Reading the offer · 11 company examples
FDA Letters About Same-Ingredient Drug Comparisons
An ingredient comparison is not a product comparison
A compounded medication and a branded drug can be discussed using the same molecule name while remaining different products. These letters show FDA challenging advertising that uses an ingredient comparison to imply the compounded offer has the same approval or evaluation as the branded product.
This matters when the argument for a lower price rests on the word “same.” A useful comparison needs the actual formulation, concentration, dosage form, dispensing arrangement and included services. The price alone cannot settle those differences.
The company sections show the specific wording cited, including short descriptions and hedged comparisons. They do not claim that mentioning an ingredient is automatically a violation in every context, or that the letters prove a product-quality defect.
An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.
This guide was organized in October 2026. Each company’s source-check date below is kept separately; the guide date does not mean its letter status was checked again.
Bioverse
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA listed five claims from Bioverse, including two that borrow professional authority rather than simply comparing ingredients: "Doctor-trusted ingredients, formulated with the same active ingredient as Ozempic and Wegovy" and "Weight loss specialists frequently prescribe compounded semaglutide, which contains the same active ingredient as Ozempic and Wegovy." Alongside those, FDA cited "Same active ingredient as Ozempic and Wegovy" and "The same active ingredient in Mounjaro and Zepbound," concluding the claims imply the compounded products are the same as an FDA-approved product when they are not.
What it means for the offer
Two of the five claims FDA quoted here work by borrowing credibility rather than stating a fact about the product: "doctor-trusted" and "weight loss specialists frequently prescribe." Neither is a price claim, and neither says anything about the cost of a Bioverse plan. What they do is put a professional endorsement next to a brand-name comparison, so a reader arrives at the price already primed to treat the compounded product as a cheaper version of the approved one. When a page pairs an authority signal with a same-ingredient line, treat the price as a price and the endorsement as marketing — FDA's position is that the two together overstate what has been established about the compounded product.
Quoted passages and recorded context
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address [Bioverse's website] in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.
"Same active ingredient as Ozempic and Wegovy" "The same active ingredient in Mounjaro and Zepbound"
"Doctor-trusted ingredients, formulated with the same active ingredient as Ozempic and Wegovy"
"Weight loss specialists frequently prescribe compounded semaglutide, which contains the same active ingredient as Ozempic and Wegovy"
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.
Bioverse's website returned a live storefront when we checked in August 2026, with semaglutide and tirzepatide listed among its popular treatments alongside a wider longevity catalog including NAD+, glutathione and hair loss.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Body Good Studio
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
A single claim was quoted, and FDA reproduced it exactly as written, error and all: "Compound semaglutide is made of the same active ingredients as Ozempic and Wegovy, which are GLP-1 receptor agonist [sic]…." The "[sic]" is FDA's, and the trailing ellipsis marks copy that continued past what the agency chose to quote. It is the only cited claim in this collection that FDA marked up rather than simply reproduced. The conclusion was the wave's standard one: "Your claim implies that your products are the same as an FDA-approved product when they are not."
What it means for the offer
Two things are worth carrying away from this one. The first is how literally FDA reads a page. The agency did not paraphrase the sentence or clean it up — it quoted the grammatical slip and marked it "[sic]", which tells you that what gets cited is the exact string a shopper would have read, not a tidied summary of the seller's intent. If a sentence is on the page, it is the sentence. The second is where this business went. The letter concerned a compounded product sold on a comparison to Ozempic and Wegovy; the storefront today leads with insurance coverage, a Medicare Part D bridge and the phrase "FDA-approved options", at $39 a month. That is a different business model with a different honest answer to "is this the approved drug" — and it is the one place in this collection where you can watch a seller move from arguing that its product is like the approved one to arranging for people to get the approved one. Neither the letter nor this page says the earlier product was unsafe: FDA made no finding about quality, contents or manufacturing, and has not closed the letter out. What it found was a sentence.
Quoted passages and recorded context
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address [Body Good Studio's website] in August 2025 and has observed that your website offers various compounded drug products, including semaglutide.
The following claim concerning compounded semaglutide products appears on your website:
• “Compound semaglutide is made of the same active ingredients as Ozempic and Wegovy, which are GLP-1 receptor agonist [sic]….”
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)].
Body Good Studio's website resolved on 2026-08-09 and redirected to Body Good's newer website, a live storefront titled "Body Good — Coverage-first weight care" — the same operator under a shortened name, now leading with "Medicare GLP-1 Bridge · Part D insurance · $39/mo", "Coverage-first pricing, with or without insurance" and "Real clinicians, FDA-approved options". That is a check of whether the site is up and where it points; it is not a check of anything the letter alleges.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
D&H Medical Services
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
Three lines were quoted, and they are the same line three times with the brand swapped: "Same ingredient as Ozempic®", "Same ingredient as Rybelsus®" and "Same ingredient as Mounjaro®". Rybelsus appears nowhere else in this collection — it is the oral tablet, not an injection — and the phrasing here drops the word every other cited site used, writing "same ingredient" rather than "same active ingredient". FDA's conclusion was that these claims "represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not."
What it means for the offer
Rybelsus is why this one is worth reading. The other letters compare an injection to an injection, which at least keeps the argument inside one dosage form. Here the same six-word template was applied to a tablet, and a tablet is where "same ingredient" quietly stops meaning very much: Rybelsus is oral semaglutide formulated with an absorption enhancer precisely because semaglutide on its own barely survives the gut, and the approval that exists is for that formulation, not for the molecule in the abstract. Note also what the sentence left out. Every other seller in this collection wrote "same ACTIVE ingredient"; this one wrote "same ingredient", which is a broader statement, not a narrower one — a finished drug is an active ingredient plus everything else, and the everything else is what an approval covers. The useful question a shopper can actually ask is therefore not "is it the same molecule" but "same as WHAT, exactly — the same route, the same formulation, the same strength, made by whom?" This is also not a telehealth-only storefront but a Doral clinic with a street address and a phone number, which makes that question askable out loud. FDA made no finding here about the products' quality or contents.
Quoted passages and recorded context
Violations were identified and documented during a review of D&H Medical Services’ website, [D&H Medical Services' website], FDA Establishment Identifier (FEI) 3044174854, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.
1. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:
“Same ingredient as Ozempic®”
“Same ingredient as Rybelsus®”
“Same ingredient as Mounjaro®”
Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
D&H Medical Services' website returned a live site on 2026-08-09 titled "D&H Medical Center | Miami | 2500 Northwest 79th Avenue, Doral, FL, USA", presenting a bricks-and-mortar clinic — primary care, weight loss, NAD+ and IV infusions, pre-surgery clearance — with a published Miami phone number (786.375.6210) and a client log-in. That is a check of whether the site is up; it is not a check of anything the letter alleges.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
DrMedHealth
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
Two lines were quoted from the site — "Same active ingredient as Ozempic®" and "Same active ingredient as Mounjaro®" — the shortest form of the comparison, registered trademark symbols included. What FDA said those lines do is the part worth reading: not that they imply sameness, but that "Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not." The finding is about a reader concluding the product was reviewed, from a sentence that only ever mentioned an ingredient.
What it means for the offer
The wording FDA chose here is worth more than the ad copy it was aimed at. Through the 2025 wave the agency's conclusion was that claims like these "imply that your products are the same as an FDA-approved product" — an argument about chemistry, which a determined shopper can at least try to reason about. By June 2026 the sentence had changed: the claims "represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not." That is an argument about REVIEW, and it is the thing a price cannot tell you. "Same active ingredient as Ozempic®" is, taken literally, a statement about a molecule; what it lands as is a statement that somebody checked. Nobody did — that is what compounded means, and it is the entire distance between the two prices being compared. The practical habit is to read the registered-trademark symbol as the tell rather than the reassurance: the ® belongs to the approved product, and its presence in the sentence is precisely the borrowed credibility the letter is about. This page's own storefront advertises a third-party certification, which is a separate thing again — a certification is a vendor screening, not an FDA approval, and neither one is a finding about what is in the vial. FDA made no finding here about the drug's quality or contents.
Quoted passages and recorded context
Violations were identified and documented during a review of DrMedHealth’s website, [DrMedHealth's website], FDA Establishment Identifier (FEI) 3044020737, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.
1. The following claims concerning compounded semaglutide and tirzepatide products appear on your website:
“Same active ingredient as Ozempic®”
“Same active ingredient as Mounjaro®”
Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
DrMedHealth's website was a live storefront in August 2026, titled "GLP-1 Medical Weight Loss | Semaglutide & Tirzepatide | Dr. Medical Health", describing itself in its own copy as "an affordable, fast LegitScript-certified GLP-1 medical weight loss telehealth platform" and running a free-assessment intake. That is a check of whether the site is up and what it says about itself; we did not independently verify the certification claim, which is recorded as the site's own wording.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Elevated
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
The first claim FDA quoted is the longest in this collection — a whole paragraph that explains compounding accurately before drawing the conclusion FDA objected to: compounded GLP-1s "are made by licensed compounding pharmacies based on a prescription from a qualified healthcare provider" and "contain the same active ingredient as the branded medications, but are compounded to offer a more personalized and often more accessible option." The second describes a dosage form that appears nowhere else here: "Semaglutide ODT is a custom-formulated, dissolvable tablet that delivers the same active ingredient found in the leading GLP-1 weight loss medications – without the need for injections." FDA's conclusion was the wave's standard one — the claims "imply that your products are the same as an FDA-approved product when they are not."
What it means for the offer
The paragraph FDA quoted is the most honest piece of copy cited anywhere in this collection, and it still did not survive — which is the useful thing about it. It tells you the products are compounded. It tells you a licensed compounding pharmacy makes them. It tells you a prescription from a qualified provider is required. All true, all more than most pages here disclose. Then it lands on "contain the same active ingredient as the branded medications", and the accuracy of everything before it is what gives that sentence its weight: a reader who has just been told the truth four times has no reason to doubt the fifth. Which is why FDA's objection is not about candour but about what "the same active ingredient" is being asked to carry — an approval covers a finished product, a specific formulation at a specific strength from a specific maker, not the molecule inside it. The tablet claim shows how far that can travel. "Semaglutide ODT", a dissolvable tablet "without the need for injections", is a dosage form no approved semaglutide weight-management product uses; the approved oral tablet is a different formulation entirely and is not approved for weight loss. So the comparison is being made across a boundary the brand names cannot cross. The practical reading: disclosure about the pharmacy is worth having, and it is not the same as an approval — the two answer different questions, and only one of them was ever issued. FDA made no finding here about quality, contents or manufacturing, and has not closed the letter out.
Quoted passages and recorded context
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address [Elevated's website] in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.
The following claims concerning compounded semaglutide and tirzepatide products appear on your website:
“Compounded GLP-1 medications are personalized versions of treatments like Semaglutide or Tirzepatide. They’re made by licensed compounding pharmacies based on a prescription from a qualified healthcare provider. They contain the same active ingredient as the branded medications, but are compounded to offer a more personalized and often more accessible option.”
“Semaglutide ODT is a custom-formulated, dissolvable tablet that delivers the same active ingredient found in the leading GLP-1 weight loss medications – without the need for injections.”
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)].
Elevated's website returned a live storefront titled "Elevated Health" on 2026-08-09, with weight-care, tadalafil and sermorelin categories, an intake flow, a log-in and a full set of published legal pages naming Elevate Your Wellness LLC at 30 N Gould St Ste N, Sheridan, WY 82801 with a working (786) contact number. The company's other domain also resolved and served a store under the same "Elevated Health" title. That is a check of whether the sites are up and who they say operates them; it is not a check of anything the letter alleges.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
HealBerry
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
A single claim was quoted — "Same active ingredient as Ozempic and Wegovy" — with no label finding and no second product, and FDA concluded that "Your claim implies that your products are the same as an FDA-approved product when they are not." What is unusual is not in the text but on the letterhead: FDA issued this letter under reference number 719809, and issued a second, entirely separate letter under that same number on the same day, to Healthon Inc. of Miami over a different set of claims. Two companies, two letters, one number.
What it means for the offer
The claim itself is the most common sentence in this collection and the page could have been written by any of forty others. The reason to keep it is what it shows about looking things up. A reader who finds "FDA warning letter 719809" in a search result, or in a screenshot, or quoted in someone else's write-up, has a number that points at two different companies in two different states over two different sets of words — and nothing in the number says so. The same trap catches software: any list that treats the reference number as an identifier will silently merge these two letters and attribute one company's conduct to the other. The fix is small and worth adopting: the fda.gov URL is the unique thing, and it is the one to keep. That habit is the same one this whole collection keeps asking for — check the thing itself rather than the label on it, whether the label is a number, a brand name or the word "generic". As for what FDA found here: one sentence on one page. No finding about how the product was made, what was in it, or whether it was safe, and the letter has not been closed out.
Quoted passages and recorded context
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address [HealBerry's website] in August 2025 and has observed that your website offers various compounded drug products, including semaglutide.
The following claim concerning compounded semaglutide products appears on your website:
“Same active ingredient as Ozempic and Wegovy”
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)].
HealBerry's website was live in August 2026, describing itself as "HealBerry — Whole-health telehealth — weight loss, TRT/HRT, urgent care, derm, and more." It carries semaglutide and tirzepatide product copy, pharmacy references and pricing including $99/month, $149 and $179 tiers. That is a check of whether the site is up and trading; it is not a check of anything the letter alleges.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Intimate Rose
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA cited two attribute-style lines from Intimate Rose's website — "Same active ingredient as Ozempic and Wegovy" and "Same active ingredient as Mounjaro and Zepbound" — with no verb, no efficacy promise and no price attached to either. FDA said that presenting the compounded semaglutide and tirzepatide products this way implies they are the same as an FDA-approved product when they are not, making them misbranded under FDCA sections 502(a) and 502(bb).
What it means for the offer
A shopping site trains you to read a bulleted line under a product photo as a specification — the material, the size, the dosage — rather than as a claim someone is making. That habit is exactly what FDA pushed back on here. The two lines it quoted sit where a spec would sit, but "same active ingredient as Ozempic" is not a spec in the sense a compounded product can support: the molecule may be the same while the finished product has not been through the approval that gives the brand name its meaning. Where the site sells a kegel trainer and a prescription injection out of the same catalog, that distinction is easy to lose. It does not make the price wrong, and the letter says nothing about the price. It means the reassurance printed above the price is doing more work than the product behind it has earned.
Quoted passages and recorded context
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address [Intimate Rose's website] in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.
"Same active ingredient as Ozempic and Wegovy"
"Same active ingredient as Mounjaro and Zepbound"
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.
Intimate Rose's website returned a live retail storefront when we checked in August 2026, selling pelvic health devices and supplements and still running a weight-management line described as personalized GLP-1 treatment from licensed providers, with semaglutide and tirzepatide named on that page.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
LeanDreams
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
The two quoted claims are full sentences rather than labels: "Compounded Semaglutide has the same active ingredient as Ozempic and Wegovy." and "With compounded Tirzepatide, you get the same active ingredient found in Mounjaro and Zepbound." Nowhere else in this collection is the comparison written out with a verb — elsewhere it is a parenthetical or a product title. FDA's conclusion was unchanged: "Your claims imply that your products are the same as an FDA-approved product when they are not."
What it means for the offer
Most of the sentences FDA quoted across this round of FDA letters are labels: a product title with a brand in brackets after it. These two are explanations. "Compounded Semaglutide has the same active ingredient as Ozempic and Wegovy" is a sentence written to be believed rather than skimmed, and "With compounded Tirzepatide, you get the same active ingredient found in Mounjaro and Zepbound" addresses the reader directly, in the second person, about what they will receive. That is a harder thing to shrug off than a bracket, and it is worth naming why FDA still called it misleading: the statement about the molecule may be literally arguable, but what it delivers is a conclusion about the PRODUCT, and the product has not been through the review the brand names stand for. An approval covers a specific manufacturer, a specific formulation, a specific strength and a specific set of controls — none of which travels with an ingredient. The page today has moved on to a physician-fronted twelve-week program, and the cited phrase was not on its homepage when checked. That is progress you can see, not a ruling: FDA has not closed this letter out, and it made no finding about how the products were made or what was in them.
Quoted passages and recorded context
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address [LeanDreams' website] in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.
The following claims concerning compounded semaglutide and tirzepatide appear on your website:
• “Compounded Semaglutide has the same active ingredient as Ozempic and Wegovy.”
• “With compounded Tirzepatide, you get the same active ingredient found in Mounjaro and Zepbound.”
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)].
LeanDreams' website was live in August 2026, titled "Weight Loss Solutions | Lean Dreams ~ Transform Your Life!", positioned around a "12-Week Executive Transformation", fronted by a named bariatric surgeon (Dr. Jay Jorge, MD) and offering an assessment, a strategy-session booking and a published phone number. The phrase "same active ingredient" did not appear on the homepage when we looked — that is an observation about one page on one day, not a claim about the whole site.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Reset IV
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
The entire cited basis for this letter is two product names and their parentheses: "Semaglutide (the same ingredient in Wegovy & Ozempic)" and "Tirzepatide (the same ingredient in Zepbound & Mounjaro)." There is no efficacy claim, no percentage and no price comparison in FDA's list. FDA said the parenthetical brand references imply the compounded products are the same as an FDA-approved product when they are not.
What it means for the offer
This letter is the useful counter-example to the assumption that a warning letter marks out a bad actor. Nothing here concerns pricing, nothing concerns safety, and nothing concerns a claim anyone wrote as a sales pitch — FDA cited two parentheses in two product names, the sort of shorthand a shopper would read as a helpful clarification rather than a claim. It is a reminder that the presence of a letter tells you what wording FDA reviewed in one month of 2025, not how a company operates. It also shows how wide this enforcement wave was cast: a regional IV-drip service got the same letter, from the same office, on the same day as the largest telehealth brands in the country.
Quoted passages and recorded context
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address [Reset IV's website] in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.
"Semaglutide (the same ingredient in Wegovy & Ozempic)"
"Tirzepatide (the same ingredient in Zepbound & Mounjaro)"
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.
Reset IV's website returned a live storefront when we checked in August 2026, still trading as a Las Vegas mobile IV therapy service with published package pricing. Neither semaglutide nor tirzepatide appeared on its homepage or its peptide-therapy page at that check, though we did not review every page on the site, so this is not a confirmation that the products named in the letter were withdrawn.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Try Nova
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
One molecule, one sentence, one finding. FDA quoted a single line — "Same active ingredient as Wegovy & Ozempic." — and wrote the whole letter in the singular around it: "your claim concerning compounded semaglutide products is false or misleading", "this claim is false or misleading", "The claim identified in this letter puts you on notice of our concerns". There is no label finding, no second drug and no second category. It is the smallest complete version of the action FDA took against fifty-eight recipients that day.
What it means for the offer
Nothing unusual happened here, and that is the reason to read it. Fifty-eight of these went out on one day in September 2025, and this is what the ordinary one looks like once you strip away the letters with invented approvals, mislabeled vials and four-molecule catalogs: a single sentence, seven words long, sitting under a product on a working checkout. "Same active ingredient as Wegovy & Ozempic." It is true about the molecule and it is the reason the page exists — the sentence is doing the entire job of explaining what you are buying, by pointing at two drugs that went through a review this one did not. That is the whole of FDA's objection, and it is worth holding onto precisely because the sentence sounds so reasonable. The practical version, for someone comparing a compounded price against a brand price: the gap is not a discount on the same thing. It is the price of the review, the approved formulation, the named manufacturer and the labeling that comes with them. This letter makes no finding about safety, quality or what was in the vial, and FDA has not closed it out.
Quoted passages and recorded context
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address [Try Nova's website] in August 2025 and has observed that your website offers various compounded drug products, including semaglutide.
The following claim concerning compounded semaglutide products appears on your website:
• “Same active ingredient as Wegovy & Ozempic.”
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)].
The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claim identified in this letter puts you on notice of our concerns but does not represent an exhaustive list of misbranding violations.
Try Nova's website was a live storefront in August 2026, trading as "Nova MD", with a product catalog, an intake and pricing including a $105/month plan with quarterly billing. That is a check of whether the site is up and trading; it is not a check of anything the letter alleges.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Tuyo Health
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA cited three claims from Tuyo Health's website and no label or compounder finding. Two are clipped comparisons — "Same active as Wegovy and Ozempic" and "Same active ingredient as Zepbound and Mounjaro". The third carries an adjective the others do not: "With compounded semaglutide, you get the same trusted active ingredient as in brand-name medications…." FDA wrote that compounded drug products are not FDA-approved and that the claims "imply that your products are the same as an FDA-approved product when they are not."
What it means for the offer
Read the three claims in order and you can watch a chemistry statement turn into a reputation statement. "Same active" is a fact about a molecule. "Same trusted active ingredient as in brand-name medications" borrows something the molecule does not carry: the trials, the approval file, the years of post-market reporting that made the brand-name product trusted in the first place. None of that follows the ingredient into a compounded vial. FDA's objection was to the impression of sameness, not to the medicine or the price, and the practical lesson for a price comparison is narrow but real — when a cheaper option leans on the brand's credibility rather than its own, you are being asked to price in something the seller has not actually bought.
Quoted passages and recorded context
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address [Tuyo Health's website] in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.
The following claims concerning compounded semaglutide and tirzepatide products appear on your website:
“Same active as Wegovy and Ozempic” “Same active ingredient as Zepbound and Mounjaro” “With compounded semaglutide, you get the same trusted active ingredient as in brand-name medications….”
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.
Tuyo Health's website returned a live storefront on 2026-08-09, titled "Tuyo Health | Online Telehealth Clinic for ED, Weight Loss & More", carrying published prices and a payment integration, so the site was transacting at that check.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.