drugs do not hold. Same two misbranding sections. MEDVi has stated that medvi.io is affiliate-operated rather than company-operated; we could not verify that, and the letter is addressed to MEDVi, LLC. We checked FDA's warning letter index for MARCS-CMS 721455 on October 6, 2026: it listed no response letter and no close-out letter, so the letter has not been closed out.
Both letters are about how a company described its products, not about a recall of any product. That is a real distinction and we are not going to inflate it. It is also not nothing: a company that has been told its own description of what the FDA approved was misleading is a company whose other descriptions you should read twice.

HSA, FSA and the parts of each service you can actually check

Maximus accepts HSA and FSA funds for ED, which is a concrete way the price gap widens further if you have either account. Our records hold no HSA or FSA information for MEDVi, so we are not claiming it either way, and you should ask before assuming.
On logistics, Maximus states that board-certified doctors review your case and that priority shipping is free. MEDVi states that a doctor consultation is included, that the private evaluation takes about three minutes with approval inside 24 hours, that you are not charged if you do not qualify, and that rush shipping is free and arrives in plain packaging.
What neither listing gives us is refund terms, state-by-state availability, or what happens to your monthly price after the introductory period. Those are three of the questions most likely to decide whether a cheap entry price stays cheap, and on both companies we have to tell you plainly that we did not verify them.
  • HSA and FSA: accepted at Maximus for ED. Not verified either way at MEDVi.
  • Clinical review: board-certified doctors at Maximus; included consultation with a decision inside 24 hours at MEDVi.
  • Shipping: free priority at Maximus; free rush in plain packaging at MEDVi.
  • Not charged unless approved: stated by MEDVi, not stated by Maximus in our records.

How to pick, in one pass

If the price is what brought you here, this is not a close comparison. Maximus is cheaper at every figure we can verify, accepts HSA and FSA funds, and will sell you a single FDA-approved generic rather than asking you to take four ingredients in one dose. If you arrived on a cost query, that is the answer.
MEDVi earns a look if the one-dose combination format is specifically what you want, or if being told at no cost whether you qualify is worth something to you. You are accepting a compounded formula outside FDA review and a company with an open warning letter citing misbranding, and you are paying about three times the entry price to do it.
Both companies score 9.2 out of 10 with us, labeled Outstanding. Those are our editorial judgments rather than a computed index, so the identical score is not a tiebreaker. The price and the product format are.

How We Compared Medvi vs Maximus

Where these facts came from

Prices are read out of our own brand feature records and printed with the date we last verified each one. We publish the floor, meaning the lowest monthly figure a company lists for the category, and we never print a figure below it. Where a company's cheapest plan price and its cheapest named medication price differ, as they do at Maximus, we show both rather than letting the smaller number stand alone.

The two warning letters were read in the FDA's warning letter index by letter number, including whether a close-out letter exists. We report what each letter says the agency found. Where a company disputes a letter's premises, as MEDVi does, we print the dispute and say we could not verify it.

Three things we could not verify at either company: refund terms, state-by-state availability, and what the monthly price becomes after any introductory period. We have left those gaps open on the page instead of filling them.

Final Verdict: Medvi vs Maximus

The verdict

On price, Maximus. It is cheaper at every figure we can verify, by $78.01 a month at the floor and still about $60 a month comparing named medication to named formula, and it accepts HSA and FSA funds while we could not confirm that MEDVi does.

On product structure, also Maximus, for a reason that has nothing to do with money. It will sell you one prescription molecule that holds its own FDA approval, and it publishes who its ED line is not for. MEDVi's ED offer is a single compounded formula with four ingredients and no single-molecule alternative in our records, and we hold no suitability or exclusion list for it.

MEDVi's genuine advantages are narrower: the one-dose format if that is specifically what you want, and a stated policy of not charging you if you do not qualify. Both companies carry an open FDA warning letter citing misbranding, so neither gets to be the cautious choice on that score. Both also score 9.2 out of 10 with us, which is a reminder that our score is not the thing to decide on here. The price and the format are.

Visit MedviVisit Maximus

Frequently Asked Questions

Which is cheaper for ED, Maximus or MEDVi?

Maximus, by a wide margin. Plans start at $35.99 a month as of 2026-09-10 against MEDVi's $114.00 a month as of 2026-09-06, a difference of $78.01 at the floor. Even comparing MEDVi against the named Maximus medications rather than the entry plan, sildenafil from $49.99 and tadalafil from $53.99, Maximus is roughly $60 a month cheaper.

What does the $35.99 Maximus plan actually include?

Our records say only that plans start at $35.99 a month, and that the named medications are priced above that: sildenafil from $49.99 a month and tadalafil from $53.99 a month. So that is the entry price for a plan rather than a confirmed price for a specific prescription. We did not verify what is bundled at that level, and you should confirm it before you sign up rather than assume the lowest number is the medication price.

Can I get a single ED medication instead of a combination formula?

At Maximus, yes. It prescribes sildenafil and tadalafil as individual medications, and each of those is FDA-approved as a standalone drug. It also offers a compounded vardenafil plus tadalafil combination as a separate option. At MEDVi, the ED listing we hold is the Quad combination only, with no single-molecule alternative named. Which medication and strength suit you is a decision for the clinician who reviews your case.

Is MEDVi's four-in-one ED formula FDA-approved?

No. MEDVi describes Quad as compounded, and compounded formulas are not approved or reviewed by the FDA for safety, effectiveness or quality. Tadalafil, sildenafil and vardenafil hold individual FDA approvals as separate drugs. That is not the same as the four-ingredient formula holding one, and it does not hold one.

Does Maximus or MEDVi accept HSA or FSA funds?

Maximus accepts HSA and FSA funds for its ED line. For MEDVi we have no information either way, so we are not going to tell you it does or it does not. Ask MEDVi directly before you plan around it. If you have either account, this is one of the larger practical differences between the two.

Does an open FDA warning letter mean I should avoid these companies?

That is your call, and here is what the letters are and are not. Both are findings about how a company described its products in its own marketing, cited as misbranding under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. Neither is a product recall and neither concerns any individual order. Maximus received MARCS-CMS 730095 on June 8, 2026 and MEDVi received MARCS-CMS 721455 on February 20, 2026, and when we checked FDA's warning letter index on October 6, 2026 it listed no response letter and no close-out letter for either, so we treat both as open. What it tells you is that both companies have been told their own claims overstated what the FDA had approved.

Sources & References

Our comparisons are informed by official sources and regulatory guidelines. We encourage you to verify information with authoritative sources.

    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

    Related Comparisons

    HimsVSMedviHimsVSMaximusHersVSMedviRoVSMedviRoVSMaximusKeepsVSMaximus

    Start With a Top Erectile Dysfunction Provider

    Our Top Choice
    1
    Strut logo

    Start for Free - Daily Tadalafil & Custom ED Formulas

    • FDA-approved generic Tadalafil and Sildenafil prescribed online by U.S.-licensed physicians
    • Once-daily Tadalafil dosing available for always-ready spontaneity
    • Strut Mojo: oral Enclomiphene + Tadalafil combo (compounded, not FDA-approved)
    • Optional at-home test kit measures Testosterone, DHEA-S, Estradiol, Cortisol and SHBG
    Strut displays LegitScript certificate 11142478, checked September 19, 2026Cert. 11142478September 19, 2026
    9.4
    OutstandingScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
    ★★★★★
    See PricingRead full review
    Best Value
    2
    Taurus Meds logo

    NEW Charge™ Liquid ED - Just $12.99/Dose or Less

    • Charge™ liquid ED treatment from $12.99 per dose, a compounded four-drug formula the FDA has not approved or reviewed for safety, effectiveness, or quality
    • Charge™ blends sildenafil, tadalafil and vardenafil with apomorphine, whose US approvals are all for Parkinson's disease rather than ED
    • 100% online - prescribed and monitored by licensed clinicians, then shipped to you
    • Part of a full men's health platform: TRT, peptides and hair regrowth
    Taurus Meds displays LegitScript certificate 44265708, checked September 19, 2026Cert. 44265708September 19, 2026
    9.6
    ExceptionalScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
    ★★★★★
    See PricingRead full review
    Most Popular
    3
    Hims logo

    ED Treatment From $22/mo - Sildenafil or Tadalafil Chews From $30/mo

    • Generic sildenafil and tadalafil plus prescription-strength flavored chews (compounded, not FDA-approved)
    • Combo plans: Sex Rx + Hair Health from $35/mo, Sex Rx + Climax Control from $39/mo
    • Daily options available so you're never caught off guard
    • 100% online consultation, free and discreet shipping
    9.4
    OutstandingScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
    ★★★★★
    See PricingRead full review

    Related Resources

    Brand Review

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    Brand Review

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    Brand Review

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    Brand Review

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    Guide

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    Guide

    Maximus Alternatives

    Ben Kowalski
    Ben KowalskiStaff Writer

    Ben Kowalski is a writer and researcher who covers men's health, sexual wellness, and online healthcare services. He stumbled into health writing after realizing how much bad information exists online about topics men are too embarrassed to ask their doctor about. Ben thinks that needs to change. When he is not untangling medical jargon or stress-testing telehealth apps, he is watching Premier League football, grilling something, or losing at trivia nights with the same group of friends he has had since college.

    Medical Disclaimer: The information on this page is for educational purposes only and is not medical advice. Always consult with a licensed healthcare provider before starting any treatment. Read our full medical disclaimer.

    How we scoreOur 1 to 10 brand scores are our own editorial judgment. They are not aggregated from third-party review platforms and they are not the output of a scoring formula.

    What a starting price isA starting price is the lowest figure a company lists for a category, not a quote. What you pay follows a clinician's review of your intake, and where a required membership or care plan sits alongside the medication we publish the two charges combined.

    Reading a warning letterA close-out letter is FDA's record that it has evaluated a company's corrective actions, so the absence of one means the file is not closed on the public record, and nothing more than that.

    Regulatory noticeRegulatory note (verified August 22, 2026): On February 20, 2026 the FDA issued MEDVi, LLC a warning letter (MARCS-CMS 721455) citing misbranding under sections 502(a) and 502(bb) of the FD&C Act. Reviewing medvi.io in December 2025, the FDA said labels bearing "MEDVi" implied MEDVi compounds the drugs when it does not, and that "Same active ingredient as Wegovy and Ozempic" and "Same active ingredient as Mounjaro and Zepbound" implied an FDA approval compounded drugs do not have. Checking FDA's warning letter index for MARCS-CMS 721455, we found no response letter and no close-out letter entered against it, so the letter is not closed out on the public record. MEDVi states medvi.io is affiliate-operated rather than company-operated; we could not verify that, and the letter is addressed to MEDVi, LLC. Read the FDA letter

    Regulatory noticeRegulatory note (verified August 22, 2026): A May 2026 review of maximustribe.com led the FDA to issue Maximus Health, Inc. warning letter MARCS-CMS 730095 on June 8, 2026. The language quoted here concerns effect and sourcing rather than ingredient comparison: "Clinically studied ingredients," "Clinically studied to help patients...," and "Proven to lose weight effectively," alongside a statement that the compounded products come from "FDA approved pharmacies." On that last point the agency was explicit that no FDA-approved or FDA-licensed designation exists for compounding pharmacies or outsourcing facilities, so describing one that way is misleading. Both findings were cited as misbranding under FD&C Act 502(a) and 502(bb). Nothing in FDA’s index records a close-out, so we log the matter as open. Read the FDA letter

    Regulatory noticeRegulatory note (verified August 22, 2026): The FDA reviewed struthealth.com in December 2025 and, on February 20, 2026, issued Strut Health, LLC a warning letter, MARCS-CMS 721448. It raises two separate problems. Pictured product labels carry the "Strut" name, which the agency said represents Strut as the compounder of the semaglutide and tirzepatide products when it is not. Three site claims are also quoted, among them "Generic Zepbound, Mounjaro" and "Semaglutide is the active ingredient in the brand medications." Because compounded drugs hold no FDA approval, the FDA said wording of that kind implies one, and it cited misbranding under sections 502(a) and 502(bb) of the FD&C Act. FDA’s warning letter index shows no response letter and no close-out letter, so we treat the matter as open. Read the FDA letter

    Regulatory noticeRegulatory note (verified August 22, 2026): On September 9, 2025 the FDA sent Hims & Hers Health, Inc. a warning letter covering the Hims brand, MARCS-CMS 716567, drawn from a review of hims.com the previous month. Two lines about compounded semaglutide are quoted in it: "Same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." Compounded drug products are not FDA-approved, and the agency said phrasing of this sort suggests otherwise, which is what makes the products misbranded under FD&C Act sections 502(a) and 502(bb). A companion letter went to the same company that day for its Hers brand. No close-out letter appears in FDA’s index; treat this as open. Read the FDA letter